On November 11, 2022 Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, reported that preclinical data on lead program IMT-009, a fully human monoclonal antibody against a novel immuno-oncology target CD161, today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, held both virtually and in Boston from November 8-12, 2022 (Press release, Immunitas Therapeutics, NOV 11, 2022, View Source [SID1234623852]).

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"The data presented at the 2022 SITC (Free SITC Whitepaper) Annual Meeting demonstrate the potential of IMT-009 as a dual-acting modality that leverages activation of both CD161+ T and NK cells to treat multiple solid and hematological cancers, and further validate our human data-driven approach to developing novel immunotherapies," said Seng-Lai "Thomas" Tan, Ph.D., Chief Scientific Officer of Immunitas Therapeutics. "Our founders discovered a novel population of functional tumor-infiltrating CD161+ T cells, which we believe can be harnessed therapeutically with IMT-009 as a differentiated approach for a better and safer cancer immunotherapy. We look forward to initiating Phase 1/2a clinical evaluation of IMT-009 later this year."

Preclinical data confirm that IMT-009 binds with high affinity and selectivity to CD161, a cell surface inhibitory receptor that is broadly expressed on NK and a subset of memory CD4+ and CD8+ T cells. Upon binding, IMT-009 disrupts CD161 interaction with its ligand, CLEC2D, restoring activation of effector functions of both CD161+ T and NK cells and thus enhancing cytotoxicity towards target tumor cells. GLP toxicity studies in non-human primates demonstrate that once weekly dosing with IMT-009 generates no significant signs of toxicity, indicating a clean safety profile for first-in-human trials. These results support the CLEC2D/CD161 axis as a novel ligand-receptor pathway for immunotherapeutic intervention across a range of solid tumor indications.

The SITC (Free SITC Whitepaper) poster presentation will be available on the Immunitas Therapeutics website on November 11, 2022.

Presentation details are as follows:
Title: Anti-CD161 antibody IMT-009 is a novel immunotherapeutic agent that reinvigorates T and NK cell function and anti-tumor efficacy through blocking interaction of CD161 with its ligand CLEC2D
Abstract Number: 1332
Date/Time: The poster will be presented on November 11, 2022 and made available for in-person attendees from 9:00 am – 8:30 pm ET.

About IMT-009

IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is anticipated to begin enrollment for a Phase 1/2a clinical trial in Q4 2022 for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The trial will then transition into Phase 2 with multiple expansion cohorts to assess the safety and efficacy of IMT-009 alone or in combination with another antineoplastic agent.