Agenus reports 42% two-year survival in colorectal cancer trial

LEXINGTON, Mass. - Agenus Inc. (NASDAQ:AGEN), a biotechnology company with a market capitalization of $166 million, announced that its botensilimab and balstilimab combination therapy achieved a 42% two-year survival rate with 21-month median overall survival in patients with microsatellite-stable metastatic colorectal cancer without active liver metastases. The stock has shown remarkable momentum, gaining over 120% year-to-date according to InvestingPro data.

The expanded data, presented at the 2025 ESMO Gastrointestinal Cancers Congress in Barcelona, included 123 patients, representing a 40% increase from earlier reports. The confirmed objective response rate was 20%, with a median duration of response of 16.6 months and disease control rate of 69%. With analyst price targets ranging from $6 to $25, InvestingPro subscribers can access detailed financial analysis and 12 additional expert insights about Agenus’s growth potential.

Patients in fourth-line or later treatment (n=37) showed similar benefits with approximately 19% objective response rate and 43% two-year survival. The company noted that historical survival with best supportive care in this refractory population has been limited to 5-8 months.

No new safety signals were observed, with immune-related side effects described as manageable. No treatment-related deaths occurred, and the combination was tolerated across dose levels.

Agenus also confirmed agreement with the U.S. Food and Drug Administration on the design of its global BATTMAN Phase 3 trial. The FDA waived the requirement for a botensilimab monotherapy arm, allowing for a simpler two-arm study design.

The company plans to initiate the BATTMAN trial in the fourth quarter of 2025. According to the press release, the FDA continues to recommend a randomized controlled trial to support approval in the metastatic setting.

"FDA’s acknowledgement of balstilimab’s role and its constructive guidance on the Phase 3 trial mark a pivotal step forward," said Jennifer Buell, Executive Chairwoman of Agenus, in the press release.

Colorectal cancer is rising fastest in people under 50 and is projected to become the leading cause of cancer death in that age group by 2030, according to information provided in the company statement. Investors tracking Agenus’s progress should note that the company’s next earnings report is scheduled for August 12, 2025, as indicated by InvestingPro data, which also reveals that two analysts have recently revised their earnings expectations upward for the upcoming period.

In other recent news, Agenus Inc. has announced a strategic collaboration with Zydus Lifesciences, valued at approximately $141 million, to accelerate the development and manufacturing of its cancer immunotherapies, botensilimab and balstilimab. This agreement includes the sale of Agenus’ biologics CMC facilities in California to Zydus for $75 million upfront, with potential additional payments of up to $50 million contingent on production orders. Zydus will also make a $16 million strategic equity investment in Agenus, purchasing approximately 2.1 million shares at a premium. As part of the collaboration, Zydus will gain exclusive rights to develop and commercialize these therapies in India and Sri Lanka, providing Agenus with a 5% royalty on net sales. Additionally, H.C. Wainwright upgraded Agenus’ stock from Neutral to Buy, citing the strategic collaboration as a key factor. The partnership is designed to leverage Agenus’s research capabilities with Zydus’s manufacturing expertise, aiming for a potential commercial launch of the therapies by 2028. Furthermore, Agenus has entered a research collaboration with Noetik to develop AI-powered predictive biomarkers for its immunotherapy combination. These developments reflect Agenus’s efforts to enhance its global oncology therapeutics footprint and advance its cancer treatment pipeline.

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