Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in Gotistobart Trials

This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.

Start Date28 Jul 2026

Sponsor / Collaborator

OncoC4, Inc.

NCT05682443

/ Active, not recruitingPhase 1/2

Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

Start Date11 Dec 2023

Sponsor / Collaborator

OncoC4, Inc.

[+1]

NCT05671510

/ Active, not recruitingPhase 3

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Start Date28 Jun 2023

Sponsor / Collaborator

OncoC4, Inc.

[+1]

100 Clinical Results associated with Gotistobart

100 Translational Medicine associated with Gotistobart

100 Patents (Medical) associated with Gotistobart

Literatures (Medical) associated with Gotistobart

01 Sep 2026·JOURNAL OF CLINICAL PHARMACOLOGY

Population pharmacokinetics for the CTLA‐4 modulator gotistobart in patients with advanced solid tumors

Article

Author: Zheng, Pan ; Yang, Tairan ; Xue, Jiahui ; Su, Juanjuan ; Madrasi, Kumpal ; Kharma, Hasan Abu ; Liang, Shuang ; Liu, Yang ; Li, Tianhong ; Yang, Jun ; Weiss, Ido D. ; Shen, Yuye ; Engler, Frank

Abstract:

Gotistobart is an investigational, next‐generation, humanized IgG1 monoclonal antibody targeting cytotoxic T‐lymphocyte antigen‐4. It is engineered to preserve cytotoxic T‐lymphocyte antigen‐4 through endosomal recycling while enhancing intratumoral regulatory T‐cell depletion. A population pharmacokinetic model was developed to characterize gotistobart pharmacokinetics and identify covariates contributing to inter‐individual variability in patients with advanced solid tumors. Serum concentration‐time data were obtained from 632 patients enrolled in three phase I–III clinical trials. In total, 3406 pharmacokinetic observations across a dose range from 0.1 to 10 mg/kg were collected. A two‐compartment model with linear elimination best described the data, with inter‐individual variability on clearance, central volume, and peripheral volume. Parameter estimates were precise, with typical values of 0.005 L/h for clearance, 0.021 L/h for inter‐compartmental clearance, 2.59 L for central volume, and 3.43 L for peripheral volume. Covariates identified in the model included body weight and albumin on clearance and volumes, and sex on volumes, with limited clinically relevant impact. The model was evaluated using parameter precision, goodness‐of‐fit diagnostics, and prediction‐corrected visual predictive checks. The model was used to simulate concentration‐time profiles for clinically relevant dosing regimens. Simulations demonstrated the expected steady‐state pharmacokinetic behavior, with dose‐dependent increases in peak and trough concentrations. Compared with 6 mg/kg every 3 weeks, administration of two 10 mg/kg loading doses followed by 6 mg/kg every 3 weeks accelerated the attainment of steady state. The validated population pharmacokinetic model provides a quantitative foundation for subsequent exposure‐response analyses and regimen selection.

01 Jun 2026·NATURE MEDICINE

Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

Article

Author: Zheng, Pan ; Fawole, Adewale ; He, Kun ; Kayali, Fadi ; Wenger, Michael ; Song, Shiling ; Li, Tianhong ; Wu, Long ; Efuni, Sergey ; Li, Luchun ; Park, Keon-Uk ; Pan, Pinhua ; Zhang, Jiliang ; Yang, Bin ; Wu, Lin ; Wang, Qiong ; Socinski, Mark A ; Singh, Preet ; Wu, Yi-Long ; Liu, Yang ; Liu, Zhi-Gang ; Yu, Xinmin ; Lee, Ki Hyeong ; Chen, Hua-Jun ; Yu, Yan ; Hamm, John ; Leddon, Jennifer L ; Şahin, Uğur ; Shpyro, Svetlana ; Balaraman, Rama ; Wang, Xicheng ; Cho, Byoung Chul ; Davarifar, Ardalan ; Jain, Vikram ; He, Kai ; Beardsley, Andrew ; Sun, Meili ; Lee, Youngjoo ; Huang, Yanjing

Abstract:

