CAMBRIDGE, Mass., April 17, 2026
Marengo Therapeutics has unveiled encouraging late-breaking Phase IIa clinical results for its investigational immunotherapy invikafusp alfa (STAR0602) in combination with TRODELVY® (sacituzumab govitecan) at the American Association for Cancer Research (AACR) Annual Meeting 2026. The company also introduced its second STAR platform clinical candidate, IPN01203/STAR0501, developed in partnership with Ipsen, marking another significant milestone for its precision immunotherapy pipeline. The Phase II findings demonstrated confirmed complete responses in heavily pretreated metastatic breast cancer patients across both triple-negative breast cancer (TNBC) and HR-positive/HER2-negative disease, highlighting the potential of Marengo’s selective T-cell activation technology to improve outcomes for patients with advanced cancers that have exhausted existing treatment options.
Phase II Study Shows Encouraging Complete Responses
The late-breaking data originated from the ongoing STARt-002 Phase Ib/IIa clinical trial, evaluating invikafusp alfa alongside TRODELVY® in patients with unresectable or metastatic breast cancer. According to the interim analysis, the investigational combination produced confirmed complete responses in patients who had previously failed multiple treatment regimens, representing a promising clinical signal in an extremely difficult-to-treat population. Importantly, investigators reported that the therapy demonstrated a manageable safety profile consistent with the known characteristics of each individual treatment. Pharmacodynamic analyses further confirmed that invikafusp alfa successfully activated its intended immune mechanism by selectively expanding Vβ6 and Vβ10 T-cell populations, reinforcing confidence in the company’s novel Selective T Cell Activation Repertoire (STAR) platform. Patient enrollment continues across North American cancer centers, with additional clinical updates expected following completion of enrollment.
STAR Platform Expands with Ipsen Collaboration
Alongside the Phase II breast cancer update, Marengo announced the first public presentation of IPN01203/STAR0501, the second clinical candidate emerging from its proprietary STAR platform through its strategic collaboration with Ipsen. The investigational therapy is a first-in-class dual T-cell activator engineered to selectively stimulate Vβ6 T cells through both T-cell receptor (TCR) and IL-15 receptor signaling pathways, thereby enhancing anti-tumor immune responses. The program has already advanced into an ongoing Phase I/II clinical study, reflecting rapid progress from discovery into human evaluation. Company executives from both Marengo and Ipsen emphasized that the advancement of IPN01203 validates the strength of their scientific collaboration while expanding opportunities to develop next-generation immunotherapies capable of transforming treatment for a broad range of solid tumors.
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Precision Immunotherapy Pipeline Continues to Advance
Marengo Therapeutics continues to position itself as a leader in precision T-cell immunotherapy, leveraging proprietary platforms designed to selectively activate immune cell populations capable of producing durable anti-tumor responses. The company’s lead asset, invikafusp alfa (STAR0602), combines selective T-cell receptor activation with co-stimulatory signaling to expand diverse effector memory T cells that recognize and eliminate cancer cells. By integrating innovative immune biology with targeted oncology strategies, Marengo aims to overcome resistance mechanisms that limit current therapies across multiple tumor types. The encouraging clinical activity observed in metastatic breast cancer, together with the continued advancement of the Ipsen-partnered STAR program, demonstrates growing momentum behind Marengo’s immuno-oncology pipeline and highlights the company’s commitment to developing transformative treatments for patients with advanced cancers facing significant unmet medical needs.
Source: Marengo Therapeutics press release
