German biopharma BioNTech has closed a licensing deal with the U.S.-based clinical-stage company OncoC4 for the development and commercialization of the latter’s lead candidate ONC-392, for the treatment of cancer.
OncoC4 will receive $200 million upfront, and the transaction is expected to be completed in the first half of 2023. The company will also be given development, regulatory and commercial milestone payments along with tiered royalties.
The agreement allows both companies to co-develop ONC-392 as a monotherapy and in combination with other cancer therapies to target solid tumors.
The candidate ONC-392, which is an anti-CTLA-4 monoclonal antibody, is in phase 1/2 trial, following the U.S. Food and Drug Administration’s (FDA) nod for Fast Track designation for immunotherapy-resistant non-small cell lung cancer (NSCLC). The FDA’s Fast Track approval is meant to expedite the evaluation of drugs that treat serious conditions which could fulfil an unmet medical need.
“The data presented by OncoC4 on their ONC-392 antibody indicate a differentiated safety profile and encouraging clinical activity in various types of tumors,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
The mechanism of ONC-392 is to block CTLA-4 – a protein receptor which inhibits the T cell immune response of recognizing and eliminating cancer cells – in order to accelerate anti-tumor activity.
The antibody ONC-392 aims to destroy T cells in the tumor region, and successfully kill the tumor, as well as preserve regulatory T cells in healthy tissues, thereby improving its safety profile.
Sahin, who believes that targeting CTLA-4 “has not reached its full potential in cancer immunotherapy” yet, expressed that the drug candidate is a “valuable addition” to BioNTech’s immuno-oncology portfolio.
Yang Liu, co-founder, CEO and chief scientific officer of OncoC4, said: “Because of its specific mechanism of action, we believe ONC-392 has the potential to broaden the reach of CTLA-4-targeting immunotherapy.”
While positive data from ongoing clinical trials prompts the initiation of a randomized phase 3 trial, ONC-392 is also being examined in a phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer.
Known for its collaborations with multinational biopharmas like Genmab and Pfizer, BioNTech focuses on novel immunotherapies for cancer, and will now hold an exclusive worldwide license for the commercialization of OncoC4’s ONC-392.