Agenus Announces First Patient Dosed in Phase 1 Study of AGEN1571 (anti-ILT2) in Advanced Solid Tumors

Study will evaluate safety and tolerability of AGEN1571 as a single agent and in combination with botensilimab and balstilimab

Preclinical data support best-in-class potential of AGEN1571

LEXINGTON, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) — Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced that 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.

About Agenus

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, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to the use of therapeutic candidate AGEN1571, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action (including validation of mechanism of action), potency, durability, and safety profile (including the absence of specific toxicities) of the therapeutic candidates, both alone and in combination with each other and/or other agents (e.g., botensilimab and/or balstilimab in combination with AGEN1571); and any other statements containing the words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Contact

Ethan Lovell

Chief External Affairs & Communications Officer

Agenus Inc.

339.927.1763

ethan.lovell@agenusbio.com