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

LEXINGTON, Mass., Feb. 20, 2020 /PRNewswire/ -- 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:

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‐Director 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.

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 regarding the Company's plans to release clinical data on balstilimab (anti-PD-1), zalifrelimab (anti-CTLA-4) and AGEN1181 at an upcoming investor day. 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:

Agenus Inc. 
Regina Grebla, PhD
781-674-4495
[email protected] 

SOURCE Agenus Inc.