Marengo Begins Phase 2 Trial of Invikafusp Alfa in PD-1 Resistant Tumors, Expands to Europe

Marengo Therapeutics, Inc., a leading clinical-stage biotechnology firm, has taken a significant step forward in cancer treatment with the initiation of the Phase 2 segment of its STARt-001 clinical trial. This trial is designed to evaluate the efficacy of invikafusp alfa as a monotherapy in patients with advanced solid tumors that are resistant to anti-PD-1 therapies, particularly those with a high tumor mutation burden (TMB-H).

The Phase 1 data from the STARt-001 trial was recently shared at prestigious events, including the SITC Annual Meeting and the ESMO Immuno-Oncology Congress. The findings from these presentations highlighted the promising potential of the STAR platform developed by Marengo. Specifically, invikafusp alfa (also known as STAR0602) demonstrated notable anti-tumor activity as a single agent, showcasing a 25% Overall Response Rate and a 50% Disease Control Rate at the targeted dose range. These results were observed in patients with PD-1 resistant tumors, including those with microsatellite-stable colorectal cancer.

The Phase 2 trial, which has now commenced, will administer the recommended Phase 2 dose (RP2D) of 0.08 mg/kg to patients. The expansion of the trial to include leading oncology centers in Europe, starting with France and Spain, is a critical move in broadening the trial's geographical scope and patient accessibility. This expansion is expected to enhance the enrollment of diverse patient populations, particularly those resistant to PD-1 treatments.

Dr. Ke Liu, the Chief Development Officer at Marengo Therapeutics, expressed optimism regarding the trial's progression. He emphasized the significance of the single-agent anti-tumor activity observed in Phase 1, particularly in challenging cases such as PD-1-resistant colorectal cancer. Dr. Liu highlighted the importance of collaborating with renowned European institutions to further the understanding and application of invikafusp alfa across various tumor types.

Invikafusp alfa, Marengo's pioneering program, is rooted in the company's innovative STAR platform. This platform involves a multi-specific antibody-fusion mechanism derived from a proprietary library of antibodies. These antibodies are designed to target variable Vβ regions of the T cell receptor (TCR), fused with T cell co-stimulatory elements. This unique approach promotes a distinctive TCR activation mechanism, fostering durable anti-tumor T cell responses.

The STAR platform and invikafusp alfa represent a novel approach in immunotherapy, aiming to selectively modulate T cell subsets and enhance the body's immune response against cancers and other diseases. Marengo's dedication to advancing this technology is backed by a team of experts in immunology and oncology, striving to harness the full potential of T cell activation for lifelong protection against cancer.

The advancement into Phase 2 of the STARt-001 trial marks a crucial milestone for Marengo Therapeutics. By expanding the trial's reach and continuing to investigate the capabilities of invikafusp alfa, the company is poised to make significant contributions to the field of cancer treatment, offering hope to patients with resistant forms of the disease.