On March 20, 2023, BioNTech SE and OncoC4, Inc. 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 pembrolizumumab in platinum-resistant ovarian cancer (NCT056715 10). The candidate is currently also be evaluated in an additional Phase 2 trials as a combination therapy with p Embrolizumab in platinum-resistant prostate cancer (NCT05446298).