Marengo to Present First Human Data on Invikafusp Alfa at SITC 2024

Marengo Therapeutics, Inc., a biotechnology company at the forefront of precision T cell activation, has unveiled its initial human clinical data for invikafusp alfa (STAR0602), their leading selective T cell activator. This was presented in a late-breaking oral session at the Society for Immunotherapy of Cancer's (SITC) 39th Annual Meeting held from November 8-10, 2024, in Houston, Texas.

The presentation, titled "A Phase 1/2 study of Invikafusp alfa (STAR0602), a first-in-class TCR β chain-targeted bispecific antibody, as monotherapy in patients with antigen-rich solid tumors resistant to anti-PD(L)1," highlighted the preliminary results from the STARt-001 study. This study evaluates invikafusp alfa as a single-agent therapy in patients with advanced solid tumors that have shown resistance to treatment with anti-PD(L)1 therapies. The presentation was given by Dr. James L. Gulley from the National Cancer Institute.

Marengo Therapeutics is known for its innovative STAR™ platform, which comprises a unique library of antibodies targeting the germline-encoded variable Vβ regions of the T cell receptor (TCR). These antibodies are integrated with T cell co-stimulatory components to foster strong anti-tumor immune responses. The company aims to revolutionize cancer treatment by selectively activating certain T cell subsets, thereby harnessing the immune system's power to fight cancer.

Invikafusp alfa (STAR0602) is the foremost candidate emerging from the STAR™ platform. It is engineered to activate a specific Vβ T cell subset present in all cancers. This is achieved by combining a non-clonal TCR activation approach with a T cell co-stimulatory signal in a single molecule, promoting the proliferation of diverse, effector memory Vβ T cells. This method enhances anti-tumor immunity and facilitates lasting tumor eradication. Preclinical studies have shown that STAR0602 exhibits significant anti-tumor activity through a novel mechanism in both mouse models and human ex vivo models.

The STARt-001 study is a Phase 1/2 clinical trial designed to assess the safety, tolerability, and early efficacy of invikafusp alfa as a monotherapy. It targets biomarker-selected patients with advanced, antigen-rich solid tumors, including those unresponsive to PD-1 therapies and rare tumor types. The trial is divided into two parts: a Phase 1 dose escalation and a Phase 2 dose expansion.

Marengo Therapeutics continues to push the boundaries of cancer immunotherapy, leveraging its proprietary technologies to develop effective treatments for challenging tumor types. This commitment is reflected in the promising preliminary results of invikafusp alfa, which could offer new hope for patients with refractory cancers. The ongoing STARt-001 study represents a significant step forward in validating the potential of Marengo's innovative T cell activation therapies.

 

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