Agenus: FDA Grants Fast Track Designation For Botensilimab And Balstilimab In Colorectal Cancer

(RTTNews) - Clinical-stage immuno-oncology company Agenus Inc. (GEN) Monday said the US Food and Drug Administration has granted Fast Track Designation for the investigation of the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034).

The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement.

In pre-market activity on Nasdaq, Agenus shares were gaining around 4.1 percent.

The company noted that patients targeted with this designation are heavily pretreated, are resistant or intolerant to a fluoropyrimidine, oxaliplatin, and irinotecan, and who have also received a VEGF inhibitor, an EGFR inhibitor and/or a BRAF inhibitor, if indicated.

Agenus is conducting a global, randomized Phase 2 trial of botensilimab in combination with balstilimab compared to standard of care in non-microsatellite instability-high (non-MSI-H) colorectal cancer patients.

Agenus in January presented positive results from its ongoing clinical trials of the botensilimab/balstilimab combination in patients with non-MSI-H colorectal cancer. The combination therapy showed an overall response rate of 23% and a 12-month survival rate of 63%, which compares to very limited activity of 1-2% overall response rate and ~25% 12-month survival rate reported for the standard of care.

Responses to the botensilimab/balstilimab therapy have been durable, with 69% ongoing at data cut-off, and median overall survival not reached.

Steven O'Day, Chief Medical Officer of Agenus, said, "The Fast Track designation offers important benefits, including the potential eligibility for a Priority Review, and we will be working with the FDA and all key stakeholders to rapidly advance the botensilimab/balstilimab combination in colorectal cancer as well as other solid tumor indications."

Agenus is conducting global, randomized Phase 2 trials in non-MSI-H colorectal cancer, pancreatic cancer, and melanoma as part of its ACTIVATE trial programs. A global Phase 3 trial in non-MSI-H CRC is expected to launch in 2023.

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