- Data to be presented from the STARt-001 trial demonstrating invikafusp’s single-agent anti-tumor activity in diverse, large cancer indications
CAMBRIDGE, Mass., Sept. 24, 2025 /PRNewswire/ — Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and inflammation and immunology (I&I), will present a late-breaking mini oral presentation on initial Phase 2 clinical results for invikafusp alfa monotherapy in tissue-agnostic, TMB-H/MSI-H solid tumors at the European Society of Medical Oncology (ESMO) Annual Meeting taking place October 17-21, 2025, in Berlin, Germany.
Presentation details:
- Title: STARt-001: Initial Phase 2 clinical activity of invikafusp alfa, a first-in-class T cell receptor (TCR) β-chain-targeted bispecific antibody as monotherapy in patients with antigen-rich solid tumors resistant to immune checkpoint blockade (ICB)
- Conference: ESMO Annual Meeting 2025
- Abstract Number: LBA55
- Session Title: Mini oral session: Investigational immunotherapy
- Session Date and Time: Friday, October 17, 2025, 14:00 – 15:30
- Session Room: Nuremberg Auditorium
- Presenter: Antione Italiano, M.D., Ph.D. (Institut Bergonié, France)
About Marengo Therapeutics
Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone’s immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com.
About the STAR™ Platform
Marengo’s STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo’s proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses
About Invikafusp alfa (STAR0602)
Invikafusp alfa (STAR0602) is the lead candidate from Marengo’s STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602’s potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action.
About the STARt-001 Clinical Study
STARt-001 is a global Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary efficacy of invikafusp alfa as a monotherapy in biomarker-selected patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumor types. The trial consists of two parts: Phase 1 dose escalation and Phase 2 dose expansion. For more information, visit clinicaltrials.gov (Identifier: NCT05592626).
Patients interested in participating in this study at the National Cancer Institute (NCI) can contact NCI’s toll-free number: 1-800-4-CANCER (1-800-422-6237) (TTY: 1-800-332-8615), visit the website at https://trials.cancer.gov, or email [email protected].
Marengo Contacts:
Media
Peg Rusconi I [email protected]
Investors
Svetlana Makhni | [email protected]
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