Ravi Shankar – Page 590

Roche’s divarasib demonstrated best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer

Posted on October 25, 2026 by Ravi Shankar

Divarasib monotherapy demonstrated superior efficacy over first-generation KRAS G12C inhibitors, lowering the risk of disease progression or death by 42% and the overall risk of death by 44%, in the phase III Krascendo 1 study^1,2
At the time of primary analysis, divarasib achieved a median overall survival of approximately 18 months, compared to 12 months for sotorasib or adagrasib^1,2
No new safety signals were observed with divarasib; the most common treatment-related adverse events were mainly low grade and manageable^1,2
Data presented as a late-breaking abstract during a Presidential Symposium at the 2026 ESMO Congress and simultaneously published in The New England Journal of Medicine^1,2

Basel, 25 October 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today pivotal results from the phase III Krascendo 1 study, which demonstrated the superior efficacy of investigational divarasib, a next-generation KRAS G12C inhibitor, compared with current standard of care KRAS G12C inhibitors in people with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).^1,2 Participants treated with divarasib monotherapy lived significantly longer, lowering the risk of death by 44% compared with sotorasib or adagrasib (overall survival, OS, HR 0.56, [95% CI: 0.41-0.78], p=0.0005).^1,2 Median OS for divarasib is currently approximately 18 months, compared to 12 months for the control arm (see table below).^1,2 No new safety findings were observed with divarasib and the most common treatment-related adverse events (TRAEs) were mainly low grade and manageable.^1,2 These data were presented as a late-breaking abstract during a Presidential Symposium at the 2026 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine.^1,2

“The phase III Krascendo 1 results demonstrate the potential for divarasib to become a new standard of care for people with previously treated KRAS G12C-mutated lung cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The superior efficacy against the current standard of care demonstrated in this head-to-head trial reinforces divarasib’s best-in-class profile. We are working closely with health authorities to bring this new treatment option to the people who need it.”

The G12C mutation is one of the most common KRAS mutations, found in approximately one in eight people with NSCLC.^3,4 Accumulating evidence suggests that people with NSCLC who have the KRAS G12C mutation may have poorer outcomes than those who have the unmutated KRAS gene (wild-type disease).^5,6 Despite the approval of current, first-generation KRAS G12C-targeted treatments, there remains a significant unmet need for more effective therapy options.

“New life-extending treatments are greatly needed, as most patients with this type of cancer will eventually relapse after initial therapy, and there are limited effective treatments for recurrent disease,” said study lead author Ferdinandos Skoulidis, MD, PhD, Professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “The Krascendo 1 results highlight divarasib’s practice-changing potential, as the first KRAS inhibitor to meaningfully improve overall survival for people with previously treated KRAS G12C-mutated lung cancer, compared with current treatment options.”

The Krascendo 1 study is the only global head-to-head study to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation KRAS G12C inhibitors.^1,2 The study met primary and key secondary endpoints, and divarasib demonstrated statistically significant and clinically meaningful improvements in OS and progression-free survival (PFS) over sotorasib or adagrasib.^1,2 In addition to the OS benefit, divarasib reduced the risk of disease progression or death by 42% (PFS HR 0.58, [95% CI: 0.44-0.76], p<0.0001).^1,2 The OS and PFS benefit was consistent across clinically relevant subgroups, and was observed regardless of PD-L1 expression or KEAP1 mutation status.^1,2 The objective response rate (ORR) with divarasib was nearly double that of sotorasib or adagrasib.^1,2

Key efficacy results from the phase III Krascendo 1 study:^1,2

Primary and key secondary endpoints	Divarasib arm (n=167)*	Control arm (adagrasib, sotorasib) (n=171)*	Hazard Ratio / (95% CI)	p-value
Median OS (months)	17.7	12.0	HR 0.56 (0.41-0.78)	p=0.0005
Median PFS (months)	9.8	5.7	HR 0.58 (0.44-0.76)	p<0.0001
12-month PFS rate (%)	44%	24%	–	–
Confirmed ORR (%)*	58%	32%	–	–
Median DOR (months)*	11.9	6.9	–	–

*Assessed in response-evaluable population (n=328; ten patients [divarasib arm, n=6; control arm, n=4] did not have measurable disease at baseline and were excluded from the response-evaluable set). Duration of Response (DOR) evaluated in those who responded to treatment (divarasib arm, n=94; control arm, n=54).

The safety profile of divarasib monotherapy was consistent with the known class effects of KRAS G12C inhibitors.^1,2 The most common TRAEs comprised GI toxicity (most commonly, diarrhoea, nausea, and vomiting) and hepatotoxicity.^1,2 Fewer participants discontinued treatment due to TRAEs with divarasib (4.8% versus 11.7%) and the rate of serious TRAEs was approximately half that of sotorasib or adagrasib (7.8% versus 15.2% respectively), despite patients remaining on treatment for more than twice as long (11.3 months compared with 5.0 months).^1,2

Roche is advancing a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C-mutated NSCLC.

About Krascendo 1^1,2
The Krascendo 1 study [NCT06497556] is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first-generation approved KRAS G12C inhibitors. This phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of divarasib monotherapy versus sotorasib or adagrasib in people with previously treated KRAS G12C-mutated advanced or metastatic non-small cell lung cancer. The study includes 338 adults, randomised to receive either divarasib once daily (n=167) or, either sotorasib once daily or adagrasib twice daily (n=171). The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival. Secondary endpoint measures include overall survival, confirmed objective response, duration of response, as well as other efficacy and safety measures.

About divarasib
Divarasib is an investigational, best-in-class, next-generation, oral, KRAS G12C inhibitor, discovered and developed by researchers within Roche and Genentech. It has shown greater potency and selectivity in preclinical studies compared with first-generation KRAS G12C-targeting treatments, sotorasib or adagrasib, with superior efficacy demonstrated in people with previously treated KRAS G12C-mutated NSCLC.^1,2,7 Divarasib is designed to selectively bind to the KRAS G12C protein, locking the protein in an inactive (off) state, thereby turning off its tumour-driving signalling.^7,8,9

Divarasib’s comprehensive clinical development programme is anchored by three phase III studies:

Study	Intervention	Patient population
Krascendo 1 [NCT06497556]	Divarasib monotherapy vs sotorasib or adagrasib	Previously treated KRAS G12C-mutated advanced or metastatic NSCLC (second-line)
Krascendo 2 [NCT06793215]	Divarasib plus pembrolizumab (chemotherapy-free combination) vs chemotherapy plus pembrolizumab	Previously untreated KRAS G12C-mutated advanced NSCLC (first-line)
Krascendo 3 [NCT07541170]	Adjuvant divarasib monotherapy vs immunotherapy or observation	Resected stage II–IIIB KRAS G12C-mutated NSCLC after standard of care chemoimmunotherapy (early-stage)

Divarasib underpins Roche’s diversified pipeline targeting the RAS signalling pathway, including other mutant-selective inhibitors and a pan-RAS inhibitor, designed to extend the benefits of RAS inhibition strategies to more patients.

About KRAS G12C-mutated non-small cell lung cancer
Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers.^10,11 Each year, it claims the lives of 1.8 million people, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases.^10,12KRAS is one of the most frequently mutated genes in lung cancer, occurring in approximately 25% of newly diagnosed lung cancers, and is associated with poor prognosis for patients.⁹ The G12C mutation is one of the most common KRAS mutations, found in approximately 12-14% of NSCLC cases.^3,4

The KRAS gene produces the KRAS protein, which acts as a cellular control switch, cycling between an active (on) and inactive (off) state to regulate cell growth and proliferation, making it a critical target for new therapeutic strategies.⁹ G12C mutation locks the KRAS protein in its active (on) state, leading to continuous, unregulated signalling for cell growth, driving tumour proliferation.^8,9

About Roche in lung cancer
Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of deep scientific expertise to improve patient outcomes and their overall experience. Roche’s strong commitment to investment in research and development has built a robust portfolio of approved medicines and companion diagnostics, which empowers physicians to better understand a patient’s disease and optimise care.

