Positive new data on BioNTech and OncoC4’s gotistobart

8 December 2025

German biotech BioNTech (Nasdaq: BNTX) and USA-based OncoC4 yesterday presented data from the non-pivotal dose-confirmation stage of the global randomized Phase III trial PRESERVE-003 for gotistobart (also known as BNT316 or ONC-392), a tumor microenvironment-selective regulatory T cell (Treg) depletion candidate, targeting CTLA-4 in patients with metastatic squamous non-small cell lung cancer (sqNSCLC).

Gotistobart, originated by OncoC4 and licensed to BioNTech, demonstrated a clinically-meaningful overall survival (OS) benefit compared to standard-of-care chemotherapy and a manageable safety profile in sqNSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy.

The data from the non-pivotal stage of the trial were presented in an oral presentation at the IASLC ASCO 2025 North America Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer in Chicago, Illinois, USA.

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