BioNTech SE (Nasdaq: BNTX, „BioNTech“) announced a strategic collaboration with the American biopharmaceutical company OncoC4 , Inc. („OncoC4”) to co-develop and commercialise a novel checkpoint-antibody for the treatment of solid tumors. The Mainz-based biotech company commits to an upfront payment of 200 Mio. $ and further success-based payments as well as shares in any sales proceeds.

BioNTech receives an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 monoclonal antibody candidate, ONC-392. In return, OncoC4 will receive an upfront payment of 200 Mio. $ and is eligible to receive development, regulatory and commercial milestone payments as well as 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 tumor indications. A randomized Phase 3 trial is planned to start this year.

The monoclonal anti-CTLA-4-antibody candidate is considered as variant of the “next generation” in this field of immunotherapy. The immune checkpoint receptor CTLA-4 inhibits the activity of immune cells through various mechanisms of action. 

ONC-392 aims to eliminate immunosuppressive T cells (regulatory T cells, „Tregs“) within the tumor microenvironment but spare Tregs in healthy tissues. With a potentially differentiated safety profile, ONC-392 may be able to achieve a more effective dosing regimen in the clinic and more successful tumor killing.

“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, M.D., Chief Executive Officer and Co-Founder of BioNTech. "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.”