Author: Ravi Shankar

• In 24 heavily pre-treated patients with advanced primary cutaneous melanoma whose cancer had progressed after multiple prior lines of therapy including anti-PD-1 therapy, data continue to show an acceptable safety profile and early signals of efficacy
• 41.7% (10/24) overall response rate (ORR) per RECIST 1.1, including 4 complete responses
• 75% (18/24) disease control rate (DCR)
• 17.8 months median Overall Survival
• Exploratory analysis in a subset of patients (n=8) identified IL-1β, a cytokine linked to treatment-induced anti-tumor immunity, as the most increased plasma cytokine after treatment
• Investigators concluded that these preliminary findings warrant further evaluation in randomized clinical trials for patients with primary cutaneous melanoma naïve or refractory to anti-PD-1

Data presented at the 2026 Congress of the European Society for Medical Oncology

PARIS and CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) — NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the “Company”), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updated results from patients with anti-PD-1-resistant advanced primary cutaneous melanoma treated in the ongoing Phase 1 Study 1100. The study evaluates JNJ-1900 (NBTXR3), which works in the presence of radiotherapy, followed by an immune checkpoint inhibitor (nivolumab or pembrolizumab) in patients with advanced solid tumors. The data were presented by Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center, in a poster session on Saturday, October 24, 2026, at the 2026 Annual Meeting of the European Society for Medical Oncology (“ESMO”) in Madrid, Spain.

ABSTRACT #3956: Safety and Anti-Tumor Activity of NBTXR3/SBRT with Immune Checkpoint Inhibitors in Anti-PD-1 Resistant Melanoma: Results from a Phase I Dose Expansion

^{J. Chan, J. Lee, A. Lam, A. Daud, F. Collichio, H. Yu, P. Mody, J. Weiss, S. Moschos, S. Powell, S. Peck, M. Lohr, E. Redstone, Z. Li, W. Smith, A. Juloori, R. Gineste, D. Rolando, A. Rosenberg and C. Shen. UCSF Helen Diller Family Comprehensive Cancer Center; UNC Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill; Sanford Cancer Center; St Luke’s University Hospital; The University of Chicago; Nanobiotix}

Patients with advanced anti-PD-1 resistant primary cutaneous melanoma whose disease has progressed after multiple prior lines of therapy have a poor prognosis; published series report a median progression-free survival of approximately three months¹ and a median overall survival of approximately one year² in this setting. Melanoma has historically been considered radioresistant, and higher radiation doses are often limited by exposure of the surrounding healthy tissue.

“Patients whose melanoma has progressed on anti-PD-1 therapy, and often on several other immunotherapies as well, have limited options left,” said Jason Chan, MD, Associate Professor, Department of Radiation Oncology, UCSF Helen Diller Family Comprehensive Cancer Center “In this study, a single injection followed by a short course of stereotactic radiotherapy was feasible across a wide range of tumor sizes and locations, and we saw responses in lesions that were injected and in lesions that were not. The observed increase in IL-1β suggests treatment-related immune activation that warrants further investigation. These are early data from a single-arm study, and they support testing the approach in a randomized trial.”

All 24 heavily pre-treated patients had advanced primary cutaneous melanoma resistant to anti-PD-1; 14 had stage IV disease. Most had received other immunotherapies before enrolling, including anti-CTLA-4 (50%), anti-LAG-3 (33.3%) and T-VEC (25%), and 87.5% had received immunotherapy as their most recent therapy. Patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) at the recommended Phase 2 dose (33% of gross tumor volume), followed by stereotactic body radiotherapy (“SBRT”) to the injected lesion and then nivolumab or pembrolizumab. Investigators observed an acceptable safety profile and early signals of efficacy.

Safety and Feasibility

Treatment consisting of a single intratumoral JNJ-1900 (NBTXR3) injection, followed by a short course of radiotherapy was feasible across a wide range of melanoma lesions, providing a minimally invasive treatment approach with an acceptable safety profile. No new safety signals have been observed.

Preliminary Efficacy

An Overall Response Rate (ORR) of 41.7% (10/24 patients) was observed. Responses were observed in both injected (ORR 45.8%; 11/24 evaluable patients) and non-injected lesions (ORR 30.0%; 3/10 evaluable patients).

Median Progression Free Survival (PFS) was 6.9 months, while median Overall Survival reached 17.8 months.

Exploratory Immune Profiling

In an exploratory analysis of plasma samples from a subset of patients (n=8), IL-1β showed the largest increase from baseline among the cytokines evaluated. Published research has linked IL-1β to treatment-induced anti-tumor immunity through its role in connecting innate immune activation to the priming of tumor-specific CD8+ T cells.³

“This updated analysis, with more patients and longer follow-up, builds on the first data we reported with consistent safety and an improvement in Overall Survival relative to the first data reported,” said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. “Responses were again seen in patients whose disease had progressed after multiple prior therapies, including in lesions that were not injected. Together with the exploratory cytokine data, these findings warrant further evaluation of JNJ-1900 (NBTXR3) followed by anti-PD-1 therapy in patients with anti-PD-1-resistant melanoma.”

Overall, the acceptable safety profile and early efficacy observed by investigators in these preliminary findings provide promising signals of activity and warrant further evaluation in larger randomized trials.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and designed to work in the presenced of radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when in the presence of radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.

In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.

Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.

For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on March 31, 2026 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2025 universal registration document filed with the AMF on March 31, 2026 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2026, which are available on the SEC’s website at www.sec.gov and on the AMF’s website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Nanobiotix
Communications Department Brandon Owens VP, Communications contact@nanobiotix.com	Investor Relations Department Joanne Choi VP, Investor Relations (US) joanne.choi@nanobiotix.com  Ricky Bhajun Director, Investor Relations (EU) investors@nanobiotix.com
Media Relations
France – HARDY Caroline Hardy +33 06 70 33 49 50 carolinehardy@outlook.fr	Global – uncapped Becky Lauer +1 (646) 286-0057 uncappednanobiotix@uncappedcommunications.com

________________ 

_{¹Patrinely JR Jr., Cancer. 2020
²Nordstrom BL, Future Oncol. 18:1343-1355, 2022
³Ghiringhelli et al. Nat Med. 15(10):1170-8, 2009}

Attachment

• PR_Study 1100 Melanoma Data ESMO 2026

Media Release

COPENHAGEN, Denmark and WILMINGTON, Del.; October 24, 2026

• Phase 1/2 study will evaluate petosemtamab plus INCB161734 and standard-of-care chemotherapy in first-line KRAS G12D-mutated metastatic colorectal cancer (mCRC)

Genmab A/S (Nasdaq: GMAB) and Incyte (Nasdaq: INCY) today announced a clinical trial collaboration to evaluate petosemtamab, Genmab’s 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 INCB161734, Incyte’s investigational, potent and selective KRAS G12D inhibitor, and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring a KRAS G12D mutation, an area with substantial unmet medical need.

“This collaboration supports our broader development strategy for petosemtamab as we explore its potential across treatment settings and in novel combinations,” said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer, Genmab. “Partnering with Incyte enables us to evaluate this investigational combination in patients with KRAS G12D-mutated metastatic colorectal cancer, reflecting our commitment to research collaborations aimed at expanding potential treatment options for more patients.”

“Metastatic colorectal cancer remains difficult-to-treat, underscoring the importance of evaluating novel combinations grounded in complementary scientific approaches with the potential to enhance efficacy,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. “Our collaboration with Genmab will explore the potential of combining KRAS G12D inhibition with LGR5-targeted EGFR inhibition and standard-of-care chemotherapy, with the goal of advancing a new first-line treatment approach for patients with metastatic colorectal cancer.”

Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating petosemtamab in combination with INCB161734 and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.

KRAS mutations occur in approximately 40% of colorectal cancers, with G12D being the most common KRAS mutation. These cancers are associated with poor prognosis, underscoring the need for new treatment approaches. The collaboration reflects a shared focus on investigating whether agents with distinct and potentially complementary mechanisms, combined with standard-of-care chemotherapy, may offer a path toward a new treatment option for patients with KRAS G12D-mutated metastatic colorectal cancer.

