Interim Phase 2 Results from First-in-Class Combination of Invikafusp Alfa and TRODELVY® Selected for Oral Presentation at SITC 2026

• STARt-002 is the first clinical study to combine a Vβ6-selective T-cell agonist with an ADC, pairing invikafusp alfa's selective T-cell activation with TRODELVY's TROP2-directed delivery of a cytotoxic payload
• Oral presentation will feature interim clinical results from two distinct metastatic breast cancer populations, triple-negative and HR-positive/HER2-negative, building on initial results presented at AACR 2026

CAMBRIDGE, Mass., Oct. 2, 2026 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), today announced that interim results from the STARt-002 clinical study have been selected for an oral presentation at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting, taking place November 4–8, 2026, in Phoenix, Arizona.

"Invikafusp alfa is designed for antigen-rich tumors. ADCs like TRODELVY help create that state by releasing tumor antigens and inflaming the tumor microenvironment, priming less immunogenic tumors for T-cell-mediated responses," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "STARt-002 is the first clinical study to test this hypothesis by pairing a selective T-cell agonist with an ADC, and this combination could extend invikafusp alfa's reach beyond tumors that are antigen-rich on their own. Triple-negative and HR-positive/HER2-negative metastatic breast cancer are two settings where patients still have limited options after standard therapies. We look forward to presenting interim results from both cohorts at SITC."

STARt-002 is the company's Phase 1b/2 trial evaluating invikafusp alfa in combination with TRODELVY® (sacituzumab govitecan-hziy) in patients with metastatic breast cancer. The Phase 2 portion is evaluating two distinct patient populations: metastatic triple-negative breast cancer (TNBC) and HR-positive/HER2-negative metastatic breast cancer. Following completion of the safety lead-in, both expansion cohorts are enrolling at the recommended Phase 2 dose at select cancer centers across North America. The SITC presentation will feature interim results from both expansion cohorts, and Marengo expects to report additional data in 2027.

The STARt-002 combination strategy reflects invikafusp alfa's long-term potential as an immuno-oncology backbone and builds on STARt-001, a Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with PD-1-resistant, biomarker-enriched solid tumors, including TNBC. Updated STARt-001 results will be presented during an oral presentation at the European Society for Medical Oncology (ESMO) 2026 Congress, taking place October 23–27 in Madrid, Spain.

Presentation Details

• Title: Initial clinical results 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 triple-negative or HR+/HER2- mBC
• Abstract Number: 514
• Session: Oral Abstract Session 3
• Date/Time: Saturday, November 7, 2026 3:30PM MT
• Presenter: Steven Isakoff, MD, PhD, MMSc; Mass General Brigham

About Marengo Therapeutics
Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T-cell subsets of the germline TCR repertoire to provide durable protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms, Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (TriSTAR) and T Cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone's immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com.

About Invikafusp Alfa (STAR0602)
Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR™ platform and a first-in-class, bispecific dual T-cell agonist. It is designed to selectively activate Vβ6 T cells, a common T-cell subset present across many tumor types, by combining a non-clonal mode of TCR activation with a T-cell co-stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ6 T cells, with the goal of enhancing and sustaining antitumor immunity. Invikafusp alfa was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade.

About the STARt-002 Clinical Study
STARt-002 (NCT06827613) is a Phase 1b/2, open-label, multicenter study investigating the combination of invikafusp alfa and TRODELVY® in patients with unresectable, locally advanced or metastatic breast cancer. The trial consists of a safety lead-in phase followed by two dose-expansion cohorts: one in metastatic TNBC and one in HR-positive/HER2-negative metastatic breast cancer. More information is available at clinicaltrials.gov.

TRODELVY® is a registered trademark of Gilead Sciences, Inc.

Marengo Contacts:
Media | Peg Rusconi | [email protected]
Investors | [email protected]

SOURCE Marengo Therapeutics