• BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC)
• Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable safety profile in patients with metastatic, PD-(L)1-resistant NSCLC
• Initiation of a pivotal Phase 3 trial with BNT316/ONC-392 as monotherapy in immunotherapy-resistant NSCLC patients is planned in Q3 2023, following FDA’s Fast Track designation in 2022
• 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

MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 2, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), today 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 Phase 2 multicenter, open-label combination trial builds upon the promising results of monotherapeutic activity of ONC-392 seen in previous clinical trial

DEC 30, 2022, Rockville, Maryland -- OncoC4, Inc., a clinical-stage biopharma company developing novel immunotherapies for cancer, today announced that the first patient has been dosed in the Phase 2 combination study of ONC-392, a nextgen target-preserving anti-CTLA-4 antibody and KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with platinum-resistant ovarian cancer (PROC) (PRESERVE-004, NCT05446298).

A Phase 1b clinical trial of ONC-392 in PD(L)1-resistant NSCLC is currently underway

April 25, 2022, Rockville, Maryland -- OncoC4, Inc., a clinical stage biopharma company developing novel immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC-392, the Company’s next-gen anti-CTLA-4 monoclonal antibody (mAb) that preserves the CTLA-4 immune checkpoint function, as a single agent for the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) who have had disease progression on prior anti-PD-(L)1 therapy.