Agenus Announces U.S. FDA Acceptance and Priority Review of Balstilimab Biologics License Application for the Treatment of Recurrent or Metastatic Cervical Cancer

LEXINGTON, Mass., June 17, 2021 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted Agenus’ Biologics License Application (BLA) for balstilimab, an anti-PD-1 antibody, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The FDA has granted Priority Review to this submission, a designation for drugs which, if approved, may provide significant improvements in the safety or effectiveness of the treatment of serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 16, 2021. About Cervical Cancer Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die. 1 Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide. 2 Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit. About balstilimab Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer. 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, adoptive cell therapies (through its AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. 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. Contact Agenus Investor Relations Jan Medina, CFA Agenus 781-674-4490 [email protected] Agenus Media Relations Kimberly Ha KKH Advisors 917-291-5744 [email protected] ______________________________ 1 https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html 2 https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660 View All News Contact Us Agenus Inc. [email protected] Quick Links SEC Filings Information Request Form Investor Email Alerts To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. After submitting your request, you will receive an activation email to the requested email address. You must click the activation link in order to complete your subscription. You can sign up for additional alert options at any time. At Agenus Inc., we promise to treat your data with respect and will not share your information with any third party. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the ‘unsubscribe’ section below. If you experience any issues with this process, please contact us for further assistance. By providing your email address below, you are providing consent to Agenus Inc. to send you the requested Investor Email Alert updates. * Required Email Address * Investor Alert Options Investor Alert Options * News Quarterly Reports Annual Reports SEC Filings End of Day Stock Quote Events & Presentations Unsubscribe Email Alert Sign Up Confirmation Request A Meeting With Management > Agenus Inc. 3 Forbes Road Lexington, MA 02421-7305 T: +1 781.674.4400 | F: +1 781.674.4200 © 2023 Agenus Inc. All rights reserved. Privacy policy Terms and conditions of use Overview Pipeline Capabilities Publications Patients Investors Media In the News Podcast Join us Contact us

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