On July 2, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, reported new clinical data from the ongoing STARt-001 Phase 1/2 trial of Invikafusp alfa during an oral session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 (Press release, Marengo Therapeutics, JUL 2, 2025, View Source [SID1234654227]).

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Presentation Details

Title: Phase 1/2 clinical investigation of Invikafusp alfa, a first-in-class TCR-beta chain-targeted bispecific antibody, as monotherapy in patients with anti-PD(L)1-resistant, antigen-rich gastrointestinal (GI) cancers
Abstract Number: 479MO (Late-breaking)
Session Title: Mini Oral session – Innovation in GI cancers
Session Date and Time: Thursday, July 2, 2025, 4:15 PM – 5:35 PM CET (UTC+01:00)
Presenter: Elena Elez, M.D. Ph.D., Vall d’Hebron Institute of Oncology
Invikafusp alfa is Marengo’s first-in-class dual T cell agonist, designed with a bi-specific antibody format to selectively engage and activate the Vβ6 and Vβ10 subsets of T cells in vivo, promoting durable anti-tumor immunity. The updated clinical data continue to reinforce invikafusp alfa’s potential as a backbone immunotherapy for PD-1 resistant gastrointestinal (GI) cancers, with monotherapy clinical responses observed in both colorectal cancer (CRC) and gastric-esophageal junction (GEJ) cancer, including tumor types where checkpoint inhibitors have very limited monotherapy activity.

"We are thrilled to see high quality single agent clinical activity in multiple PD-1 resistant tumor types including MSS CRC, PD-L1 negative NSCLC and now, additional GI cancers including GEJ cancer," said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics. "Invikafusp’s ability to drive meaningful responses in both PD-1-resistant/insensitive tumors, and across diverse tissue types, underscores the potential of our precision T cell activation platform to deliver real impact as a new class of IO backbone in immunotherapy-refractory tumors. These results further validate our commitment to advancing invikafusp as next gen IO especially in GI cancers."

"The activity we are observing with invikafusp in both CRC and GEJ tumors is highly compelling and highlights the clinical potential of a novel T cell agonist approach," said Aparna Parikh, M.D., GI Oncologist and Director of Colorectal Medical Oncology and the Center for Young Adult Colorectal Cancer at Massachusetts General Hospital Cancer Center and Harvard Medical School. "Having a new class of cancer immunotherapy with such a differentiated mechanism in GI tumors, especially in those not responsive to checkpoint inhibitors, is truly exciting for the GI cancer research field and cancer patients."

Updated Findings from the ESMO (Free ESMO Whitepaper) GI 2025 Clinical Plenary Presentation:

In 17 heavily pretreated PD-1 resistant TMB-H GI cancer patients, invikafusp alfa monotherapy demonstrated:
Disease control rate (DCR): 63%
Tumor Regression Rate of 53%
Overall response rate (ORR): 23%
Responses included:
Three CRC responders across major molecular subtypes (MSS RASwt, MSS RASmut, PD-1 resistant MSI-H)
One objective response in PD-1 resistant MSI-H GEJ
In PD-1 resistant TMB-H metastatic CRC specifically, ORR was 25% (3/12 patients)
Safety Profile:

No new safety signals observed in Phase 2a
Safety profile consistent with invikafusp alfa’s selective T cell activation mechanism
Adverse events were generally transient and manageable with supportive care
Invikafusp alfa (STAR0602) is a first-in-class, dual T cell agonist designed to selectively activate Vβ6 and Vβ10 T cell subsets in vivo, promoting durable anti-tumor immunity. Marengo is currently enrolling patients in the Phase 2a expansion cohorts of STARt-001 trial across multiple tumor types, including TMB-H metastatic CRC, and MSI-H or TMB-H solid tumors.