Agenus shares surge as company secures up to $340M to advance colon cancer trial

Agenus (Agenus Inc (NASDAQ:AGEN)) shares jumped about 100% on Monday after the biotechnology company announced an oversubscribed private placement of up to $340 million to support development of its botensilimab and balstilimab (BOT+BAL) immunotherapy combination in microsatellite-stable (MSS)...

Agenus (Agenus Inc (NASDAQ:AGEN)) shares jumped about 100% on Monday after the biotechnology company announced an oversubscribed private placement of up to $340 million to support development of its botensilimab and balstilimab (BOT+BAL) immunotherapy combination in microsatellite-stable (MSS) colon cancer. The financing includes approximately $85 million in upfront gross proceeds, with an additional potential $255 million available through the full exercise of purchase warrants. The transaction was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals.

Agenus said proceeds from the financing will be used to advance ROBBIN, a planned registrational Phase 3 trial evaluating neoadjuvant BOT+BAL in previously untreated high-risk Stage II and Stage III MSS colon cancer. The company expects the financing, assuming full warrant exercise, to provide funding through the end of 2031. The ROBBIN trial is designed to enroll 850 patients globally and will compare neoadjuvant BOT+BAL followed by standard of care against standard of care alone.

The primary endpoint will be event-free survival (EFS). A genus said it has aligned key elements of the trial design with the US Food and Drug Administration, including the patient population, treatment regimen, control arm, endpoint and interim analysis plan. The company highlighted data from two Phase 2 studies, NEST and UNICORN, which evaluated neoadjuvant BOT+BAL in MSS colorectal cancer.

Agenus reported pathologic responses in approximately 60% to 70% of patients, major pathologic responses in approximately 35% to 40%, and pathologic complete responses in about 30%. The company said all treated patients remained disease-free at median follow-up periods ranging from approximately nine to 18 months. Agenus estimates that high-risk Stage II and Stage III MSS colon cancer represents an annual US addressable market opportunity of more than $7 billion, with no new curative-intent therapies approved in the setting in more than two decades.

The company expects the first patient in the ROBBIN trial to be dosed in the first quarter of 2027, with interim pathologic response data anticipated in the second half of 2027. Interim EFS analysis is expected in the second half of 2029, followed by final EFS analysis in the second half of 2030. "Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer," Chief Executive Officer Garo H. Armen said in a statement.

"Our plan to prioritize neoadjuvant BOT+BAL in MSS colon cancer reflects both the strength of the emerging clinical evidence and the opportunity to bring this important combination regimen to patients where it may have the greatest impact."