Marengo Doses First Patient in STARt-002 Clinical Trial Evaluating First-in-Class Dual T Cell Agonist, Invikafusp Alfa in Combination with TROP2-directed ADC Trodelvy® in Metastatic Breast Cancer

• STARt-002 is a Phase 1b/2 clinical study assessing invikafusp alfa in combination with Gilead's Trodelvy® for HR+/HER2- and TNBC breast cancer patients across leading U.S. and Canadian breast cancer centers

CAMBRIDGE, Mass., May 8, 2025 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, today announced that the first patient has been dosed in its STARt-002 clinical trial. The Phase 1b/2 study evaluates the safety and efficacy of Marengo's lead clinical T cell agonist in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead's approved TROP2-directed antibody-drug conjugate (ADC), in patients with metastatic breast cancer (mBC).

"The growing body of evidence supporting combinations of ADCs and immunotherapies is encouraging, including the recent success of the ASCENT-04 trial combining sacituzumab govitecan with pembrolizumab in metastatic TNBC," said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Director of Breast Cancer Clinical Research at Massachusetts General Hospital. "Invikafusp alfa is a novel bi-specific immunotherapy designed as a dual T cell agonist, and the recent AACR presentation highlighting its single-agent activity in PD-1 resistant tumors is particularly compelling. Coupled with preclinical evidence of efficacy in breast cancer models, this combination with an ADC offers a promising and innovative approach to expanding immunotherapy options for patients with both HR+/HER2- and triple-negative breast cancers."

STARt-002 (NCT06827613) is a Phase 1b/2 trial, beginning with a run-in phase to determine the optimal tolerated combined dose of the two agents, followed by dose expansion in two patient cohorts: metastatic triple-negative breast cancer (mTNBC) and hormone receptor-positive, HER2-negative (HR+/HER2−) metastatic breast cancer.

The study is currently enrolling patients at three leading North American cancer centers: Massachusetts General Hospital, Sarah Cannon Research Institute, and Princess Margaret Cancer Centre, with additional sites expected to join soon.

"As presented in recent SITC, EMSO IO and AACR meetings, invikafusp clearly demonstrates promising monotherapy activity in PD-1 resistant tumors including MSS CRC and PD-1 negative NSCLC," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "These data reinforce our belief that invikafusp could serve as a best-in-class immunotherapy backbone for multiple tumor types, particularly when paired with ADCs in immunologically cold tumors such as breast cancer. We are honored to partner with world-class clinical investigators to explore this promising combination for patients with high unmet needs."

About Marengo Therapeutics

Marengo Therapeutics, Inc. is a clinical-stage biotechnology company developing a first-in-class pipeline of novel TCR-targeting antibodies designed to selectively modulate disease-driving and protective T cell subsets. With its proprietary STAR™, TriSTAR™, and MSTAR™ platforms, Marengo is advancing precision immunotherapies that harness the body's T cell repertoire to provide durable responses against cancer and autoimmune diseases. Learn more at www.marengotx.com.

About the STAR™ Platform

Marengo's STAR™ (Selective T cell Activation Repertoire) platform is a proprietary multispecific antibody-fusion technology targeting germline-encoded TCR Vβ regions fused with T cell co-stimulatory domains. This novel approach enables non-clonal activation and selective expansion of tumor-reactive T cells, driving durable anti-tumor immune responses.

About Invikafusp Alfa (STAR0602)

Invikafusp alfa (STAR0602) is the first clinical candidate emerging from Marengo's STAR™ platform. It selectively targets a common, tumor-associated Vβ T cell subset and combines non-clonal TCR activation with T cell co-stimulation in a single molecule. This unique mechanism promotes the expansion of effector memory T cells with anti-tumor activity. Invikafusp alfa is currently being evaluated in a Phase I/II clinical trial as monotherapy (STARt-001 trial) and in combination (STARt-002 trial) settings.

About the STARt-002 Trial

STARt-002 (NCT06827613) is a Phase Ib/II, open-label, multicenter study investigating the combination of invikafusp alfa and sacituzumab govitecan 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 triple-negative breast cancer (mTNBC) and one in HR+/HER2− metastatic breast cancer. More information is available at clinicaltrials.gov.

Media Contact:
Peg Rusconi | peg.rusconi@deerfieldgroup.com

Investor Contact:
Svetlana Makhni | smakhni@marengotx.com

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