Agenus Inc. (NASDAQ: AGEN) has enrolled its first patient in the global Phase 3 BATTMAN (CO.33) trial (NCT07152821), a registrational‑enabling study of the botensilimab (BOT) and balstilimab (BAL) combination versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC). The trial is designed to enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand, and is led by the Canadian Cancer Trials Group (CCTG).
The BATTMAN study targets the largest segment of mCRC patients—about 95% of cases are MSS—by evaluating a novel dual‑checkpoint approach that combines an Fc‑enhanced anti‑CTLA‑4 antibody (BOT) with an investigational PD‑1 antibody (BAL). The global scope and the inclusion of 100+ sites underscore the trial’s ambition to generate robust, regulatory‑ready data that could support accelerated or conditional approval pathways in the United States and Europe.
Prior phase II data underpin the decision to advance to Phase 3: in an expanded cohort of 123 MSS mCRC patients without active liver metastases, the BOT/BAL combination achieved a two‑year survival rate of 42% and a median overall survival of 21 months. These results, coupled with safety data from 1,200 patients treated in earlier trials, provide a compelling rationale for the current study and suggest that the combination may overcome the historically poor response rates seen with single‑agent immunotherapies in MSS disease.
Agenus’ financial performance in the most recent quarter supports its continued investment in the BATTMAN program. In Q4 2025, the company reported an operating income of $14.4 million and a full‑year 2025 operating loss of $20.2 million. Net revenue from early‑access programs, including paid named‑patient and French AAC access, reached $4.2 million for the year, while the Zydus Lifesciences collaboration provided $91 million in upfront capital and a $20 million contingent payment. The Q4 2025 earnings per share of –$0.37 beat analyst expectations of –$1.28, reflecting disciplined cost management amid ongoing clinical development investments.
Dr. Steven O'Day, Chief Medical Officer, said, "Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program. This study advances our goal of developing effective immunotherapies for patients who currently have few options." The comment highlights the company’s confidence that the trial will generate the evidence needed to support a regulatory submission and potentially open a substantial commercial opportunity in the MSS mCRC market.
The BATTMAN trial represents a strategic pivot for Agenus, positioning the company to address an unmet need in a large patient population that has historically been refractory to immunotherapy. Successful results could establish the BOT/BAL combination as a new standard of care for MSS mCRC, differentiating Agenus in a competitive immuno‑oncology landscape and potentially generating significant revenue streams from early‑access programs and future commercial sales. The trial’s global design and partnership with the CCTG also signal Agenus’ commitment to rigorous, high‑quality data collection that will be critical for regulatory approval and market adoption.
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