Marengo Therapeutics Advances Key Phase 2 Study in Europe

Marengo Therapeutics Moves Forward with Phase 2 Trial

Marengo Therapeutics, Inc., a pioneering clinical-stage biotechnology company, has announced an exciting milestone in its research journey. The company recently dosed the first patient in the significant Phase 2 portion of its STARt-001 trial. This trial focuses on invikafusp alfa, a promising treatment option for patients dealing with advanced anti-PD-1 resistant solid tumors. With the initial results from Phase 1 demonstrating a noteworthy overall response rate and disease control rate, Marengo is poised to make a substantial impact in this field.

STARt-001 Trial Shows Promising Results

The Phase 1 portion of the STARt-001 trial has revealed a 25% overall response rate and a 50% disease control rate in patients who have high tumor mutation burdens. These findings are particularly relevant for those battling PD-1 resistant tumors. Notably, there have been confirmed responses noted in microsatellite-stable colorectal cancer, which showcases the potential effectiveness of this approach.

Expansion of the Study into Europe

In response to these positive results, Marengo has expanded its global Phase 2 study from North America to include prestigious oncology clinical research centers in Europe. The initial activation of study sites has taken place in leading locations, with a focus on maximizing patient enrollment opportunities across the region.

Key Mechanism of Action and Treatment Potential

Invikafusp alfa, also recognized by its code name STAR0602, is designed to serve as a monotherapy aimed at enriching the biomarker profiles of patients with advanced cancers. The treatment's unique mechanism of action works by selectively activating T cells, supporting a more robust immune response against tumors that typically resist conventional therapies. This novel approach holds promise for patients who have limited treatment options.

Insights from Marengo's Chief Development Officer

Dr. Ke Liu, Chief Development Officer at Marengo Therapeutics, expressed enthusiasm about advancing invikafusp alfa into the essential Phase 2 stage, emphasizing the importance of including renowned European oncology centers. He stated, "The single-agent anti-tumor activity observed in Phase 1, particularly in PD-1-resistant matches such as colorectal cancer, inspires us and fuels our hope to reach a broader group of patients." This expansion not only enhances patient access but also deepens the understanding of how invikafusp alfa operates across various tumor types.

About Marengo Therapeutics

Marengo Therapeutics, Inc. is steadfast in its mission to provide innovative solutions in the field of oncology. The company specializes in developing novel TCR-targeting antibodies that selectively interact with specific T cell subsets. By engaging both common and unique T cell responses, Marengo's STAR platform aspires to create a future where the immune system effectively combats cancer and other serious diseases.

Exploration of the STAR™ Platform

The STAR™ platform represents a breakthrough in therapeutic design, utilizing a proprietary library of antibodies that target critical elements of T cell activation. This innovative, dual-action mechanism promotes the immune system's ability to resist cancer pathogens, thereby fostering durable anti-tumor responses. By leveraging detailed biological insights, Marengo's approach aims to revolutionize T cell therapies.

Safe and Promising Path Forward

The Phase 2 clinical trial will focus on patients receiving the recommended Phase 2 dose (0.08mg/kg) while actively enrolling participants at selected sites across Europe. Marengo continues to prioritize patient safety and aims to affirm the manageable safety profile observed during earlier trials, aligning with the commitment to innovate in cancer care.

Frequently Asked Questions

What is the main focus of the STARt-001 trial?

The STARt-001 trial primarily evaluates the effectiveness of invikafusp alfa as a treatment for patients with advanced anti-PD-1 resistant solid tumors.

What were the results from the Phase 1 portion of the trial?

The Phase 1 trial showed a 25% overall response rate and a 50% disease control rate in patients with high tumor mutation burdens.

Why has the study expanded into Europe?

The study has expanded to reach more patients with PD-1 resistant tumors and to collaborate with premier European oncology research centers.

What is invikafusp alfa?

Invikafusp alfa (STAR0602) is a T cell activator that enhances the body's immune response against cancer cells, specifically for those with high tumor mutation burdens.

How does Marengo Therapeutics aim to help patients?

Marengo Therapeutics focuses on developing personalized cancer treatments that efficiently activate T cells to improve patient outcomes and offer hope for long-term cancer management.

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