Roche’s broad portfolio includes approved medicines such as Alecensa® (alectinib), Tecentriq® (atezolizumab), and Rozlytrek® (entrectinib). Its extensive pipeline includes investigational treatments across three key focus areas: small cell lung cancer, non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGA), and NSCLC without AGA. Utilising diverse approaches, ranging from cancer-cell-killing ‘cytotoxics’ and immunotherapies to treatments targeting specific characteristics of cancer cells, we aim to translate scientific discoveries into meaningful progress in patient care.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Skoulidis F, et al. Krascendo 1: efficacy and safety of divarasib vs sotorasib or adagrasib in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC. Presented at: ESMO Congress; 2026 October 23-27; Madrid, Spain. #LBA5.
[2] Skoulidis F, et al. Divarasib as compared with sotorasib or adagrasib in KRAS G12C–mutated NSCLC. N Engl J Med 2026; DOI: 10.1056/NEJMoa2605703
[3] Nassar AH, et al. Distribution of KRAS (G12C) Somatic Mutations across Race, Sex, and Cancer Type. N Engl J Med. 2021; 384 (2): 185-187.
[4] Lee JK, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;9;6(1):91.
[5] Wankhede D, et al. Prognostic role of KRAS G12C mutation in non-small cell lung cancer: a systematic review and meta-analysis. Diagnostics. 2023: 25;13(19): 3043.
[6] Isaksson J, et al. KRAS G12C Mutant Non-Small Cell Lung Cancer Linked to Female Sex and High Risk of CNS Metastasis: Population-based Demographics and Survival Data From the National Swedish Lung Cancer Registry. Clin Lung Cancer. 2023: 24(6):507-518.
[7] Endres NF, et al. Discovery and Characterization of Divarasib (GDC-6036), a Potent Covalent Inhibitor of KRAS G12C. J Med Chem. 2026; 69 (5): 5147-5165.
[8] Friedlaender A, et al. KRAS as a druggable target in NSCLC: rising like a phoenix after decades of development failures. Cancer Treat Rev. 2020;85:101978.
[9] Pakkala S, et al. Personalized therapy for lung cancer: striking a moving target. JCI Insight. 2018; 3 (15).
[10] World Health Organization. Global cancer burden growing, amidst mounting need for services [Internet; cited 2026 September]. Available from: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services.
[11] American Lung Association. Lung Cancer Statistics [Internet; cited 2026 September]. Available from: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.
[12] World Health Organization. Lung cancer [Internet; cited 2026 September]. Available from: https://www.who.int/news-room/fact-sheets/detail/lung-cancer.

Roche Global Media Relations
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Media&Investor Release divarasib in KRAS G12C lung cancer English

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Leads Biolabs’ LBL-034 Shows 21.8-Month Median PFS in First-in-Human RRMM Data at ESMO 2026, Validating Its Proprietary TCE Platform

Posted on October 25, 2026 by Ravi Shankar

Updated Results Show Deep and Durable Responses in High-Risk, Heavily Pretreated Multiple Myeloma, Supporting Further Development of the Company’s TCE Pipeline

NANJING, China, Oct. 25, 2026 (GLOBE NEWSWIRE) — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”, Stock Code: 9887.HK) today announced updated first‑in‑human clinical data for LBL‑034, its GPRC5D/CD3 bispecific T‑cell engager (TCE). The updated results were delivered in an oral presentation at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO), showcasing compelling efficacy and safety outcomes in patients with relapsed/refractory multiple myeloma (RRMM). In the effective dose range of 400–1,200 μg/kg, median progression-free survival (mPFS) reached 21.8 months, approximately twice the level reported in the pivotal studies of approved therapies against the same target.

LBL-034 demonstrated deep and durable antitumor activity across multiple difficult-to-treat patient subgroups, including those with extramedullary disease (EMD), prior exposure to BCMA-directed therapies, and extensive prior treatment. Its safety profile was characterized by predominantly low-grade cytokine release syndrome (CRS) and manageable treatment-related adverse events. These findings provide important clinical validation of the conditional T-cell redirection and activation mechanism underpinning Leads Biolabs’ proprietary LeadsBody TCE platform, supporting its continued development and potential application beyond hematologic malignancies, including autoimmune diseases and solid tumors.

Key Clinical Findings

Patient Baseline Characteristics

As of the data cutoff date of July 16, 2026, 56 patients with RRMM had been enrolled. Patients were heavily pretreated, with a median of 4.5 prior lines of therapy (range: 3–12).

Extensive prior treatment: 73.2% of patients were triple-class exposed, 57.1% were penta-drug exposed, and 60.7% were triple-class refractory.
Prior advanced therapies: 28.6% had received autologous stem-cell transplantation (ASCT), and 16.1% had received BCMA-directed CAR-T therapy.
High-risk disease features: 23.2% had EMD, and 64.3% had high-risk cytogenetic abnormalities.

Overall Efficacy

Among the 41 patients treated within the effective dose range of 400–1,200 μg/kg, with a median follow-up of 17.8 months, LBL-034 demonstrated encouraging long-term disease control.

Durable disease control: The mPFS was 21.8 months, although the PFS data remained immature at the cutoff. Median duration of response (mDoR) had not been reached.
Sustained PFS: The 15-month and 18-month PFS rates were 62.0% and 54.8%, respectively.
Durable responses: The 12-month and 18-month duration-of-response (DoR) rates were 77.0% and 68.4%, respectively.
Dose-dependent depth of response: Median time to achieving complete response (CR) or better decreased with increasing dose, from 5.60 months at 400 μg/kg to 3.45 months at 800 μg/kg and 3.06 months at 1,200 μg/kg. This trend provides pharmacodynamic support for the selection of the recommended Phase 2 dose (RP2D).

Encouraging Efficacy in High‑Risk, Hard‑to‑Treat Subgroups

LBL-034 demonstrated promising antitumor activity in several patient populations with substantial unmet medical needs.

Patients with EMD: The overall response rate (ORR) was 75.0%, with two patients achieving stringent complete response (sCR). In the 1,200 μg/kg cohort, all patients with EMD responded (ORR: 100%), accompanied by rapid and substantial reductions in extramedullary lesions.
Patients with prior BCMA-targeted therapy failure: ORR was 85.7%, with an sCR rate of 57.1%.
Penta-drug-exposed patients: ORR was 73.9%, with an sCR rate of 34.8%.

These results highlight the potential of LBL-034 to deliver deep clinical responses in heavily pretreated patients, including those whose disease has become resistant to established treatment approaches.

Favorable and Manageable Safety Profile

LBL-034 continued to demonstrate a favorable safety profile across the evaluated dose range.

No dose-limiting toxicities: No dose-limiting toxicities (DLTs) were observed during dose escalation up to 1,200 μg/kg, and the maximum tolerated dose (MTD) was not reached.
Predominantly low-grade CRS: Nearly all CRS events were low-grade, with only one Grade 3 or higher event reported.
Manageable neurotoxicity: Two cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported; both patients recovered fully. No movement disorders or ataxia-related neurotoxic events were observed.
Manageable treatment-emergent adverse events: Adverse events affecting quality of life were predominantly Grade 1–2. Most treatment-emergent adverse events occurred during step-up dosing and the first treatment cycle, with event rates declining substantially in subsequent cycles.
Sustained treatment exposure: Median treatment exposure was 11.3 months, supporting the feasibility of prolonged treatment with LBL-034.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: “The updated results presented at ESMO 2026 are highly encouraging. LBL-034 has demonstrated deep and durable clinical responses in heavily pretreated patients with RRMM, including those with high-risk features such as extramedullary disease, prior failure of BCMA-targeted therapies, and penta-drug exposure. These findings underscore the potential of LBL-034 to become a differentiated treatment option for patients with substantial unmet medical needs and support its best-in-class potential.

“We are also encouraged by the dose-dependent trend toward a shorter time to complete response or better, which provides important pharmacodynamic support for RP2D selection. The safety findings are equally meaningful: adverse events were predominantly low-grade and concentrated in the early treatment period, while treatment exposure extended to a median of 11.3 months. Together, these results support the potential for sustained treatment with LBL-034.

“Importantly, LBL-034 represents the first clinical validation of our TCE platform. The findings demonstrate the potential of our proprietary LeadsBody platform to generate TCE molecules that combine deep anti-improve responses with a manageable safety profile. Building on this milestone, we aim to advance our TCE pipeline and explore its potential across broader therapeutic areas, including autoimmune diseases and solid tumors.”

About LBL‑034

LBL‑034 is a humanized GPRC5D × CD3 bispecific T‑cell engager (TCE) generated from Leads Biolabs’ proprietary LeadsBody™ platform. It adopts a 2:1 molecular architecture: two high‑affinity GPRC5D‑targeting Fab domains paired with one CD3‑binding single‑chain variable fragment (scFv).

The molecule is engineered to selectively engage GPRC5D‑positive tumor cells and conditionally activate T‑cells. This design aims to lower risks of cytokine release, systemic toxicity and T‑cell exhaustion while delivering potent, sustained anti‑myeloma activity.

Preclinical and clinical programs have yielded promising efficacy signals for LBL‑034. Preliminary monotherapy data for RRMM were featured as an opening oral presentation at ASH 2025, and this updated dataset was selected for a proffered paper oral session at ESMO 2026. LBL‑034 secured FDA Orphan Drug Designation (ODD) in October 2024 and FDA Fast Track Designation in January 2026. Preparation work for its Phase III clinical trial is now underway.

