#USA #Cambridge #Marengo Therapeutics #Invikafusp Alfa #PD-1 Resistant

Marengo Therapeutics Unveils Promising Data on Invikafusp Alfa

On July 2, 2025, Marengo Therapeutics, a company at the forefront of biotechnology and precision immunotherapy, made waves at the European Society of Medical Oncology (ESMO) Gastrointestinal Cancers Congress. During a pivotal oral session, they presented significant findings from their ongoing STARt-001 Phase 1/2 trial concerning Invikafusp alfa, a groundbreaking selective dual T cell agonist specifically aimed at combating PD-1 resistant gastrointestinal (GI) tumors.

Understanding Invikafusp Alfa

Invikafusp alfa represents a revolutionary approach in cancer treatment. This first-in-class dual T cell agonist employs a bispecific antibody format designed to specifically engage the Vβ6 and Vβ10 T cell subsets within the human immune system. Its unique mechanism is engineered to evoke durable anti-tumor immunity, providing hope for patients with cancers that have shown resistance to conventional therapies such as checkpoint inhibitors.

Key Findings from the Latest Data

The clinical results presented were indeed promising. Marengo researchers observed the following outcomes in heavily pre-treated patients with PD-1 resistant, high Tumor Mutational Burden (TMB-H) GI cancers:

• - Disease Control Rate (DCR): 63%
• - Tumor Regression Rate: 53%
• - Objective Response Rate (ORR): 23%

Among the patients studied, responses were noted across significant colorectal cancer (CRC) subtypes, indicating a broad therapeutic potential. Notably, one patient with metastatic gastroesophageal junction (GEJ) tumor experienced an objective response, further emphasizing the dual agonist's clinical viability.

Clinical Significance of Results

Dr. Zhen Su, CEO of Marengo Therapeutics, expressed enthusiasm regarding the latest findings, highlighting the strong single-agent clinical efficacy observed across multiple PD-1 resistant tumor types, including MSS colorectal tumors and now extending to certain GEJ cancers. The results strongly illustrate Invikafusp alpha's promise as a cornerstone immunotherapy, especially for patients facing therapeutic challenges with existing treatment options.

Dr. Aparna Parikh from Massachusetts General Hospital presented additional insights, underscoring the innovative nature of Invikafusp, particularly its distinct mechanism of action targeting gastrointestinal malignancies that fail to respond to standard checkpoint inhibitors. This new approach could significantly shift how oncologists treat these complex cases, offering renewed hope for patients who previously had limited options.

Insights on Safety Profile

As significant as the efficacy data is, the safety profile of Invikafusp alfa also stood firm during the trials. Remarkably, no new safety signals were observed throughout the Phase 2a trial, maintaining a profile consistent with its selective T cell activation mechanism. Adverse events noted were transient and manageable, indicating a favorable therapeutic window for future treatments.

Continuing the Journey

Currently, Marengo is actively enrolling patients in the Phase 2a expansion cohorts of the STARt-001 trial, which aims to extend these promising results across an even broader range of tumor types. The expectation is that Invikafusp alfa will usher in a new era of treatment for TMB-H metastatic CRC and other challenging malignancies resistant to existing therapies.

Conclusion

The recent unveiling of Invikafusp alfa's results at the ESMO Congress illuminates the evolving landscape of cancer immunotherapy. With ongoing clinical trials and further research, Marengo Therapeutics is set to challenge conventional treatment paradigms and provide effective strategies for patients grappling with resistant cancer forms. The implications of this innovative approach resonate deeply within the oncology community, reinforcing the urgent need for developing targeted therapies that address unmet medical needs.

For anyone interested in learning more or participating in trials, detailed information is available on the clinical trials registry or through Marengo's official channels.