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Invikafusp alfa (STAR0602) is the first dual T cell agonist generated from Marengo’s STAR™ platform delivering two activation signals to a targeted subset of the T cell populations. It is designed to selectively activate Vβ6/10 T cells, a common subset of T cells highly prevalent in tumor infiltrating T cells (TILs) found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ 6/10 T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602’s potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action.

STARt-001 is a Phase I/II clinical trial evaluating the safety, tolerability, and preliminary clinical activity of Invikafusp alfa as a single agent in biomarker-selected patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumors. This open-label, multi-center trial consists of two parts: Phase I dose escalation and Phase II dose expansion.

Phase I results shared in a late-breaking plenary session at the 2024 SITC Annual Meeting demonstrated initial single agent anti-tumor activity and a favorable safety profile in heavily pre-treated, biomarker-enriched patients who were resistant to prior PD-1 therapy. Read more.

U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to Invikafusp alfa (STAR0602), Marengo’s first-in-class selective dual T cell agonist being studied as a potential new treatment for advanced colorectal cancer with TMB-H. Learn more.

For more information, please visit ClinicalTrials.gov (trial identifier: NCT05592626).

For patients interested in enrolling in this study, contact: kliu@marengotx.com.

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STARt-002 is a Phase Ib/II, clinical trial to investigate the safety and efficacy of Invikafusp alfa (STAR0602) in combination with Sacituzumab Govitecan in participants with unresectable, locally advanced, or metastatic breast cancer. This open-label, multi-center trial consists of two parts: Phase Ib safety run-in and two Phase II dose expansion cohorts in triple negative breast cancer (TNBC) and HR+/HER2- breast cancer.



For more information, please visit ClinicalTrials.gov (trial identifier: NCT06827613).

For patients interested in enrolling in this study, contact: kchin@marengotx.com.