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Biopharmaceuticals FDA

 News Release - June 2, 2020

FDA Clears IND for iNKT Cells to Treat COVID-19 Patients

AgenTus allogeneic iNKTs have potential to clear SARS-CoV-2 virus & mitigate harmful inflammation

COVID-19 and cancer clinical trials to commence

Dr. Koen van Besien at Weill Cornell/New York Presbyterian Hospital to lead COVID-19 trials


LEXINGTON, Mass., June 2, 2020 -- (Healthcare Sales & Marketing Network) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, announced today the FDA's clearance of AgenTus' IND application for an allogeneic iNKT therapy. AgenT-797 was submitted by AgenTus Therapeutics, a subsidiary of Agenus. A clinical trial for the treatment of patients with COVID-19 is expected to commence shortly. Agenus previously reported the FDA clearance of the IND for the use of allogeneic iNKTs for patients with cancer.

"We are excited to evaluate this novel allogeneic iNKT cell therapy platform as a potential therapy for patients in moderate to severe respiratory distress from COVID-19," said Koen van Besien, M.D., Ph.D., Professor of Medicine and Director of the Stem Cell Transplant program at Weill Cornell Medical Center and New York Presbyterian Hospital. "The preclinical data reveal the potential of iNKTs to eliminate virus, dampen harmful inflammation, and promote protection from reinfection. These are all particularly important features as we attempt to overcome COVID-19."

Separately, Agenus indicated that it is contemplating several options regarding its AgenTus Therapeutics subsidiary. These options include the potential of spinning out AgenTus and issuing a portion of its holdings in AgenTus to Agenus shareholders in the form of a stock dividend. Agenus expects that such a decision will be made by the end of this year.

About AgenTus Therapeutics, Inc.

AgenTus Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of breakthrough allogeneic iNKT cells in the unmodified and modified with engineered receptors, such as T cell receptors (TCRs) and Chimeric Antigen Receptors (CARs), designed to supercharge the human immune system cells to seek and destroy cancer. AgenTus also aims to advance adoptive cell therapy formats which would enable off-the-shelf living drugs. AgenTus has locations in Lexington, MA and Cambridge, UK. For more information, please visit www.agentustherapeutics.com.

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 the anticipated therapeutic benefit of iNKTs for COVID-19 patients, clinical development plans and timelines, the potential spinning out of AgenTus therapeutics and issuing a portion of Agenus' holdings in AgenTus to Agenus shareholders in the form of a stock dividend, and the expectation to make such a decision by the end of 2020. 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.


Source: Agenus

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