Agenus Reveals Latest Phase 1 Findings and Advances in BOT/BAL Development for Metastatic MSS Colorectal Cancer

Agenus Inc. (NASDAQ: AGEN), a renowned player in the realm of discovering and advancing novel immunological treatments for diverse cancers, has disclosed the latest outcomes from its Phase 1 clinical assessment of BOT/BAL combination therapy targeting patients with metastatic CRC lacking microsatellite instability-high (MSS) or deficient mismatch repair (dMMR). These results underscore the promising clinical efficacy of BOT/BAL observed across nine different cancer types within Agenus’ extensive clinical development program. In the Phase 1 trial encompassing 77 patients grappling with refractory MSS-CRC without active liver metastases, a notable 23% overall response rate (ORR) was recorded following a median follow-up of 13.6 months as of the data cutoff on March 1, 2024. Notably, the median duration of response among the 18 responders has yet to be determined. Moreover, the estimated 12-month and 18-month overall survival (OS) rates stood at 71% and 62%, respectively, with a median OS of 21.2 months.

With the Phase 2 trial concluding its enrollment, Agenus intends to engage in discussions with the U.S. Food and Drug Administration (FDA) concerning the encouraging interim results.

Dr. Steven O’Day, Chief Medical Officer at Agenus, emphasized, “These results underscore the potential of BOT/BAL in metastatic CRC, the second leading cause of cancer mortality in the U.S. We continue to work expeditiously to bring this promising combination to patients in need.”

Pending scheduled meetings with the FDA, Agenus plans to submit a Biologics License Application (BLA) for BOT/BAL in refractory MSS CRC later this year. Additionally, the company aims to unveil detailed Phase 2 efficacy outcomes, encompassing response durability and updated Phase 1 survival data, at a major medical conference in the latter half of 2024. This evolving clinical evidence underscores the substantial potential of BOT/BAL to revolutionize the treatment landscape for challenging-to-treat solid tumors.

About Agenus: Agenus is a leading immuno-oncology enterprise dedicated to combatting cancer and infectious diseases through a comprehensive pipeline of immunological agents. The company’s mission revolves around broadening the patient populations benefiting from cancer immunotherapy through combination approaches, leveraging a diverse range of antibody therapeutics, adoptive cell therapies (via MiNK Therapeutics), and adjuvants (through SaponiQx). Headquartered in Lexington, MA, Agenus aims to disseminate crucial information to investors through its website and social media channels.

Forward-Looking Statements: This press release contains forward-looking statements within the purview of the federal securities laws, reflecting Agenus’ endeavors in its botensilimab and balstilimab programs, expected regulatory timelines and filings, and other aspects. However, these forward-looking statements are subject to risks and uncertainties that could lead to actual results differing materially. Agenus urges investors to exercise caution and not rely unduly on the forward-looking statements outlined in this release. These statements are valid only as of the date of this press release, and Agenus undertakes no obligation to update or revise them beyond what is required by law, with all forward-looking statements being subject to this cautionary statement in its entirety.

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