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Immunitas Cleared by FDA to Begin Trial of IMT-009 in Hematologic Malignancies, Solid Tumors

NEW YORK – Immunitas Therapeutics said Wednesday that the US Food and Drug Administration cleared an investigational new drug application for its CD161-targeted monoclonal antibody IMT-009.

The Waltham, Massachusetts-based company will advance the drug into a Phase I/II trial using a biomarker-driven development plan that will assess biological response and inform future patient selection. The trial is expected to begin enrolling patients in the fourth quarter of 2022.

The Phase I portion of the trial will assess safety, tolerability, and pharmacodynamic biomarkers. Researchers will gather preliminary efficacy data and determine the recommended Phase II dose. In the Phase II portion, Immunitas will study the activity of IMT-009 in multiple expansion cohorts and in combination with another agent.

IMT-009, which Immunitas is developing as a treatment for solid and blood cancers, has been shown to block interactions between the CD161 receptor and its ligand CLEC2D, which is expressed on the surface of cancer cells and immune cells. In preclinical studies, a blockade of CD161 by IMT-009 led to enhanced anti-tumor activity. IMT-009's mechanism does not overlap with other immune checkpoint pathways, opening up the possibility for combination therapies with other anti-cancer agents.

In addition to IMT-009, Immunitas has IMT-073, an NK- and T-cell modulator in preclinical development.

Immunitas closed a $58 million Series B financing round in August 2021, led by Agent Capital with participation from several investors including the Leukemia and Lymphoma Society Therapy Acceleration Program. That brought the company's total capital raised to $97 million since its founding in 2019 by scientists from Dana-Farber Cancer Institute, Massachusetts General Hospital, the Broad Institute, and Massachusetts Institute of Technology.