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). Petosemtamab is being evaluated in combination with chemotherapy in two Phase 3 trials in first- and second-line RAS/BRAF wild-type metastatic CRC. Please visit https://clinicaltrials.gov/ for more information.

About INCB161734
INCB161734 is an investigational, novel, selective and orally bioavailable small molecule ON/OFF KRAS G12D inhibitor. KRAS is one of the most frequently altered oncogenic drivers across solid tumors, and the KRAS G12D mutation is among the most common KRAS alterations, occurring in approximately 40% of pancreatic ductal adenocarcinoma (PDAC) cases and approximately 15% of colorectal cancer (CRC) cases.

INCB161734 is being evaluated in the global Phase 3 DAWN-303 (NCT07522073) study which is currently enrolling patients with previously untreated KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) to further evaluate the efficacy and safety of INCB161734 in combination with standard-of-care (SoC) chemotherapy.

INCB161734 is also being evaluated as a monotherapy and in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel [GEMNabP] or modified FOLFIRINOX [mFOLFIRINOX]), in an ongoing open-label Phase 1 study across KRAS G12D-mutated solid tumors (NCT06179160).

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.

About Incyte®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Genmab Contacts

Media:        
Jyoti Sharma, Director, Global Communications & Corporate Affairs
T: +1 609 480 9844; E: jysh@genmab.com

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

Incyte Contacts

Media:                                                         
media@incyte.com
                
Investors:
ir@incyte.com

Genmab Forward-Looking Statements
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^®.

Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding Incyte’s clinical trial collaboration with Genmab; the design, initiation, timing, conduct, sponsorship and funding of the planned studies; the potential presented by INCB161734, petosemtamab and the combination of these investigational therapies with standard-of-care chemotherapy; the potential for the combination to provide a new treatment option for patients with first-line KRAS G12D-mutated metastatic colorectal cancer; expectations regarding the initiation, timing, progress and results of ongoing and planned clinical trials for INCB161734; whether or when INCB161734, petosemtamab or any combination regimen will be approved or commercially available for use in humans anywhere in the world; Incyte’s oncology portfolio and development strategy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including whether preclinical or early clinical results will be replicated in later-stage or larger clinical trials; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and to enroll subjects in accordance with planned schedules; changes in clinical development plans; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory approval; the efficacy or safety of Incyte’s products and product candidates; Incyte’s ability to successfully develop and commercialize its product candidates; Incyte’s reliance on third parties and collaboration partners, including with respect to the planned studies described herein; the availability and effectiveness of competing treatments; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; greater than expected expenses, including expenses relating to clinical development, litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended June 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

Attachment

• 102426 MR13 Genmab Incyte CRC

• As published in the Journal of Clinical Oncology (JCO) and presented at ESMO, COMPANION-002 met its primary endpoint of ORR and key secondary endpoint of PFS, with a 56% reduction in the risk of disease progression or death.
• Responses were durable, with a median duration of response (DOR) of 4.9 months, and disease control rate (DCR) was also significantly improved (62.2% vs. 36.8%).
• A new, post hoc analysis of overall survival (OS) included in the JCO publication uses the Two-Stage Estimation, an established method for adjusting for crossover, and demonstrates an OS hazard ratio of 0.85 (95% CI, 0.59–1.26; p=0.53).
• Safety profile was consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified.

BOSTON, Oct. 24, 2026 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced the publication of results from the positive Phase 2/3 COMPANION-002 study of tovecimig in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer (BTC) in the Journal of Clinical Oncology (JCO). The results are also being presented today by Nilofer S. Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The full publication is available via open access at https://ascopubs.org/toc/jco/0/ja.

COMPANION-002 is a randomized Phase 2/3 study that evaluated tovecimig plus paclitaxel versus paclitaxel alone in 168 patients with advanced BTC who had received one prior therapy. As previously reported, and now published following peer review, the study met its primary endpoint, with tovecimig plus paclitaxel demonstrating a statistically significant improvement in ORR of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) evaluated by blinded independent central review (BICR). The study also met its key secondary endpoint of PFS with a median PFS of 4.7 vs. 2.6 months (HR=0.44, p<0.0001), representing a 56% reduction in the risk of disease progression or death.

Key findings from COMPANION-002 include:

• Duration of response and disease control: Responses with tovecimig plus paclitaxel lasted a median of 4.9 months. The disease control rate, which includes patients whose cancer responded or remained stable, significantly improved at 62.2% vs. 36.8% with paclitaxel alone (p=0.0018).
• Intrahepatic cholangiocarcinoma subgroup: Patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts inside the liver), a prespecified subgroup, made up more than half of the study population (92 of 168). In these patients, results were consistent with the overall study population, with an ORR of 15.3% vs. 0% (p=0.0258) and median PFS of 5.1 vs. 3.0 months (HR=0.32).
• Overall survival (OS) and crossover-adjusted analysis: Patients in the paclitaxel arm could cross over to tovecimig plus paclitaxel arm after BICR-confirmed progression. 31 of 57 (54%) patients crossed over, resulting in 85% of all patients in the study (142 of 168) ultimately receiving tovecimig. The intent-to-treat OS analysis was confounded by the high rate of crossover and no statistically significant difference in OS was observed. To estimate the treatment effect if crossover had not occurred, the JCO publication includes a post hoc exploratory analysis using the Two-Stage Estimation, an established method for adjusting for crossover, in which the OS hazard ratio was 0.85 (95% CI, 0.59–1.26; p=0.53).
• Outcomes in crossover patients: Among the 31 patients who crossed over, median PFS after the addition of tovecimig to paclitaxel, a prespecified secondary endpoint, was 3.5 months, compared with 1.9 months during their initial treatment with paclitaxel alone (HR=0.40, p=0.0035). In a post hoc exploratory analysis, these patients who crossed over to receive tovecimig had a median OS of 12.8 months, compared with 6.1 months for control-arm patients who did not cross over (HR=0.54, p=0.04), even though crossover patients had progressed more quickly on initial paclitaxel treatment. These crossover comparisons were not randomized and are exploratory.
• Safety: The safety profile was generally manageable and consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified. The most common treatment-emergent adverse events (TEAEs) in the combination arm were hypertension (69%) and fatigue (67%). Grade 3 or higher TEAEs occurred in 93.5% of patients in the combination arm and 64.2% of patients who received paclitaxel alone. TEAEs leading to overall treatment discontinuation occurred in 27.8% and 11.3%, respectively, and were mostly consistent with known anti-angiogenic and chemotherapy toxicities. No hypertensive crises or unexpected severe cardiovascular toxicities were observed. TEAEs leading to death occurred in 5.6% and 1.9% of patients, respectively.

“COMPANION-002 is an important, randomized study in patients with previously treated, advanced biliary tract cancer,” said Dr. Azad. “The significant improvements in response rate and progression-free survival, together with the durability of responses and disease control, are encouraging for patients in this setting. We also saw activity in patients who switched to tovecimig after their disease progressed on paclitaxel alone, which is notable in a setting where disease often progresses quickly.”

“Publication of the COMPANION-002 results in the Journal of Clinical Oncology following independent peer review is a significant milestone for patients with BTC,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “These data, including the new two-stage estimation adjusting for the crossover impact on overall survival, strengthen our conviction that tovecimig has the potential to make a meaningful difference for patients with previously treated, advanced biliary tract cancer who have few treatment options. We are determined to bring tovecimig to these patients and will continue working with the FDA toward that goal.”

Additional analyses from COMPANION-002, including patient-reported quality of life and translational research, are ongoing and will be reported separately.

About Tovecimig
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously, representing a first-in-class approach to disrupting tumor angiogenesis. In COMPANION-002, tovecimig was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. Tovecimig has received Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration. Tovecimig remains investigational and has not been approved by the FDA.

About Biliary Tract Cancer
BTC is an aggressive, life-threatening cancer estimated to affect approximately 26,500 patients annually in the United States. For the vast majority of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second-line setting. The therapies most commonly used in this setting, which are not labeled or approved by the FDA for the treatment of patients with BTC, generally have an ORR of approximately 5% or less.

About COMPANION-002
COMPANION-002 (NCT05506943) is a randomized, controlled Phase 2/3 study of tovecimig in patients with unresectable advanced, metastatic or recurrent BTC who received one prior systemic chemotherapy regimen. The study randomized 168 patients 2:1 to tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). The primary endpoint was ORR by blinded independent central review; secondary endpoints included PFS, OS and duration of response.