About Leads Biolabs

Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.

Leads Biolabs is a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 15 innovative drug candidates, including five clinical-stage drug candidates and one registration-stage asset.

The Company adopts a science-driven R&D approach and has successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. It has also developed multiple proprietary technology platforms, including LeadsBody (a CD3 T-cell engager platform), X-body (a 4-1BB engager platform), TOPiKinectics (an ADC platform) and ImBiTDC (a TDC platform), which serve as the cornerstone for its continued innovation and have been validated by the clinical outcomes of its bispecific antibody portfolios.

Leads Biolabs has established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of its drug candidates, coupled with its global perspectives, proactive strategy, and efficient clinical validation, have made it an attractive partner for leading industry players and investment institutions. For more information, please visit https://en.leadsbiolabs.com/

CONTACT: Contact:

yizi@leadsbiolabs.com

Posted in UncategorizedTagged GlobeNewswire

ArriVent Announces Initial Phase 1 Data for CDH17-targeted ADC ARR-217 in Patients with Gastrointestinal Cancers at ESMO Congress 2026

Posted on October 25, 2026 by Ravi Shankar

44.8% ORR at 6mg/kg dose in late-line CRC patients
ARR-217 was generally well-tolerated
ArriVent to host virtual webinar on Monday, October 26, 2026, at 8 am ET to discuss the data from the ARR-217 program

NEWTOWN SQUARE, Pa., Oct. 25, 2026 (GLOBE NEWSWIRE) — ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced initial encouraging Phase 1 results for ARR-217, (MRG007), a cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC) developed in partnership with Lepu Biopharma Co., Ltd., in patients with gastrointestinal malignancies. The findings were presented as part of an oral presentation at the 2026 European Society for Medical Oncology (ESMO) Congress 2026.

“These initial results reinforce our confidence in ARR-217 and in CDH17 as a potential therapeutic target for patients with gastrointestinal cancers who face limited treatment options following prior lines of therapy,” said Bing Yao, Ph.D., Chief Executive Officer of ArriVent. “We believe the responses observed in this heavily pretreated patient population, together with a manageable safety profile, provided a strong foundation for advancing ARR-217 into a Phase 1b dose optimization study. As the first ADC from our pipeline to enter clinical development, ARR-217 represents an important milestone for our ADC pipeline, and we look forward to dose optimization data expected in 2027.”

The ongoing multicenter, open-label Phase 1 study (NCT07066657) conducted in the US and China is evaluating the safety, tolerability, efficacy, and pharmacokinetics of ARR-217 in patients with unresectable, locally advanced, or metastatic solid tumors, with an initial clinical development focus in colorectal, pancreatic, and other gastrointestinal (GI) cancers. As of the August 5, 2026 data cutoff, 123 patients with heavily pretreated GI malignancies were treated across 6 dose levels ranging from 2 mg/kg to 8 mg/kg, including 113 patients with Colorectal Cancer (CRC).

Key Highlights for ARR-217 Phase 1 Study Include:

Strong Anti-tumor Activity with ARR-217 at Multiple Dose Levels
- At 6 mg/kg Q3W dose, 44.8% (13/29) objective response rate (ORR) observed in pre-treated CRC patients, including 7 confirmed partial responses, 4 partial responses pending confirmation, and 2 unconfirmed partial responses
- At 6 mg/kg Q3W dose, 93.1% (27/29) disease control rate (DCR) observed
- At doses 4 mg/kg Q3W and higher, 34.2% (25/73) ORR observed in CRC patients, including 15 confirmed partial responses, 5 partial responses pending confirmation and 5 unconfirmed partial responses
- At doses 4 mg/kg Q3W and higher, 91.8% DCR observed
- Majority of the responding patients remained on study treatment as of the August 5, 2026 data cutoff

Generally, Well Tolerated Safety Profile
- The most common treatment-related adverse events were Grade 1/2
- Across all doses, 30.1% (37/123) patients experienced Grade 3 or higher treatment-related adverse events, including neutropenia (12.2%) and diarrhea (8.9%)
- At 6.0 mg/kg Q3W dose, Grade 3 or higher TRAE was 20.4% (10/49) including 2.0% diarrhea (1/49)
- No grade 5 TRAE or ILD observed

Dose Optimization and Next Steps
ARR-217 has advanced into Phase 1b dose optimization at doses of 5 and 6 mg/kg Q3W with further dose optimization data expected in 2027.

About ARR-217
ARR-217 (also known as MRG007) is a potentially best-in-class cadherin-17 (CDH17)-targeted antibody-drug conjugate (ADC), utilizing a glycan-linked, exatecan-based payload. CDH17 is a membranous cell adhesion molecule frequently overexpressed in colorectal cancer and several other gastrointestinal cancers, with limited expression in normal intestinal tissue and pancreatic duct, making it an attractive target for ADC therapy. ArriVent obtained exclusive rights to develop and commercialize ARR-217 worldwide outside of Greater China under a collaboration agreement with Lepu Biopharma Co., Ltd. ARR-217 is the lead clinical candidate from ArriVent’s growing ADC portfolio.

About ArriVent
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.

Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding, business strategy and plans; the activity safety and tolerability of ARR-217; the expected timing and future results of the ongoing clinical study of ARR-217, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law.

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

Posted in UncategorizedTagged GlobeNewswire

ArriVent Announces Initial Phase 1 Data for CDH17-targeted ADC ARR-217 in Patients with Gastrointestinal Cancers at ESMO Congress 2026

Posted on October 25, 2026 by Ravi Shankar

44.8% ORR at 6mg/kg dose in late-line CRC patients
ARR-217 was generally well-tolerated
ArriVent to host virtual webinar on Monday, October 26, 2026, at 8 am ET to discuss the data from the ARR-217 program

Key Highlights for ARR-217 Phase 1 Study Include:

Strong Anti-tumor Activity with ARR-217 at Multiple Dose Levels
- At 6 mg/kg Q3W dose, 44.8% (13/29) objective response rate (ORR) observed in pre-treated CRC patients, including 7 confirmed partial responses, 4 partial responses pending confirmation, and 2 unconfirmed partial responses
- At 6 mg/kg Q3W dose, 93.1% (27/29) disease control rate (DCR) observed
- At doses 4 mg/kg Q3W and higher, 34.2% (25/73) ORR observed in CRC patients, including 15 confirmed partial responses, 5 partial responses pending confirmation and 5 unconfirmed partial responses
- At doses 4 mg/kg Q3W and higher, 91.8% DCR observed
- Majority of the responding patients remained on study treatment as of the August 5, 2026 data cutoff

Generally, Well Tolerated Safety Profile
- The most common treatment-related adverse events were Grade 1/2
- Across all doses, 30.1% (37/123) patients experienced Grade 3 or higher treatment-related adverse events, including neutropenia (12.2%) and diarrhea (8.9%)
- At 6.0 mg/kg Q3W dose, Grade 3 or higher TRAE was 20.4% (10/49) including 2.0% diarrhea (1/49)
- No grade 5 TRAE or ILD observed

Dose Optimization and Next Steps
ARR-217 has advanced into Phase 1b dose optimization at doses of 5 and 6 mg/kg Q3W with further dose optimization data expected in 2027.

Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com

Posted in UncategorizedTagged GlobeNewswire

Amarin Provides Update on University of Leeds Sponsored Phase 3 EPA for Metastasis Trial 2 (EMT2) Evaluating VAZKEPA®/VASCEPA® (icosapent ethyl) Capsules on Top of Standard of Care Treatment in Patients Undergoing Liver Resection for Colorectal Cancer Liver Metastases (CRCLM)

Posted on October 25, 2026 by Ravi Shankar

Pre-specified and Statistically Powered Key Endpoints Included Progression-free Survival (PFS) and Overall Survival (OS). Although Primary Endpoint of PFS Was Not Met, The Key Secondary Endpoint of OS Was Improved With VAZKEPA/VASCEPA

Patients Taking VASCEPA Prior to and Following Liver Resection for CRCLM Were Estimated to Have an Approximately 32% Reduction in the Risk of Death at 5 Years Relative to the Control Arm

DUBLIN and BRIDGEWATER, N.J., Oct. 25, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today highlighted findings from the EPA for Metastasis Trial 2 (EMT2), a randomized, double-blind, placebo-controlled, multi-center, Phase 3 investigator-initiated trial sponsored by the University of Leeds and presented as a late breaker at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain. The research presented by the Chief Investigator, Professor Mark Hull, added to the scientific understanding of VAZKEPA^®/VASCEPA^® (icosapent ethyl or IPE), a highly purified ethyl ester form of eicosapentaenoic acid (EPA), and its potential role as an add-on therapy in improving outcomes for patients undergoing liver resection and standard of care treatment for colorectal cancer liver metastases (CRCLM). The investigational medicinal product used in EMT2 was the same prescription IPE clinical formulation and dosage utilized in the landmark REDUCE-IT cardiovascular outcomes trial.

