Lexington, Mass. — Agenus has entered into a private placement expected to provide about $85 million in upfront gross proceeds and up to an additional $255 million if associated warrants are fully exercised.
The financing will support the company’s planned Phase 3 ROBBIN trial evaluating botensilimab and balstilimab, known as BOT+BAL, as a neoadjuvant treatment for microsatellite-stable colon cancer.
The transaction was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus and Ligand Pharmaceuticals. Agenus said the financing could fund its operations through the end of 2031 if all warrants are exercised.
ROBBIN is expected to enroll 850 patients with previously untreated, high-risk Stage II or Stage III microsatellite-stable colon cancer. Participants will be randomly assigned to receive BOT+BAL followed by standard-of-care treatment or standard-of-care treatment alone.
The trial’s primary endpoint will be event-free survival. Agenus said it has aligned with the FDA on key elements of the study design, including the patient population, treatment regimen, control arm and interim analysis plan.
“We have seen neoadjuvant and perioperative immunotherapy improve outcomes in immunologically ‘hot’ or ‘warm’ tumors such as melanoma and lung cancer, but MSS colon cancer — a ‘cold’ tumor — has resisted standard checkpoint inhibitors. BOT was engineered to overcome that resistance and has produced deep pathologic responses with no recurrences reported in the NEST and UNICORN studies. With the ROBBIN trial, we are bringing this regimen to patients with high-risk Stage II and Stage III MSS colon cancer, where treating an intact tumor gives BOT+BAL its greatest opportunity to generate a durable immune response and improve long-term outcomes,” said Dr. Steven O’Day, Chief Medical Officer of Agenus.
Agenus cited results from the Phase 2 NEST and UNICORN studies, which evaluated neoadjuvant BOT+BAL in microsatellite-stable colorectal cancer. The company said the studies showed pathologic responses in about 60% to 70% of patients, major pathologic responses in approximately 35% to 40% and complete pathologic responses in about 30%.
Agenus plans to discontinue financial support for the ongoing Phase 3 BATTMAN study in late-line metastatic microsatellite-stable colorectal cancer as it focuses resources on the neoadjuvant program. The company said it will continue meeting its obligations to patients currently receiving treatment.
“Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer,” said Garo H. Armen, Ph.D., Founder, Chairman and Chief Executive Officer of Agenus. “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. With ROBBIN, we are advancing a randomized global trial designed to confirm the rapid and deep activity observed across the NEST and UNICORN trials.”
Agenus expects to dose the first patient in the first quarter of 2027. Interim pathologic response data are expected in the second half of 2027, followed by an interim event-free survival analysis in the second half of 2029 and a final analysis in the second half of 2030.