PRESERVE-003 is a two-stage phase 3 trial evaluating gotistobart (BNT316/ONC-392), a novel pH-sensitive anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) antibody that selectively depletes regulatory T cells within the tumor microenvironment, in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) without actionable genomic alterations who progressed on programmed cell death protein/programmed death ligand 1 inhibitor/platinum-based chemotherapy—a population with a poor prognosis. Here we report on stage 1, which aimed to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel. Patients with sqNSCLC were randomized (1:1) to gotistobart (6 mg kg −1 with two 10 mg kg −1 loading doses every 3 weeks ( N = 45)) or docetaxel (75 mg m −2 every 3 weeks ( N = 42)). After a median follow-up of 14.5 months, median overall survival was not reached with gotistobart (95% confidence interval (CI) 9.3 to not evaluable) versus 10.0 months (95% CI 6.2 to 11.9 months) with docetaxel (hazard ratio 0.46, 95% CI 0.25 to 0.84, nominal two-sided P = 0.0102). Safety was manageable, with grade ≥3 treatment-related adverse events in 42% and 49% of patients receiving gotistobart and docetaxel, respectively. Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC. ClinicalTrials.gov identifier: NCT05671510 .

01 Feb 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Carbon nanocone oxide-mediated controlled interaction to increase Favipiravir's bioavailability: An extensive in silico research

Article

Author: Arif, Khadija ; Zubair, Sadia ; Arshed, Saher Mubeen ; Afzal, Fatima ; Arif, Sandila ; Ayub, Ali Raza ; Hamid, Hira ; Raza, Usama ; Naseem, Zubera ; Salba

Nano cones have several benefits in treating chronic illnesses through targeted and site-specific drug delivery. Density functional theory (DFT) was used in this work to explore the therapeutic potential of carbon nanocone oxide (ONC) as a drug carrier for Favipiravir (FPV) against viral infection. The Frontier Molecular Orbitals (FMOs) defined the bandgap as a decline from 5.52 to 5.36 eV of Favipiravir when interacting with ONC. The molecular electrostatic potential (MEP) surfaces revealed that in the FPV-ONC complex, the Favipiravir acts as nucleophile and ONC as electrophile. The FMOs also calculated quantum chemical parameters in the gas and solvent phases to confirm the correlation between Favipiravir and ONC stabilization energy in complex formation. The density of state and charge deposition analysis showed the charge transfer phenomenon during complex formation. NBO, ELF, NCI, and iso-surfaces were used to identify the charge transfer between Favipiravir and ONC. The excited states were analyzed by plotting the TDM and spectral investigation (Raman, UV-Vis, IR, and NMR) of FPV, ONC, and FPV-ONC. The drug-carrier interaction generated fluorescence quenching in PET, which also gave a pictorial description of the unique excited states from 1 to 10. The results collectively indicate the therapeutic potential of the ONC carrier as a favipiravir carrier for managing viral disease.

News (Medical) associated with Gotistobart

19 Oct 2026

·www.prnewswire.com

OncoC4 Announces NMPA Acceptance of Two IND Applications for Cesalatamig Combination Studies with ADCs and Pan-RAS Inhibitors

