BioNTech in-licenses cancer candidate from OncoC4

In a further move to broaden the clinical development of its cancer immunotherapy pipeline, Germany’s BioNTech (Nasdaq: BNTX) has entered into an exclusive worldwide license and collaboration agreement with privately-held US drug developer Oncc4 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 German company, which like its partner Pfizer (NYSE: PFE) is flush with cash from sales of coronavirus vaccine Comirnaty, has been investing heavily in clinical and commercial development.

ONC-392 has already received fast track designation from the US 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 III trial which will evaluate ONC-392 as monotherapy against the current standard of care in that indication. The candidate is currently also being evaluated in an additional Phase II trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer.