Marengo Presents Monotherapy Activity of Invikafusp Alfa, a First-in-Class Selective Dual T Cell Agonist in PD-1 Resistant GI Tumors, as a Late-Breaking Oral Presentation at ESMO Gastrointestinal Cancers Congress 2025

• Promising monotherapy activity observed in all three major metastatic colorectal cancer subtypes harboring high tumor mutational burden (MSS RASwt, MSS RASmut and PD-1 resistant MSI-H) supported by recent FDA fast track designation
  
• New clinical response observed in PD-1 resistant gastroesophageal junction (GEJ) tumor
  
• Invikafusp alfa demonstrates overall Disease Control Rate of 63%, Tumor Regression Rate of 53% and Objective Response Rate of 23% in heavily pretreated PD-1 resistant TMB-H GI cancer patients

Excerpt from the Press Release:

CAMBRIDGE, Mass., July 2, 2025 /PRNewswire/ — Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, today presented 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) Gastrointestinal Cancers Congress 2025.

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.

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