Agenus Doses First Cancer Patient with iNKT Cell Therapy

Rhea-AI Summary

Agenus Inc. (NASDAQ: AGEN) announced the dosing of the first patient with agenT-797, an allogeneic iNKT cell therapy, in a Phase 1 clinical trial targeting hematologic cancers. This trial, led by the Dana-Farber Cancer Institute, aims to assess safety and preliminary efficacy, with initial data expected in Q4 2021. The iNKT cell therapy, which previously showed promise for COVID-19, is believed to offer a safer, more accessible treatment option for various cancers. Agenus leverages its extensive portfolio of checkpoint antibodies for optimal therapeutic combinations.

Positive

• Initiation of Phase 1 clinical trial for agenT-797 targeting hematologic cancers.
• Initial data for the trial expected in Q4 2021, which could provide insights into the therapy's efficacy.
• iNKT cell therapy shows potential to be a safer and more accessible treatment compared to current options.
• Access to a broad portfolio of checkpoint antibodies enhances therapeutic combination potential.

Negative

• No current financial metrics or revenue projections related to the trial's outcomes.

LEXINGTON, Mass., April 14, 2021 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced the dosing of the first cancer patient with agenT-797, an allogeneic iNKT cell therapy, in a Phase 1 clinical trial through its subsidiary, AgenTus Therapeutics.

"Our proprietary iNKT cell therapy has been advancing in the clinic in patients with acute respiratory distress syndrome (ARDS) secondary to COVID-19; we are now expanding our iNKT cell therapy to treat patients with cancer,” said Jennifer Buell, PhD, President and COO of Agenus. “iNKT cells penetrate tissues, demonstrate potent tumor killing, and show compelling curative potential in solid tumor models with activating iNKT cell therapies and checkpoint antibodies. We are thrilled to advance this cell therapy for broader benefit in patients with solid tumors and in combination with antibodies.”

The Phase 1 trial has been initiated in hematologic cancers, with expansion into solid tumors expected to begin shortly. Led by Clifton Mo, MD, Director of Autologous Stem Cell Transplantation for Multiple Myeloma at the Dana-Farber Cancer Institute, the Phase I dose-escalation trial will explore the safety, tolerability, and preliminary clinical activity of agenT-797 in patients with relapsed/refractory multiple myeloma. Agenus anticipates initial data readouts for the Phase 1 study in the fourth quarter of 2021.

A Phase 1 trial of agent-797 for intubated patients with moderate to severe symptoms of COVID-19 was initiated in late 2020. Preliminary data show no adverse events attributable to agent-797 and suggest early signals of activity. Dose escalation is expected to be completed in the first half of 2021 with expansion into a Phase 2 trial with data readouts expected this year.

iNKT cell therapy is expected to eliminate graft-versus-host disease, may not require genetic manipulation, and can be manufactured to treat large numbers of patients from a single dose. These attributes support the possibility of a safer and more affordable and accessible therapy than currently approved cell therapies.

As a subsidiary of Agenus, AgenTus currently has unique access to Agenus’ portfolio of checkpoint antibodies and cancer vaccines which allows for optimal combinations with its cell therapies. This gives the company enormous flexibility to develop effective combinations with curative potential for patients with cancer and infectious disease.

About AgenTus Therapeutics, Inc.
AgenTus Therapeutics is a biopharmaceutical company focused on developing allogeneic iNKT cell therapies to treat cancer and other life-threatening diseases. 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 data readouts from cell therapy phase 1 clinical trials for cancer and COVID-19, expansion of phase 1 clinical trials into solid tumors, the anticipated commencement of future clinical trials and the expected benefits to be observed in these trials and with these cell therapy treatments generally. 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 Investor Relations
Jan Medina, CFA
Agenus
781-674-4490
Jan.Medina@agenusbio.com

Agenus Media Relations
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com 

FAQ

What is the Phase 1 clinical trial for agenT-797 by Agenus?

The Phase 1 trial for agenT-797 is aimed at assessing safety and preliminary efficacy in hematologic cancers.

When will initial data from the agenT-797 trial be available?

Initial data readouts for the Phase 1 study are anticipated in the fourth quarter of 2021.

What are the expected benefits of the iNKT cell therapy?

iNKT cell therapy is expected to be a safer and more accessible treatment option for various cancers.

What types of cancers are being targeted in the agenT-797 trial?

The trial initially focuses on hematologic cancers, with plans to expand into solid tumors.

Who is leading the Phase 1 trial for agenT-797?

The trial is led by Clifton Mo, MD, from the Dana-Farber Cancer Institute.