Another hold for BioNTech

Fresh from resolving one clinical hold BioNTech has been hit by another, this time for its supposedly less toxic anti-CTLA-4 MAb gotistobart, licensed from OncoC4 for $200m. Few details are available – BioNTech only said in an SEC filing on Friday that the Preserve-003 trial, testing gotistobart versus docetaxel in PD-(L)1-relapsed NSCLC, had shown “varying results” between the squamous and non-squamous populations. Patients already enrolled into the study will continue to receive therapy, and the hold doesn’t affect other gotistobart trials, BioNTech said. The company didn’t mention adverse events, but it’s worth noting that the initial stage of Preserve-003 tests gotistobart at 3mg/kg and 6mg/kg every three weeks; these doses were dialled down in the Preserve-004 ovarian cancer trial following toxicities seen in a phase 1 basket study, Preserve-001. And, even at lower doses of 1mg/kg and 2mg/kg, Preserve-004 found high levels of adverse events and discontinuations; however, gotistobart is being combined here with Keytruda, while the NSCLC Preserve-003 trial is evaluating gotistobart monotherapy. Gotistobart is claimed to have a smart design, using a pH-sensitive molecule to avoid autoimmunity-related side effects, but it’s still unclear whether it really is less toxic than Bristol Myers Squibb’s Yervoy.

Global gotistobart trials

Source: OncologyPipeline & clinicaltrials.gov.