Updated STARt-001 results will highlight invikafusp alfa’s single-agent activity in PD-1–resistant tumors using a biomarker-enrichment strategyEric Rubin, former Senior Vice President of Global Clinical Oncology at Merck, who led the initial development of pembrolizumab (KEYTRUDA®) through its global regulatory approvals, joins Marengo to guide invikafusp alfa’s next phase
CAMBRIDGE, Mass., July 20, 2026 /PRNewswire/ — Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies, today announced that key Phase 2 data from the ongoing STARt-001 study of invikafusp alfa, a first-in-class bispecific dual T-cell agonist, have been selected for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026. The presentation will evaluate invikafusp alfa’s single-agent activity in patients whose cancers have progressed following PD-1–directed treatment, using biomarker-enriched cohorts to identify patients most likely to benefit. The company also appointed renowned oncology drug developer Eric Rubin, M.D., to its Scientific Advisory Board.
The ESMO presentation will feature updated clinical and translational data from tumor mutational burden-high (TMB-H) patients with advanced solid tumors that are refractory or resistant to PD-1–directed therapy. Building on data reported at SITC 2025, the results will further assess whether selective activation of Vβ6/Vβ10 T-cell subsets in vivo can generate single-agent activity across biomarker-enriched tumor types after PD-1 resistance.
“Selection of our Phase 2 data for an ESMO oral presentation reflects the encouraging clinical efficacy signal from the ongoing Phase 2 study of invikafusp alfa and its differentiated biology,” said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics. “STARt-001 is designed to test single-agent activity after PD-1–directed treatment has stopped working, using a biomarker-enriched strategy such as TMB-H. These studies will help us determine whether selective activation of Vβ6/Vβ10 T-cell subsets can support a broader pan-tumor development strategy. Eric led the initial development of KEYTRUDA® and its broad immuno-oncology backbone development strategy, and his experience will be invaluable as we rigorously evaluate invikafusp alfa’s potential.”
Dr. Rubin’s appointment strengthens Marengo’s scientific leadership in precision T-cell activation research as invikafusp alfa enters its next stage of development. His experience leading the initial development of KEYTRUDA® and large-scale oncology clinical programs will inform Marengo’s strategy for evaluating invikafusp alfa for single-agent activity in biomarker-selected, heavily pretreated PD-1–resistant cancers and, over time, as a potential combination backbone in larger and earlier-line settings.
“Invikafusp alfa is one of the more compelling novel immunotherapy approaches I have seen in recent years,” said Eric Rubin, M.D. “Its precision T-cell agonist mechanism provides a strong rationale for testing single-agent activity after PD-1 resistance while avoiding broad activation of the entire T-cell compartment. The biomarker-enriched design of STARt-001 should help define the patients and tumor settings in which this approach may offer the greatest benefit and inform its potential role in future combination strategies.”
Dr. Rubin brings more than 35 years of cancer drug-development experience across academic and industry settings, including leading large-scale oncology clinical programs. Most recently, he was Senior Vice President of Global Clinical Oncology at Merck, where he held several senior leadership roles during his 16-year tenure and led the initial development of pembrolizumab (KEYTRUDA®). Earlier, he served on the faculty of Dana-Farber Cancer Institute and as Director of Investigational Therapeutics at Rutgers Cancer Institute of New Jersey, with a research focus on oncology translational science.
Dr. Rubin has authored more than 100 peer-reviewed publications and served on national research and policy committees, including for the National Cancer Institute, American Cancer Society, American Association for Cancer Research and American Society of Clinical Oncology.
Presentation Details:
Title: START-001: Phase 2 results of invikafusp alfa, a first-in-class T cell receptor β-chain–targeted bispecific antibody, as monotherapy in patients with TMB-H solid tumors resistant to immune checkpoint blockade (ICB)Conference: ESMO Annual Meeting 2026Session Category and Title: Proffered paper: Investigational immunotherapySession Date and Time: Friday October 23 2026, 1:30 – 3:00 PM CETPresentation Number: #4703Presenter: Dr. Elena Garralda
About Marengo Therapeutics
Marengo Therapeutics, Inc. is a clinical-stage biotechnology company developing TCR-targeting antibodies that selectively modulate disease-relevant T-cell subsets for cancer and autoimmune diseases. Its three proprietary platforms—Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (TriSTAR) and T Cell Depletor (MSTAR)—are designed to target the right T cells in the right patients. To learn more, visit marengotx.com.
About Invikafusp alfa (STAR0602)
Invikafusp alfa (STAR0602), the lead candidate from Marengo’s STAR™ platform, is designed to selectively activate Vβ6/Vβ10 T-cell subsets found across cancers by combining non-clonal TCR activation with an IL-2 signal in a single molecule. This precision approach is intended to generate durable antitumor immunity while limiting broader systemic immune activation. Marengo is evaluating invikafusp alfa’s single-agent activity in biomarker-selected, PD-1–resistant cancers and its longer-term potential as a combination backbone.
About the STARt-001 Clinical Study
STARt-001 is a global Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are refractory or resistant to PD-1–directed therapy. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit. For more information, visit ClinicalTrials.gov (NCT05592626).
Marengo Contacts:
Media | Peg Rusconi | peg.rusconi@deerfieldgroup.com
Investors | bd@marengotx.com
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