France Approves Reimbursed Compassionate Access (AAC) for Agenus' BOT/BAL in Treating Refractory MSS Metastatic Colorectal Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 09 2025
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Should l Buy AGEN?
Source: Newsfilter
Agenus' New Treatment Availability: Agenus Inc. announced that its investigational combination therapy, botensilimab plus balstilimab (BOT/BAL), is now accessible to eligible patients with refractory microsatellite-stable metastatic colorectal cancer in France under the compassionate access framework.
Compassionate Access Framework: The French National Agency of Medicines and Health Products Safety (ANSM) has authorized the use of BOT/BAL, which allows hospitals to provide the treatment at no cost to patients, with reimbursement covering the purchase price outside the standard diagnosis-related group system.
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Analyst Views on AGEN
Wall Street analysts forecast AGEN stock price to rise
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Current: 2.850
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About AGEN
Agenus Inc. is an immuno-oncology (I-O) company targeting cancer with a comprehensive pipeline of immunological agents. The company is focused on expanding patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Its I-O portfolio is driven by several platforms and programs, which include multiple antibody discovery platforms, antibody candidate programs, its saponin-based vaccine adjuvant platform, and a pipeline of novel allogeneic invariant natural killer T cell (iNKT) therapies for treating cancer and other immune-mediated diseases, controlled by MiNK. Its antibody candidate programs include botensilimab (BOT) and balstilimab (BAL) (a PD-1 blocking antibody). The Company has secured committed manufacturing capacity to support BOT+BAL supply needs for its clinical trials, global access programs and future commercialization.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Agenus Advances Immunotherapy with Botensilimab Data Presentation
- Clinical Data Presentation: Agenus announced that new translational and clinical biomarker analyses from its botensilimab immunotherapy program will be presented at the AACR-IO conference in February 2026, showcasing the therapy's potential in treating immunologically cold tumors, which may enhance the company's leadership in cancer immunotherapy.
- Research Findings Overview: The poster titled 'Systemic and Tumor-Microenvironment Inflammation Shape Outcomes in Patients with Immunologically Cold, Treatment-Refractory Tumors Treated with Fc-Enhanced Anti–CTLA-4 Botensilimab' evaluates how systemic inflammatory markers and tumor microenvironment immune activity correlate with clinical outcomes, potentially providing critical insights for future treatment strategies.
- Patient Treatment Statistics: Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials, demonstrating clinical responses across nine metastatic, late-line cancers, further validating the efficacy and safety of the therapy.
- Strategic Company Positioning: Agenus aims to expand the patient populations benefiting from cancer immunotherapy through its comprehensive pipeline and robust R&D capabilities, with the expectation that this data presentation will bolster investor confidence and drive future financing and partnership opportunities.
See More
Agenus Announces First Stakeholder Webcast of 2026 Focused on BOT+BAL Program
- Webcast Announcement: Agenus will host its first Stakeholder Webcast on January 28, 2026, at 4 PM ET, focusing on the global momentum of the BOT+BAL program, which is expected to attract significant investor interest.
- Expert Insights: The session will feature perspectives from CEO Garo Armen and an international oncology expert, sharing the latest developments in authorized access programs and clinical advancements, aimed at enhancing investor understanding of the company's strategy.
- Clinical Progress Report: Approximately 1,200 patients have been treated in the BOT+BAL program, demonstrating clinical responses across various metastatic cancers, further solidifying Agenus' leadership in the immuno-oncology sector.
- Future Outlook: This webcast marks the beginning of Agenus' 2026 Stakeholder Briefing Series, aimed at fostering ongoing discussions about BOT+BAL's clinical progress and patient access pathways, thereby strengthening the company's influence in the industry.
See More
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- Successful Transaction Closure: Zydus Lifesciences has finalized its asset purchase and exclusive licensing agreements with Agenus, receiving all necessary regulatory approvals, marking a significant advancement in its global biologics CDMO business.