The presented results showed the trial did not meet its pre-specified primary endpoint of progression-free survival (PFS) in the intent-to-treat (ITT) population: median PFS was 13.5 months with IPE versus 12.9 months with placebo (adjusted HR 0.89; 95% CI 0.70–1.13; p=0.329). However, the pre-specified key secondary endpoint of overall survival (OS) demonstrated a statistically significant benefit in the ITT population. The 5-year OS estimate was 62.0% with IPE versus 45.1% with placebo, corresponding to an approximately 32% reduction in the risk of death (adjusted HR 0.68; 95% CI 0.48–0.96; p=0.030). IPE was reported to be safe and well tolerated, with no excess of total adverse events, bleeding episodes, atrial fibrillation, or deterioration in quality of life.ⁱ

“Today’s presentation reflects years of commitment from the funder (Yorkshire Cancer Research), investigators, research teams, and, most importantly, the patients who took part in EMT2, helping to advance our understanding of whether IPE could improve outcomes in patients with metastatic colorectal cancer,” said Professor Mark A. Hull, Chief Investigator, University of Leeds. “An overall survival benefit without a corresponding progression-free survival benefit is not an unprecedented finding in oncology. This type of oncology endpoint pattern can be observed where delayed effects on host anti-tumor immunity may influence long-term outcomes. There are also several biologically plausible hypotheses, including direct anti-inflammatory or anti-neoplastic activity of prescription IPE and potential augmentation of host anti-tumor immune surveillance through effects on the gut microbiome. These potential mechanisms remain investigational and require further analyses of the EMT2 dataset as well as further study.”

The study investigators concluded that high-dose, high-purity prescription IPE did not alter subsequent cancer progression but did reduce mortality in patients undergoing liver resection for CRCLM. Colorectal cancer is the second leading cause of cancer-related death globally. Approximately half of all CRC patients develop liver metastases and, even after curative-intent liver resection with contemporary multimodality treatment, five-year survival rates remain between 40 to 60%, with outcomes dependent on several factors.ⁱⁱ There remains a critical and largely unmet need for safe, affordable adjunctive therapies that can extend survival in this population.

“We would like to acknowledge and thank the University of Leeds, as well as the other institutions that were part of the EMT2 trial team, and all patients for their dedication and multi-year commitment to conducting and participating in this important research exploring a new potential way of positively impacting survival in colorectal cancer with liver metastases on top of current standard of care therapy and surgery,” said Steve Ketchum, President R&D and Chief Scientific Officer of Amarin. “We are encouraged by the presented findings, including the significant improvement in overall survival, a clinically important and meaningful endpoint in oncology and a key result that warrants further scientific evaluation. These findings add to clinical and mechanistic evidence suggesting that highly purified prescription IPE may have biological effects of relevance to areas beyond cardiovascular disease.”

“Perhaps the most exciting part of these findings is the new questions they allow us to ask regarding potential novel therapeutic pathways for VAZKEPA/VASCEPA,” said Aaron Berg, Chief Executive Officer of Amarin. “These results give us an opportunity to explore whether this safe and proven therapy for cardiovascular risk reduction – which has been prescribed approximately 32 million times – could make a meaningful difference in the adjunctive care of colorectal cancer patients with liver metastases eligible to undergo liver surgery. Our team will continue to collaborate with the study sponsor to better understand the results and develop a clearer perspective on the potential opportunity. Patent protection in Europe through 2039 for VAZKEPA/VASCEPA provides a substantial runway to evaluate this type of opportunity and its potential to deliver long-term value for patients and shareholders.”

The study investigators reported that prescription IPE was well tolerated throughout the trial. There was no excess of total adverse events, serious adverse events, atrial fibrillation, bleeding episodes, or clinically meaningful quality-of-life detriment versus placebo. The safety findings were consistent with the known safety profile of prescription IPE. Serious bleeding events requiring transfusion or re-operation were numerically lower in the IPE arm than in the placebo arm. 

While REDUCE-IT established VAZKEPA/VASCEPA as a foundational add-on therapy for cardiovascular risk reduction, published cancer literature,ⁱⁱⁱ including recent mechanistic data reporting the incorporation of EPA in colorectal tissue after IPE administration,^iv as well as the recent EMT2 findings provide additional clinical evidence supporting continued scientific investigation into the broader biological effects of prescription IPE and its potential role in areas of significant unmet medical need.

About The EMT2 Trial
The EPA for Metastasis Trial 2 (EMT2; ClinicalTrials.gov NCT03428477) is a randomized, double-blind, placebo-controlled, multicenter Phase 3 investigator-initiated trial funded by Yorkshire Cancer Research and sponsored by the University of Leeds, along with involvement from Leeds Teaching Hospitals NHS Trust, University of Bradford, University of Liverpool, and University of Edinburgh. The trial enrolled 418 patients across 13 hepatobiliary surgery centers in England and Wales between 2018 and 2023. Patients undergoing liver resection for colorectal cancer liver metastases were randomized 1:1 to highly purified prescription EPA ethyl ester 4 g/day or matched mineral oil placebo. Treatment was initiated before surgery and continued for up to a maximum of four years. Investigational product was supplied by Amarin Corporation free of charge. A link to the published rationale and design of EMT2 can be found here: https://bmjopen.bmj.com/content/13/11/e077427

About Amarin
At the Heart of Amarin Corporation is a singular focus on advancing cardiovascular disease prevention worldwide. Our flagship oral prescription therapy, VASCEPA^® (icosapent ethyl or IPE), is the U.S. market leader across all available IPE products and has been prescribed approximately 32 million times globally. Through our independent U.S. commercial operations and global commercial partnerships, Amarin supports access to VASCEPA/VAZKEPA^® across nearly 100 markets worldwide. For more information, visit www.amarincorp.com and follow Amarin on LinkedIn, X, Facebook. To be added to the Company’s email list and receive news directly, please visit https://investors.amarincorp.com/email-alerts.

About REDUCE-IT^®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.^v The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.^vi The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.^vii

About VASCEPA^®/VAZKEPA^® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, the Netherlands, Scotland, Greece, Portugal, Italy, Slovenia, Romania, Denmark and Austria. 

United States Indications and Limitation of Use

VASCEPA is indicated:

As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Europe 
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA^® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf

Globally, prescribing information varies; refer to the individual country product label for complete information. 

Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.

Amarin Contact Information
Media Inquiries:
Amarin Corporation plc
PR@amarincorp.com

Investor Inquiries:
Devin Sullivan & Conor Rodriguez
The Equity Group on Behalf of Amarin
devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com
Investor.relations@amarincorp.com

_________________________
ⁱ https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/session/calendar?q=eicosapentaenoic
ⁱⁱ Hull MA, Ow PL, Ruddock S, et al. Randomised, placebo-controlled, phase 3 trial of the effect of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) on colorectal cancer recurrence and survival after surgery for resectable liver metastases: EPA for Metastasis Trial 2 (EMT2) study protocol. BMJ Open. 2023;13:e077427. doi: 10.1136/bmjopen-2023-077427
ⁱⁱⁱ Song M, Ou FS, Zemla TJ, Hull MA, Shi Q, Limburg PJ, Alberts SR, Sinicrope FA, Giovannucci EL, Van Blarigan EL, Meyerhardt JA, Chan AT. Marine omega-3 fatty acid intake and survival of stage III colon cancer according to tumor molecular markers in NCCTG Phase III trial N0147 (Alliance). Int J Cancer. 2019;145(2):380-389. doi: 10.1002/ijc.32113.
^iv Chen Y, Bae S, Wang K, et al. Effect of icosapent ethyl treatment on colorectal tissue marine ω-3 polyunsaturated fatty acid levels among patients with a history of adenoma: a prospective, single-arm clinical trial. Am J Clin Nutr. 2026;124(3):101419. doi: 10.1016/j.ajcnut.2026.101419.
^v Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148
^vi Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792
^vii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802. 