About Compass Therapeutics
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company dedicated to transforming the standard of care for patients with cancer through the discovery and development of innovative antibody-based therapeutics. The company leverages deep expertise in tumor biology and proprietary antibody engineering technologies to develop differentiated therapies that target the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression. Compass has a robust pipeline of novel product candidates in clinical development designed to address significant unmet needs and improve outcomes for patients with cancer. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com 

Media Contact
Anna Gifford, Chief of Staff
media@compasstherapeutics.com
617-500-8099

• As published in the Journal of Clinical Oncology (JCO) and presented at ESMO, COMPANION-002 met its primary endpoint of ORR and key secondary endpoint of PFS, with a 56% reduction in the risk of disease progression or death.
• Responses were durable, with a median duration of response (DOR) of 4.9 months, and disease control rate (DCR) was also significantly improved (62.2% vs. 36.8%).
• A new, post hoc analysis of overall survival (OS) included in the JCO publication uses the Two-Stage Estimation, an established method for adjusting for crossover, and demonstrates an OS hazard ratio of 0.85 (95% CI, 0.59–1.26; p=0.53).
• Safety profile was consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified.

BOSTON, Oct. 24, 2026 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced the publication of results from the positive Phase 2/3 COMPANION-002 study of tovecimig in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer (BTC) in the Journal of Clinical Oncology (JCO). The results are also being presented today by Nilofer S. Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The full publication is available via open access at https://ascopubs.org/toc/jco/0/ja.

COMPANION-002 is a randomized Phase 2/3 study that evaluated tovecimig plus paclitaxel versus paclitaxel alone in 168 patients with advanced BTC who had received one prior therapy. As previously reported, and now published following peer review, the study met its primary endpoint, with tovecimig plus paclitaxel demonstrating a statistically significant improvement in ORR of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) evaluated by blinded independent central review (BICR). The study also met its key secondary endpoint of PFS with a median PFS of 4.7 vs. 2.6 months (HR=0.44, p<0.0001), representing a 56% reduction in the risk of disease progression or death.

Key findings from COMPANION-002 include:

• Duration of response and disease control: Responses with tovecimig plus paclitaxel lasted a median of 4.9 months. The disease control rate, which includes patients whose cancer responded or remained stable, significantly improved at 62.2% vs. 36.8% with paclitaxel alone (p=0.0018).
• Intrahepatic cholangiocarcinoma subgroup: Patients with intrahepatic cholangiocarcinoma (cancer of the bile ducts inside the liver), a prespecified subgroup, made up more than half of the study population (92 of 168). In these patients, results were consistent with the overall study population, with an ORR of 15.3% vs. 0% (p=0.0258) and median PFS of 5.1 vs. 3.0 months (HR=0.32).
• Overall survival (OS) and crossover-adjusted analysis: Patients in the paclitaxel arm could cross over to tovecimig plus paclitaxel arm after BICR-confirmed progression. 31 of 57 (54%) patients crossed over, resulting in 85% of all patients in the study (142 of 168) ultimately receiving tovecimig. The intent-to-treat OS analysis was confounded by the high rate of crossover and no statistically significant difference in OS was observed. To estimate the treatment effect if crossover had not occurred, the JCO publication includes a post hoc exploratory analysis using the Two-Stage Estimation, an established method for adjusting for crossover, in which the OS hazard ratio was 0.85 (95% CI, 0.59–1.26; p=0.53).
• Outcomes in crossover patients: Among the 31 patients who crossed over, median PFS after the addition of tovecimig to paclitaxel, a prespecified secondary endpoint, was 3.5 months, compared with 1.9 months during their initial treatment with paclitaxel alone (HR=0.40, p=0.0035). In a post hoc exploratory analysis, these patients who crossed over to receive tovecimig had a median OS of 12.8 months, compared with 6.1 months for control-arm patients who did not cross over (HR=0.54, p=0.04), even though crossover patients had progressed more quickly on initial paclitaxel treatment. These crossover comparisons were not randomized and are exploratory.
• Safety: The safety profile was generally manageable and consistent with prior tovecimig studies and the anti-VEGF class, with no new safety signals identified. The most common treatment-emergent adverse events (TEAEs) in the combination arm were hypertension (69%) and fatigue (67%). Grade 3 or higher TEAEs occurred in 93.5% of patients in the combination arm and 64.2% of patients who received paclitaxel alone. TEAEs leading to overall treatment discontinuation occurred in 27.8% and 11.3%, respectively, and were mostly consistent with known anti-angiogenic and chemotherapy toxicities. No hypertensive crises or unexpected severe cardiovascular toxicities were observed. TEAEs leading to death occurred in 5.6% and 1.9% of patients, respectively.

“COMPANION-002 is an important, randomized study in patients with previously treated, advanced biliary tract cancer,” said Dr. Azad. “The significant improvements in response rate and progression-free survival, together with the durability of responses and disease control, are encouraging for patients in this setting. We also saw activity in patients who switched to tovecimig after their disease progressed on paclitaxel alone, which is notable in a setting where disease often progresses quickly.”

“Publication of the COMPANION-002 results in the Journal of Clinical Oncology following independent peer review is a significant milestone for patients with BTC,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “These data, including the new two-stage estimation adjusting for the crossover impact on overall survival, strengthen our conviction that tovecimig has the potential to make a meaningful difference for patients with previously treated, advanced biliary tract cancer who have few treatment options. We are determined to bring tovecimig to these patients and will continue working with the FDA toward that goal.”

Additional analyses from COMPANION-002, including patient-reported quality of life and translational research, are ongoing and will be reported separately.

About Tovecimig
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously, representing a first-in-class approach to disrupting tumor angiogenesis. In COMPANION-002, tovecimig was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. Tovecimig has received Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration. Tovecimig remains investigational and has not been approved by the FDA.

About Biliary Tract Cancer
BTC is an aggressive, life-threatening cancer estimated to affect approximately 26,500 patients annually in the United States. For the vast majority of patients with BTC whose tumors do not harbor an actionable mutation with an approved targeted therapy, there is currently no FDA-approved treatment in the second-line setting. The therapies most commonly used in this setting, which are not labeled or approved by the FDA for the treatment of patients with BTC, generally have an ORR of approximately 5% or less.

About COMPANION-002
COMPANION-002 (NCT05506943) is a randomized, controlled Phase 2/3 study of tovecimig in patients with unresectable advanced, metastatic or recurrent BTC who received one prior systemic chemotherapy regimen. The study randomized 168 patients 2:1 to tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). The primary endpoint was ORR by blinded independent central review; secondary endpoints included PFS, OS and duration of response.

About Compass Therapeutics
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company dedicated to transforming the standard of care for patients with cancer through the discovery and development of innovative antibody-based therapeutics. The company leverages deep expertise in tumor biology and proprietary antibody engineering technologies to develop differentiated therapies that target the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression. Compass has a robust pipeline of novel product candidates in clinical development designed to address significant unmet needs and improve outcomes for patients with cancer. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com 

Media Contact
Anna Gifford, Chief of Staff
media@compasstherapeutics.com
617-500-8099

Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases 

ORR and median duration of response was 59% and 19.4 months for the gedatolisib triplet and 43% and 27.8 months for the gedatolisib doublet, respectively, compared to 33% and 7.5 months for alpelisib + fulvestrant

The discontinuation rate for gedatolisib due to treatment-emergent adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib

MINNEAPOLIS, Oct. 24, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced new subgroup analyses from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 study evaluating gedatolisib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”). These data were presented by Dr. Barbara Pistilli, Head of the Breast Cancer Unit, Gustave Roussy, at the European Society of Medical Oncology (ESMO) Congress 2026 today, Saturday, October 24, 2026, at 4:15 a.m. EST/10:15 a.m. CEST during a late breaking rapid oral presentation:

Presentation LBA 16: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2)

Gedatolisib plus fulvestrant with palbociclib (“gedatolisib triplet”) or without palbociclib (“gedatolisib doublet”) significantly improved median progression-free survival (“PFS”) compared with alpelisib plus fulvestrant in HR+/HER2-, PIK3CA mutant ABC patients with and without liver metastases and those with or without visceral metastases:

Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Liver metastases, n	77	28	76
mPFS, mos. (95% CI)	21.5 (11.4-NR)	11.5 (9.2-NR)	9.1 (5.6-16.9)
HR (90% CI) vs. control	0.46 (0.30-0.72)	0.71 (0.41-1.25)
p-value	0.0016	0.1627
Liver Metastases, n	78	24	79
mPFS, mos. (95% CI)	9.1 (5.7-11.1)	11.1 (3.7-NR)	4.6 (3.7-5.6)
HR (90% CI) vs. control	0.47 (0.34-0.65)	0.38 (0.23-0.62)
p-value	<0.0001	0.0006
Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Visceral Metastases, n	38	13	37
mPFS, mos. (95% CI)	21.5 (9.6 – NR)	NR (1.6-NR)	9.2 (3.9-16.9)
HR (90% CI) vs. control	0.38 (0.21-0.73)	0.40 (0.15-1.1)
p-value	0.0059	0.0703
Visceral Metastases, n	117	39	118
mPFS, mos (95% CI)	9.8 (7.5-12.9)	11.3 (7.4-22.1)	5.6 (4.6-7.2)
HR (90% CI) vs. control	0.52 (0.39-0.70)	0.53 (0.35-0.79)
p-value	<0.0001	0.0042

* NR, not reached

In patients with evaluable disease, the gedatolisib-based regimens induced higher objective response rates (“ORR”) (confirmed and unconfirmed) and longer median durations of response in both the PIK3CA mutant and wild-type cohorts compared to the control:

Study 2 (PIK3CA Mutant Cohort)
Endpoint	Gedatolisib Triplet (n=133)	Gedatolisib Doublet (n=42)	Alpelisib + Fulvestrant (n=127)
Objective Response Rate, n (%)	78 (59%)	18 (43%)	42 (33%)
Median Duration of Response, mos. (95% CI)	19.4 (11.1-25.1)	27.8 (9.2-NR)	7.5 (5.6 – 16.6)
Study 1 (PIK3CA Wild-type Cohort)
	Gedatolisib Triplet (n=124)	Gedatolisib Doublet (n=113)	Fulvestrant (n=105)
Objective Response Rate, n (%)	48 (39%)	38 (34%)	1 (1%)
Median Duration of Response, mos. (95% CI)	19.2 (10.7-NR)	13.8 (9.4-NR)	Not evaluable

In the PIK3CA mutant cohort, the discontinuation rate of gedatolisib due to treatment-emergent adverse events (“TEAEs”) was 5% and 4% for the gedatolisib triplet and doublet, respectively, compared to a 19% discontinuation rate due to TEAEs for alpelisib. Grade 3 stomatitis with gedatolisib was transient. By the second cycle of treatment, less than 3% of patients had Grade 3 stomatitis, and all grade 3 events improved within 1-2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet and gedatolisib doublet were minimal, 1% and 0%, respectively.

“The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “For patients who do not have liver metastases and received the gedatolisib triplet, the median progression-free survival was approximately 21 months, versus approximately 9 months for the alpelisib regimen. This is a particularly important result since patients with no liver metastases represent approximately 60%-70% of all patients treated in this setting.”

“Additionally, the median duration of response was over 19 months for the gedatolisib triplet in both the PIK3CA wild-type cohort, or Study 1, and the PIK3CA mutant cohort, or Study 2, compared to not evaluable for fulvestrant in the PIK3CA wild-type cohort and 7.5 months for alpelisib plus fulvestrant in the PIK3CA mutant cohort. To our knowledge, the gedatolisib triplet in each study demonstrated the longest median duration of response results ever reported for a therapeutic regimen used in the primary analysis for a Phase 3 trial in the second-line HR+/HER2- advanced breast cancer setting.”

VIKTORIA-1 PIK3CA Wild-Type Cohort Comparative Analysis

Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer.

Poster 1873P: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA)

Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR+/HER2- advanced breast cancer with CDK4/6 inhibitor experience and PIK3CA wild-type tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and in progression-free survival rate at 6 months relative to the non-gedatolisib regimens evaluated. Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were a statistically significant 2x and 1.5x more likely to survive without disease progression or death compared to imlunestrant plus abemaciclib, respectively.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

About Celcuity

Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK™ (gedatolisib), pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; and the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; and the development of therapies and tools competitive with gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025). https://seer.cancer.gov/statfacts/html/breast-subtypes.html

Contacts

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com   
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

Median PFS was 21.5 months with the gedatolisib triplet and 11.5 months with the gedatolisib doublet versus 9.1 months with alpelisib + fulvestrant in patients who had no liver metastases 

ORR and median duration of response was 59% and 19.4 months for the gedatolisib triplet and 43% and 27.8 months for the gedatolisib doublet, respectively, compared to 33% and 7.5 months for alpelisib + fulvestrant

The discontinuation rate for gedatolisib due to treatment-emergent adverse events was 5% and 4% with the gedatolisib triplet and doublet, respectively, compared to 19% for alpelisib

MINNEAPOLIS, Oct. 24, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced new subgroup analyses from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 study evaluating gedatolisib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”). These data were presented by Dr. Barbara Pistilli, Head of the Breast Cancer Unit, Gustave Roussy, at the European Society of Medical Oncology (ESMO) Congress 2026 today, Saturday, October 24, 2026, at 4:15 a.m. EST/10:15 a.m. CEST during a late breaking rapid oral presentation:

Presentation LBA 16: VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv) ± palbociclib (palbo) vs standard of care in patients with HR+/HER2- advanced breast cancer (ABC) (Study 2)

Gedatolisib plus fulvestrant with palbociclib (“gedatolisib triplet”) or without palbociclib (“gedatolisib doublet”) significantly improved median progression-free survival (“PFS”) compared with alpelisib plus fulvestrant in HR+/HER2-, PIK3CA mutant ABC patients with and without liver metastases and those with or without visceral metastases:

Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Liver metastases, n	77	28	76
mPFS, mos. (95% CI)	21.5 (11.4-NR)	11.5 (9.2-NR)	9.1 (5.6-16.9)
HR (90% CI) vs. control	0.46 (0.30-0.72)	0.71 (0.41-1.25)
p-value	0.0016	0.1627
Liver Metastases, n	78	24	79
mPFS, mos. (95% CI)	9.1 (5.7-11.1)	11.1 (3.7-NR)	4.6 (3.7-5.6)
HR (90% CI) vs. control	0.47 (0.34-0.65)	0.38 (0.23-0.62)
p-value	<0.0001	0.0006
Subgroup	Gedatolisib Triplet	Gedatolisib Doublet	Alpelisib + Fulvestrant
No Visceral Metastases, n	38	13	37
mPFS, mos. (95% CI)	21.5 (9.6 – NR)	NR (1.6-NR)	9.2 (3.9-16.9)
HR (90% CI) vs. control	0.38 (0.21-0.73)	0.40 (0.15-1.1)
p-value	0.0059	0.0703
Visceral Metastases, n	117	39	118
mPFS, mos (95% CI)	9.8 (7.5-12.9)	11.3 (7.4-22.1)	5.6 (4.6-7.2)
HR (90% CI) vs. control	0.52 (0.39-0.70)	0.53 (0.35-0.79)
p-value	<0.0001	0.0042

* NR, not reached

In patients with evaluable disease, the gedatolisib-based regimens induced higher objective response rates (“ORR”) (confirmed and unconfirmed) and longer median durations of response in both the PIK3CA mutant and wild-type cohorts compared to the control:

Study 2 (PIK3CA Mutant Cohort)
Endpoint	Gedatolisib Triplet (n=133)	Gedatolisib Doublet (n=42)	Alpelisib + Fulvestrant (n=127)
Objective Response Rate, n (%)	78 (59%)	18 (43%)	42 (33%)
Median Duration of Response, mos. (95% CI)	19.4 (11.1-25.1)	27.8 (9.2-NR)	7.5 (5.6 – 16.6)
Study 1 (PIK3CA Wild-type Cohort)
	Gedatolisib Triplet (n=124)	Gedatolisib Doublet (n=113)	Fulvestrant (n=105)
Objective Response Rate, n (%)	48 (39%)	38 (34%)	1 (1%)
Median Duration of Response, mos. (95% CI)	19.2 (10.7-NR)	13.8 (9.4-NR)	Not evaluable

In the PIK3CA mutant cohort, the discontinuation rate of gedatolisib due to treatment-emergent adverse events (“TEAEs”) was 5% and 4% for the gedatolisib triplet and doublet, respectively, compared to a 19% discontinuation rate due to TEAEs for alpelisib. Grade 3 stomatitis with gedatolisib was transient. By the second cycle of treatment, less than 3% of patients had Grade 3 stomatitis, and all grade 3 events improved within 1-2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet and gedatolisib doublet were minimal, 1% and 0%, respectively.

