Marengo Therapeutics Announces First Patient Dose in Phase 1/2 Clinical Trial of Its Novel TCR Vβ-Targeted Antibody Fusion Molecule STAR0602, in Cancer Patients Refractory to Anti-PD1 Therapy | DNA, RNA and cells

Marengo Therapeutics Announces First Patient Dose in Phase 1/2 Clinical Trial of Its Novel TCR Vβ-Targeted Antibody Fusion Molecule STAR0602, in Cancer Patients Refractory to Anti-PD1 Therapy

  • The START-001 study uses a tissue-agnostic biomarker-enriched approach to evaluate the activity of STAR0602 monotherapy in advanced solid tumors resistant to checkpoint inhibitors

CAMBRIDGE, MA, USA I January 27, 2023 I Marengo Therapeutics, Inc., a company pioneering novel therapies targeting the T cell receptor (TCR) Vβ to selectively activate the right T cell subsets to fight cancer, today announced that the first patient has received a dose in the ongoing STAR0602 clinical trial ( START -001). Marengo’s START-001 trial is an ongoing phase 1/2 clinical trial evaluating the safety and clinical activity of STAR0602 as monotherapy in a biomarker-enriched cohort of patients with PD-1 refractory advanced solid tumors.

The START-001 trial (NCT05592626) is currently enrolling patients at two top US cancer research institutes, the National Institutes of Health (NIH) National Cancer Institute (NCI) and Mass General Hospital (MGH)/Harvard Medical School, jointly led by experienced clinical and translational researchers James Gulley, MD, Ph.D., of NCI and Ryan Sullivan, MD, of MGH. Additional cancer centers of excellence plan to join these clinical sites to support further expansion of the study.

“The NCI Center for Cancer Research’s Center for Immuno-Oncology was recently established to investigate the fundamental questions of cancer immunotherapy through rigorous preclinical studies and to translate these findings into clinical trials with the goal of developing new therapies for a spectrum of cancers with high unmet medical need. We look forward to study of this novel TCR agonist that selectively activates a subset of αβ T cells in cancer patients at NCI,” said Dr. Gulley, co-director of the Center for Immuno-Oncology (CIO), deputy director of the Center for Cancer Research (CCR) at NCI and Acting Clinical Director of the NCI.

“The initiation of our first clinical trial with STAR0602 is an important milestone for Marengo and our selective T cell targeting platform STAR,” said Zhen Su, MD, MBA, Chief Executive Officer of Marengo. “The START-001 trial uses a deep biology-driven study design to address the unmet clinical needs of patients for whom PD-1 therapies are no longer effective. Our clinical development approach uses a biomarker-enriched, tumor-agnostic strategy that offers a much-needed new approach to cancer drug development. We are confident that the evaluation of STAR0602 in well-defined populations will enable us to effectively investigate biological and clinical activity, paving the way for further research.”

“Cancer immunotherapy has changed the standard of care in many tumor settings and significantly improved the overall survival of cancer patients. Despite these innovative therapies, most patients progress after treatment, creating an urgent need to develop the next wave of new therapeutics,” said Dr. Sullivan, associate director, Melanoma Program, MGH Cancer Center. “We are excited to test this new biology by re-energizing the T cell compartment in tumors to drive an anti-tumor immune response that is distinct from the PD-1 mechanism.”

About Marengo Therapeutics

Marengo Therapeutics, Inc, an ATP company, is pioneering a first-in-class therapy that activates a true immune response to promote lifelong protection against cancer. With a passionate team of dedicated scientists with expertise in immunology and oncology, Marengo’s proprietary Selective T Cell Activation Repertoire (STAR) platform leverages a comprehensive biological understanding of T cell function and receptor signaling to create a world where everyone’s immune system can defeat cancer. For more information, visit

About STAR0602

STAR0602 is Marengo’s flagship program, the first T cell activator generated from Marengo’s STAR platform; library of antibodies targeting nonclonal variable (V)β regions of the TCR fused to different costimulatory moieties. STAR0602 selectively targets a common subset of Vβ T cells present in all cancers and, by combining a novel non-clonal mode of TCR activation with a T cell costimulator in the same molecule, promotes the expansion of a new population of clonally enriched effector memory Vβ T cells that turbo boost the tumor immune response and promote sustained clearance tumors. STAR0602 has undergone extensive preclinical testing, demonstrating potent antitumor activity in mouse and human ex vivo tumor models attributed to a different mechanism of action from existing cancer immunotherapies.

About the START-001 clinical study

START-001 is a Phase 1/2 clinical study evaluating the safety, tolerability and preliminary clinical activity of STAR0602 as a single agent in patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumors. This open-label, multicenter trial consists of two parts: a dose-escalation phase 1 and a dose-escalation phase 2. For more information, visit (trial identifier: NCT05592626).

For patients interested in enrolling in this study at NCI, please contact NCI toll-free at 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and /or the website and/or email This e-mail address is being protected from spambots. You need JavaScript enabled to view it..

SOURCE: Marengo Therapeutics

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