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NovaBridge Biosciences Reports Mature Phase 1b Data at ESMO 2026 Positioning Givastomig for Registrational Development

Posted on October 25, 2026 by Ravi Shankar

Nearly 18 months of median follow-up, selection of the 8 mg/kg dose and FDA engagement strengthen the foundation for registrational development in first-line metastatic gastroesophageal adenocarcinoma

Updated Phase 1b dataset provides nearly 18 months of median follow-up and shows the durability of clinical benefit observed with givastomig
Clinical activity observed across CLDN18.2 expression levels, including in patients with lower-expression tumors not eligible for currently approved CLDN18.2-targeted therapies
Totality of efficacy, safety and long-term follow-up data supports selection of the 8 mg/kg dose for registrational development
Ongoing U.S. Food and Drug Administration (FDA) interactions, Orphan Drug Designation, Fast Track Designation and progress on Phase 3 planning further support a defined path towards registrational development
NovaBridge to host investor webcast on November 2, 2026, to discuss the updated data and registrational development strategy

ROCKVILLE, Md., Oct. 25, 2026 (GLOBE NEWSWIRE) — NovaBridge Biosciences (“NovaBridge” or “Company”) (Nasdaq: NBP) today announced the presentation of updated results from the ongoing Phase 1b study of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy for patients with HER2-negative first-line metastatic gastroesophageal adenocarcinoma. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

Updated Clinical Dataset Strengthens Foundation for Registrational Development
The updated analysis includes data through August 6, 2026 and provides the most comprehensive assessment of givastomig generated to date. The dataset includes 71 patients across the 8 mg/kg and 12 mg/kg dose cohorts with nearly 18 months of median follow-up in the 8 mg/kg dose cohort and provides a more mature assessment of givastomig’s clinical profile, substantially increasing confidence in the durability and consistency of clinical benefit while informing dose selection and registrational planning.

Among efficacy-evaluable patients treated at the selected 8 mg/kg dose:

Objective response rate of 79% (23/29)
Disease control rate of 97% (28/29)
Median duration of response of 15.2 months
Median progression-free survival of 16.9 months
Median follow-up of 17.8 months

Clinical activity was observed across CLDN18.2 expression levels, including:

Objective response rate of 82% in patients with CLDN18.2 expression ≥75%
Objective response rate of 75% in patients with CLDN18.2 expression between 1% and 74%

“These updated data provide greater confidence in the durability of clinical benefit observed with givastomig and are encouraging given the persistent need for more effective first-line treatment options for patients with metastatic gastroesophageal adenocarcinoma,” said Samuel J. Klempner, M.D., Associate Professor of Medicine at Massachusetts General Hospital. “What stands out in the updated analysis is not only the durability of benefit with longer follow-up, but also the strength and consistency of efficacy results across a broad range of CLDN18.2 expression, including very low expression. The updated dataset provides a more mature view of givastomig’s activity and supports its continued advancement to a Phase 3 trial.”

Selected 8 mg/kg Dose Demonstrates Durable Activity and Manageable Safety
A key objective of the Phase 1b program was to identify the dose with the most appropriate overall benefit-risk profile for registrational development. Based on the totality of efficacy, safety and long-term follow-up data, NovaBridge selected the 8 mg/kg dose for the next stage of givastomig’s development.

The safety profile of givastomig in the updated analysis from the ongoing Phase 1b study remained manageable and generally consistent with previous observations. No Grade 4 or Grade 5 treatment-related adverse events were attributed to givastomig. Immune-related adverse events were uncommon, other than gastritis, the majority of which were Grade 2 events. The selected 8 mg/kg dose demonstrated a favorable overall benefit-risk profile and provides a strong foundation for registrational development.

Mature Phase 1b Dataset and FDA Engagement Support Registrational Development
Over the past year, NovaBridge has substantially expanded the clinical dataset for givastomig, gained a more mature understanding of the durability and safety profile of givastomig, selected the 8 mg/kg dose for potential registrational development, and achieved alignment with the FDA on a global registrational study protocol. Combined with the program’s Orphan Drug Designation and Fast Track Designation, these accomplishments support NovaBridge’s view that givastomig has evolved into a registrational-ready program.

NovaBridge’s engagement with the FDA has informed key elements of the planned Phase 3 strategy, including the intended patient population, dose, and primary endpoints. Together with the more mature clinical dataset and regulatory designations, NovaBridge believes this progress establishes a clear regulatory pathway for registrational development of givastomig.

“The updated dataset provides a more mature view of givastomig’s clinical profile, including longer follow-up, greater insight into durability and safety, and increased confidence in the 8 mg/kg dose, which has been selected for registrational development,” said Phillip Dennis, M.D., Ph.D., Chief Medical Officer of NovaBridge. “Over the past year, we have significantly strengthened the clinical and regulatory foundation for the program through continued dataset maturation, dose selection, and productive engagement with the FDA, culminating in alignment on a Phase 3 study design. Together with the program’s Orphan Drug and Fast Track Designations, we believe these advances position givastomig as a registrational-ready program.”

“The maturation of the givastomig dataset over the past year has significantly increased our confidence in the program,” said Srishti Gupta, M.D., M.P.P., Chief Executive Officer of NovaBridge. “The updated efficacy, durability and safety findings, together with productive interactions with the FDA and important regulatory milestones, have advanced givastomig into a late-stage development program. We believe this represents an important inflection point for givastomig and its potential to make a meaningful difference for patients with metastatic gastroesophageal adenocarcinoma.”

ESMO Congress 2026 Presentation Materials and Supplemental Data
The ESMO Congress 2026 poster presentation and supplemental analyses based on the August 2026 data cutoff are available on NovaBridge’s investor relations website and can be accessed here.

NovaBridge to Host Webcast to Discuss Updated Givastomig Data and Path to Registrational Development
NovaBridge will host a webcast on November 2, 2026, at 8:00 a.m. ET to discuss the updated results presented at ESMO, the clinical rationale for selection of the 8 mg/kg dose and the implications of the mature Phase 1b dataset for givastomig’s registrational readiness. The event will feature Samuel J. Klempner, M.D., Associate Professor of Medicine at Massachusetts General Hospital, who will discuss the clinical significance of the updated data, the unmet need in first-line gastric and gastroesophageal cancers, and the potential role of givastomig in CLDN18.2-positive disease. Company management will also discuss the maturation of the clinical dataset, regulatory progress, ongoing FDA interactions and the considerations informing future development planning for the program. A question-and-answer session will follow the formal presentations.

Webcast Details
Title: Givastomig: Mature Clinical Data and Path to Registrational Development
Date: November 2, 2026
Time: 8:00 a.m. EST
Featured Speaker: Samuel J. Klempner, M.D., Associate Professor of Medicine at Massachusetts General Hospital and lead investigator of the Phase 1b givastomig study
Format: Live webcast followed by Q&A
Registration and webcast details are available on the Investor Relations section of the NovaBridge website and can be accessed here.

About Givastomig
Givastomig (TJ033721 / ABL111), a potential first-in-class Conditional T-cell Engager and Immune Amplifier (CTIA), is a Claudin 18.2 x 4-1BB bispecific antibody. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for the potential treatment of gastroesophageal carcinoma, its current lead indication. Givastomig also has potential applicability across other Claudin 18.2-positive gastrointestinal malignancies, including biliary tract cancer and pancreatic ductal adenocarcinoma.

Givastomig is being evaluated in a global, randomized Phase 2 study (NCT07432295), following positive topline results from a Phase 1b, multicenter, open-label study in first-line metastatic gastroesophageal carcinoma. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinoma in combination with nivolumab and chemotherapy.

About NovaBridge Biosciences
NovaBridge Biosciences (“NovaBridge”) (NASDAQ: NBP) is a global biotechnology company focused on identifying, developing and maximizing the value of differentiated therapeutic assets. The Company advances programs through clinical development and pursues the financing and partnering strategies best suited to each opportunity.

NovaBridge’s portfolio is led by givastomig, a Claudin 18.2 × 4-1BB bispecific antibody being developed for the potential treatment of gastrointestinal malignancies, and Visara, its majority-owned ophthalmology subsidiary. Through Visara, NovaBridge is building a diversified ophthalmology franchise designed to address unmet needs across diseases of the front and back of the eye.

NovaBridge’s objective is to build a sustainable biotechnology company by repeatedly identifying differentiated innovation, advancing it efficiently, and bringing novel therapies to patients through the path best suited to each opportunity.

For more information, please visit www.novabridge.com and follow us on LinkedIn.

Forward-Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “believes,” “designed to,” “anticipates,” “future,” “intends,” “plans,” “potential,” “estimates,” “confident,” “look forward to,” and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the potential benefits of givastomig, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials; the potential of FDA interactions, Orphan Drug Designation, Fast Track Designation and progress on Phase 3 planning for givastomig to result in a defined path towards registrational development; the selection of the 8 mg/kg dose and its implications for registrational development; NovaBridge’s engagement with the FDA, including alignment on a global registrational study protocol and Phase 3 study design;; and anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval or eligibility for accelerated approval pathway or receipt of accelerated approval; the content and timing of decisions made by the relevant regulatory authorities, including the FDA, regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of macroeconomic conditions, including inflation, tariffs, volatile interest rates, regulatory uncertainty, potential government shutdowns, volatility in the capital markets, and regional and other global events, including ongoing armed conflicts in different regions of the world; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 7, 2026, and amended on June 16, 2026, as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.

