Marengo Therapeutics Advances First-In-Class Selective T cell Activator, STAR0602, into Human Trials in Solid Tumors and Enters Cooperative Research and Development Agreement with the National Cancer Institute

CAMBRIDGE, MA, USA I September 16, 2022 I Marengo Therapeutics, a company pioneering novel therapeutics targeting the T cell receptor Vβ chain (TCR Vβ) to selectively activate the right T cell subsets to fight cancer, today announced it is advancing its lead TCR activator, STAR0602, into the 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 novel mechanism of T cell activation that has demonstrated potent single agent activity in PD-1 refractory settings in preclinical studies. Marengo plans to initiate a Phase I/II clinical trial of STAR0602 as a single agent in advanced solid tumors in the fourth quarter of 2022.

To conduct the clinical trial for STAR0602 and advance translational research via the company's TCR Vβ targeted STAR platform, Marengo 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 Dr. Jeffrey Schlom, Co-Director of CIO, and Dr. 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. 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).

"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," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo. "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."

About Marengo Therapeutics

Marengo Therapeutics, Inc, an ATP company, is pioneering first-in-class therapeutics that activate the right immune response to promote lifelong protection against cancer. With a passionate team of dedicated scientists experienced in immunology and oncology, Marengo's proprietary Selective T Cell Activation Repertoire (STAR) platform leverages an extensive biological understanding of T cell function and receptor signaling to create a world in which everyone's immune system can defeat cancer. To learn more, visit marengotx.com.

About STAR0602

Marengo's STAR0602 program is the company's lead program and is the first T cell activator generated by the STAR platform. Marengo's Selective T Cell Activation Repertoire (STAR) platform is a multi-specific fusion protein library that targets specific TCR Vβ variants fused to different co-stimulatory moieties to develop potent T cell activators. The unique feature of this platform is to fine-tune the T cell response in selected T cell subsets to generate endogenous, highly functional, cancer-killing T cells for solid tumors. STAR0602, is a fusion protein that binds to a specific region of TCR Vβ and delivers a unique activation signal on the same T cell, leading to a selective expansion of the targeted T cell subclones. This molecule has shown remarkable single agent activity in a vast array of preclinical models.

SOURCE: Marengo Therapeutics

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