“The additional data from Study 2 of VIKTORIA-1 show consistent and significant clinical benefit for important sub-groups of breast cancer patients treated with gedatolisib regimens,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “For patients who do not have liver metastases and received the gedatolisib triplet, the median progression-free survival was approximately 21 months, versus approximately 9 months for the alpelisib regimen. This is a particularly important result since patients with no liver metastases represent approximately 60%-70% of all patients treated in this setting.”

“Additionally, the median duration of response was over 19 months for the gedatolisib triplet in both the PIK3CA wild-type cohort, or Study 1, and the PIK3CA mutant cohort, or Study 2, compared to not evaluable for fulvestrant in the PIK3CA wild-type cohort and 7.5 months for alpelisib plus fulvestrant in the PIK3CA mutant cohort. To our knowledge, the gedatolisib triplet in each study demonstrated the longest median duration of response results ever reported for a therapeutic regimen used in the primary analysis for a Phase 3 trial in the second-line HR+/HER2- advanced breast cancer setting.”

VIKTORIA-1 PIK3CA Wild-Type Cohort Comparative Analysis

Dr. Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer.

Poster 1873P: Gedatolisib (Ged) vs Other Regimens Post-CDK4/6i and Endocrine Therapy (ET) in PIK3CA Wild-Type (WT) HR+/ HER2- Advanced Breast Cancer (aBC): A Network Meta-Analysis (NMA)

Eight studies were included in this network meta-analysis comparing progression-free survival outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR+/HER2- advanced breast cancer with CDK4/6 inhibitor experience and PIK3CA wild-type tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and in progression-free survival rate at 6 months relative to the non-gedatolisib regimens evaluated. Of note, the analysis found that patients treated with the gedatolisib triplet and doublet were a statistically significant 2x and 1.5x more likely to survive without disease progression or death compared to imlunestrant plus abemaciclib, respectively.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

About Celcuity

Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company’s first FDA-approved product is REVTORPYK™ (gedatolisib), pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM (PI3K/AKT/mTOR) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer, supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; and the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; and the development of therapies and tools competitive with gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025). https://seer.cancer.gov/statfacts/html/breast-subtypes.html

Contacts

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com   
(763) 392-0123
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

ORION CORPORATION
PRESS RELEASE
24 OCTOBER 2026 at 9.35 EEST
        

Darolutamide plus ADT and radiation therapy reduces risk of metastasis or death by 58% in prostate cancer patients at high risk of recurrence

• Interim analysis results from the Phase 3 trial DASL-HiCaP show a 58% reduction in the risk of metastasis or death in the combined primary endpoint of metastasis-free survival (MFS-CI) with darolutamide versus placebo, in addition to androgen deprivation therapy (ADT) and radiation therapy
• Four-year metastasis-free survival rate in trial reached 95% with darolutamide compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
• Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

ESPOO, Finland, October 24, 2026 – New late-breaking data to be presented today at the European Society for Medical Oncology (ESMO) Congress 2026 will show that adding darolutamide, an androgen receptor inhibitor (ARi) initially discovered by Orion Pharma, to standard-of-care androgen deprivation therapy (ADT) and locoregional radiation therapy (RT), significantly improves metastasis-free survival based on conventional imaging (MFS-CI) in prostate cancer patients with high risk of recurrence compared to placebo. Darolutamide is currently not approved for this treatment setting. These data will be presented at Presidential Symposium I at the ESMO Congress 2026 (LBA4, Saturday 24 October, 16:30 CET).

At a median follow-up of 3.8 years, the interim analysis demonstrated a 58% reduction in the risk of metastasis or death with darolutamide plus ADT and RT compared with placebo plus ADT and RT (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001). The 4-year metastasis-free survival rate was 95% for patients receiving darolutamide compared with 88% for those receiving placebo.

Secondary endpoints also showed consistent positive trends with darolutamide, with a 53% reduction in the risk of prostate-specific antigen progression free survival (PSA-PFS; HR 0.47; 95% CI: 0.33–0.67), and a 4-year PSA-PFS rate of 91% versus 83% with placebo. Prostate cancer-specific survival (PCSS) and overall survival (OS) hazard ratios were 0.58 (95% CI: 0.17–1.97; 99% vs 99% at 4 years) and 0.88 (95% CI: 0.49–1.59; 97% vs 95% at 4 years), respectively, with follow-up ongoing.

The safety profile of darolutamide was consistent with its known tolerability, with adverse events being similar to the placebo group. Proportions of patients experiencing Grade ≥2 adverse events of special interest for darolutamide versus placebo were: fatigue/asthenia (14% vs 10%), hypertension (7% vs 9%), fractures (2% vs 3%), and cardiac events (3% vs 3%). Any Grade ≥3 adverse event occurred in 43% of patients in the darolutamide group versus 36% in the placebo group.

Follow-up of participants is continuing to provide further information on longer-term outcomes, including overall survival.

About the DASL-HiCaP trial (ANZUP1801)
The DASL-HiCaP trial is an investigator-initiated, randomized, placebo-controlled, Phase III trial (NCT04136353) evaluating darolutamide added to standard-of-care ADT and locoregional radiation therapy in prostate cancer patients at high risk of recurrence. DASL-HiCaP is conducted by the University of Sydney and ANZUP Clinical Trials Group and is the fourth Phase III trial for darolutamide. Following ARAMIS, ARASENS, and ARANOTE, which demonstrated darolutamide’s efficacy and safety in advanced prostate cancer, DASL-HiCaP represents the first Phase III study of darolutamide in early prostate cancer. A total of 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom were randomized 1:1 to receive darolutamide (600 mg twice daily) or matching placebo for 96 weeks, combined with an LHRH analog for 96 weeks and RT to the prostate/prostate bed and pelvic lymph nodes. The primary endpoint was metastasis-free survival based on conventional imaging (MFS CI). Secondary endpoints included prostate-specific antigen progression free survival (PSA-PFS), prostate cancer-specific survival (PCSS), and overall survival (OS). The protocol specified an interim analysis after 87 MFS-CI events; follow-up is ongoing to evaluate long-term overall survival.

About Prostate Cancer
Prostate cancer is the second most common cancer and the fourth most common cause of cancer death in men worldwide. Over 1.5 million men are diagnosed with prostate cancer each year and almost 420,000 die from the disease worldwide. By 2040, prostate cancer diagnoses are projected to increase to 2.9 million.

Standard therapy for prostate cancer patients at high risk of recurrence combines radiation therapy with androgen deprivation therapy (ADT). However, despite this approach, a significant proportion of patients experience treatment failure, local recurrence, or distant metastases. Intensifying therapy early with an advanced androgen receptor inhibitor aims to improve long-term disease control and delay metastatic progression.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide’s low potential for blood-brain barrier penetration and low potential for clinically relevant drug drug interactions.

Darolutamide, under the brand name Nubeqa™ plus androgen deprivation therapy (ADT), is already approved in more than 85 markets around the world, including the US, EU and China. It is approved for the treatment of adult patients with mHSPC without docetaxel in 75 markets and with docetaxel in more than 85 countries, and for adult patients with nmCRPC at high risk of developing metastatic disease in more than 85 countries.

Darolutamide is developed jointly by Orion Pharma and Bayer.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. Current ongoing trials include the Phase III ARASTEP trial evaluating the efficacy of darolutamide plus ADT compared to ADT alone in hormone sensitive prostate cancer (HSPC), in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

Media contact:
Maddie Davidshofer, Lead, Scientific & Pipeline Communications
tel. +1 857 529 0169

Investor contact:
Tuukka Hirvonen, Head of Investor Relations
tel. +358 10 426 2721                                                 

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.

