CAMBRIDGE, Mass., Oct. 31, 2025 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and inflammation & immunology (I&I), today announced that it will present a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.
The presentation will include initial Phase 2 monotherapy results from the ongoing STARt-001 trial, which is evaluating Invikafusp alfa in tissue-agnostic, tumor mutational burden-high (TMB-H) advanced cancers. The findings underscore Invikafusp alfa's potential to selectively activate unique T cell subsets, leading to reinvigoration of anti-tumor immunity across a broad range of solid tumors.
Presentation Details:
- Title: Initial monotherapy clinical activity of invikafusp alfa, a first-in-class TCR β-chain-targeted bifunctional antibody, in tissue-agnostic, TMB-H patients from STARt-001, a Phase 1/2 trial
- Conference: SITC Annual Meeting 2025
- Abstract Number: LBA1316
- Session Title: Clinical Oral Abstract Session 1
- Session Date and Time: Friday, November 7, 2025, 11:30 AM ET
- Presenter: Aurélien Marabelle, MD, PhD (Gustave Roussy Cancer Center, France)
Marengo will also present data from its TriSTAR T cell engager platform in addition to four preclinical analyses in collaboration with the National Cancer Institute (NCI) exploring rational combinations of Invikafusp alfa with standard-of-care modalities.
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 NCIMO_referrals@mail.nih.gov.
Marengo Contacts:
Media
Peg Rusconi I peg.rusconi@deerfieldgroup.com
Investors
Svetlana Makhni | smakhni@marengotx.com
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