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Agenus' (AGEN) IND for iNKT Therapy Gets FDA Acceptance

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Agenus Inc. (AGEN - Free Report) announced that the FDA has accepted its investigational new drug (IND) application for the allogeneic iNKT therapy candidate, agenT-797, seeking approval to begin clinical studies on the same for cancer treatment. The studies are expected to begin in the second half of this year.

Notably, the company has also submitted a separate IND for agenT-797 to address the deadly COVID-19. This IND is expected to get a clearance soon.

Shares of Agenus have declined 37.8% so far this year against the industry’s increase of 5.9%.


Agenus is a clinical-stage, immuno-oncology company with a comprehensive portfolio of antibody-based therapeutics, adjuvants and cancer vaccine platforms.

We remind investors that in March 2020, the FDA granted a Fast Track designation to the combination of Agenus’ CTLA-4 antibody, Zalifrelimab, and the PD-1 antibody, balstilimab, for the treatment of patients with relapsed/refractory metastatic cervical cancer.

Later in April, the FDA granted a Fast Track tag to balstilimab as a monotherapy for treating advanced cervical cancer.

The company expects to file two biologics license applications (BLAs) seeking accelerated approval for the balstilimab + zalifrelimab combo and balstilimab monotherapy for metastatic cervical cancer.

Successful development of these candidates will lend a huge boost to the company, given the market it targets and the high unmet medical need for the second-line cervical cancer.

In January, Agenus initiated a phase I study on another candidate AGEN1223, a novel bi-specific antibody, designed to deplete regulatory T cells in the tumor microenvironment.

Agenus is currently responsible for developing AGEN122 while Gilead Sciences, Inc. (GILD - Free Report) has an exclusive option to license this candidate.

Zacks Rank & Other Stocks to Consider

Agenus currently sports a Zacks Rank #1 (Strong Buy). Other top-ranked stocks in the healthcare sector include Moleculin Biotech Inc (MBRX - Free Report) and Abeona Therapeutics Inc (ABEO - Free Report) , both flaunting the same Zacks Rank as Agenus. You can see the complete list of today’s Zacks #1 Rank stocks here.

Moleculin Biotech’s loss per share estimates have narrowed 11.1% for 2020 and 10.4% for 2021 over the past 60 days.

Abeona Therapeutics’ loss per share estimates have narrowed 16.7% for 2020 and 30% for 2021 over the past 60 days.

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