BioNTech, OncoC4 Phase 3 study put on partial hold by FDA

BioNTech (NASDAQ:BNTX) and OncoC4 have had a partial clinical hold placed by the FDA on a Phase 3 study for their drug candidate BNT316/ONC-392 in the treatment of non-small cell lung cancer, or NSCLC.

In an SEC filing, BioNTech said the hold was placed due to “varying results between the squamous and non-squamous NSCLC patient populations.” It added that a recent assessment by the study’s independent data monitoring board “identified a possible variance in the population results.”

“Consequently, OncoC4 and BioNTech decided to proactively pause enrollment of new patients and informed the FDA of the possible variance for further alignment,” BioNTech said in the filing.

BioNTech said patients already enrolled in the study will continue to receive treatment while the companies assess the next steps. Studies for the drug candidate in other indications are unaffected by the hold.

The study is evaluating BNT316/ONC-392 as a monotherapy in patients with metastatic NSCLC who have progressed under previous PD-L1 inhibitor treatment.

In addition to the NSCLC study, BNT316/ONC-392 is being evaluated in a Phase 2 trial as a combination therapy with pembrolizumab for platinum-resistant ovarian cancer, in a Phase 1/2 trial for metastatic castration-resistant prostate cancer, and in a Phase 1/2 trial for multiple solid tumors.

BioNTech and OncoC4 entered into an agreement to co-develop ONC-392 in March 2023.