- New Subsidiary Formation: The newly established Zylidac Bio LLC will focus on biologics manufacturing, offering CDMO services to meet the needs of biopharmaceutical companies globally, thereby enhancing Zydus's competitiveness in the U.S. market.
- Deepened Strategic Collaboration: This transaction allows Agenus to monetize its manufacturing assets while securing high-quality U.S. biologics capacity to support late-stage development of its immunotherapy candidates, thereby enhancing the market positions of both companies.
- Compliance Manufacturing Advantage: The establishment of Zylidac Bio LLC aligns with the BIOSECURE Act, providing a compliant U.S. manufacturing solution for global biopharmaceutical companies, ensuring supply chain security and agility.
See More
Zydus Lifesciences Closes Acquisition of Agenus Assets, Establishes Zylidac Bio LLC
- Successful Transaction: Zydus Lifesciences has completed the acquisition of assets and shares from Agenus Inc., receiving all necessary regulatory approvals, marking a significant expansion in the global biologics contract development and manufacturing sector.
- New Subsidiary Launch: The newly formed Zylidac Bio LLC will focus on providing high-quality CDMO services to biopharmaceutical companies, ensuring a secure, compliant, and efficient supply chain in the U.S., thereby enhancing Zydus's competitiveness in the biopharmaceutical industry.
- Deepened Strategic Collaboration: This transaction allows Agenus to monetize its manufacturing assets while securing high-quality biologics capacity in the U.S. to support the development of its immunotherapy candidates Botensilimab and Balstilimab, further advancing treatment options for patients globally.
- Policy Opportunity Seized: By establishing a domestic manufacturing footprint in California, Zydus aligns with the BIOSECURE Act requirements, providing compliant supply chain solutions for global biopharmaceutical companies and enhancing its strategic position in the industry.
See More
Agenus Receives Approval for Updated AAC Protocol in France Expanding BOT+BAL Access
- Expanded Eligibility: France's ANSM has approved an updated AAC protocol that broadens access to BOT+BAL for patients with certain ovarian cancers and soft tissue sarcomas, addressing significant unmet medical needs in these disease areas.
- Full Reimbursement Policy: Under the AAC framework, eligible French patients treated with BOT+BAL in hospitals will receive full reimbursement, significantly reducing the financial burden on patients and enhancing treatment accessibility.
- Multi-Tumor Early Access: The updated protocol provides a unified early access framework for colorectal cancer, ovarian cancer, and sarcoma patients, representing an uncommon level of national early-access authorization for a single investigational immunotherapy combination.
- Clinical Research Support: Clinical studies have demonstrated antitumor activity of BOT+BAL in heavily pretreated patients, and the updated protocol will facilitate access to this innovative therapy for more patients lacking effective treatment options.
See More
Agenus (AGEN) Q1 2025 Earnings Call Transcript
See More
Agenus Advances Immunotherapy with Botensilimab Data Presentation
- Clinical Data Presentation: Agenus announced that new translational and clinical biomarker analyses from its botensilimab immunotherapy program will be presented at the AACR-IO conference in February 2026, showcasing the therapy's potential in treating immunologically cold tumors, which may enhance the company's leadership in cancer immunotherapy.
- Research Findings Overview: The poster titled 'Systemic and Tumor-Microenvironment Inflammation Shape Outcomes in Patients with Immunologically Cold, Treatment-Refractory Tumors Treated with Fc-Enhanced Anti–CTLA-4 Botensilimab' evaluates how systemic inflammatory markers and tumor microenvironment immune activity correlate with clinical outcomes, potentially providing critical insights for future treatment strategies.
- Patient Treatment Statistics: Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials, demonstrating clinical responses across nine metastatic, late-line cancers, further validating the efficacy and safety of the therapy.
- Strategic Company Positioning: Agenus aims to expand the patient populations benefiting from cancer immunotherapy through its comprehensive pipeline and robust R&D capabilities, with the expectation that this data presentation will bolster investor confidence and drive future financing and partnership opportunities.