• IMA402 PRAME bispecific continues to demonstrate encouraging anti-tumor activity in multiple indications, alongside a favorable safety profile
• IMA402 achieved a cORR of 32%, 12.5 months median DOR and a 1-year OS rate of 91% in advanced melanoma patients with high PRAME expression
• Clinical profile of IMA402 reinforces development path across multiple solid tumor indications, including melanoma, gynecologic cancers and lung cancer, in earlier and later treatment lines, supported by Immatics’ innovative, rapid liquid biopsy-based PRAME testing
• IMA203CD8 PRAME cell therapy demonstrated deep and durable anti-tumor activity across multiple tumor types with a manageable safety profile, supporting its tumor-agnostic potential. At clinically relevant dose levels in patients with advanced, heavily pretreated gynecologic cancers, cORR was 55% with a median DOR of 8.4 months

Houston, Texas and Tuebingen, Germany, October 24, 2026 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), the global leader in precision targeting of PRAME with multiple clinical-stage programs spanning cell therapies and bispecifics, today announced updated clinical trial data from its ongoing Phase 1b study with IMA402 PRAME bispecific and its Phase 1 study with IMA203CD8 PRAME cell therapy.

The IMA402 data will be presented in a rapid oral presentation (1955RO) by Dirk Schadendorf, M.D., and the IMA203CD8 data were presented in an oral presentation (1946O) by Antonia Busse, M.D., at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO) in Madrid, Spain. In addition, exploratory analyses of the anzu-cel Phase 1b melanoma cohort will be presented in a poster (2128P) by Sapna Patel, M.D. The slides are available in the ‘Events & Presentations’ section of the Investor & Media page on the Company’s website.

“The data presented at ESMO further underscore the potential of IMA402 as an off-the-shelf treatment option for patients with solid cancers. This promising clinical profile reinforces our strategy as we continue to advance IMA402 across multiple cancer types and treatment lines, with combination approaches further expanding its reach,” said Cedrik Britten, M.D., Ph.D., Chief Medical Officer at Immatics. “In addition, as the IMA203CD8 PRAME cell therapy data continue to mature, we are increasingly encouraged by its broad potential for patients with advanced PRAME-positive cancers. Together with anzu-cel, IMA402 and IMA203CD8 give us three distinct and complementary approaches to target PRAME, with the potential to reach more patients across a broad range of cancers.”

Rapid Oral Presentation Summary – IMA402 PRAME TCR Bispecific Phase 1b Trial

Patient Population: Heavily pretreated patient population with a median of 3 prior lines of therapy
As of the data cutoff on June 1, 2026, 126 heavily pretreated patients across multiple tumor types, primarily melanoma and ovarian cancer, received at least one infusion of IMA402 during the dose escalation or dose expansion part of the ongoing trial (NCT05958121). Patients had received a median of 3 prior lines of systemic treatment, had a median target lesion sum of diameter of 7.4 cm and had a median of 4 tumor lesions. The efficacy population included 40 patients treated within the recommended Phase 2 dose (RP2D) range of 10 to 45 mg across varying levels of PRAME expression. Within this population, 31 patients exhibited high PRAME expression levels (PRAME-high)¹ in their tumors. Of these, all patients with PRAME-high melanoma had received prior systemic treatment with immune checkpoint inhibitors (ICI), with a median of 2 prior ICI regimens and all patients with PRAME-high ovarian cancer were previously treated with platinum-based chemotherapy.

Safety: Favorable tolerability profile as monotherapy and as combination therapy
IMA402 showed favorable tolerability across all doses. The most frequent treatment-related adverse events (TRAEs) were expected, transient lymphopenia and low-grade cytokine release syndrome (CRS), consistent with the mechanism of action. No cases of ICANS were reported. No IMA402-related Grade 5 events were reported. Tolerability was consistent across all evaluated doses, including the RP2D range, with no additive toxicity observed when combined with an ICI.

Anti-tumor Activity and Durability: 32% cORR in PRAME-high melanoma with promising durability and survival
IMA402 showed promising anti-tumor activity as monotherapy (n=36) or in combination with an immune checkpoint inhibitor (n=4) in the efficacy population at RP2D range. Treatment with IMA402 demonstrated 10 confirmed responses resulting in an overall confirmed objective response rate (cORR) of 25% (10/40) and a disease control rate (DCR) of 63% (25/40). This includes one confirmed complete response in melanoma. The longest ongoing response exceeded 2 years. In the PRAME-high population, cORR was 32% (10/31) across all indications and 32% (7/22) in patients with melanoma. The PRAME-high melanoma population further showed a median duration of response (mDOR) of 12.5 months (median follow-up, mFU, 16.8 months). Median overall survival (mOS) was not reached (mFU 8.8 months), with 91% of patients alive at 1 year (versus 60% of patients treated below RP2D range), indicating promising overall survival data irrespective of best response. Among 6 patients with PRAME-high ovarian cancer, 3 confirmed responses were reported.

^a Includes cutaneous melanoma and one patient with uveal melanoma. ^b Includes endometrial cancer (n=2), sqNSCLC (n=2), and synovial sarcoma (n=1); BOR, best overall response; BL, baseline; cCR, confirmed complete response; cORR, confirmed objective response rate; DCR, disease control rate; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

BOR, best overall response; BL, baseline; cCR, confirmed complete response; cORR, confirmed objective response rate; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

Next Development Steps for IMA402:
The promising clinical profile of IMA402 supports a development path across various solid tumors in earlier and later treatment lines. These include combination approaches with ICIs in melanoma and in gynecologic cancers as well as IMA402 in combination with the Company’s MAGEA4/8-directed bispecific, IMA401, in lung cancer with first data expected in 2027. Furthermore, the use of Immatics’ proprietary rapid, sensitive and reliable liquid biopsy-based PRAME testing enables precise patient selection and could support potential fast-to-market strategies, subject to regulatory approval, in PRAME-high melanoma and beyond.

Oral Presentation Summary – IMA203CD8 PRAME Cell Therapy Phase 1 Trial

Patient population: Heavily pretreated patient population with limited treatment options
As of the data cutoff on August 7, 2026, 98 heavily pretreated patients across multiple advanced solid tumor types expressing PRAME that had undergone a median of 3 prior systemic treatments were enrolled in the ongoing Phase 1 dose escalation/dose expansion trial (NCT03686124). Of these, 90 patients were evaluable for efficacy, including 27 with gynecologic cancers (ovarian and uterine cancer), 44 with melanoma, 12 with synovial sarcoma and 7 with other solid tumor types. All patients with ovarian cancer had received prior platinum-based therapy.

Safety: Treatment with IMA203CD8 was manageable
IMA203CD8 demonstrated a consistent and manageable safety profile across different solid tumor types and a wide dose range (median dose 1.81×10⁹ TCR T cells, range 0.44-12.50×10⁹). The most frequent treatment-emergent adverse events (TEAEs) were expected and included transient cytopenias associated with the lymphodepletion regimen and low-grade cytokine release syndrome (CRS), consistent with the mechanism of action. ICANS was infrequently observed, and no IMA203CD8-related Grade 5 events occurred. Maximum tolerated dose (MTD) was not reached with doses up to 12.5 billion IMA203CD8 cells.

Anti-tumor Activity and Durability: One-time infusion of IMA203CD8 PRAME cell therapy showed anti-tumor activity across multiple tumor types
Across all evaluated dose levels and tumor types, including lower dose levels not selected for further clinical development, a one-time infusion of IMA203CD8 demonstrated an ORR of 51% (46/90) and a cORR of 41% (36/87). The DCR was 82% (74/90) and 83% (71/86) of patients with evaluable target lesions experienced tumor reduction. Responses were observed across multiple solid tumors expressing PRAME, including ovarian cancer, uterine cancer, melanoma, synovial sarcoma, and others. Durable long-term responses were observed with ongoing responses for more than 2.5 years.

