#USA #Cambridge #Immunotherapy #Marengo Therapeutics #Invikafusp Alfa

Marengo's Phase 2 Data Presentation at ESMO 2025

Marengo Therapeutics, a pioneering clinical-stage biotech firm focused on precision immunotherapy, recently amazed attendees at the ESMO 2025 Conference by unveiling interim data from its ongoing Phase 2 clinical trial of Invikafusp Alfa. This innovative drug shows significant activity as a single-agent therapy for patients suffering from PD-1 refractory or resistant solid tumors, marking a notable advancement in oncology treatment.

Impressive Results Across Multiple Tumor Types

During the late-breaking oral session held on October 17-21, 2025, in Berlin, Germany, Marengo presented encouraging findings that included a 20.5% overall response rate (ORR) and a 79% disease control rate (DCR) among heavily pretreated tumors noted for high mutational burdens (TMB-H) or microsatellite instability (MSI-H/dMMR). This clinical study investigated diverse solid tumors, including colorectal, lung, breast, and gastric cancers. Notably, 52% of participants experienced observable target-lesion tumor shrinkage, displaying the efficacy of Invikafusp Alfa in the battle against otherwise resistant tumors.

M.D. Zhen Su, CEO of Marengo Therapeutics stated, “The compelling single-agent activity and tumor regression observed across multiple tumor types, particularly in PD-1-resistant tumors, underscores the potential of Invikafusp Alfa as a new pan-tumor backbone immunotherapy.” This breakthrough could be pivotal for patients who have not effectively responded to existing PD-1 therapies, filling a significant gap in the current treatment landscape.

Innovative Approach to Immunotherapy

Invikafusp Alfa is distinguished by its mechanism of selectively activating T-cell subsets associated with immune responses, specifically focusing on Vβ6 and Vβ10 T-cell populations. By reinvigorating anti-tumor T cell responses, it aims to reprogram the tumor microenvironment, which might otherwise remain unresponsive to traditional therapies.

As of the data cutoff on July 29, 2025, the trial has enrolled 55 patients with advanced solid tumors across 21 distinct histologies. The promising data obtained reflects not only the compound's efficacy but also a manageable safety profile, characteristic of its targeted mechanism of action. Treatment-related adverse effects were described as transient, suggesting that the benefits may far outweigh the risks for the majority of patients involved.

Moving Forward: Expansion and Combination Strategies

Building on this momentum, Marengo plans to escalate the Phase 2 monotherapy expansion within TMB-H or MSI-H/dMMR solid tumors while detailing the durability of the responses across various indications. Additionally, the company is implementing a biomarker-enriched strategy aimed at broadening the patient populations eligible for Invikafusp Alfa, having recently secured U.S. FDA Fast Track designation for its use in TMB-H metastatic colorectal cancer (mCRC).

Moreover, Marengo is actively studying combinations with Trodelvy® (an antibody-drug conjugate directed against TROP2) in triple-negative breast cancer and hormone receptor-positive/HER2-negative breast cancer to evaluate synergy in potential treatment regimens.

About Marengo Therapeutics

Founded on innovative approaches to immunotherapy, Marengo Therapeutics focuses on creating therapies that modulate T-cell activity to combat cancer and autoimmune diseases. Their proprietary STAR™ platform is central to their research, seeking to unlock new pathways in T-cell activation. The ongoing STARt-001 clinical study further embodies this commitment by exploring Invikafusp Alfa's potential in various solid tumors, elucidating its role as an essential player in modern oncology.

As Marengo Therapeutics continues to gather and evaluate further data, the future of Invikafusp Alfa presents a potential breakthrough, promising enhanced treatment options for patients battling challenging and resistant cancer forms.

For more details on the STARt-001 clinical trial, interested candidates can visit clinicaltrials.gov or contact the National Cancer Institute directly. Marengo's long-term vision remains focused on a world where effectively treating cancer becomes a reality for everyone, leveraging the potent abilities of the immune system.

In summary, Marengo's findings not only provide hope for cancer patients but also demonstrate the promising capabilities of cutting-edge biotechnologies in developing groundbreaking therapies.