NovaBridge Investor & Media Contacts

Investors:
Bill Begien, SVP, Investor Relations
bill.begien@novabridge.com
IR@novabridge.com

Media Inquiries:
Eric Van Zanten, VP, Communications
+1-610-529-6219
eric.vanzanten@novabridge.com

Posted in UncategorizedTagged GlobeNewswire

Genmab Announces Updated Follow-Up Analyses from Phase 2 Study of Petosemtamab Demonstrate Meaningful Objective Response Rates in Patients with Metastatic Colorectal Cancer

Posted on October 25, 2026 by Ravi Shankar

Media Release

COPENHAGEN, Denmark; October 25, 2026

Petosemtamab demonstrates encouraging objective response rates (ORRs), with promising depth and durability of response, in first- and second-line metastatic colorectal cancer (mCRC)
Data reinforces the ongoing global Phase 3 trials of petosemtamab in mCRC, which are actively enrolling patients

Genmab A/S (Nasdaq: GMAB) today announced updated follow-up analyses from a Phase 2 trial evaluating petosemtamab, an investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with FOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC). At a median follow-up of 5.9 months in the first-line (1L) setting and 7.1 months in the second-line (2L) setting, confirmed and unconfirmed objective response rates (ORRs) were 75% and 67%, respectively, with an ORR of 81% observed among 1L patients with left-sided tumors. With longer follow-up, most of the previously unconfirmed objective responses were subsequently confirmed, reinforcing the consistency of the clinical activity observed across treatment settings. The updated analyses reinforce the depth and durability of responses observed in both 1L and 2L treatment settings and support the ongoing global Phase 3 development program. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2026, held in Madrid, Spain.

“Despite advances in the treatment of metastatic colorectal cancer, outcomes remain poor for many patients once disease has spread, including those with RAS/BRAF wild-type disease who may face limited options after standard chemotherapy and targeted therapy,” said Ruth Vera, M.D., Medical Oncology Department, Hospital Universitario de Navarra, and study investigator. “The encouraging response rates observed in both the first- and second-line settings, along with the maturation of the dataset over time, suggest that treatment with petosemtamab plus chemotherapy may offer a potential new approach for these patients.”

As of May 15, 2026, 79 patients were treated with the petosemtamab combination, including 45 patients in the 1L setting and 34 patients in the 2L setting. Among efficacy-evaluable patients, confirmed and unconfirmed ORR was 75% in 1L patients and 67% in 2L patients. In 1L patients with left-sided tumors, ORR was 81%. Responses were observed across key patient subgroups, including patients with liver metastases, which is a poor prognostic factor in mCRC, with ORRs of 76% and 67% in the 1L and 2L settings, respectively. Median follow-up was 5.9 months in the 1L setting and 7.1 months in the 2L setting, with 76% and 74% of patients, respectively, remaining on treatment at the data cutoff. Disease control rate was 95% in 1L patients and 93% in 2L patients.

Petosemtamab-related treatment-emergent adverse events (TEAEs) led to petosemtamab discontinuation in 2 of 42 patients (5%) treated with petosemtamab + mFOLFOX6 and in 1 of 37 patients (3%) treated with petosemtamab + FOLFIRI. No TEAEs leading to death were reported. Infusion-related reactions (IRRs) occurred in 48% of patients receiving petosemtamab plus FOLFOX and 43% of patients receiving petosemtamab plus FOLFIRI; grade 3 IRRs occurred in 3 of 42 (7%) and 1 of 37 (3%) patients, respectively.

“These updated Phase 2 results presented at ESMO continue to build on the encouraging clinical efficacy of petosemtamab,” said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. “The confirmation of previously unconfirmed responses with longer follow-up further reinforces the durability of responses observed across treatment lines and strengthens our confidence in petosemtamab. The data provide a compelling rationale for our ongoing global Phase 3 trials, where we aim to establish the potential benefit for patients in 1L and 2L settings.”

Petosemtamab has the only triple mechanism of action that uniquely targets the LGR5+ stem-like cancer cells that drive tumor recurrence and metastases in epithelial cancers. In addition to this ongoing Phase 1/2 trial (NCT03526835), the petosemtamab clinical program includes four Phase 3 LiGeR trials: in 1L PD-L1+ recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) (LiGeR-HN1; NCT06525220); in 2L/3L r/m HNSCC (LiGeR-HN2; NCT06496178), in 1L RAS/BRAF wild-type, left-sided unresectable or metastatic CRC (LiGeR-CRC1; NCT07702032); and in 2L RAS/BRAF wild-type recurrent, unresectable, or metastatic CRC (LiGeR-CRC2; NCT07775287).

On Wednesday, October 28 at 5:00 p.m. CET/12:00 p.m. EDT, Genmab will host an investor update. To register, visit genmab.com/events-presentations.

About the Phase 2 Petosemtamab Trial (NCT03526835)
The Phase 2 trial (NCT03526835) is an ongoing, single-arm, open-label, multicenter study evaluating petosemtamab as monotherapy and in combination with standard-of-care therapies across multiple solid tumors, including metastatic colorectal cancer. Patients with left- and/or right-sided, RAS/BRAF wildtype, anti-EGFR naïve mCRC received 1500 mg of petosemtamab every two weeks plus FOLFOX or FOLFIRI until disease progression or unacceptable toxicity. Patients were treated either in 1L or 2L setting after one prior chemotherapy regimen. The primary endpoints include investigator-assessed objective response rate (ORR) and safety.

About Colorectal Cancer (CRC)
Colorectal cancer (CRC) is a malignant disease of the colon or rectum and is the third most commonly diagnosed cancer globally, with an estimated 1.9 million new cases annually.ⁱ While CRC is typically diagnosed in older adults, incidence is increasing among younger individuals in many countries.ⁱⁱ In metastatic CRC, treatment selection is increasingly informed by molecular characteristics, including RAS and BRAF mutation status, primary tumor sidedness, and prior therapy.ⁱⁱⁱ Patients with RAS/BRAF wild-type metastatic CRC may be eligible for EGFR-targeted treatment approaches in 1L settings for left-sided tumors and in 2L settings for both left- and right-sided tumors.ⁱⁱⁱ Survival outcomes vary widely by stage and geographic region, with an estimated five-year survival rate of 15% in late-stage metastatic CRC.^iv

About Petosemtamab (GEN1158)
Petosemtamab is an investigational human IgG1-based bispecific antibody targeting the EGFR and the LGR5 and designed to support multiple anti-tumor mechanisms. It inhibits EGFR-mediated signaling by engaging a unique site on the receptor to prevent ligand binding. In addition, petosemtamab triggers EGFR degradation in cancer stem-like cells expressing both EGFR and LGR5. Petosemtamab is also engineered to enhance innate immune-mediated activity through interactions with macrophages and natural killer cells. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC). Please visit https://clinicaltrials.gov/ for more information.

About Genmab
Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com or follow us on LinkedIn, X, Facebook and Instagram.

Contact:
David Freundel, Senior Director, Global Communications & Corporate Affairs
T: +1 609 613 0504; E: dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media Release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^®, and KYSO^®.

ⁱ World Health Organization. “Colorectal cancer.” World Health Organization, accessed May 14, 2026. https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer.
ⁱⁱ Sung H, Siegel RL, Laversanne M, Jiang C, Morgan E, Zahwe M, Cao Y, Bray F, Jemal A. “Colorectal cancer incidence trends in younger versus older adults: an analysis of population-based cancer registry data.” Lancet Oncol, 2025 Jan;26(1):51-63. doi: 10.1016/S1470-2045(24)00600-4. Epub 2024 Dec 12. PMID: 39674189; PMCID: PMC11695264.
ⁱⁱⁱ Cremolini C, Chalabi M, Elez E, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Annals of Oncology. 2026.
^iv National Cancer Institute. “Colorectal cancer—cancer stat facts.” Surveillance, Epidemiology, and End Results Program (SEER)”, accessed May 14, 2026. Cancer of the Colon and Rectum – Cancer Stat Facts

Media Release no. 14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

251026_MR14_Peto_mCRC_ESMO2026

Posted in UncategorizedTagged GlobeNewswire

Libtayo® (cemiplimab) Longer-Term Data Show Increasing and Clinically Meaningful Overall Survival Benefit with Adjuvant Treatment in High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Posted on October 25, 2026 by Ravi Shankar

Longer-term data reflecting nearly 4 years of follow-up show a further reduction in the risk of death from 14% to 37% for those initially treated with Libtayo, despite an 88% crossover from the placebo arm upon recurrence

New prospective analyses confirm sustained disease-free survival (DFS) benefit with adjuvant Libtayo, including in patients who are minimal residual disease (MRD) negative at baseline

The late-breaking data were presented during a rapid oral session at the European Society for Medical Oncology (ESMO) 2026 Meeting

TARRYTOWN, N.Y., Oct. 25, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced longer-term data reflecting nearly four years of follow-up from the Phase 3 C-POST trial evaluating PD-1 inhibitor Libtayo^® (cemiplimab) as adjuvant treatment for patients with cutaneous squamous cell carcinoma (CSCC) at a high risk of recurrence after surgery and radiation. The late-breaking results were presented in a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026.

