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Marengo Therapeutics Reports Encouraging Data on Invikafusp Alfa in Cancer Treatment

In a major presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, Marengo Therapeutics showcased astonishing new findings from their ongoing STARt-001 clinical trial, emphasizing the effectiveness of invikafusp alfa against multiple PD-1 resistant tumors. This presentation highlighted not only the drug's initial ability to control diseases but also its potential to induce tumor regression and deliver objective responses in challenging cases.

Clinical Trial Highlights

Invikafusp alfa, a pioneering immunotherapy based on a bi-specific antibody format, demonstrated promising results with a substantial 30% overall response rate (ORR) among the first ten treated patients diagnosed with TMB-high colorectal cancer (CRC) at an effective dosage. Noteworthy also is the fact that the drug has been granted FDA fast track designation, allowing for prioritized development due to its potential to address significant unmet needs in oncology.

The data collected indicated an impressive 61% rate of disease control among patients whose cancers had previously resisted other treatments, with a tumor regression rate of 52% reported across a spectrum of cancer types. This included patients with colorectal cancer, non-small cell lung cancer (NSCLC), cervical, and squamous cell carcinoma of the head and neck, as well as melanoma.

Mechanism of Action

The innovative mechanism of invikafusp alfa facilitates the selective activation and expansion of specific T cell subsets—Vβ6 and Vβ10—which are crucial in the immune defense against cancer. This approach results in a notable enhancement of anti-tumor immunity that has the potential to drive sustained patient responses even in notoriously tough cases of advanced cancer.

Dr. Zhen Su, CEO of Marengo Therapeutics, described this event as a significant leap for both the company and the field of immuno-oncology. He stated, "The insights from our data reflect not just a breakthrough for our company, but a transformative step towards more effective therapies for patients with PD-1 resistant tumors. Our work emphasizes a precision approach to T cell activation, which holds great promise not only for CRC but also for various cancer types."

Expert Reactions

Dr. Josep Tabernero, the director at the Vall d'Hebron Institute of Oncology, indicated that the results mark a substantial stride in the domain of immunotherapy for cancers that typically show resistance to existing treatments, notably CRC. He noted, "The observed clinical signals with invikafusp alfa provide a solid rationale for further clinical exploration to fully leverage the therapeutic potential it holds as a T cell agonist."

Safety and Future Directions

Regarding safety, adverse events associated with invikafusp alfa usually occurred in a manageable and transient fashion, consistent with a selective activation mechanism. This positive safety profile bodes well for its continued development in clinical settings.

Following these encouraging findings, Marengo has initiated the Phase 2 segment of the STARt-002 trial aimed at expanding their patient enrollment across various tumor types, including both TMB-high metastatic colorectal cancer and other tissue-agnostic solid tumors.

About Marengo Therapeutics

Marengo Therapeutics is focused on advancing its innovative technology aimed at harnessing the body's immune system against cancer. By exploiting its proprietary STAR platform, Marengo promotes T cell responses that may provide enduring protection against both cancer and autoimmune diseases. Their commitment to developing cutting-edge treatments reveals their ambition to create a medical landscape where every individual's immune system is empowered to combat illness effectively. For more information, interested parties are encouraged to explore Marengo's official site.

With these promising results, Marengo is on the cusp of reshaping cancer therapy and providing new hope for patients facing some of the most difficult challenges in oncology today.