BioNTech SE and OncoC4, Inc. announced positive preliminary data from the ongoing Phase 1/2 trial with the companies' anti-CTLA-4 antibody candidate, BNT316/ONC-392 (gotistobart), in a patient cohort with metastatic, PD-(L)1-resistant non-small cell lung cancer (“NSCLC”). The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile. The data will be presented in a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting by Kai He, M.D., Ph.D., Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio, USA.

The results featured at the ASCO Annual Meeting include a total of 27 patients with metastatic, PD-(L)1-resistant NSCLC, available for tumor response assessment who have received at least two doses of 10 mg/kg of BNT316/ONC-392. At data cut-off, the overall response rate (“ORR”) among evaluable patients was 29.6%, with a disease control rate (“DCR”) of 70.4%, including 1 complete response, 7 partial responses and 11 patients with stable disease. BNT316/ONC-392 continues to be well tolerated with a manageable safety profile.

Immune-related adverse events (irAE) of Grade 3 and 4 were observed in 10 patients (30%), which is considered lower than what was reported for similar drugs. Lung cancer remains one of the most commonly diagnosed malignant cancer types and the leading cause of cancer deaths worldwide, with NSCLC1 making up approximately 85% of all lung cancers. The new data further support the initiation of a pivotal Phase 3 study with BNT316/ONC-392 as monotherapy for immunotherapy-resistant NSCLC, for which the candidate received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) in 2022.

The Phase 3 trial, PRESERVE-003 (NCT05671510), is planned to start in Third Quarter 2023.