“As the Phase 3 C-POST trial data continue to mature, we are seeing an evolving and clinically meaningful overall survival benefit with adjuvant Libtayo in high-risk cutaneous squamous cell carcinoma, as well as sustained disease-free survival benefit regardless of whether minimal residual disease is detectable at baseline,” said Danny Rischin, M.D., M.B.B.S., F.R.A.C.P., Research Lead, Head and Neck Cancer and Cutaneous SCC, Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, and lead investigator of the trial. “These data provide compelling evidence of the long-term, durable benefit of adjuvant treatment with Libtayo in high-risk CSCC after surgery and radiation, further supporting Libtayo as a transformative standard of care for these patients.”

With a median follow-up of 44 months, efficacy results for Libtayo compared to placebo showed sustained benefits for the primary endpoint of disease-free survival (DFS), and notably, an increasing overall survival (OS) benefit, a secondary endpoint. Specifically, there was a 37% reduction in the risk of death (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.36-1.11) at a median follow up of 44 months, up from 22% at a median follow up of 30 months (HR: 0.78; 95% CI: 0.39-1.56) and 14% at a median follow up of 24 months (HR: 0.86; 95% CI: 0.39-1.90). Notably, patients randomized to placebo were able to cross over to Libtayo after recurrence, and 61 of 69 placebo patients (88%) with recurrence received subsequent Libtayo. The emerging OS benefit, despite the high crossover rate, therefore supports treating high-risk patients with Libtayo after surgery and radiation, rather than waiting for their disease to recur.

Additionally, an exploratory analysis of patients with baseline circulating tumor DNA (ctDNA) data (Libtayo n=93; placebo n=98) was conducted. Compared to placebo, treatment with adjuvant Libtayo improved DFS regardless of baseline minimal residual disease (MRD) status, supporting the broad clinical utility of adjuvant Libtayo in high-risk CSCC. In particular, patients who were MRD negative at baseline – and thus had lower risk of recurrence – still had improved DFS with Libtayo (HR: 0.45; 95% CI: 0.22-0.95); patients who were MRD positive at baseline also had improved DFS with Libtayo (HR: 0.24; 95% CI: 0.07-0.86).

Safety results remained consistent with previously reported data. Treatment emergent adverse events (TEAEs) of any grade occurred in 94% of patients in the Libtayo arm and 91% of patients in the placebo arm. Grade ≥3 TEAEs occurred in 26% of patients (Libtayo) and 17% of patients (placebo). Treatment discontinuations due to TEAEs occurred in 10% of patients (Libtayo) and 3% of patients (placebo). TEAEs leading to death occurred in 2% of patients in each arm.

The longer-term C-POST data at ESMO expand on results shared at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine. Libtayo has since been approved by the U.S. Food and Drug Administration (October 2025) and the European Commission (November 2025) as the first and only immunotherapy for this indication.

About the Phase 3 Trial
C-POST was a randomized, placebo-controlled, double-blind, multicenter, global Phase 3 trial investigating Libtayo versus placebo as adjuvant treatment for patients with features associated with a high-risk of CSCC recurrence and who had completed surgery and post-operative radiation therapy. Trial participants were at high risk of recurrence due to nodal features (extracapsular extension or ≥3 involved lymph nodes) and/or non-nodal features (in-transit metastases, T4 lesion, perineural invasion, or locally recurrent tumor with ≥1 additional poor prognostic features).

The trial enrolled 415 patients who were randomized to receive either Libtayo (n=209) or placebo (n=206) for up to 48 weeks. For the first 12 weeks, Libtayo 350 mg or placebo was administered intravenously every three weeks, followed by Libtayo 700 mg or placebo administered intravenously every six weeks for 36 weeks. After disease recurrence, patients randomized to placebo could cross over to receive Libtayo, and patients randomized to Libtayo could receive Libtayo again, if recurrence was ≥3 months since the last dose of adjuvant Libtayo.

About Regeneron in Cancer
We aspire to turn revolutionary discoveries into medicines that can transform the lives of those impacted by cancer. Our team around the world is driven to solve the needs and challenges of those affected by one of the most serious diseases of our time.

Backed by our legacy of scientific innovation and a deep understanding of biology, genetics and the immune system, we’re pursuing potential therapies across more than 30 types of solid tumors and blood cancers. Our cancer strategy is powered by cutting-edge technologies and therapies that can be flexibly combined to investigate potentially transformative treatments for patients. Oncology assets in clinical development comprise nearly half of Regeneron’s pipeline, and include checkpoint inhibitors, bispecific antibodies and costimulatory bispecific antibodies. Our approved PD-1 inhibitor Libtayo serves as the backbone of many of our investigational combinations.

To complement our extensive in-house capabilities, we collaborate with patients, healthcare providers, governments, biopharma companies and each other to further our shared goals. Together, we are united in the mission to serve as a beacon of transformation in cancer care.

About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron’s proprietary VelocImmune^® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo has been approved by regulatory authorities in more than 30 countries in one or more indications, including for certain adult patients with advanced basal cell carcinoma (BCC), CSCC that is advanced or at high risk of recurrence, advanced non-small cell lung cancer (NSCLC) and advanced cervical cancer.

In the U.S., the generic name for Libtayo in its approved indications is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA. Outside of the U.S., the generic name of Libtayo in its approved indications is cemiplimab.  

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat:

Adults with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC):
- that has spread or cannot be cured by surgery or radiation, or
- to help prevent CSCC from coming back if your CSCC is at high risk of coming back after it has been removed by surgery and radiation.
Adults with a type of skin cancer called basal cell carcinoma (BCC) when your BCC cannot be removed by surgery (locally advanced BCC) or when it has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.
Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- LIBTAYO may be used in combination with chemotherapy that contains a platinum medicine as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
- LIBTAYO may be used alone as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.

It is not known if Libtayo is safe and effective in children. 

IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS 

What is the most important information I should know about LIBTAYO?
LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: nausea, vomiting, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ or tissue transplant, including corneal transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby

Females who are able to become pregnant:

- Your healthcare provider will give you a pregnancy test before you start treatment
- You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk to your healthcare provider about birth control methods that you can use during this time
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO
are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of LIBTAYO when used alone to treat CSCC that has spread or cannot be cured by surgery or radiation, BCC or NSCLC include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia).

The most common side effects of LIBTAYO when used alone to help prevent CSCC from coming back include rash and itching.

The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy to treat NSCLC include hair loss, muscle or bone pain, nausea, tiredness, numbness, pain, tingling, or burning in your hands or feet, and decreased appetite.

These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

Please see full Prescribing Information, including Medication Guide. 

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite^® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes Dupixent^® (dupilumab), Libtayo, Praluent^® (alirocumab), Kevzara^® (sarilumab), Evkeeza^® (evinacumab-dgnb), Inmazeb^® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz^® (pozelimab-bbfg) and Pasatru™ (garetosmab-grts). In addition, REGEN-COV^® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^®and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Libtayo^® (cemiplimab) as adjuvant treatment for patients with cutaneous squamous cell carcinoma at a high risk of recurrence after surgery and radiation; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products (such as Libtayo) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products (such as Libtayo) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA^® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended June 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Contacts:

Media Relations
Taylor Ramsey Skott
Tel: +1 914-409-2381
taylor.ramsey@regeneron.com

Investor Relations
Mark Hudson
Tel: +1 914-847-3482
mark.hudson@regeneron.com

Posted in UncategorizedTagged GlobeNewswire

BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy

Posted on October 25, 2026 by Ravi Shankar

Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy
An early median progression-free survival of 6.9 months was observed
Significant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel
Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care

MAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial (NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy.

The data showed encouraging antitumor activity, with responses observed in both squamous and non-squamous NSCLC and across PD-L1 expression levels, together with a manageable safety profile consistent with prior global datasets for pumitamig. The data were presented today in a late-breaking rapid oral presentation (abstract #LBA76) at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain.

“Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years,”¹ said Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. “These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy. These findings support continued investigation of pumitamig in this population with high unmet need.”

ROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel every three weeks. The July 10, 2026, data cut-off included 50 patients with a median follow-up of 12.2 weeks, and 33 patients remained on treatment. Among 30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed objective response rate (“cORR”) of 36.7% with a disease control rate (“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels (cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies (cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all subgroups. Median time to response was 1.4 months. In the overall treated population (n=50), median progression-free survival (“PFS”) was 6.9 months (95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%. Historically, standard-of-care docetaxel has delivered a median PFS of approximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC patients, respectively, following prior immunotherapy plus chemotherapy.¹

“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”

“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. “Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”

Across 50 patients in the safety evaluation, pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals. Pumitamig treatment-related adverse events (“TRAEs”) of any grade were reported in 52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment discontinuation in four (8.0%) patients. Immune- related AEs occurred in 11 (22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients. VEGF-related events were reported in 13 (26.0%) patients; grade 3 events were rare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events occurred in eight (16.0%) patients and were limited to grade 1 or 2 severity. There were no pumitamig-related deaths or dose-limiting toxicities (“DLTs”).

BioNTech and BMS are advancing a broad development plan for pumitamig in multiple cancer types, including lung cancer across disease stages, subgroups and lines of therapy. ROSETTA Lung-107 extends the program into the second-line NSCLC setting, and these data will inform the further development of pumitamig in this underserved patient population.

About ROSETTA Lung-107
The global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055) is evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in patients with stage IV squamous or non-squamous NSCLC whose disease progressed following first-line immunotherapy plus chemotherapy, with any level of PD-L1 expression. Patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in), patients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every three weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig 1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal review committee based on the totality of evidence from Part 1 and the broader pumitamig lung cancer program. The primary endpoints are dose-limiting toxicities (Part 1 only), safety, and objective response rate (“ORR”) per investigator’s assessment (RECIST 1.1). Secondary endpoints include disease control rate (“DCR”), duration of response (“DOR”), depth of response, time to response, progression-free survival (“PFS”), overall survival (“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial enrolled 59 patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States.

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.² Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.³ Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

About Bristol Myers Squibb
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy (such as docetaxel) may not achieve its primary study endpoint or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether pumitamig alone or in combination with chemotherapy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by Bristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

CONTACTS

BioNTech
Media Relations
Jasmina Alatovic
Media@biontech.de

Investor Relations
Douglas Maffei, PhD
Investors@biontech.de

Bristol Myers Squibb
Media Relations
media@bms.com

Investor Relations
Investor.relations@bms.com

1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.
2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.
3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.

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Climb Bio Presents Initial PrisMN Phase 2 Data from Budoprutug in pMN at an Oral Session at ASN Kidney Week 2026

Posted on October 24, 2026 by Ravi Shankar

Low dose (200 mg) budoprutug demonstrated B-cell depletion, PLA2R Ab reduction, and immunologic remission at 12 weeks, consistent with Phase 1b data; additional data from the PrisMN Phase 2 study anticipated in 2027

200 mg and 600 mg doses have been generally well-tolerated

Separate MCD case study described three-year steroid-free remission following budoprutug treatment, supporting further investigation

WELLESLEY HILLS, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced new clinical data for budoprutug, its anti-CD19 monoclonal antibody (mAb), in two immune-mediated renal diseases, primary membranous nephropathy (pMN) and minimal change disease (MCD). These data were presented at the American Society of Nephrology (ASN) Kidney Week 2026, which is taking place October 21-25, 2026, in Denver, Colorado.

PrisMN is an ongoing Phase 2 dose-escalation trial evaluating budoprutug at three dose levels (200 mg, 600 mg, and 1000 mg) in patients with moderate to severe pMN. Patients enrolled in the reported cohorts were treatment-experienced, with high proteinuria and elevated PLA2R antibody levels at baseline. At Week 12, the 200 mg cohort demonstrated B-cell depletion, reductions in PLA2R antibody levels, and immunologic remission. Initial data from the ongoing 600 mg cohort suggest greater drug exposure and deeper peripheral B-cell depletion compared with 200 mg. Budoprutug has been generally well tolerated in both cohorts to date, with follow-up through Week 12 for 200 mg and Week 6 for 600 mg. Enrollment is ongoing in the 1000 mg cohort.

In a separate case study presented yesterday, one patient with frequently relapsing MCD received 100 mg of budoprutug. The patient experienced three-year steroid-free remission and remained in remission for one year following B-cell reconstitution. This observation supports further investigation of budoprutug in MCD.

“Current treatment strategies fail to induce complete remission in most patients with pMN, underscoring the need for more effective treatments,” said Dr. Frank Cortazar, Director of the New York Nephrology Vasculitis and Glomerular Center. “While complete remission often takes more than a year to achieve, changes in PLA2R antibody levels can be appreciated much earlier in the treatment course and serve as an early indicator of therapeutic efficacy. Reductions in PLA2R antibody levels have been shown to correlate with downstream improvements in proteinuria, and ultimately complete remission. In the PrisMN study, the low-dose budoprutug cohort demonstrated encouraging PLA2R antibody reductions and immunologic remission rates in patients with moderate to severe pMN. These early results are highly promising, and I look forward to seeing how these data evolve as follow-up continues and higher-dose cohorts read out. These data provide further evidence that targeting CD19 with budoprutug may be a compelling approach in the treatment of pMN.”

“These initial PrisMN results build on our Phase 1b findings, demonstrating early immunologic activity at 200 mg and the potential for increased activity at higher doses,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “The observed pharmacokinetics confirm that patients with pMN have increased clearance of budoprutug compared to patients who do not have proteinuria. We are encouraged by the greater exposure and deeper B-cell depletion we are seeing at these early time points in the 600 mg cohort. As enrollment and follow-up continue, we look forward to sharing additional data. Beyond pMN, we are encouraged by the sustained steroid-free remission reported in the MCD case, supporting further investigation of budoprutug in additional glomerular diseases and highlighting its potential impact across different B-cell mediated diseases.”

Key highlights from the oral presentation:

Early immunologic activity at 200 mg
- Mean PLA2R antibody reduction of 70% at Week 12; five of 13 patients (38%) achieved immunologic remission. Mean reduction of 80% at Week 12 for patients with baseline PLA2R antibody (Ab) <175 RU/mL
- Phase 2 Week 12 data consistent with Phase 1b Week 12 data across B-cell depletion, anti-PLA2R antibody reduction, and immunologic remission rate
Population PK analysis and emerging 600 mg data support the evaluation of higher doses
- Population PK analysis completed across all budoprutug studies (n≈120) found that patients with high proteinuria (median UPCR of 6.8 g/g) clear budoprutug ≥2-fold faster than non-proteinuric individuals, supporting the use of higher doses in pMN
- Mean peripheral CD20+ B-cell suppression at Week 4 was 98% at 600 mg, compared with 74% at 200 mg
Safety and tolerability
- Budoprutug was generally well tolerated in the 200 mg and 600 mg cohorts
- Most adverse events were mild to moderate (Grade 1 or 2), with no treatment-related serious adverse events, adverse events leading to treatment discontinuation, or deaths reported

Following the oral presentation at 5:30 p.m. MT., the presentation and poster will be available on the Pipeline & Science—Publications page of the Company’s website here.

About Primary Membranous Nephropathy (pMN)
Primary membranous nephropathy is an autoantibody mediated disease characterized by proteinuria, nephrotic syndrome, and progressive loss of renal function. Patients with uncontrolled disease may develop chronic kidney disease or end-stage kidney disease, requiring dialysis or transplantation. There are about 75,000 people in the U.S. living with pMN. Currently, there are no FDA approved therapies for pMN.

About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company with a mission to deliver high impact, disease-modifying medicines for individuals living with immune-mediated diseases, including those affecting kidney health. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy. For more information, please visit climbbio.com.

About Budoprutug
Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody with the potential to address a broad range of B-cell mediated, immune-driven diseases. Designed with enhanced effector function and low picomolar affinity, budoprutug targets and depletes CD19-expressing B cells, including plasmablasts and certain plasma cells, key sources of pathogenic autoantibodies. Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in primary membranous nephropathy (pMN). Budoprutug is being evaluated in clinical trials for pMN, immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). A subcutaneous formulation is also in development to enable broader patient access. Budoprutug has been granted Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of pMN.

Forward-Looking Statements
This press release contains “forward-looking statements” including, without limitation, statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug; the anticipated timelines for announcing data from Climb Bio’s ongoing and planned clinical trials; the anticipated timelines for enrolling patients in planned clinical trials; and other statements containing the words “anticipate,” “continue,” “could,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “suggest,” “target,” “will” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its technology transfer and exclusive license agreement with Mabworks; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials or nonclinical studies; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; managing expenses; changes in applicable laws or regulations; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.

Investors and Media
Carlo Tanzi, Ph.D.
Kendall Investor Relations
ctanzi@kendallir.com

Posted in UncategorizedTagged GlobeNewswire