FDA Schedules Agenus Meeting for BOT/BAL Therapy in Metastatic Colorectal Cancer

Agenus Inc. (Nasdaq: AGEN), a leader in the development of innovative immunological treatments for cancer, has announced a significant upcoming meeting with the U.S. Food and Drug Administration (FDA). The company is set to hold a Type B End-of-Phase 2 (EOP2) meeting in July to discuss their promising combination therapy studies involving botensilimab and balstilimab (BOT/BAL) for patients suffering from relapsed or refractory metastatic colorectal cancer (CRC) that is neither MSI-high nor dMMR (r/r MSS mCRC). This discussion is aimed at outlining the critical elements necessary for a future biologics license application (BLA) submission.

Agenus is actively working to fast-track the development of this combination therapy due to its potential to address colorectal cancer, one of the most challenging types of cancer. Colorectal cancer is particularly noted for its high incidence and mortality rates, and is one of the fastest-growing cancer types in the U.S., especially among younger adults. The company intends to collaborate closely with the FDA to map out the next steps, including the design of a Phase 3 study and other key elements required to support a BLA filing under the FDA’s accelerated approval pathway. The FDA granted BOT/BAL fast track designation in April 2023.

Dr. Steven O’Day, Chief Medical Officer of Agenus, emphasized the significance of the upcoming EOP2 meeting. "It represents a crucial milestone in the ongoing development of BOT/BAL for patients diagnosed with metastatic MSS CRC who do not have active liver metastases," he stated. He highlighted the importance of the Phase 1 and Phase 2 study results, which have provided valuable insights into the potential of this therapy to manage a specific and difficult subgroup of colorectal cancer. Dr. O’Day reiterated the company’s commitment to exploring innovative immunotherapeutic strategies.

Additionally, the Phase 2 data will be submitted to a major medical conference later this year. Apart from advancing BOT/BAL in colorectal cancer, Agenus is also dedicated to investigating the potential of this combination therapy in other cancer indications. The company is preparing to present further data at upcoming medical conferences.

Botensilimab, one of the key components of the BOT/BAL combination, is a human Fc enhanced CTLA-4 blocking antibody. It is designed to bolster both innate and adaptive anti-tumor immune responses. Its novel design aims to extend the benefits of immunotherapy to "cold" tumors, which typically do not respond well to standard treatments or are resistant to conventional PD-1/CTLA-4 therapies. By priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells, and inducing long-term memory responses, botensilimab has shown potential across a wide range of tumor types.

To date, approximately 900 patients have been treated with botensilimab in Phase 1 and Phase 2 clinical trials. The combination of botensilimab with Agenus’ investigational PD-1 antibody, balstilimab, has demonstrated clinical responses in nine different metastatic, late-line cancers. For detailed information about botensilimab trials, one can refer to the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

Agenus, headquartered in Lexington, MA, is a prominent immuno-oncology company focused on targeting cancer and infectious diseases through a comprehensive pipeline of immunological agents. The company’s mission is to broaden the range of patients who benefit from cancer immunotherapy by employing combination approaches. These include a wide array of antibody therapeutics, adoptive cell therapies through MiNK Therapeutics, and adjuvants through SaponiQx.