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Agenus Announces ESMO Oral Presentation of Two Clinical Trials of Balstilimab Alone and in Combination with Zalifrelimab in Recurrent or Metastatic Cervical Cancer

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Agenus Inc. (NASDAQ: AGEN) announced that data from two Phase 2 trials of balstilimab, both alone and in combination with zalifrelimab, will be presented at the European Society of Medical Oncology (ESMO) Conference on September 18, 2020. Dr. David O'Malley from Ohio State University will present the findings. The company remains on track to initiate a rolling Biologics License Application (BLA) submission for balstilimab monotherapy this quarter and aims to complete a data packet for the combination therapy by year-end.

Positive
  • Upcoming oral presentation of Phase 2 trial data at ESMO could enhance visibility and investor interest.
  • Progress towards initiating rolling BLA submission for balstilimab monotherapy this quarter.
  • Planned completion of data packet for balstilimab and zalifrelimab combination therapy by year-end.
Negative
  • None.

LEXINGTON, Mass., Aug. 26, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab will be presented in an oral presentation at the upcoming European Society of Medical Oncology (ESMO) Conference on September 18, 2020. 

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Data will be presented by Dr. David O'Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology at the James Cancer Hospital of The Ohio State University Comprehensive Cancer Center. Agenus remains on track to initiate rolling BLA submission for balstilimab monotherapy this quarter. Agenus also plans to have a completed data packet supporting BLA submission of balstilimab in combination with zalifrelimab by the end of this year.

Abstract title: Single-agent Anti-PD-1 Balstilimab or in Combination with Anti-CTLA-4 Zalifrelimab for Recurrent/Metastatic (R/M) Cervical Cancer (CC). Preliminary Results of Two Independent Ph2 Trials [LBA34]

Session:  Gynaecological cancers   

Date:  September 18, 2020

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.

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 clinical development and regulatory plans and timelines. 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. 
Jennifer S. Buell, PhD
781-674-4420 
Jennifer.Buell@agenusbio.com  

Cision View original content:http://www.prnewswire.com/news-releases/agenus-announces-esmo-oral-presentation-of-two-clinical-trials-of-balstilimab-alone-and-in-combination-with-zalifrelimab-in-recurrent-or-metastatic-cervical-cancer-301119154.html

SOURCE Agenus Inc.

FAQ

What results will Agenus present at the ESMO Conference regarding balstilimab?

Agenus will present data from two Phase 2 trials of balstilimab, both as a monotherapy and in combination with zalifrelimab, focusing on recurrent/metastatic cervical cancer.

When is the ESMO Conference presentation scheduled?

The presentation is scheduled for September 18, 2020.

What are the next steps for Agenus following the ESMO presentation?

Agenus plans to initiate a rolling BLA submission for balstilimab monotherapy this quarter and complete the data packet for the combination therapy by the end of 2020.

Who will present the data at the ESMO Conference?

Dr. David O'Malley from Ohio State University will present the data.

Agenus Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
LEXINGTON