Marengo Therapeutics, Inc. has announced the dosing of the first patient in the Phase 2 portion of its STARt-001 trial, building on the Phase 1/2 trial evaluating invikafusp alfa as a monotherapy in biomarker-enriched patients with advanced anti-PD-1 resistant solid tumors. The global Phase 2 study has expanded from North American sites to include European oncology clinical research centers, with initial activation in France and Spain. This expansion aims to enhance patient enrollment and deepen the understanding of invikafusp alfa's mechanism of action across diverse tumor types.
Promising Phase 1 Results
Data from the Phase 1 portion of the STARt-001 trial, presented at the SITC Annual Meeting and the ESMO Immuno-Oncology Congress, demonstrated a 25% Overall Response Rate (ORR) and a 50% Disease Control Rate (DCR) at the targeted dose range in patients with PD-1 resistant tumors and high tumor mutation burden (TMB-H). Notably, confirmed responses were observed in microsatellite-stable colorectal cancer, a traditionally 'cold' tumor.
Invikafusp Alfa: A Novel T Cell Activator
Invikafusp alfa (STAR0602) is Marengo's lead program, derived from its Selective T Cell Activation Repertoire (STAR) platform. This platform utilizes antibodies targeting germline-encoded variable Vβ regions of the T cell receptor (TCR) fused to T cell co-stimulatory moieties. Invikafusp alfa selectively targets a common Vβ T cell subset present in various cancers, promoting the expansion of clonally enriched, effector memory Vβ T cells to enhance tumor immune responses and durable tumor clearance.
Phase 2 Trial Design and Objectives
The Phase 2 clinical trial will treat patients with the recommended Phase 2 dose (RP2D) of 0.08mg/kg. The study is enrolling patients at leading oncology centers in Europe, starting with sites in France and Spain. The primary objective is to further evaluate the safety and efficacy of invikafusp alfa in PD-1 resistant tumors. "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," said Ke Liu, M.D., Ph.D., Chief Development Officer of Marengo Therapeutics. "Through our Phase 2 study, we aim to deepen our understanding of invikafusp alfa’s mechanism of action across diverse tumor types."
