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2021-03-26T12:01:19.000Z

FDA clears investigational new drug application for ‘OncoMimic’ based immunotherapy EO2463

Mar 26, 2021
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On March 24, 2021, it was announced that the U.S. Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for EO2463, an ‘OncoMimic’ based immunotherapy being investigated for the treatment of indolent non-Hodgkin lymphoma.

A phase I/II clinical trial (NCT04669171), expected to be initiated in Q2 2021, will evaluate the safety, tolerability, and efficacy of EO2463 as a monotherapy and in combination with standard of care (rituximab, and rituximab plus lenalidomide) in 60 patients with follicular lymphoma and marginal zone lymphoma.

EO2463

EO2463 is a novel investigational immunotherapy that comprises four peptides, derived from bacteria present in the gut microbiome, which mimic B lymphocyte-specific lineage markers. The ‘OncoMimic’ based therapy is designed to induce full depletion of the malignant B lymphocytes that are enriched in indolent non-Hodgkin lymphoma.

  1. Enterome. Enterome receives FDA IND clearance for EO2463, an ‘OncoMimic’ based immunotherapy targeting liquid tumors. https://www.enterome.com/enterome-receives-fda-ind-clearance-for-eo2463-an-oncomimic-based-immunotherapy-targeting-liquid-tumors/. Published Mar 24, 2021. Accessed Mar 26, 2021.

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