Agenus Announces First Patient Dosed in Phase 1 Study of AGEN1571 in Advanced Solid Tumors

Agenus Inc. recently announced the first patient has been dosed in the Phase 1 study of AGEN1571 in advanced solid tumors. The dose-escalation and expansion study will evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571, a novel anti-ILT2 antibody designed to modulate tumor-associated macrophages, T, NK, and NKT cells. Participants will receive treatment with AGEN1571 as a single agent or in combination with botensilimab (Fc-enhanced anti-CTLA-4) and/or balstilimab (anti-PD-1).

“ILT2 is a major suppressor of anti-tumor immune responses and contributes to resistance to PD-1-directed therapies,” said Steven O’Day, MD, Chief Medical Officer of Agenus. “We believe AGEN1571 has best-in-class potential to overcome this resistance and combining AGEN1571 with botensilimab and/or balstilimab may further enhance innate and adaptive anti-tumor immunity.”

The initiation of the AGEN1571 study in patients with advanced solid tumors is based on preclinical data reported at the American Association for Cancer Research (AACR) Annual Meeting 2022, demonstrating the ability of AGEN1571 to polarize macrophages to a pro-inflammatory phenotype and enhance the activation of CD8 T, NK, and NKT cells in the tumor microenvironment to overcome resistance to immune checkpoint blockade. These data demonstrate the superior potency and functional activity of AGEN1571 compared to the only known clinical-stage competitor and enhanced immune cell activation when combined with botensilimab or balstilimab.

The poster presentation on these data can be accessed in the investor section of the Agenus website at https://investor.agenusbio.com/events/event-details/2022-aacr-annual-meeting-agen1571-preclinical-data

More information on the Phase I study (NCT05377528) is available at clinicaltrials.gov.

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. The company’s vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com.