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News & Resources

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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30 December 2022

OncoC4 Announces First Patient Dosed in PRESERVE-004, a Phase 2 Clinical Trial of ONC-392 in Combination with KEYTRUDA® (Pembrolizumab) in Patients with Platinum-Resistant Ovarian Cancer

The Phase 2 multicenter, open-label combination trial builds upon the promising results of monotherapeutic activity of ONC-392 seen in previous clinical trial

DEC 30, 2022, Rockville, Maryland -- OncoC4, Inc., a clinical-stage biopharma company developing novel immunotherapies for cancer, today announced that the first patient has been dosed in the Phase 2 combination study of ONC-392, a nextgen target-preserving anti-CTLA-4 antibody and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with platinum-resistant ovarian cancer (PROC) (PRESERVE-004, NCT05446298).

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07 November 2022

OncoC4 to Present Positive Data from Ongoing Phase 1/2 PRESERVE-001 Trial of ONC-392 in Combination with pembrolizumab at SITC 2022

  • 30% ORR and 90% DCR in evaluable patients were achieved in the dose escalation portion of the study in metastatic cancer patients
  • Initial results from dose-expansion show 5 partial responses (PR) and 1 disease stabilization (SD) in 6 evaluable metastatic melanoma patients

Nov 07, 2022, Rockville, Maryland -- OncoC4, Inc., a clinical-stage biopharma company developing novel immunotherapies for cancer, today announced clinical and safety data from the ongoing Phase 1/2 PRESERVE-001 trial for the part involving ONC-392 in combination with pembrolizumab in metastatic cancer. ONC-392 is an anti-CTLA-4 monoclonal antibody that preserves the CTLA-4 immune tolerance checkpoint function as a single agent in advanced solid tumors or in combination with anti-PD-(L)1 therapy.

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26 April 2022

Oncoc4 Announces Fast Track Designation Granted By The U.S. FDA For ONC-392 Monotherapy In PD(L)1-Resistant NSCLC

A Phase 1b clinical trial of ONC-392 in PD(L)1-resistant NSCLC is currently underway

April 25, 2022, Rockville, Maryland -- OncoC4, Inc., a clinical stage biopharma company developing novel immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC-392, the Company’s next-gen anti-CTLA-4 monoclonal antibody (mAb) that preserves the CTLA-4 immune checkpoint function, as a single agent for the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) who have had disease progression on prior anti-PD-(L)1 therapy.

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01 April 2022

Dr. Yang Liu Acknowledged as Top 20 Dynamic CEOs of 2022

ROCKVILLE, Md., Mar. 31, 2022 - The CEO Publication, a unique digital platform featuring the industry experts who have created ripples across various areas of expertise, has acknowledged Dr. Yang Liu, Chairman, CEO & CSO, OncoC4 — a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment — one among the “Top 20 Dynamic CEOs of 2022″ who is transforming the industry with his unique solutions. The CEO Publication has become a pioneering magazine owing to their unique coverage of news, articles & industry leaders concentrating on transforming various arenas.