— New Studies Expand Cesalatamig into Biomarker-driven Precision Immuno-oncology Strategies — Cesalatamig is Also Being Evaluated in Ongoing Phase 2 Studies in the United States and in China ROCKVILLE, Md. , Oct. 19, 2026 /PRNewswire/ -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced that the China National Medical Products Administration (NMPA) has accepted two new Investigational New Drug (IND) applications (CXSL2601129 and CXSL2601130) to evaluate cesalatamig (AI-081), the company's differentiated PD-1/VEGF bispecific antibody, in novel combination regimens for patients with advanced solid tumors. The INDs will support clinical studies evaluating cesalatamig in combination with antibody-drug conjugates (ADCs) across selected solid tumors and with pan-RAS inhibitors in molecularly defined patient populations. The studies represent an important expansion of OncoC4's strategy to establish cesalatamig as a foundational immuno-oncology backbone with the potential to enhance activity across multiple therapeutic modalities. "The acceptance of these new IND applications in China marks an important milestone in the evolution of our cesalatamig development strategy," said Dr. Pan Zheng, Co-founder and Chief Medical Officer of OncoC4. "We believe the dual targeting of PD-1 and VEGF may provide a highly complementary platform for combination approaches. By integrating cesalatamig with next-generation ADCs and precision oncology therapies such as RAS pathway inhibitors, we aim to unlock new treatment options for patients whose cancers remain difficult to treat with current standards of care." Cesalatamig is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immune responses through dual blockade of VEGF and PD-1. OncoC4 is evaluating cesalatamig across multiple tumor types in ongoing clinical studies in the United States and China. In September 2026, cesalatamig received U.S. FDA Fast Track Designation for non-small cell lung cancer (NSCLC) that progressed after concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy. The ADC combination program is intended to evaluate the potential for cesalatamig to enhance anti-tumor activity through complementary mechanisms of action, leveraging the targeted cytotoxic activity of ADCs together with immune activation and vascular normalization associated with dual PD-1/VEGF blockade. The precision medicine program will evaluate cesalatamig in combination with inhibitors of the RAS signaling pathway, one of the most frequently dysregulated oncogenic pathways across solid tumors1-2. These studies will assess whether concurrently targeting tumor-intrinsic signaling and the tumor microenvironment can produce deeper and more durable clinical responses in biomarker-selected patient populations. "Having obtained clinical proof-of-concept data demonstrating the activity of cesalatamig monotherapy in several challenging cancer indications, as well as its combinability with chemotherapy, we are now advancing rational combinations with precision therapies," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "These INDs expand our ability to evaluate cesalatamig in high-priority combinations and advance our vision of precision immuno-oncology." Patient enrollment is expected to begin following NMPA approval and completion of site activation activities. About Cesalatamig Cesalatamig (AI-081) is a differentiated PD-1/VEGF bispecific antibody designed to promote stronger cooperative interaction between PD-1 and VEGF blockade through high affinity to PD-1 and substantially higher VEGF-binding affinity than bevacizumab-based PD-(L)1/VEGF bispecific antibodies. As a result, cesalatamig shows best-in-class potential that favors its action in a PD-1 and VEGF-rich tumor microenvironment. Cesalatamig also has more effective Fc-silencing modifications to avoid the depletion of PD-1-positive effector T cells. The U.S. FDA granted cesalatamig Fast Track Designation for the treatment of non-small cell lung cancer (NSCLC) that progressed after concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy in September 2026. About OncoC4 Headquartered 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 neurodegenerative 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, including neurodegenerative diseases. Among them, cesalatamig is a wholly owned and highly differentiated PD-1/VEGF bispecific antibody currently undergoing rapid global clinical development in multiple oncology indications. Tasafustobart (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. In addition, OncoC4 recently initiated a first-in-human trial of ONC-783, a first-in-class T cell engager targeting a novel CD24 epitope selectively expressed across a broad spectrum of human cancers, including solid tumors and hematological malignancies, in the United States. 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. More information: CONTACTS Media Relations Helen Schiltz [email protected] Investor Relations Ryan Cui [email protected] References 1. Yang X, Wu H. RAS signaling in carcinogenesis, cancer therapy and resistance mechanisms. J Hematol Oncol. 2024;17:108. doi: 10.1186/s13045-024-01631-9. 2. Stites EC. The abundance of KRAS and RAS gene mutations in cancer. Methods Mol Biol. 2024;2797:13–22. doi: 10.1007/978-1-0716-3822-4_2. SOURCE OncoC4 21% more press release views with Request a Demo

ImmunotherapyFast TrackPhase 2Phase 1IND

19 Oct 2026

·www.biospace.com

BioNTech to Showcase Oncology Late-Stage Pipeline Progress and Pumitamig Novel-Novel Combination Data at ESMO 2026

