Marengo Initiated Phase 2 Trial of Invikafusp Alfa for PD-1 Resistant Tumors, Expands to Europe
Marengo Therapeutics, Inc., a clinical-stage biotechnology company focused on precision T cell activation, has announced the dosing of the first patient in the Phase 2 portion of its STARt-001 clinical trial.
The trial is evaluating invikafusp alfa (STAR0602), a novel monotherapy, in patients with PD-1 resistant solid tumors.
The Phase 1 portion of the STARt-001 trial, presented at the 2024 SITC Annual Meeting and ESMO Immuno-Oncology Congress, demonstrated promising results, including a 25% overall response rate and a 50% disease control rate.
These results were observed in patients with PD-1 resistant tumors and high tumor mutation burden (TMB-H), including those with microsatellite-stable colorectal cancer.
Invikafusp alfa also exhibited a manageable safety profile, supporting its potential as a treatment for patients with heavily pre-treated cancers.
The Phase 2 study has now expanded beyond North America, with study sites activated in leading oncology centers in France and Spain.
The trial will continue to evaluate invikafusp alfa at the recommended Phase 2 dose (RP2D) of 0.08mg/kg.
“We are excited to move invikafusp alfa into Phase 2 and expand the trial to prominent European oncology centers, The positive data from Phase 1, particularly in PD-1 resistant ‘cold’ tumors such as colorectal cancer, reinforce our confidence in this approach. The expansion to Europe will enable us to reach a broader patient population and further explore the potential of invikafusp alfa in treating diverse tumor types.”- Ke Liu, Chief Development Officer of Marengo Therapeutics.
About Marengo Therapeutics
Marengo Therapeutics is a clinical-stage biotechnology company that is pioneering novel immunotherapies to target T cell subsets for the treatment of cancer. The company’s STAR™ Platform leverages proprietary antibodies to selectively activate T cell receptors (TCRs) with a non-clonal mechanism, fostering durable immune responses against tumors.
About Invikafusp Alfa (STAR0602)
Invikafusp alfa (STAR0602) is Marengo’s lead program, designed to activate T cell subsets and enhance anti-tumor responses. It targets specific Vβ regions of the TCR and combines this with a T cell co-stimulator, resulting in the expansion of effector memory T cells that drive long-term tumor clearance.
About the STARt-001 Trial
The STARt-001 trial is a Phase 1/2 clinical study investigating the safety, tolerability, and preliminary efficacy of invikafusp alfa as a monotherapy in patients with PD-1 resistant and antigen-rich solid tumors. The trial is designed to evaluate the treatment in biomarker-enriched populations, including those with advanced, rare, and refractory cancers.
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