FDA Clears AgenTus IND for Allogeneic iNKT Cell Therapy

- Cancer and COVID-19 Clinical trials expected to commence soon

- Designed for anti-cancer treatment & iNKTs are synergistic with Agenus' checkpoint antibodies

- Potential to clear SARS-CoV-2 virus and control harmful inflammation

- COVID-19 IND expected to clear shortly

LEXINGTON, MA, USA I May 13, 2020 I 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 acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics. A clinical trial for the treatment of patients with cancer is expected to commence 2H2020. AgenTus has also submitted a separate IND for the treatment of COVID-19, which is expected to clear soon.

"We are extremely pleased to rapidly advance our proprietary iNKT cell therapy to the clinic to combat cancer and also address the urgent COVID-19 pandemic," said Dr. Walter Flamenbaum, CEO of AgenTus Therapeutics. "We expect our clinical trials to demonstrate the key features of agent-797 and the benefits of combinations of our allogeneic iNKTs with Agenus' pipeline of checkpoint antibodies in solid tumors."

"I am heartened by our team's efforts to rapidly advance our allogeneic iNKT cells to treat patients with cancer and COVID-19," said Dr. Garo Armen, Chairman and CEO of Agenus and Chairman of AgenTus Therapeutics.  "Our iNKTs are streamlined for treating large numbers of patients from a single batch. They are manufactured without the need for genetic manipulation, are expected to suppress graft-versus-host disease, can be manufactured affordably, and are designed for quick access by patients."

Separately, Agenus indicated that it is contemplating several options with regard to its AgenTus Therapeutics subsidiary. This is given its previous guidance and the advancement of AgenTus' first cell therapy candidates towards the clinic. These options include the potential spinning out of 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.

SOURCE: AgenTus Therapeutics

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