On December 20, 2024 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision T cell activation, reported the dosing of the first patient in the Phase 2 portion of its STARt-001 trial. The clinical study builds on the Phase 1/2 trial evaluating invikafusp alfa as a monotherapy in biomarker-enriched patients with advanced anti-PD-1 resistant solid tumors (Press release, Marengo Therapeutics, DEC 20, 2024, View Source [SID1234649246]).
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The results of the Phase 1 portion of the STARt-001 trial were recently presented during a plenary late-breaking oral session at the SITC (Free SITC Whitepaper) Annual Meeting and an oral presentation at the 2024 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress. The data collectively validate Marengo’s STAR platform design and demonstrate early single agent anti-tumor activity of invikafusp alfa (STAR0602), including clinical benefit in heavily pre-treated, anti-PD-1 resistant cancer patients. Invikafusp alfa exhibited a manageable safety profile consistent with its novel mechanism of action, reinforcing its potential as a treatment option across high tumor mutation burden (TMB-H) cancers or virally associated malignancies.
The Phase 2 clinical trial will treat patients with the RP2D (0.08mg/kg) and is now enrolling patients in Europe at leading oncology centers, with initial activation of sites in France and Spain.
"We are thrilled to advance invikafusp alfa into Phase 2 with the addition of premier European oncology centers," said Ke Liu, M.D., Ph.D., Chief Development Officer of Marengo Therapeutics. "The single-agent anti-tumor activity observed in Phase 1, particularly in PD-1-resistant ‘cold’ tumors like colorectal cancer, gives us confidence in our approach and fuels our hope to reach as many patients as possible. The addition of renowned European institutions expands our geographical footprint and enhances our ability to enroll more PD-1 resistant patient populations. Through our Phase 2 study, we aim to deepen our understanding of invikafusp alfa’s mechanism of action across diverse tumor types."