Agenus Announces Positive Interim Data from Balstilimab and Zalifrelimab Clinical Trials in Second-Line Cervical Cancer

- Balstilimab and zalifrelimab combination yield >20% response rates

- Balstilimab and zalifrelimab combination has best-in-class potential for the treatment of second-line cervical cancer

- On track to submit 2 BLAs for these agents in 2020

- Low-dose AGEN1181 monotherapy demonstrated a confirmed complete response in a patient with difficult-to-treat endometrial cancer

LEXINGTON, MA, USA I February 20, 2020 I Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced new clinical data from pre-planned interim analyses of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) and data from a dose escalation study of AGEN1181, a novel multi-functional enhanced CTLA-4 antibody.

The interim analysis from 34 evaluable patients treated with the combination of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) demonstrated a 20.6% overall response rate (ORR), which included a complete response (CR) rate of 8.8% in second-line cervical cancer. The interim analysis from 44 evaluable patients treated with balstilimab monotherapy demonstrated an ORR of 11.4% in second-line cervical cancer. The clinical activity observed in both studies are comparable to other agents in these therapeutic classes. Both balstilimab monotherapy and the combination of balstilimab and zalifrelimab were well-tolerated with no new safety signals.

Additionally, early clinical data from a dose-escalation study of AGEN1181 revealed a confirmed CR in a patient with a difficult-to-treat, PD-L1 negative, microsatellite stable, endometrial cancer. The patient was treated with a low dose of AGEN1181 (1 mg/kg) and had failed prior treatment with a PD-1 inhibitor. Additionally, stable disease was noted in the majority of patients treated. AGEN1181 monotherapy was well-tolerated. Balstilimab, zalifrelimab and AGEN1181 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.

Details for today's Investor Day:

Date: Thursday, February 20, 2020
Time: 9:00 – 11:00AM
Location: New York, NY (by invitation only)

Link to Webcast

Presenters will include global experts in immune-oncology, Dr. Chuck Drake, Co-Director, Cancer Immunotherapy Program, Columbia University Herbert Irving Comprehensive Cancer Center, and Dr. Bradley Monk, M.D., FACS, FACOG, Co‚ÄźDirector of GOG Partners, Arizona Oncology (US Oncology Network) and Professor, Gynecologic Oncology at University of Arizona, and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona.

The event will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website at www.agenusbio.com or by using the link below. A replay of the webcast, as well as a copy of the slide presentations that will be presented at the event, will be available on the Agenus website following the event.

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. 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, proprietary cancer vaccine platforms, and adoptive cell therapies (through its AgenTus Therapeutics subsidiary). 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 early phase 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.

SOURCE: Agenus

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