Late-breaking oral presentation will feature first data from the global ROSETTA Lung-107 Phase 2 clinical trial evaluating pumitamig, a PD-L1×VEGF-A bispecific immunomodulator , plus docetaxel in patients with metastatic non-small cell lung cancer following prior immunotherapy plus chemotherapy Global Phase 2 data for pumitamig plus elfetabart drozuntecan, a B7-H3-targeting antibody-drug conjugate, expand the body of evidence for this novel-novel combination in multiple advanced solid tumors Updates from across the pumitamig clinical development program underscore its pan-tumor potential, including in lung and breast cancer patients with brain metastases and patients with neuroendocrine neoplasms MAINZ, Germany, October 19, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its late-stage oncology pipeline with 16 abstracts spanning the Company’s tumor focus areas, including lung and breast cancer, at the European Society for Medical Oncology (“ESMO”) 2026 Congress held in Madrid, Spain, from October 23–27, 2026. Key oral presentations will focus on clinical data for pumitamig (BNT327/BMS986545), a PD-L1×VEGF-A bispecific immunomodulator being jointly developed with Bristol Myers Squibb (“BMS”), plus docetaxel in second-line metastatic non-small cell lung cancer (“NSCLC”) as well as pumitamig in combination with elfetabart drozuntecan (elfe-D or BNT324/DB-1311), a B7-H3-targeting antibody-drug conjugate (“ADC”) being jointly developed with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), across several advanced solid tumors – complementing the data in lung cancer presented earlier this year. This new clinical data advances BioNTech’s differentiated novel-novel combination approach. Additional presentations for pumitamig and ADCs reflect BioNTech’s tumor-focused strategy aimed at addressing significant unmet medical needs across various stages of disease. “Sixteen abstracts spanning ten tumor types – this is our significant data presence at this year’s ESMO. It demonstrates momentum for our late-stage oncology pipeline across strategic key assets and tumor areas such as lung and breast cancer,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “For our PD-L1xVEGF immunomodulator pumitamig, we will be sharing new data that highlights its pan-tumor potential, including in challenging treatment settings where patients still show limited benefit from current standard of care therapies. Our goal is to establish pumitamig as a potential backbone for future combination regimens across multiple tumor types, including novel-novel treatment combinations. At this year's conference, we will showcase the potential of this approach in two presentations featuring ADC combinations, aimed to further enhance outcomes for patients.” Highlights from BioNTech’s presentations at ESMO 2026: Pumitamig – an investigational PD-L1×VEGF-A bispecific immunomodulator: NSCLC: First data from the global ROSETTA Lung-107 Phase 2 clinical trial ( NCT06841055 ) evaluating pumitamig plus docetaxel in patients with metastatic NSCLC whose disease progressed after immunotherapy plus chemotherapy will be presented in a late-breaking oral presentation. This clinical trial extends evidence for pumitamig’s non-small cell lung cancer development program into the second-line setting where there remains high unmet medical need, representing the third global Phase 2 dataset in lung cancer. SCLC and TNBC with brain metastases: Results from a subgroup analysis of two Phase 2 clinical trials ( NCT06449209 ; NCT06449222 ) evaluating pumitamig plus chemotherapy in patients with small cell lung cancer (“SCLC”) or triple-negative breast cancer (“TNBC”) showed systemic efficacy generally consistent in patients with and without brain metastases. These early data suggest intracranial efficacy and add to the clinical evidence for pumitamig plus chemotherapy in tumor types where brain metastases often occur and remain challenging to treat as many systemic therapies have limited ability to cross the blood-brain barrier. 2L neuroendocrine neoplasms: First results from a Phase 2 clinical trial conducted in China ( NCT05879055 ) evaluating pumitamig plus FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy in patients with unresectable neuroendocrine neoplasms after first-line platinum-based chemotherapy showed encouraging preliminary antitumor activity and a manageable safety profile. These data broaden the clinical evidence for pumitamig across diverse tumor types. Novel-novel combination of pumitamig and elfetabart drozuntecan, an investigational B7-H3-targeted ADC: Advanced solid tumors: First results from the global Phase 2 clinical trial ( NCT06953089 ) evaluating pumitamig in combination with elfetabart drozuntecan in patients with advanced solid tumors showed encouraging preliminary antitumor activity across multiple tumor types and a manageable safety profile, with minimal overlapping toxicities observed. These data support the potential of pumitamig as a backbone in novel treatment combinations, furthering BioNTech’s combination