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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.
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.
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).
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.
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.