Transgene’s therapeutic cancer vaccine candidate has failed a mid-stage test in certain HPV-driven cancers, sending its shares down around 14% Monday morning.
The French biotech’s TG4001 plus Merck KGaA’s PD-L1 drug Bavencio did not meet the progression-free survival primary endpoint versus Bavencio alone in a Phase 2 study in people with recurrent or metastatic HPV16-positive cervical and anogenital cancers, according to a Monday release.
Alessandro RivaBut a planned subgroup analysis in patients with cervical cancer showed a positive efficacy trend in favor of the treatment cohort, the company said. Transgene CEO Alessandro Riva added it would run a “rigorous analysis” of the data before deciding if there’s a path forward for TG4001 in cervical cancer, taking into account the “evolving treatment landscape.”
In March, Transgene announced it had completed the trial’s enrollment with 86 patients. The company plans to present the full data at an upcoming scientific conference.
For now, Transgene said it is focused on advancing its lead therapeutic vaccine candidate, TG4050, for head and neck cancers. The biotech will present Phase 1 follow-up data on this asset at the Society for Immunotherapy of Cancer annual meeting next month. In June, Transgene said the first patient had been enrolled in the Phase 2 part of an ongoing Phase 1/2 study of TG4050.
In May 2023, AstraZeneca walked away from an oncolytic virus pact with Transgene. At the end of June this year, the company reported just €15.3 million ($16.7 million) in cash and other financial assets and said it should have “financial visibility” through the end of 2025.