strategy across multiple tumor types with high unmet medical need. BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel-novel combination approaches. With 13 ongoing Phase 3 trials as well as multiple novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early- to late-stage conditions. All abstracts are available through the ESMO website . Further information on BioNTech’s oncology pipeline can be accessed here . Full presentation details: Candidate Abstract Title Abstract Number/Presentation Details Pumitamig A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107 Abstract #LBA76 Rapid Oral Presentation NSCLC, Metastatic Oct 25, 2026: 8:30 - 10:00am CET Efficacy of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in patients with SCLC or TNBC with brain metastases: A subgroup analysis of two phase 2 trials Abstract #1951RO Rapid Oral Presentation Investigational Immunotherapy Oct 24, 2026: 8:30 - 10:00am CEST First results from a phase 2 trial of second-line pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in unresectable neuroendocrine neoplasms Abstract #2393O Proffered Paper Presentation NETs and Endocrine Tumours Oct 26, 2026: 10:15 - 11:45am CET ROSETTA RCC-208: A phase 1/2, open-label, randomized study of pumitamig alone or in combination with ipilimumab or cabozantinib in advanced renal cell carcinoma (RCC) Abstract #3639TiP Poster Presentation Renal Cancer Oct 23, 2026: 3:15 - 4:00pm CEST ROSETTA Gastric-204: A randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC) Abstract #3081eTiP ePoster Presentation Oesophagogastric Cancer Oct 23 - 27, 2026 A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (ROSETTA HCC-206) Abstract #1762eTiP ePoster Presentation Hepatocellular Carcinoma Oct 23 - 27, 2026 Pumitamig + elfetabart drozuntecan Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trial Abstract #999O Proffered Paper Presentation Developmental Therapeutics Oct 24, 2026: 2:45 - 4:15pm CEST Pumitamig + trastuzumab pamirtecan Pumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): Phase 1 results of a phase 1/2, open-label trial (BNT323-03) Abstract #1777P Poster Presentation HER2+ Breast Cancer Oct 24, 2026: 12:00 - 12:45pm CEST Elfetabart drozuntecan Elfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) in patients with platinum-resistant ovarian cancer (PROC): Efficacy and safety data from a Phase 2 dose optimization cohort Abstract #1255P Poster Presentation Gynaecological Cancers Oct 26, 2026: 12:00 - 12:45pm CET BNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients (pts) with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC) Abstract #2300TiP Poster Presentation Metastatic Prostate Cancer Oct 23, 2026: 3:15 - 4:00pm CEST Gotistobart Gotistobart plus pembrolizumab demonstrates durable antitumor activity in advanced melanoma refractory or resistant to both prior anti-CTLA-4 and anti-PD-(L)1 therapies Abstract #2106P Poster Presentation Melanoma Oct 24, 2026: 12:00 - 12:45 pm CEST BNT317 BNT317: An anti–PD-1 × CD39 bispecific antibody demonstrating preclinical antitumor activity Abstract #420P Poster Presentation Basic Science Oct 23, 2026: 3:15 - 4pm CEST Beruzatatug pelitecan (YL202/BNT326) Clinical outcomes of YL202/BNT326 (HER3 ADC) in advanced/metastatic HR+/HER2-null/low breast cancer (BC) in chemotherapy (chemo)-naïve and exposed patients (pts) Abstract #1881P Poster Presentation HR+ Breast Cancer Oct 24, 2026: 12:00 - 12:45pm CEST BNT329 A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients (pts) with advanced solid tumors that express CA19-9 Abstract #1076TiP Poster Presentation Developmental Therapeutics Oct 23, 2026: 3:15 - 4:00 pm CEST Health Economics and Outcomes Research (HEOR) Real-world progression-free survival (rwPFS) from chemotherapy initiation in patients with HR+/HER2– metastatic breast cancer (mBC) in the US Abstract #1880P Poster Presentation HR+ Breast Cancer Oct 24, 2026: 12:00 - 12:45pm CEST Real-world outcomes with first-line pembrolizumab-based chemoimmunotherapy in patients with advanced/metastatic non-small cell lung cancer in the USA Abstract #2705P Poster Presentation NSCLC, Metastatic Oct 26, 2026: 12:00 - 12:45pm CET About BioNTech BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer. For more information, please visit . BioNTech Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545), the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392), the investigational B7H3-targeting ADC elfetabart drozuntecan (BNT324/DB-1311) alone and in combination with pumitamig, the investigational HER2-targeting ADC trastuzumab pamirtecan (BNT323/DB-1303) in combination with pumitamig, the investigational anti-PD-1×CD39 antibody BNT317, the investigational HER3-targeting ADC Beruzatatug pelitecan (Beru-Pel/YL202/BNT326), and the investigational CA19-9-targeting ADC BNT329; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at . These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. CONTACTS Media Relations Jasmina Alatovic Media@BioNTech.de Investor Relations Douglas Maffei, Ph.D. Investors@BioNTech.de

