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

(MENAFN- PR Newswire) "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 STARTM, TriSTARTM, and MSTARTM 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 .

About the STARTM Platform

Marengo's STARTM (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 STARTM 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.

Media Contact:
Peg Rusconi | [email protected]

Investor Contact:
Svetlana Makhni | [email protected]

SOURCE Marengo Therapeutics

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