Summary of Agenus Stakeholder Webcast Company Overview - **Company**: Agenus - **Focus**: Development of immunotherapy treatments for cancer patients globally Key Industry Insights - **Immuno-Oncology (IO) Landscape**: - Approximately 60% of cancer patients have access to approved IO therapies during their treatment journey, but only 11% achieve durable responses [9][10] - The need for novel treatments to extend benefits of IO to more patients is urgent, particularly for those with "cold" tumors that historically do not respond to existing therapies [9][10][12] Core Developments and Data - **Botensilimab and Balstilimab (bot/bal)**: - Studied in over 1,200 patients across more than nine tumor types, showing remarkable efficacy, especially in colorectal cancer [4][5][6] - Data presented at the European Society for Medical Oncology (ESMO) Congress indicated improved response rates when administered in earlier disease stages [5][6][15] - The combination has shown robust activity in traditionally cold tumors, with response rates and durability comparable to hot tumors [13][14][50] Regulatory and Market Developments - **French Approval**: - The French National Agency of Medicines and Health Product Safety granted compassionate access (AAC) for bot/bal in refractory metastatic microsatellite stable colorectal cancer, covering 100% of treatment costs for patients [17][22][57] - This approval is seen as a significant endorsement of bot/bal's efficacy and may influence other countries to adopt similar programs [25][28] Patient Access and Real-World Evidence - **Patient Access Programs**: - Agenus has initiated access programs in France, the U.S., and other regions to support patients with no viable treatment options [18][19] - The French AAC program will provide real-world evidence to support future full approval of bot/bal [21] Future Directions - **Clinical Trials**: - Ongoing studies in various cancer types, including plans for a neoadjuvant setting in colorectal cancer [55] - Anticipation of data from the phase 2 study and the Batman study in Canada, with enrollment expected to begin soon [32][47] Financial and Strategic Considerations - **Partnership with Zydus Lifesciences**: - Progressing towards closing a deal for manufacturing and market access in India and Sri Lanka, pending CFIUS review [34][36] Conclusion - The advancements in bot/bal and the regulatory support from France mark a pivotal moment for Agenus and the broader immuno-oncology field, with potential implications for patient care and treatment options globally. The company is committed to expanding access and gathering real-world evidence to further validate its therapies.