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- France grants reimbursed access with patients having commenced treatment<\/i><\/li>\n
- Two-year BOT\/BAL survival presented at ESMO spanning more than five cancers in over 400 patients<\/i><\/li>\n
- Phase 3 on track to commence in fourth quarter 2025<\/i><\/li>\n<\/ul>\n
LEXINGTON, Mass.–(BUSINESS WIRE<\/a>)–Agenus Inc<\/a>. (Nasdaq: AGEN) today reported quarterly results for the period ended September 30, 2025, and provided a business update. Highlights include government\u2011funded, reimbursed compassionate access (AAC) in France for botensilimab plus balstilimab (BOT\/BAL), new survival data presented at ESMO and ESMO\u2011GI across more than 400 patients spanning more than five refractory cancers, and initiation of the global Phase 3 BATTMAN trial.<\/p>\n
Access & Regulatory<\/b><\/p>\n
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- France authorizes reimbursed AAC for BOT\/BAL<\/b>. In September, France\u2019s medicines agency (ANSM) authorized reimbursed compassionate access (Acc\u00e8s Compassionnel, AAC) for BOT\/BAL in refractory MSS mCRC without active liver metastases\u2014the first government-funded access for this population and the first reimbursed access provided for BOT\/BAL by a regulatory agency. link<\/i><\/a><\/li>\n<\/ul>\n
Clinical Highlights<\/b><\/p>\n
\nBOT\/BAL has demonstrated durable, long-term survival in patients with advanced solid tumors, reinforcing its potential to expand the reach of immunotherapy to those historically unresponsive to treatment.<\/p>\n
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- MSS metastatic colorectal cancer (ESMO\u2011GI 2025):<\/b> In 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT\/BAL achieved 42% two\u2011year overall survival<\/b> (OS) and 20.9\u2011month median OS<\/b>. Median OS benchmarks in this third\u2011line\u2011plus setting is 8-14i<\/sup> months with current standards of care. link
\n<\/i><\/a><\/p>\n<\/i><\/li>\n
- Pan\u2011tumor cohort (ESMO 2025):<\/b> Updated Phase 1b results in >400 patients demonstrated 39% two\u2011year OS<\/b> across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Important to note that responses were seen after prior checkpoint inhibitor failure; immune\u2011related AEs were treatable and reversible. link<\/i><\/a><\/li>\n<\/ul>\n
Phase 3 Program<\/b><\/p>\n
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- Global registrational trial initiated.<\/b> The BATTMAN (CCTG CO.33)<\/b> Phase 3 trial conducted with the Canadian Cancer Trials Group and supported by AGITG (Australasia), and PRODIGE (France)\u2014is launching in Q4 2025 across 100+ sites in Canada, France, Australia, and New Zealand to evaluate BOT\/BAL versus best supportive care in refractory, unresectable MSS\/pMMR colorectal cancer. link<\/i><\/a><\/li>\n<\/ul>\n
Q3 2025 Financial Highlights<\/b><\/p>\n
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- Zydus transactions: <\/b>In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million upon closing of the transaction which also includes an equity investment at $7.50 per share.\n<\/li>\n<\/ul>\n
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- MiNK deconsolidation<\/b>: In July 2025, Agenus\u2019 ownership of MiNK fell below 50%, resulting in deconsolidation in Q3 2025. This generated approximately $100.9 million gain, resulting in net income for the three\u2011month and nine-month period ended September 30, 2025.\n<\/li>\n<\/ul>\n
- Zydus transactions: <\/b>In October, Agenus and Zydus agreed to a $10 million bridge facility ahead of the anticipated $91 million upon closing of the transaction which also includes an equity investment at $7.50 per share.\n<\/li>\n<\/ul>\n
- Pan\u2011tumor cohort (ESMO 2025):<\/b> Updated Phase 1b results in >400 patients demonstrated 39% two\u2011year OS<\/b> across more than five refractory cancers, including colorectal, ovarian, sarcoma, lung, and hepatocellular tumors. Important to note that responses were seen after prior checkpoint inhibitor failure; immune\u2011related AEs were treatable and reversible. link<\/i><\/a><\/li>\n<\/ul>\n
- MSS metastatic colorectal cancer (ESMO\u2011GI 2025):<\/b> In 123 heavily pretreated MSS mCRC patients without active liver metastases, BOT\/BAL achieved 42% two\u2011year overall survival<\/b> (OS) and 20.9\u2011month median OS<\/b>. Median OS benchmarks in this third\u2011line\u2011plus setting is 8-14i<\/sup> months with current standards of care. link
- Two-year BOT\/BAL survival presented at ESMO spanning more than five cancers in over 400 patients<\/i><\/li>\n
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