The FDA put a partial clinical hold on a Phase 3 trial of an anti-CTLA-4 antibody from OncoC4 and its partner BioNTech, the German biotech disclosed in a Friday SEC filing.
BioNTech paid $200 million upfront to OncoC4 in the spring of 2023 to get access to the drug, gotistobart. The drug is a next-generation example of a class of cancer immunotherapies that includes Bristol Myers Squibb’s Yervoy and AstraZeneca’s Imjudo.
The hold applies to a trial of gotistobart in patients with metastatic non-small cell lung cancer whose disease has progressed despite receiving anti-PD-1/PD-L1-based medicines. The Phase 3 PRESERVE-003 trial is testing whether gotistobart is better than chemotherapy at prolonging life for these patients.
The hold came after the trial’s independent data monitoring committee found “varying results between the squamous and non-squamous NSCLC patient populations,” according to the companies.
“Consequently, OncoC4 and BioNTech decided to proactively pause enrollment of new patients and informed the FDA of the possible variance for further alignment,” BioNTech wrote in the SEC filing.
The companies said they’re determining next steps for the trial, which is continuing for already-enrolled patients. The hold doesn’t impact other tests of gotistobart, such as a Phase 2 trial in combination with Merck’s Keytruda in certain ovarian cancers, and a Phase 1/2 trial pairing it with Novartis’ Pluvicto in metastatic castration-resistant prostate cancer.
OncoC4, an OncoImmune spinout, is currently merging with AcroImmune. The companies already share founders and investors.