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

Agenus (Agenus Inc (NASDAQ:AGEN)) shares jumped astir 100% connected Monday aft the biotechnology institution announced an oversubscribed backstage placement of up to $340 cardinal to enactment improvement of its botensilimab and balstilimab (BOT+BAL) immunotherapy operation successful microsatellite-stable (MSS) colon cancer.

The financing includes astir $85 cardinal successful upfront gross proceeds, with an further imaginable $255 cardinal disposable done the afloat workout of acquisition warrants. The transaction was led by Commodore Capital, with information from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals.

Agenus said proceeds from the financing volition beryllium utilized to beforehand ROBBIN, a planned registrational Phase 3 proceedings evaluating neoadjuvant BOT+BAL successful antecedently untreated high-risk Stage II and Stage III MSS colon cancer. The institution expects the financing, assuming afloat warrant exercise, to supply backing done the extremity of 2031.

The ROBBIN proceedings is designed to enroll 850 patients globally and volition comparison neoadjuvant BOT+BAL followed by modular of attraction against modular of attraction alone. The superior endpoint volition beryllium event-free endurance (EFS). A

genus said it has aligned cardinal elements of the proceedings plan with the US Food and Drug Administration, including the diligent population, attraction regimen, power arm, endpoint and interim investigation plan.

The institution highlighted information from 2 Phase 2 studies, NEST and UNICORN, which evaluated neoadjuvant BOT+BAL successful MSS colorectal cancer.

Agenus reported pathologic responses successful astir 60% to 70% of patients, large pathologic responses successful astir 35% to 40%, and pathologic implicit responses successful astir 30%. The institution said each treated patients remained disease-free astatine median follow-up periods ranging from astir 9 to 18 months.

Agenus estimates that high-risk Stage II and Stage III MSS colon crab represents an yearly US addressable marketplace accidental of much than $7 billion, with nary caller curative-intent therapies approved successful the mounting successful much than 2 decades.

The institution expects the archetypal diligent successful the ROBBIN proceedings to beryllium dosed successful the archetypal 4th of 2027, with interim pathologic effect information anticipated successful the 2nd fractional of 2027. Interim EFS investigation is expected successful the 2nd fractional of 2029, followed by last EFS investigation successful the 2nd fractional of 2030.

"Since Agenus was founded 32 years ago, our ngo has been to harness the immune strategy to amended outcomes and, wherever possible, cure cancer," Chief Executive Officer Garo H. Armen said successful a statement.

"Our program to prioritize neoadjuvant BOT+BAL successful MSS colon crab reflects some the spot of the emerging objective grounds and the accidental to bring this important operation regimen to patients wherever it whitethorn person the top impact."