Agenus Inc. announced first-time and updated data from its ongoing botensilimab/balstilimab (BOT/BAL) clinical programs in advanced colorectal cancer (CRC), neoadjuvant CRC, pancreatic cancer, non-small cell lung cancer (NSCLC), melanoma, and sarcoma. Members of the Agenus leadership team along with key opinion leaders will discuss these findings during a live webcast at 1:00 p.m. EDT (19:00 CEST) at a corporate event at the European Society for Medical Oncology 2023 Conference. 12-month overall survival (OS) of 74% and median OS (mOS) not yet reached.

Median follow up now 12.3 months. Subsequent data from expanded cohorts and early signals from a 230 patient Phase 2 trial is consistent with the earlier cohort of 70 patients. Based on the totality of the evidence from the Phase 1 and Phase 2 trials, Agenus plans to submit its Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for BOT/BAL in patients with 2/3L+ MSS CRC in midyear 2024.

Interactions with U.S. and EU regulatory agencies are ongoing. Robust Clinical Outcomes in Neoadjuvant MSS CRC Underscore BOT/BAL's Potential in Earlier-Stage Patients: All patients treated with one dose of BOT and two doses of BAL. After dosing, observations of responses were made within approximately four-we weeks prior to surgery.

Importantly, in patients with EGFR mutations refractory to SOC responded to the BOT/BAL combo, with one patient experiencing an -90% tumor reduction at 12 weeks and the second having a -42% tumor reduction at 6 weeks and is pending confirmation. Expansion cohorts are underway with anticipated enrollment of 100 patients by First Quarter 2024. Additional data from this study will be reported in midyear 2024.

Updated data was presented at ESMO 2023 from the Phase 1b study in 41 efficacy evaluable heavily pretreated advanced sarcoma patients, demonstrating durability with extended follow-up and additional activity in difficult-to-treat subtypes such as leiomyosarcoma. BOT/BAL combination demonstrated 6-month progression-free survival of 40%, ORR of 20%, and median response duration of 19.4 months (iRECIST). Differential responses observed by dose level, with 29% ORR at 2 mg/kg BOT compared to 15% at 1 mg/kg BOT.

Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 750 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials.

Botensilimab alone, or in combination with Agenus' investigational therapies. BotensILimab alone, or in addition with Agenus' investigation is currently being conducted in the European Society for Medical OnCology 2023 Conference.