BioNTech and OncoC4 to partner for development and commercialisation of novel checkpoint antibody

BioNTech and OncoC4 have entered a strategic collaboration for the co-development and commercialisation of a novel checkpoint antibody for multiple solid tumor indications. BioNTech will receive an exclusive worldwide license from OncoC4 for its anti-CTLA-4 monoclonal antibody candidate, ONC-392.
The companies are expected to co-develop ONV-392 as either a monotherapy or in combination with anti-PD1 for the treatment of various solid tumour indications, with BioNTech also planning to combine ONC-392 with its other oncology candidates ‒ allowing the company to assess complementary treatments to increase the therapeutic impact of the drug.
OncoC4 will receive an upfront payment of $200m as well as being eligible for development, regulatory and commercial milestone payments and tiered royalties. The drug has already received Fast Track designation from the FDA as a monotherapy for immunotherapy-resistant non-small cell lung cancer (NSCLC).
It is expected that a phase 3 trial assessing ONC-392 will begin this year, although it is currently also being evaluated in a phase 2 trial as a combination therapy alongside pembrolizumab to treat platinum-resistant ovarian cancer.
Professor Ugur Sahin, MD, co-founder and CEO of BioNTech, commented: “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. The data presented by OncoC4 on its ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in various types of tumours. We believe that this antibody is a valuable addition to our immuno-oncology portfolio, whether used alone or in combination with our personalised immunotherapies.”
Yang Liu, PhD, co-founder, CEO and CSO of OncoC4, added: “Because of its specific mechanism of action, we believe ONC-392 has the potential to broaden the reach of CTLA- 4-targtting immunotherapy. We very much look forward to working hand-in-hand with BioNTech in developing ONC-392 for cancer indications with unmet medical needs.”