#USA #Cambridge #Marengo Therapeutics #Invikafusp Alfa #STARt-001

Marengo Therapeutics Advances Invikafusp Alfa to Phase 2 Trials

Marengo Therapeutics, a pioneering force in the biotechnology arena, has recently announced the dosing of its first patient in the Phase 2 segment of its STARt-001 clinical study. This groundbreaking research examines the efficacy of Invikafusp Alfa (STAR0602) in combating advanced solid tumors that have shown resistance against anti-PD-1 therapies.

The initiative marks a significant progression in Marengo's clinical efforts, building on preceding Phase 1 trial results which exhibited a 25% overall response rate and a 50% disease control rate among patients presenting with PD-1 resistant tumors. Notably, these results included encouraging outcomes for patients suffering from microsatellite-stable colorectal cancer, a specific type of tumor known for its challenging prognosis.

Following the successful results of the initial phase, Marengo is extending this promising study into Europe, activating premier oncology research institutions in countries such as France and Spain. This expansion into European medical landscapes underlines Marengo's commitment to broadening patient access and diversity within the trial, thereby enhancing the robustness of their clinical data.

Dr. Ke Liu, Chief Development Officer at Marengo Therapeutics, expressed enthusiasm about this development, stating, "We are thrilled to advance invikafusp alfa into Phase 2 with the addition of premier European oncology centers. 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."

In terms of safety, the STARt-001 trial has documented a manageable safety profile for Invikafusp Alfa, suggesting that its unique mechanism of action offers a novel therapeutic avenue for patients with high tumor mutation burden (TMB-H) cancers, including those associated with viral infections. The treatment aims not only to target these resistant tumors but to do so with an innovative therapeutic approach that harnesses and enhances the body’s own immune responses against cancer.

Marengo’s STAR™ platform is central to this process, utilizing a multi-specific antibody-fusion technology that modulates T cell activation. This advanced platform is designed to create a more effective immune response by selectively targeting T cell subsets that play crucial roles in achieving sustained anti-tumor effects.

The ongoing Phase 2 trial will focus on administering a specific recommended dose of 0.08mg/kg, with recruitment efforts concentrating on highly qualified participants who meet the trial's biomarker specifications. As the trial progresses, Marengo hopes to further elucidate the anti-tumor mechanisms of Invikafusp Alfa, establishing more comprehensive insights into its effectiveness across various tumor types.

As the medical community eagerly anticipates further developments from Marengo Therapeutics, the STARt-001 trial promises to reveal significant findings that could potentially reshape treatment paradigms for patients grappling with PD-1 resistant tumors. The outcome of this innovative approach could pave the way for new, life-saving therapies within the oncology space, demonstrating the crucial need for medical advances in cancer treatment. For those interested in learning more or potentially enrolling in the study, Marengo encourages contacting clinical trial coordinators through the National Cancer Institute.

This exciting stride by Marengo Therapeutics symbolizes a brighter path forward for cancer treatment, reinforcing the hope that through scientific innovation and dedication, barriers in cancer therapy can be surmounted.