Marengo's Invikafusp Alfa Gets FDA Fast Track for Advanced Colorectal Cancer with High Tumor Mutational Burden

Marengo Therapeutics, Inc., a biotechnology company specializing in innovative T cell activation methods, has announced a significant regulatory milestone for its lead candidate, invikafusp alfa (STAR0602). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to this novel therapy, currently under investigation as a treatment for advanced colorectal cancer characterized by high tumor mutational burden (TMB-H). This designation is intended to accelerate the development and review process for therapies that address severe or life-threatening conditions with limited treatment options.

The Fast Track status signifies a crucial advancement for Marengo's STAR0602 program, which focuses on their unique dual T cell agonist platform. This recognition underscores the potential of STAR0602 as a groundbreaking therapy for patients with metastatic colorectal cancer that does not respond to existing PD-1 inhibitor treatments.

The FDA's decision is based on promising findings from Marengo's Phase 1 clinical trial of invikafusp alfa, which involved patients with heavily pretreated cancers. These results, presented at key industry events such as the 2024 SITC Annual Meeting and the 2024 ESMO Immuno-Oncology Congress, highlighted the therapy's anti-tumor efficacy and favorable safety profile.

Dr. Zhen Su, CEO of Marengo Therapeutics, emphasized the importance of the FDA's Fast Track designation as a validation of their platform's potential to address significant challenges in oncology. He pointed out that this acknowledgment supports the further development of STAR0602 as an innovative treatment for TMB-H metastatic colorectal cancer, which is typically resistant to PD-1 therapies.

Bruce Chabner, M.D., a respected figure in the oncology field, expressed optimism about Marengo's approach of selectively activating specific T cell subsets to enhance anti-tumor responses. He noted that the ongoing Phase 2 clinical trials of invikafusp alfa could potentially lead to a new class of treatments for cancers unresponsive to PD-1 inhibitors, especially colorectal cancer, where therapeutic options remain limited.

Marengo's commitment to advancing STAR0602 is evident as the candidate progresses through Phase 2 clinical trials, which began at the end of 2024. The company anticipates releasing additional efficacy data later this year, further fueling their efforts to bring this innovative therapy to patients.

Marengo Therapeutics is dedicated to developing novel antibodies that target T cell receptors, aiming to provide lifelong protection against cancer and other diseases. Their proprietary Selective T Cell Activation Repertoire (STAR) platform leverages a deep understanding of T cell functionality to engineer therapies that empower the immune system to combat cancer effectively.

The STAR platform, a cornerstone of Marengo's innovation, includes a library of antibodies targeting specific T cell receptor regions. By integrating a novel mode of TCR activation with T cell co-stimulation, the platform fosters robust anti-tumor T cell responses. This approach is embodied in invikafusp alfa, the first T cell activator from the STAR platform, designed to enhance T cell populations that drive tumor clearance.

The STARt-001 clinical trial, a Phase 1/2 study, is assessing the safety and efficacy of invikafusp alfa in patients with advanced antigen-rich solid tumors, including those resistant to PD-1 therapies. This trial aims to determine the optimal dosing strategy and expand the therapeutic potential of invikafusp alfa across various tumor types.

As Marengo continues to push the boundaries of immunotherapy, the FDA's Fast Track designation for invikafusp alfa marks a pivotal step in their mission to develop cutting-edge cancer treatments. With a focus on harnessing the power of T cells, Marengo Therapeutics is poised to make significant contributions to the field of oncology, offering hope to patients with challenging cancers.