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News & Resources

22 February 2024

OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1/2 Trial of BioNTech-partnered BNT316/ONC-392 Program

  • The Phase 1/2 trial will assess the efficacy and safety of BNT316/ONC-392 in combination with the radioligand therapy lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with metastatic castration resistant prostate cancer (“mCRPC”) who have progressed on an androgen receptor (“AR”) pathway inhibitor.
  • The trial is expected to enroll 144 patients at clinical trial sites in the United States
  • The study is in furtherance of the strategic collaboration between BioNTech and OncoC4 which includes joint development BNT316/ONC-392 in a range of solid tumor indications

ROCKVILLE, Md., Feb. 22, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”) today announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). BNT316/ONC-392 is being jointly developed by BioNTech and OncoC4.

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04 January 2024

OncoC4 to Present at the 42nd Annual J.P. Morgan Healthcare Conference

ROCKVILLE, Md., USA, Jan 04, 2024 (GLOBE NEWSWIRE) — OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, today announced its participation in the 42nd Annual J.P. Morgan Healthcare Conference being held in San Francisco, California. Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4 will present an overview of the company and its pipeline at 11 a.m. Pacific Time on Thursday, January 11, 2024, in the Mission Bay Room (32nd Floor) of The Westin St. Francis Hotel.

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28 September 2023

OncoC4 Strengthens Leadership Team with the Appointment of Abid Ansari as Chief Financial Officer

ROCKVILLE, Md., USA, Sept 28, 2023 (GLOBE NEWSWIRE) — OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, today announced the appointment of Abid Ansari as Chief Financial Officer (CFO), effective immediately. Abid brings over 20 years of expertise in financial strategy and business development for public and private life science companies to OncoC4. He will lead the company’s finance, business development, investor relations, and public relations functions.

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29 June 2023

BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC

  •  Initiation of pivotal Phase 3 trial in non-small cell lung cancer (NSCLC) marks the first landmark in BioNTech’s and OncoC4’s strategic collaboration initiated in March 2023 with the aim to evaluate BNT316/ONC-392 in various solid tumor indications
  • The randomized Phase 3 trial is expected to enroll approximately 600 patients with metastatic, immunotherapy-resistant NSCLC at clinical trial sites initially in the United States, followed by Europe and other countries and regions
  • The trial initiation follows the FDA Fast Track Designation granted in 2022, based on Phase 1/2 safety and efficacy data for the monotherapy in metastatic, immunotherapy-resistant NSCLC
  • BNT316/ONC-392 is entering the pivotal clinical evaluation as part of BioNTech’s strategy to initiate multiple trials with registrational potential in 2023 and 2024

MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 29, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024.

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02 June 2023

BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO

  • BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC)
  • Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable safety profile in patients with metastatic, PD-(L)1-resistant NSCLC
  • Initiation of a pivotal Phase 3 trial with BNT316/ONC-392 as monotherapy in immunotherapy-resistant NSCLC patients is planned in Q3 2023, following FDA’s Fast Track designation in 2022
  • Lung cancer remains one of the most commonly diagnosed malignant cancer types and the leading cause of cancer deaths worldwide, with NSCLC1 making up approximately 85% of all lung cancers

MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 2, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), today announced positive preliminary data from the ongoing Phase 1/2 trial with the companies’ anti-CTLA-4 antibody candidate, BNT316/ONC-392 (gotistobart), in a patient cohort with metastatic, PD-(L)1-resistant non-small cell lung cancer (“NSCLC”). The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile. The data will be presented in a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting by Kai He, M.D., Ph.D., Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio, USA.

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20 March 2023

BioNTech and OncoC4 Announce Strategic Collaboration to Co-Develop and Commercialize Novel Checkpoint Antibody in Multiple Solid Tumor Indications

  • BioNTech to receive exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 monoclonal antibody candidate, ONC-392

  • BioNTech and OncoC4 will co-develop ONC-392 as monotherapy or in combination with anti-PD1 in various solid tumor indications, with a randomized Phase 3 trial planned to start in 2023

  • BioNTech also plans to combine ONC-392 with its proprietary oncology product candidates to evaluate complementary modes of action with the aim to increase therapeutic effect and unlock larger patient populations

  • OncoC4 will receive $200 million upfront and is eligible to receive development, regulatory and commercial milestone payments and double-digit tiered royalties 

MAINZ, Germany and ROCKVILLE, Maryland, USA, March 20, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel biologicals for cancer treatment, today announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.

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