Agenus Begins Mid-Stage Global Studies On Colorectal And Skin Cancer Candidate

Agenus AGEN has initiated Phase 2 ACTIVATE trials of botensilimab to advance globally in metastatic patients who have progressed on available therapies.

This global Phase 2 program include clinical trials of ACTIVATE-Colorectal and ACTIVATE-Melanoma studies.

The ACTIVATE-Colorectal is a Phase 2 study designed to evaluate botensilimab as monotherapy and in combination with balstilimab (anti-PD-1) for the treatment of microsatellite stable colorectal cancer (MSS CRC). The primary endpoint of the study is overall response rate (ORR); secondary endpoints include duration of response (DOR), progression-free survival (PFS) and overall survival (OS)

The ACTIVATE-Melanoma is also a Phase 2 study designed to evaluate botensilimab as a single agent for advanced melanoma, refractory to either prior anti-PD-1 or combined anti-PD-1/anti-CTLA-4 therapy. The primary endpoint is overall response rate (ORR); secondary endpoints include duration of response (DOR), progression-free survival (PFS) and overall survival (OS)

Steven O'Day, MD, Chief Medical Officer, said, "The Phase 1 botensilimab program demonstrated remarkable activity in poorly immunogenic and difficult to treat tumor types In light of our compelling clinical data, we have received clearance from the FDA to initiate our Phase 2 development program in two indications and intend to expand to multiple additional indications as rapidly as possible with the aim of delivering a transformative new treatment option to patients in need."

Further, the company anticipates an additional Phase 2 study in pancreatic cancer to begin later in 2022.

Price Action : Agenus shares traded around $2.69 on Monday.