3 patients without any post-baseline scan not evaluable for assessment of tumor reduction, not depicted in the plot, but included in efficacy calculations. For patients achieving a (c)CR with <100% change from baseline, target lesions were lymph nodes that resolved to <10 mm per RECIST 1.1; BOR, best overall response; (c)CR, (confirmed) complete response; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

In 20 patients with gynecologic cancers (ovarian and uterine cancer) treated at clinically relevant dose levels (≥DL4c), IMA203CD8 demonstrated consistent anti-tumor activity with an ORR of 60% (12/20) and a cORR of 55% (11/20), a DCR of 70% (14/20) and tumor reduction in 68% (13/19) of patients. Early durability data showed a mDOR of 8.4 months (mFU 6.0 months), a mPFS of 5.8 months (mFU 8.1 months) and mOS not reached at 7.8 months mFU.

1 patient without any post-baseline scan not evaluable for assessment of tumor reduction, not depicted in plot, but included in efficacy calculations; those patients achieving a (c)CR with <100% changes from baseline, target lesions were lymph nodes that resolved to <10 mm per RECIST 1.1; BOR, best overall response; (c)CR, (confirmed) complete response; PD, progressive disease; (c)PR, (confirmed) partial response; SD, stable disease.

Next Development Steps for IMA203CD8:
Phase 1a dose escalation is complete. Immatics is currently enrolling patients with uterine cancer at clinically relevant doses to further expand the clinical dataset in this indication. In addition, a Phase 1/2 investigator-initiated trial (IIT) in patients with PRAME-positive pediatric cancers is planned to start in 1H 2027. The clinical activity of IMA203CD8 observed across tumor types with distinct biology and differing levels of PRAME expression, including ovarian cancer, uterine cancer, melanoma and synovial sarcoma, supports the broad applicability of IMA203CD8 across PRAME-positive cancers. The development approach for IMA203CD8 will leverage targeted cohorts of selected tumor types, such as ovarian cancer, uterine cancer, rare cancers and pediatric cancers to build the clinical evidence base for broader, tumor-agnostic application.

Poster Presentation Summary – Anzu-cel Phase 1b Melanoma Cohort
Additional exploratory analyses (data cutoff Sept 24, 2025) of anzu-cel (anzutresgene autoleucel, IMA203), presented in a poster (2128P) by Sapna Patel, M.D., demonstrated durable clinical benefit following a one-time treatment in a heavily pretreated population of patients with advanced melanoma. Durable clinical benefit was observed across patients with varied baseline clinical and treatment characteristics, with no single characteristic identified as a predictor of prolonged PFS. Exploratory analyses suggested that lower tumor burden, lower LDH, and a higher effector-to-target ratio may be associated with longer PFS. These findings further strengthen the clinical profile of anzu-cel, which is currently being evaluated in the Phase 3 SUPRAME trial in advanced melanoma.

About IMA402 PRAME Bispecific
IMA402 is a molecule from Immatics’ TCR bispecifics (TCER®) pipeline directed against an HLA-A*02:01-presented peptide derived from PRAME. IMA402 is currently being evaluated in a Phase 1b clinical trial in patients with solid tumors expressing PRAME. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies.

About IMA203CD8 PRAME Cell Therapy
IMA203CD8 is Immatics’ PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Co-transduction of CD8αβ with the PRAME TCR adds functional CD4+ T cells designed to boost anti-tumor activity. IMA203CD8 is currently being evaluated in a Phase 1b clinical trial in solid tumors expressing PRAME.

About Anzu-cel PRAME Cell Therapy
Anzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1/2 clinical trial is ongoing with a focus on uveal melanoma.

About PRAME
PRAME is a tumor-associated target expressed in more than 50 cancers. Immatics’ PRAME franchise includes multiple product candidates, therapeutic modalities, indications and combination approaches: anzu-cel (anzutresgene autoleucel; IMA203) and IMA203CD8, both PRAME-directed cell therapies, and IMA402, a PRAME-directed bispecific. Combination approaches include IMA402 with immune checkpoint inhibitors, IMA402 with the MAGEA4/8-directed bispecific IMA401, and anzu-cel in combination with Moderna’s PRAME mRNA therapy designed to enhance the cell therapy response.

About Immatics
Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.

Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram.

Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing and outcomes of IND, CTA, BLA and other regulatory filings, the timing of commercial launches, estimated market opportunities, manufacturing timetables, capacity and success rates, the potential benefits of product candidates, the Company’s intended strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management’s control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

Media
Trophic Communications
Phone: +49 151 74416179
immatics@trophic.eu

Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com

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¹ Patients showed PRAME expression 3-fold higher than the PRAME qPCR threshold, based on an exploratory analysis in the efficacy population. More than 80% of patients with cut. melanoma are estimated to have PRAME-high expression based on Immatics and TCGA RNA seq data.

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• ZW191 demonstrates compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer across folate receptor alpha (FRα) expression levels
• Confirmed objective response rates (cORR) of 64.5% at the 6.4 mg/kg dose in patients with high-grade serous platinum-resistant ovarian cancer
• Median duration of response not yet reached at either dose level at median 7 months follow-up, with six-month progression-free survival rate of 61% in both groups
• Favorable tolerability profile, particularly at 6.4 mg/kg, supports continued clinical development in partnership or through a strategic collaboration
• Conference call with Zymeworks management on October 27 at 8:30 am Eastern Time (ET)

VANCOUVER, British Columbia, Oct. 24, 2026 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today presented new clinical data from the randomized dose-optimization portion of its ongoing Phase 1 study evaluating ZW191, a FRα-targeting antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

The presentation highlights compelling anti-tumor activity in heavily pretreated patients with platinum-resistant ovarian cancer (PROC), including patients with high-grade serous disease across all levels of FRα expression. The results demonstrate compelling response rates, durability and a favorable tolerability profile, particularly at the 6.4 mg/kg dose, further supporting the potential of ZW191 to address limitations of currently available FRα-targeted therapies and expand treatment opportunities for patients with ovarian cancer.

“We are highly encouraged by these results, which further demonstrate the differentiated clinical profile of ZW191 and its potential to deliver meaningful benefit to patients with platinum-resistant ovarian cancer,” said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer, Zymeworks. “The robust response rates observed at both doses, including meaningful activity in patients with low or negative FRα expression, reinforce the potential of ZW191 to benefit a broader patient population. Importantly, the encouraging durability of responses and favorable tolerability profile, particularly at 6.4 mg/kg, provide valuable insights to guide dose selection and the next stage of clinical development.”

The analysis included efficacy and safety data from 80 patients with PROC randomized to receive ZW191 at 6.4 mg/kg (n=37) or 9.6 mg/kg (n=43) every three weeks, as of the September 10, 2026 data cutoff date. Patients were heavily pretreated, having received a median of four prior lines of therapy, with 45% receiving five or more prior lines. Median follow-up was seven months. FRα expression was assessed by immunohistochemistry and categorized as low/negative (0%–24%), intermediate (25%–74%) or high (75%–100%) based on the percentage of tumor cells with 2+ or 3+ staining intensity.

Key Findings

Among response-evaluable patients with high-grade serous PROC, ZW191 demonstrated a cORR of 64.5% at 6.4 mg/kg and 55.3% at 9.6 mg/kg, with disease control rates of 100% and 92.1%, respectively. These findings demonstrate compelling anti-tumor activity at both doses in a heavily pretreated patient population.

ZW191 demonstrated meaningful anti-tumor activity across FRα expression in patients with high-grade serous PROC. Confirmed objective response rates were 69.2% in patients with high FRα expression, 50.0% in patients with intermediate FRα expression and 55.0% in patients with low or negative FRα expression. These findings support the potential of ZW191 to show improved efficacy than existing FRα targeted therapies in FRα high population and meaningfully benefit patients with lower expression who may not be eligible for currently approved FRα targeting therapies.

Responses to ZW191 were deep and durable, with median duration of response not yet reached at either dose. Six-month progression-free survival (PFS) was 61% in both groups, while median PFS was 7.9 months at 6.4 mg/kg and 9.8 months at 9.6 mg/kg in patients with high-grade serous PROC. At the time of data cutoff, 45% of patients remained on treatment, and PFS data continue to mature, especially at 6.4 mg/kg.

