Press Release BioNTech and OncoC4 Announce Strategic...

Press Release BioNTech and OncoC4 Announce Strategic Collaboration to Co-Develop and Commercialize Novel Checkpoint Antibody in Multiple Solid Tumor Indications 20 March 2023 PDF Version BioNTech to receive exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 monoclonal antibody candidate, ONC-392BioNTech and OncoC4 will co-develop ONC-392 as monotherapy or in combination with anti-PD1 in various solid tumor indications, with a randomized Phase 3 trial planned to start in 2023BioNTech also plans to combine ONC-392 with its proprietary oncology product candidates to evaluate complementary modes of action with the aim to increase therapeutic effect and unlock larger patient populationsOncoC4 will receive $200 million upfront and is eligible to receive development, regulatory and commercial milestone payments and double-digit tiered royalties MAINZ, Germany and ROCKVILLE, Maryland, USA, March 20, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel biologicals for cancer treatment, today announced that they have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances. CTLA-4 is a molecule that inhibits the activity of immune cells via various mechanisms. OncoC4’s CTLA-4 antibody candidate ONC-392 aims to delete immunosuppressive T cells (regulatory T cells, “Tregs”) in 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. Data from the ongoing Phase 1/2 trial (NCT04140526) in patients with advanced solid tumors were presented at SITC in 2022 and 2021, where ONC-392 showed encouraging clinical activity, either as single agent or in combination with pembrolizumab in patients with metastases, particularly those who progressed on immunotherapies targeting PD-1 and CTLA-4. ONC-392 received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) as a monotherapy for immunotherapy-resistant non-small cell lung cancer (“NSCLC”). The data in monotherapy of PD-1-resistant NSCLC support the initiation of a randomized Phase 3 trial which will evaluate ONC-392 as monotherapy against the current standard of care in that indication (NCT05671510). The candidate is currently also being evaluated in an additional Phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer (NCT05446298). “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.” “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, PhD, Co-Founder, CEO and Chief Scientific Officer of OncoC4. “We very much look forward to working hand-in-hand with BioNTech in developing ONC-392 for cancer indications with unmet medical needs.” Under the terms of the agreement, OncoC4 will receive a $200 million upfront payment