Clinical ResultPhase 2ImmunotherapyASCOADC

14 Oct 2026

·firstwordpharma.com

BioNTech's HPV-targeted cancer vaccine misses PFS goal

BioNTech's experimental mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran) failed to significantly improve progression-free survival (PFS) when combined with Merck & Co.'s Keytruda (pembrolizumab) in patients with advanced head and neck cancer.Investors reacted by sending the German biotech's US-listed shares down more than 5% on Tuesday, marking a setback for its mRNA cancer vaccine ambitions.The Phase II/III AHEAD-MERIT trial is evaluating the combo as a first-line treatment for patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1.The investigational immunotherapy encodes the HPV16-derived E6 and E7 proteins, which are frequently expressed by HPV16-positive solid tumours.OS still in playThe study compared BNT113 plus Keytruda with Keytruda alone and has dual primary endpoints of PFS and overall survival (OS). Although the combination missed the PFS endpoint, an independent data monitoring committee recommended continuing the study to assess OS.BioNTech noted that under the prespecified statistical design, a significant improvement in OS could establish a positive trial outcome despite the PFS miss. The company didn't disclose numerical PFS data in Tuesday's announcement."While the PFS result was not statistically significant at this first analysis, the data support continued evaluation of BNT113 plus pembrolizumab in this trial and show that it is engaging its intended therapeutic mechanism," said Chief Medical Officer Özlem Türeci. "As immune-mediated antitumour effects build and deepen over time, the analysis of the second dual primary endpoint, overall survival, will be critical to fully assess the potential of this approach."Limits to added benefit?However, Citi analyst Geoffrey Meacham suggested that the cancer's biology could make it difficult for BNT113 to improve on Keytruda's efficacy. "While disappointing, HNSCC is heterogeneous and heavily immunosuppressed, making incremental efficacy over pembrolizumab challenging despite the HPV16 target," he said.BioNTech's mRNA oncology efforts have yielded mixed results. In late August, the company and Roche's Genentech unit decided to terminate a Phase II trial of the individualised cancer immunotherapy autogene cevumeran (BNT122) in patients with resected colorectal cancer and detectable circulating tumour DNA after an independent monitoring board had flagged a "numerical imbalance" in OS between patient groups in the study.However, there was better news last month when BioNTech and partner OncoC4 reported median OS of 18.5 months with the investigational immunotherapy gotistobart (BNT316/ONC-392) versus 10 months with chemotherapy in previously treated squamous non–small-cell lung cancer, based on the non-pivotal first stage of the Phase III PRESERVE-003 trial.