See More
Agenus Announces First Stakeholder Webcast of 2026 Focused on BOT+BAL Program
- Webcast Announcement: Agenus will host its first Stakeholder Webcast on January 28, 2026, at 4 PM ET, focusing on the global momentum of the BOT+BAL program, which is expected to attract significant investor interest.
- Expert Insights: The session will feature perspectives from CEO Garo Armen and an international oncology expert, sharing the latest developments in authorized access programs and clinical advancements, aimed at enhancing investor understanding of the company's strategy.
- Clinical Progress Report: Approximately 1,200 patients have been treated in the BOT+BAL program, demonstrating clinical responses across various metastatic cancers, further solidifying Agenus' leadership in the immuno-oncology sector.
- Future Outlook: This webcast marks the beginning of Agenus' 2026 Stakeholder Briefing Series, aimed at fostering ongoing discussions about BOT+BAL's clinical progress and patient access pathways, thereby strengthening the company's influence in the industry.
See More
Zydus Lifesciences Closes Acquisition of Agenus Assets, Establishes Zylidac Bio LLC
- Successful Transaction Closure: Zydus Lifesciences has finalized its asset purchase and exclusive licensing agreements with Agenus, receiving all necessary regulatory approvals, marking a significant advancement in its global biologics CDMO business.
- New Subsidiary Formation: The newly established Zylidac Bio LLC will focus on biologics manufacturing, offering CDMO services to meet the needs of biopharmaceutical companies globally, thereby enhancing Zydus's competitiveness in the U.S. market.
- Deepened Strategic Collaboration: This transaction allows Agenus to monetize its manufacturing assets while securing high-quality U.S. biologics capacity to support late-stage development of its immunotherapy candidates, thereby enhancing the market positions of both companies.
- Compliance Manufacturing Advantage: The establishment of Zylidac Bio LLC aligns with the BIOSECURE Act, providing a compliant U.S. manufacturing solution for global biopharmaceutical companies, ensuring supply chain security and agility.
See More
Zydus Lifesciences Closes Acquisition of Agenus Assets, Establishes Zylidac Bio LLC
- Successful Transaction: Zydus Lifesciences has completed the acquisition of assets and shares from Agenus Inc., receiving all necessary regulatory approvals, marking a significant expansion in the global biologics contract development and manufacturing sector.
- New Subsidiary Launch: The newly formed Zylidac Bio LLC will focus on providing high-quality CDMO services to biopharmaceutical companies, ensuring a secure, compliant, and efficient supply chain in the U.S., thereby enhancing Zydus's competitiveness in the biopharmaceutical industry.
- Deepened Strategic Collaboration: This transaction allows Agenus to monetize its manufacturing assets while securing high-quality biologics capacity in the U.S. to support the development of its immunotherapy candidates Botensilimab and Balstilimab, further advancing treatment options for patients globally.
- Policy Opportunity Seized: By establishing a domestic manufacturing footprint in California, Zydus aligns with the BIOSECURE Act requirements, providing compliant supply chain solutions for global biopharmaceutical companies and enhancing its strategic position in the industry.
See More
Agenus Receives Approval for Updated AAC Protocol in France Expanding BOT+BAL Access
- Expanded Eligibility: France's ANSM has approved an updated AAC protocol that broadens access to BOT+BAL for patients with certain ovarian cancers and soft tissue sarcomas, addressing significant unmet medical needs in these disease areas.
- Full Reimbursement Policy: Under the AAC framework, eligible French patients treated with BOT+BAL in hospitals will receive full reimbursement, significantly reducing the financial burden on patients and enhancing treatment accessibility.
- Multi-Tumor Early Access: The updated protocol provides a unified early access framework for colorectal cancer, ovarian cancer, and sarcoma patients, representing an uncommon level of national early-access authorization for a single investigational immunotherapy combination.
- Clinical Research Support: Clinical studies have demonstrated antitumor activity of BOT+BAL in heavily pretreated patients, and the updated protocol will facilitate access to this innovative therapy for more patients lacking effective treatment options.
See More
Agenus (AGEN) Q1 2025 Earnings Call Transcript
See More
