On April 17, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), reported multiple presentations that highlight clear progress for key assets at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 17-22, 2026 in San Diego, CA.
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Findings to be shared include late-breaking interim Phase 2a clinical results from Marengo’s ongoing STARt-002 Phase 1b/2a trial of invikafusp alfa plus TRODELVY as part of a collaboration with Gilead Sciences and the first public disclosure of its second precision T cell activator from the STAR program, IPN01203/STAR0501, being advanced in partnership with Ipsen in the prestigious New Drugs on the Horizon session.
"Combining invikafusp alfa with ADC-mediated immunogenic tumor killing is a scientifically compelling approach, and it is exciting to see this translate into meaningful clinical responses in patients with metastatic breast cancer," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "The observation of confirmed complete responses in heavily pretreated breast cancer patients that did not respond to any prior therapy further reinforces our confidence in this novel combination. As enrollment progresses rapidly, we look forward to reporting additional data that both validate our platform and potentially offer a critical new treatment option in a disease with high unmet need."
The initial Phase 2a data build on results presented at the 2025 San Antonio Breast Cancer Symposium, demonstrating encouraging clinical activity with invikafusp alfa plus TRODELVY (sacituzumab govitecan-hziy) in heavily pretreated metastatic breast cancer patients, including confirmed complete responses, across both metastatic triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer.
To date, invikafusp alfa with TRODELVY has shown a safety profile consistent with the known profiles of the individual agents. Pharmacodynamic analyses further confirmed that invikafusp alfa maintains its mechanism of action in a combination regimen, driving robust and selective expansion of Vβ6/Vβ10 T cells. The STARt-002 Phase 1b/2a trial is actively enrolling patients at select cancer centers across North America, with enrollment expected to be completed later this year.
"In a heavily pretreated metastatic breast cancer population, the observation of confirmed complete responses is notable and warrants attention," said Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director of Breast Cancer Research. "While these are early data, the activity observed across both TNBC and HR+/HER2− subtypes, along with a safety profile consistent with the individual agents, supports further clinical evaluation of this combination."
In parallel, Marengo will highlight the continued advancement of the STAR platform through its collaboration with Ipsen. The next clinical candidate, IPN01203/STAR0501, has been selected for an oral presentation during the New Drugs on the Horizon session.
"Together with Marengo, we are advancing a novel precision T cell activation approach with the potential to transform treatment paradigms in solid tumors," said David Jenkins, Senior Vice President, Head of Research and External Innovation at Ipsen. "The rapid progression of this program into the clinic underscores the strength of our collaboration and the quality of scientific execution, and we look forward to exploring its clinical potential."
"We are excited to see the second STAR program advance into the clinic with Ipsen and to share these important data with the scientific community," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "This milestone reflects both the strength of our platform and the productivity of our collaboration as we work together to bring novel immunotherapies to patients with solid tumors."
Additional presentation details are as follows:
Presentation: Initial clinical and translational results and selection of recommended phase 2 dose (RP2D) from START-002: A Phase 1b/2 study of invikafusp alfa, a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in metastatic triple-negative or HR+/HER2- breast cancer
Abstract Number: LBA045 / 5
Session: First-in-Human Phase I Clinical Trials
Date/Time: Monday April 20, 9:00 AM – 12:00 PM PT
Presentation: Development of IPN01203, a dual T cell agonist activating Vβ6/Vβ10 TCR-expressing T cells
Abstract Number: ND12
Session: New Drugs on the Horizon: Part 3
Date/Time: Monday, April 20, 10:15 AM – 11:45 AM PT
(Press release, Marengo Therapeutics, APR 17, 2026, View Source [SID1234664486])