VaccineImmunotherapyPhase 2Phase 3mRNA

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Phase 3	United States	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Australia	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Belgium	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Canada	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Germany	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Italy	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Netherlands	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	South Korea	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Spain	OncoImmune-Guangzhou, Inc.	15 Jun 2023
metastatic non-small cell lung cancer	Phase 3	Turkey	OncoImmune-Guangzhou, Inc.	15 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PRESERVE-003 (WCLC2026)	Phase 3	Squamous non-small cell lung cancer	87	Gotistobart	tpvlninanq(ksgripswon) = qptjrkbckp xdbpzxklbl (agjdrbbyxk, 9.3 - NE) View more	Positive	12 Sep 2026
				Docetaxel	tpvlninanq(ksgripswon) = loxtvpknfq xdbpzxklbl (agjdrbbyxk, 6.2 - 12.0)
PRESERVE-003 (CSCO2026)	Phase 3	Squamous non-small cell lung cancer	87	Gotistobart	yeeykudqku(wosdtvrmml) = izgycsvswf tktukfdmyt (fpbtrtxwvs, 9.33 - NE) View more	Positive	11 Sep 2026
				Docetaxel	yeeykudqku(wosdtvrmml) = aagtjqpfly tktukfdmyt (fpbtrtxwvs, 6.2 - 12.0) View more
NCT05446298 (PRESERVE-004, ASCO2026)	Phase 2	Platinum-Resistant Ovarian Carcinoma	62	Gotistobart 1 mg/kg + Pembrolizumab	cwyfhkbmvu(olllmrjvjd) = wnvtbqoyks wnntovhnze (vtglfwxrhh, 9.0 - 38.9) View more	Positive	29 May 2026
				Gotistobart 2 mg/kg + Pembrolizumab	cwyfhkbmvu(olllmrjvjd) = mldfnxixdi wnntovhnze (vtglfwxrhh, 8.0 - 39.7) View more
NCT05682443 (PRESERVE-006, ASCO_GU2026)	Phase 1	Metastatic castration-resistant prostate cancer	25	Gotistobart 3 mg/kg + Lu 177	vhqummjtoy(filnxlitqj) = uomxudbeja qhbcrzwsdz (kzjywygwbv, 22.3 - 95.7) View more	Positive	26 Feb 2026
				Gotistobart 6 mg/kg + Lu 177	vhqummjtoy(filnxlitqj) = czvbqqlogz qhbcrzwsdz (kzjywygwbv, 11.8 - 88.2) View more
NCT05671510 (PRESERVE-003, GlobeNewswire) Manual	Phase 3	Squamous non-small cell lung cancer	87	gotistobart	kxikiygkgf(kqujlydvtd) = ztkzkzhbgw ajzqwebmgu (hlxwdqktxt ) View more	Positive	06 Dec 2025
				docetaxel	kxikiygkgf(kqujlydvtd) = uxgfvpwuso ajzqwebmgu (hlxwdqktxt ) View more
NCT04140526 (PRESERVE-001, ASCO2025)	Phase 1/2	Melanoma BRAF mutation status	67	Gotistobart 3 mg/kg + Pembrolizumab 200 mg	kdtskoeydp(qeqvzvtlkd) = gklkumsgiy fdtuhgpzrv (nycbusxfmn ) View more	Positive	30 May 2025
				Gotistobart 6 mg/kg + Pembrolizumab 200 mg	kdtskoeydp(qeqvzvtlkd) = xtmdayrbxr fdtuhgpzrv (nycbusxfmn ) View more
NCT05682443 (PRESERVE-006, ASCO2025)	Phase 1/2	Metastatic castration-resistant prostate cancer androgen receptor pathway inhibition	24	Gotistobart 3 mg/kg	yzcfbmahcy(naifbcpbbq) = hwzntwkhhn jmybrkxxxb (onyhluxsas )	Positive	30 May 2025
				Gotistobart 6 mg/kg	yzcfbmahcy(naifbcpbbq) = htnkflfpwo jmybrkxxxb (onyhluxsas )
NCT05446298 (preserve-004, IGCS2024)	Phase 2	Platinum-Resistant Ovarian Carcinoma	83	Gotistobart 1 mg/kg + Pembrolizumab 200 mg	noqwhbjoed(fdsqcpiqhz) = mtpssfpegp epikvzsoak (ghcvhhgurx, 13.9 - 54.9) View more	Positive	16 Oct 2024
				Gotistobart 2 mg/kg + Pembrolizumab 200 mg	noqwhbjoed(fdsqcpiqhz) = wvchwxdbgr epikvzsoak (ghcvhhgurx, 17.2 - 59.3) View more
NCT04140526 (PRESERVE-001, SITC2023)	Phase 1/2	metastatic non-small cell lung cancer PD-(L)1 resistant	35	ONC-392/BNT316 10 mg/kg x 2 followed by 6 mg/kg, Q3W	wqsvzupbqz(upqaifeeag) = ktflgvbxem yjewodfsxa (tthxsqhpnv ) View more	Positive	02 Nov 2023
NCT04140526 (PRESERVE-001, ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Non-Small Cell Lung Cancer	33	Gotistobart	asdlmonciz(ffesjmpifj) = coshmrktqx rpxqnngrrz (wimpjzxhud ) View more	Positive	31 May 2023

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