Gotistobart

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategies Updated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squamous non-small cell lung cancer following prior immunotherapy BioNTech is advancing a diversified development program in lung cancer treatment spanning more than 16 ongoing clinical trials across subtypes, biomarkers and treatment settings, including five ongoing Phase 3 clinical trials and two novel-novel combination trials August 20, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer (“WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026. The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate (“ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer. “Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients.” Highlights from BioNTech’s presentations at WCLC 2026: Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company (“BMS”), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”): Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer (“SCLC”) and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies. Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”): 2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer (“NSCLC”) who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing. Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer. BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer. The content above comes from the network. if any infringement, please contact us to modify.

— ONC-783 is the first-and-only clinical-stage T-cell engager targeting a cancer-specific glycoform of CD24 (neoCD24) — — Subcutaneous formulation designed to provide gradual systemic exposure, potentially mitigating CRS risk — Aug. 17, 2026 -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company's investigational T-cell engager developed based on the proprietary neoCD24 platform. "This milestone demonstrates OncoC4's leading position in developing first-in-class cancer therapeutics," said Dr. Yang Liu, CEO and Chief Scientific Officer, "CD24 is expressed in nearly 70% of human cancers 1, and abnormal glycosylation in malignant cells produces the neoCD24 epitope that is largely absent from the normal tissues. By exploiting this cancer-specific epitope, ONC-783 is designed to maximize selectivity for tumor cells while minimizing the risk of on-target/off-tumor toxicity that has limited other T-cell engagers." ONC-783 is the world's first and only clinical stage T-cell engager targeting the cancer-specific glycoform of CD24 (neoCD24). The drug candidate is designed to address the limitations of existing immunotherapies by selectively targeting the tumor-specific epitope while redirecting T cells for potent anti-tumor activity. Preclinical studies have demonstrated broad anti-tumor activity for ONC-783 across multiple solid tumor and hematologic malignancies, including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, ovarian cancer, glioblastoma, and mantle cell lymphoma, which supports the potential of ONC-783 as a treatment across multiple tumor types. In addition, a subcutaneous formulation was developed for ONC-783 to enable gradual systemic exposure and provide a potential safety advantage compared with intravenously administered T-cell engagers. "We are extremely excited to partner with OncoC4 to explore the potential of targeting neoCD24 to bring clinical benefit for cancer patients with limited treatment options," added Dr. Aiwu Ruth He, Professor of Medicine and medical oncologist at Columbia University Irving Medical Center in New York City. "Advanced solid tumors remain a significant challenge, and this innovative mechanism offers a promising new approach for patients who have progressed or intolerant to standard therapy." ONC-783 is being tested in ONC-783-001, a Phase 1 trial in the US for patients with advanced solid tumors. The first study patient was successfully dosed at Columbia University Irving Medical Center. The treatment was well tolerated. No severe Adverse Events, Cytokine Release Syndrome, or Immune Effector Cell-Associated Neurotoxicity Syndrome have been observed to date. OncoC4 will continue the innovation in cancer immunotherapy and remain committed to the development of first-in-class therapeutics to address the unmet needs in cancer treatments. ONC-783-001 is a Phase 1 open-label, dose-escalation study in the United States (U.S.) to evaluate the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. OncoC4 has engaged several clinical centers across the U.S. to recruit patients for ONC-783-001 including Columbia University Irving Medical Center and The University of Texas MD Anderson Cancer Center. The clinical trial registration number is NCT07408258. About the NeoCD24 Platform CD24 is expressed in nearly 70% of human cancers1, along with a significant level of expression also in normal tissues, where it plays a key role in regular cell growth, tissue maintenance, and immune system function. Targeting CD24 as a cancer treatment has been challenging due to the lack of selectivity to tumor cells. OncoC4 has discovered that abnormal glycosylation in malignant cells produces the neoCD24 epitope, a tumor-specific antigen that is largely absent from normal tissues, enabling the development of cancer-specific therapeutics targeting CD24. OncoC4 is developing several first-in-class cancer treatments based on the neoCD24 platform. Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the treatment of cancer and immunological diseases. OncoC4's pipeline features assets with first-in-class and best-in-class potential targeting both novel and well-validated targets across oncology and immunological diseases. Among them, AI-081 is a fully owned bispecific antibody candidate targeting PD-1 and VEGF. ONC-841 is a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer. References Ju-Han Lee, Seo-Hee Kim, Eung-Seok Lee, Young-Sik Kim CD24 overexpression in cancer development and progression: a meta-analysis Oncol Rep 2009 Nov;22(5):1149-56. doi: 10.3892/or_00000548. 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