Marengo advancing its lead TCR activator into clinic after FDA clearance

September 16, 2022 - 2 minutes
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Marengo Therapeutics is advancing its lead TCR activator, STAR0602, into clinic following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA).

STAR0602 is a bi-functional fusion antibody that deploys a mechanism of T cell activation that has demonstrated potent single agent activity in PD-1 refractory settings in preclinical studies.

Marengo Therapeutics plans to initiate a phase 1/2 clinical trial of STAR0602 as a single agent in advanced solid tumors in the fourth quarter of 2022.

Research

To conduct the clinical trial and advance translational research via the company’s TCR Vb targeted STAR platform, Marengo Therapeutics has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI)’s Center for Cancer Research (CCR) and its recently announced Center for Immuno-Oncology (CIO).

The CIO is co-led by Jeffrey Schlom, co-director of CIO, and James Gulley, co-director of CIO, deputy director of the CCR, NCI, and acting clinical director, NCI.

The NCI and its collaborators at Marengo Therapeutics, Inc. will conduct preclinical and clinical investigations of Marengo Therapeutics’ selective immune activation antibody repertoire in cancer and other T cell related diseases.

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Newly formed team

This is the first CRADA with the newly formed CIO team at the NCI, which is one of the institutes of the National Institutes of Health (NIH).

Zhen Su, CEO of Marengo Therapeutics, said: “Advancing our lead asset into the clinic marks a key inflection point for Marengo as we begin to translate our novel discovery into life-saving medicines. The collaboration with NCI will help us accelerate enrollment for our clinical trial while ensuring that it is executed in accordance with the highest standards of ethics and quality

“We are truly honored to be the CIO’s first CRADA partner and look forward to combining our expertise with that of Dr. Gulley, Dr. Schlom, and their teams to create paradigm-shifting immunotherapeutics for patients. The studies conducted as part of this CRADA will help us expand the opportunities for our lead asset and the STAR platform to address high unmet medical needs.”

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