ZW191 continued to demonstrate a favorable tolerability profile, particularly at 6.4 mg/kg. Grade 3 or higher treatment-related adverse events occurred in 22% of patients receiving 6.4 mg/kg compared with 44% at 9.6 mg/kg. Treatment-emergent adverse events leading to dose reductions occurred in 5% and 33% of patients, respectively, while discontinuations due to adverse events occurred in 14% and 19%. No deaths due to treatment-emergent adverse events were reported in either treatment group. The overall safety profile was manageable and supports continued clinical development.

“These results are particularly promising for patients with platinum-resistant ovarian cancer who have exhausted available treatment options,” said Jung-Yun Lee, M.D., Ph.D., Yonsei Cancer Center and Severance Hospital, Seoul, Republic of South Korea, and primary investigator who presented the results at ESMO 2026. “We observed substantial anti-tumor activity in patients who had received multiple prior therapies, including meaningful responses across high, intermediate and low or negative FRα expression levels. The encouraging durability of responses, together with the favorable safety profile observed at the lower dose, suggests ZW191 has the potential to become an important new treatment option for patients with this difficult-to-treat disease.”

The findings demonstrate encouraging anti-tumor activity across the 6.4 mg/kg and 9.6 mg/kg dose levels, with a more favorable tolerability profile at 6.4 mg/kg. These results will inform optimal dose selection for further clinical development.

ZW191’s differentiated profile, including its novel FRα-targeting antibody, proprietary topoisomerase I inhibitor payload, ZD06519, and high drug-to-antibody ratio, supports its potential to address key limitations of existing therapies and broaden the applicability of FRα-targeted treatment approaches.

The presentation will be available on Zymeworks’ website at www.zymeworks.com/publications/.

Investor Call Details

Zymeworks invites investors and the general public to view and listen to a live webcast of its conference call with investment analysts at 8:30 am ET on October 27, 2026.

Dial-in details and webcast link are available on Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations. A webcast replay of the call will be available on the Zymeworks website within 24 hours following the conclusion of the live call and will be archived for a limited period.

About ZW191

ZW191 is an antibody-drug conjugate engineered to target a protein called folate receptor-⍺ found in ~75% of high-grade serous ovarian carcinomas,¹ over 50% of endometrial cancers^,2,3 and ~70% of lung adenocarcinomas⁴. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

The Company has engaged MTS Healthcare to evaluate strategic partnering opportunities to fund further development for ZW191 with the objective of maximizing long-term value.

About Zymeworks Inc.

Zymeworks is a global biotechnology company building a diversified portfolio of healthcare assets designed to generate durable cash flows while advancing innovative medicines for difficult-to-treat diseases. The Company’s asset and royalty aggregation strategy combines a growing portfolio of commercial and near-commercial assets, including YUPELRI® (revefenacin), with a differentiated internal research and development engine. Zymeworks’ portfolio also includes Ziihera® (zanidatamab-hrii), a HER2-targeted bispecific antibody discovered and developed by Zymeworks and commercialized through global partnerships with Jazz Pharmaceuticals and BeOne Medicines, and pasritamig, a clinical-stage multispecific antibody developed by Johnson & Johnson using Zymeworks’ proprietary antibody engineering technologies.

Zymeworks is advancing a diverse pipeline of novel biotherapeutics, leveraging its proprietary Azymetric™ platform and expertise in antibody-drug conjugates, multispecific antibodies and other next-generation antibody technologies. These capabilities, together with Zymeworks’ integrated drug development expertise, enable the Company to develop differentiated therapeutics and create value through both internal innovation and strategic partnerships.

For more information about Zymeworks, its portfolio and pipeline, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the potential safety profile and therapeutic effects of ZW191; Zymeworks’ development of product candidates; status of studies and the related data; anticipated clinical data presentations; Zymeworks’ implementation of its long-term strategy; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates, including ZW191, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates, including ZW191; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Contacts:

Investor Inquiries:

Shrinal Inamdar
Vice President, Investor Relations
(604) 678-1388
ir@zymeworks.com   

Media Inquiries:

Diana Papove
Vice President, Corporate Communications
(604) 678-1388
media@zymeworks.com

—

¹ Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).
² May B, Conway N, Truong T, Linhart S, et al. FRα, B7-H4, & HER2 Expression in Endometrial Cancer: Assessing the Promise of Antibody Drug Conjugate Therapies. Presented at: SGO 2025 Winter Meeting; January 30 – February 1, 2025; Whistler, British Columbia, Canada.
³ Senol S, Ceyran AB, Aydin A, Zemheri E, Ozkanli S, Kösemetin D, Sehitoglu I, Akalin I. Folate receptor α expression and significance in endometrioid endometrium carcinoma and endometrial hyperplasia. Int J Clin Exp Pathol. 2015 May 1;8(5):5633-41.
⁴ O’Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.

SHANGHAI, China, Oct. 23, 2026 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the first patient dosing has been completed in a randomized, open-label, multicenter phase 3 clinical study of the company’s product, a recombinant humanized anti-CD20/CD3 bispecific antibody (code: JS203), in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) (the JS203-003-III-DLBCL Study; NCT07808827). This study is the first registrational clinical study for JS203.

DLBCL is one of the most common types of non-Hodgkin lymphoma (NHL), accounting for approximately 40% of adult NHL cases in China. According to GLOBOCAN 2022 statistics, there are approximately 45,000 new cases of DLBCL in China each year, and the incidence rate shows a slow increasing trend. DLBCL is characterized by high aggressiveness and rapid progression. A retrospective study in an Asian population showed that, even after active treatment, patients with relapsed or refractory DLBCL had a median overall survival (mOS) of over one year and a 5-year survival rate of approximately 30%, which necessitates the exploration of more proactive and effective treatment options.

JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi Biosciences. It consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively.

Results from a phase 1 clinical study showed that, for JS203 monotherapy at the recommended phase 2 dose (RP2D) administered with step-up dosing (SUD) to 30 mg for the treatment of patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma, the objective response rate (ORR) reached 72.4%. Among patients with DLBCL, the ORR was 69.7%, and the complete response rate CRR was 39.4%, with persistent relief observed. Meanwhile, the overall safety profile was manageable, with a cytokine release syndrome (CRS) incidence rate of only 27.3% and no occurrence of immune effector cell-associated neurotoxicity syndrome (ICANS).

The JS203-003-III-DLBCL Study is a randomized, open-label, multicenter phase 3 clinical trial, with Professor Yuqin SONG of Beijing Cancer Hospital serving as the principal investigator. It aims to compare the efficacy and safety of JS203 in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma. The study plans to enroll 282 subjects, with overall survival (OS) as its primary endpoint. This study is the first registrational clinical study for JS203.

The JS203-003-III-DLBCL study team commented: “Early clinical studies have shown encouraging efficacy and a favorable safety profile for JS203 in combination with chemotherapy in patients with R/R DLBCL, reinforcing our confidence in the ongoing Phase 3 study. We are committed to advancing the study with rigor and efficiency, with the aim of making a new treatment option available to patients as soon as possible.”

About JS203

JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi Biosciences. CD20 is a B lymphocyte restricted differentiation antigen and one of the most successful targets for B-cell lymphoma treatment. CD3 is an important marker on the surface of T cells, and the main mechanism of T cell engaging bispecific antibodies is using CD3 as a mediator to activate T cells to specifically attack tumor cells. JS203 consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively. To date, a Phase 3 clinical study evaluating JS203 in combination with chemotherapy versus rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) is ongoing.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. With our outstanding capacity for innovative drug discovery, strong biotechnology R&D capability, and large-scale production capacity, we have successfully developed a drug candidate portfolio with global competitiveness and a well-structured research pipeline, which covers therapeutic areas including cancer, autoimmune, metabolic, and infectious diseases. Our innovative field spans cutting-edge therapeutic modalities, including mAbs, small-molecule drugs, ADCs, bsAb/msAb, fusion proteins, nucleic acid drugs and vaccines. Five of the company’s products have received marketing authorizations in China and international markets, one of which is toripalimab, China’s domestically developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 50 countries and regions including China, the US, and Europe.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” The company currently employs more than 3,000 people worldwide. Headquartered in Shanghai, China, it has a business presence in multiple countries and regions around the world. For more information, please visit: http://www.junshipharma.com.

Junshi Biosciences Contact Information

IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800