The collaboration aims to develop and market OncoC4’s monoclonal antibody candidate, ONC-392, as a standalone, or combination therapy to treat several cancer types
BioNTech main administration and laboratory building. (Credit: Epizentrum/ Wikimedia Commons)
German biotechnology company BioNTech has entered into an exclusive worldwide license and collaboration agreement with clinical-stage biopharmaceutical company OncoC4.
The collaboration aims to develop and market OncoC4’s monoclonal antibody candidate, ONC-392, as a standalone, or combination therapy to treat several cancer types.
Under the terms of the collaboration, OncoC4 will receive an upfront payment of $200m and is eligible to receive milestone payments, along with double-digit tiered royalties.
BioNTech and OncoC4 will jointly develop ONC-392 as monotherapy and in combination with anti-PD-(L)-1 antibodies in a range of solid tumour indications, including NSCLC.
Both parties will equally share development costs until regulatory approval.
BioNTech will obtain exclusive global rights to commercialise any of the products resulting from the collaboration, with OncoC4 participating in certain markets subject to negotiation.
The company will be responsible for developing all combinations outside of PD-1 inhibition, particularly with a compound in its own pipeline.
The transaction is expected to be completed in the first half of this year, subject to customary closing conditions and regulatory clearances.
BioNTech chief executive officer and co-founder Ugur Sahin said: “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 their 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.”
OncoC4 designed ONC-392 as a next-generation antibody candidate that targets immune checkpoint receptor CTLA-4, which inhibits T cell immune response.
By blocking CTLA-4, ONC-392 restores T cell activity and enhances anti-tumour activity, resulting in fewer immune-related adverse effects and a positive safety profile.
The drug has been granted US Food and Drug Administration (FDA) Fast Track designation as monotherapy for immunotherapy-resistant NSCLC.
It is currently also being evaluated in an additional Phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer.
OncoC4 co-founder, CEO, and chief scientific officer Yang Liu said: “Because of its specific mechanism of action, we believe ONC-392 has the potential to broaden the reach of CTLA-4-targeting immunotherapy.
“We very much look forward to working hand-in-hand with BioNTech in developing ONC-392 for cancer indications with unmet medical needs.”