On January 4, 2023 Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, reported the first patient has been dosed in a Phase 1/2a clinical trial evaluating use of novel cancer immunotherapeutic IMT-009 in solid tumors and hematologic malignancies. The company also announced the addition of James Wooldridge, M.D., to their Clinical Advisory Board (Press release, Immunitas Therapeutics, JAN 4, 2023, View Source [SID1234625836]).
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"Despite significant therapeutic advancements, there are still a substantial number of patients who remain unresponsive to standard treatments and would benefit from more effective cancer immunotherapies," said Melissa L. Johnson, M.D., Director of Lung Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology, Study Chair and Principal Investigator for the study. "IMT-009 inhibits the CD161/CLEC2D axis, a novel cancer immunotherapeutic target, and has been shown to re-stimulate the anti-cancer activity of key immune cell populations with a reasonable safety profile in preclinical studies. We look forward to further investigation of IMT-009 and its potential for patients awaiting improved treatment options."
The Phase 1 study (NCT05565417) 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) for treatment of patients with advanced solid tumors or lymphomas. The trial will subsequently transition into Phase 2 to assess the safety and efficacy of IMT-009 as a monotherapy and in combination with another anticancer agent.
"The successful dosing of the first patient in this trial of IMT-009 marks an important milestone for Immunitas and, most importantly, brings us one step closer to delivering novel differentiated therapeutics to patients in need," said Amanda Wagner, Chief Executive Officer of Immunitas. "The timing is ideal for adding James Wooldridge, M.D., to our Clinical Advisory Board. Jim has extensive immuno-oncology development expertise and brings important clinical insight to our pipeline. We are excited to be working with him and look forward to the continued enrollment and dosing of patients in this inaugural trial of IMT-009."
Dr. Wooldridge has more than 20 years of experience in clinical oncology research and drug development, spanning the biotechnology, pharmaceutical, and academic sectors. He previously served as the Chief Medical Officer at Checkmate Pharmaceuticals before the company’s acquisition by Regeneron. He also held the role of Chief Medical Officer at Aeglea BioTherapeutics, where he oversaw development of enzyme-based treatments for rare genetic diseases. Prior to his work as a biotech executive, Dr. Wooldridge spent nearly 11 years heading cancer therapeutic development through various roles at Eli Lilly, most recently serving as Chief Scientific Officer, Immuno-oncology Clinical Development. Dr. Wooldridge also previously conducted clinical and translational cancer research as a faculty member at the University of Iowa and the University of Missouri. He earned his M.D. at the Tulane University School of Medicine and completed post-graduate training in internal medicine and medical oncology at the University of Iowa.
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 under evaluation in a Phase 1/2a clinical trial 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.