FDA Discourages Accelerated Approval for Agenus’ Colorectal Cancer Combination, Prompting Partnership Search

1. FDA Discouragement: The FDA has advised against Agenus seeking accelerated approval for its botensilimab (BOT) and balstilimab (BAL) combination for treating relapsed or refractory colorectal cancer.
2. Phase II Results: The combination showed an overall response rate (ORR) of 19.4% at a 75-mg BOT dose with 240 mg of BAL, but the ORR dropped to 8.2% at a higher BOT dose.
3. Alternative Pathways: Agenus is now exploring alternative pathways, including partnerships, to initiate a Phase III trial for BOT/BAL.
4. Financial Support: Agenus has $52.9 million in cash and a $100 million royalty financing agreement with Ligand Pharmaceuticals to support the development and potential launch of BOT/BAL.
5. CEO's Concerns: CEO Garo Armen expressed concerns about funding a full-fledged Phase III trial without near-term commercialization revenue.