BIOBRIEF
A late stage (phase 3) trial of its botensilimab plus balstilimab cancer immunotherapy combination, in metastatic disease, dies three months after launch; the same drugs now target earlier stage colon cancer with intact tumors, before they go cold
Agenus is scrapping a three-month-old phase 3 trial of its botensilimab-plus-balstilimab combo in metastatic colorectal cancer and redirecting the drug to earlier-line colon cancer, where tumors are still intact, on a $340M bet that the biology works better upstream.
The abandoned study, Battman, aimed to enroll 830 patients with microsatellite-stable metastatic colorectal cancer and launched in April. Agenus pulled it Monday and is now pushing the same combination into a new study. Chief Medical Officer Steven O'Day framed the move as a mechanistic reframe: in metastatic disease, the immune system has already been exhausted by a "cold" tumor, one the body largely ignores, while earlier-stage disease still has an immune substrate to work with. Agenus pegs the U.S. addressable population at about 38,000 and the U.S. sales opportunity at roughly $7B.
The pivot is funded by an up-to-$340M private placement led by Commodore Capital, with RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals on the cap table. Agenus says it will honor obligations to patients currently on Battman and transition with participating investigators.
Three months is fast even for a strategic pivot, and BOT+BAL's earlier combination with MiNK's agenT-797 missed the primary endpoint of a phase 2 in gastroesophageal cancer earlier this year. Both belong in the calculus, though neither directly tested the intact-tumor hypothesis the new study is built around.