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BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.
On March 20, 2023, BioNTech and OncoC4, a US-based clinical-stage biopharmaceutical company, announced that they have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of OncoC4’s next-generation anti-cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) monoclonal antibody (mAb) candidate, ONC-392. The companies aim to co-develop and commercialize ONC-392 as a monotherapy or in combination therapy for various solid tumor cancer indications.
Under the agreement, OncoC4 will receive $200 million in an upfront payment. The company is also eligible to receive development, regulatory, and commercial milestone payments in addition to double-digit tiered royalties. The two companies will jointly develop ONC-392 as monotherapy and in combination with anti-programmed cell death (PD)-(L)-1 antibodies. The companies will be aiming for a range of solid tumor indications, including non-small cell lung cancer (NSCLC). The joint effort will continue until approval of the candidate is achieved. Both parties will share equally in the development costs for studies. The transaction is expected to close in the first half of 2023, dependent on customary closing conditions and regulatory clearances.
BioNTech will solely develop all combinations outside of the PD-1 inhibition indication—in particular all combinations with a compound in BioNTech’s pipeline. BioNTech will hold exclusive worldwide commercialization rights for any products it develops from these candidates, with OncoC4 participating in certain markets, which are to be negotiated in the future.
ONC-392 has received fast track designation from FDA as a monotherapy for immunotherapy-resistant NSCLC. It is also currently being evaluated in an additional Phase II trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer.
“Despite being a prime target for more than a decade, we believe that targeting CTLA-4 has not reached its full potential in cancer immunotherapy," said Prof. Ugur Sahin, CEO and co-founder of BioNTech, in a company press release. "The data presented by OncoC4 on their ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in various types of tumors. We believe that this antibody is a valuable addition to our immuno-oncology portfolio, whether used alone or in combination with our personalized immunotherapies.”
“Because of its specific mechanism of action, we believe ONC-392 has the potential to broaden the reach of CTLA-4-targeting immunotherapy,” said Yang Liu, co-founder, CEO and chief scientific officer of OncoC4, in the release. “We very much look forward to working hand-in-hand with BioNTech in developing ONC-392 for cancer indications with unmet medical needs.”