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Marengo Therapeutics Begins Phase I/II Trial of Selective T-Cell-Targeted Antibody

NEW YORK – Marengo Therapeutics on Friday said that an advanced cancer patient refractory to anti-PD-1 drugs has received its bispecific antibody STAR0602 within a Phase I/II trial.

The trial comprises a Phase I dose escalation portion and a Phase II dose expansion portion. The Phase I study will include patients whose tumors have high mutational burden (TMB-H), high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), or virally associated tumors. In Phase II, Marengo will expand enrollment to patients with metastatic triple-negative breast cancer, relapsed and refractory epithelial ovarian cancer, metastatic castration-resistant prostate cancer, KRAS-mutant and wild-type colorectal cancer, and primary, stage IV or recurrent non-small cell lung cancer. Researchers will track patients' toxicities and adverse events as well as their responses to STAR0602.

The Cambridge, Massachusetts-based company developed STAR0602 from a technology platform that relies on a library of antibodies targeting non-clonal variable β regions of the T-cell receptor linked to co-stimulatory chemical groups.

"The START-001 trial leverages a deep biology-driven study design to address high unmet clinical needs in patients for whom PD-1 therapies are no longer effective," Marengo CEO Zhen Su said in a statement. "Our clinical development approach utilizes a biomarker-enriched, tumor-agnostic strategy that offers a much-needed novel approach to cancer drug development."