On April 17, 2023 Agenus Inc. (Nasdaq: AGEN), a leading immuno-oncology company specializing in immunological agents for cancer and infectious diseases, reported that it has been granted Fast Track Designation from the US Food and Drug Administration (FDA) for the investigation of the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034) (Press release, Agenus, APR 17, 2023, View Source [SID1234630186]). The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement. 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. The company 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.
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"We are pleased that the FDA has granted Fast Track designation for the combination of botensilimab with balstilimab in patients with non-MSI-H colorectal cancer, recognizing the high unmet medical need in this population," said Dr. Steven O’Day, Chief Medical Officer of Agenus. "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."
During the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Gastrointestinal Cancers Symposium in January 2023, Agenus 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.
About Botensilimab
Botensilimab is a novel, multifunctional CTLA-4 investigational antibody that has been designed to extend clinical benefits to "cold" tumors that have not historically responded to standard of care or investigational therapies. In addition to binding to the CTLA-4 receptor, its Fc-enhanced structure induces a memory immune response, downregulates regulatory T cells, and delivers better priming and activation of T cells, thereby amplifying immune responses.
In a Phase 1b clinical study of more than 350 patients, botensilimab has demonstrated clinical responses in nine, previously IO unresponsive, solid tumor cancers, either alone or in combination with Agenus’ PD-1 antibody, balstilimab (data presented at ASCO (Free ASCO Whitepaper) GI 2023, SGO 2023, CTOS 2022, SITC (Free SITC Whitepaper) 2022). 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. Additional information about these botensilimab trials can be found at www.clinicaltrials.gov under the identifiers NCT05608044, NCT05630183, and NCT05529316, respectively. A global Phase 3 trial in non-MSI-H CRC is expected to launch in 2023.