BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC

BioNTech and US based OncoC4 today announced that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024, the companies said in a press release Thursday.

The two-stage, open-label, randomized Phase 3 trial, PRESERVE-003 (NCT05671510), will assess the efficacy and safety of BNT316/ONC-392 as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. Approximately 600 patients are planned to be enrolled at clinical sites in the United States, Europe and other countries and regions, including Belgium, Germany, Italy, Spain, and Türkiye. The primary endpoint measure will be overall survival. Secondary endpoints include overall response rate, progression-free survival and adverse event profile. The program received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2022 and represents an innovative approach which aims to leverage the full potential of CTLA-4-targeting therapies.

“We believe this investigational treatment has the potential to become a new option for patients with late-stage NSCLC who have an otherwise poor prognosis. Given its specific mode of action, this treatment approach may also be applicable in a synergistic combination with other immunotherapeutic modalities to provide benefit to further patient populations,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. “We are committed to rapidly advancing our oncology pipeline towards late-stage development for multiple product candidates in cancer indications with high unmet medical need.”

“Today represents a significant landmark for the differentiated program we developed with BNT316/ONC-392, aiming to overcome current challenges of CTLA-4-targeting cancer therapeutics and in particular the very narrow therapeutic window that restricts them from delivering on their full potential,” said Pan Zheng, M.D., Ph.D., Chief Medical Officer and Co-Founder at OncoC4. “With less than three years from first-in-human dosing to Phase 3 initiation, we are hopeful these results will build on the responses we have seen so far.”