# Marengo Therapeutics

> Marengo Therapeutics is a Cambridge, Massachusetts clinical-stage biotech reprogramming the immune system from the inside out. Instead of releasing the brakes on T cells the way checkpoint inhibitors do, Marengo's STAR (Selective T Cell Activation Repertoire) platform builds antibody-fusion molecules that target variable regions of the T cell receptor (Vβ) to selectively wake up the specific subsets of T cells that can attack tumors - and remember them. Launched in 2021 with $80M from Apple Tree Partners, its lead drug invikafusp alfa (STAR0602) is in Phase 1/2 trials, has earned FDA Fast Track designation, and is being studied across cancers that no longer respond to PD-1 therapy.

- **Founded:** 2021
- **Headquarters:** Cambridge, Massachusetts, United States
- **Founders:** Apple Tree Partners (ATP) (Founding investor / incubator), Seth Harrison (Founder & Managing Partner, Apple Tree Partners (Board)), Zhen Su (Chief Executive Officer & Board Director)
- **Team size:** ~39 employees
- **Products:** STAR Platform, Invikafusp alfa (STAR0602), STAR0603 / STAR0501 / STAR0502, TriSTAR (Trispecific T Cell Engagers), MSTAR (Precision T Cell Depleters)
- **Notable:** Launched in 2021 with $80M from Apple Tree Partners, Advanced invikafusp alfa (STAR0602) from discovery into the clinic (first patient dosed in Phase 1/2, early 2023), Received U.S. FDA Fast Track designation for invikafusp alfa in TMB-H metastatic colorectal cancer (Jan 2025)

## Products & services

- **STAR Platform** — Selective T Cell Activation Repertoire - a discovery engine that builds antibody-fusion molecules targeting variable regions (Vβ) of the T cell receptor, selectively activating defined T cell subsets while combining a TCR signal with a co-stimulatory signal in a single molecule.
- **Invikafusp alfa (STAR0602)** — First-in-class, selective dual T cell agonist and lead candidate. A TCR Vβ-directed antibody-fusion molecule in Phase 1/2 trials (START-001) for PD-1 refractory, TMB-high advanced solid tumors. FDA Fast Track designation granted for TMB-H metastatic colorectal cancer.
- **STAR0603 / STAR0501 / STAR0502** — Additional bispecific STAR precision T cell agonists in oncology; STAR0603 is IND-enabling (wholly owned), STAR0501 and STAR0502 are in/advancing toward Phase 1 partnered with Ipsen.
- **TriSTAR (Trispecific T Cell Engagers)** — Tri-specific precision T cell engagers including TriSTAR0701 (Nectin-4, bladder and other cancers, Phase 1) and partnered programs spanning oncology and autoimmune disease.
- **MSTAR (Precision T Cell Depleters)** — Platform aimed at selectively depleting pathogenic T cell subsets for autoimmune disease; MSTAR0801 is IND-enabling (wholly owned).

## Achievements

- Launched in 2021 with $80M from Apple Tree Partners
- Advanced invikafusp alfa (STAR0602) from discovery into the clinic (first patient dosed in Phase 1/2, early 2023)
- Received U.S. FDA Fast Track designation for invikafusp alfa in TMB-H metastatic colorectal cancer (Jan 2025)
- Reported 20% ORR and 80% disease control rate as monotherapy in TMB-H tumors across seven solid tumor types (SITC/ESMO 2025)
- Secured partnerships with Ipsen ($45M upfront) and Gilead Sciences
- Peer-reviewed publications in Science Translational Medicine and Science Advances
- Five major oral presentations for invikafusp alfa across SITC, ESMO and AACR

## Latest updates

- **2026-04** — Reported late-breaking initial Phase 2 results for invikafusp alfa plus Trodelvy and unveiled the partnered IPN01203/STAR0501 STAR program entering Phase 1 at AACR 2026.
- **2025-11** — Late-breaking oral presentation at SITC 2025 highlighting single-agent, pan-tumor activity of invikafusp alfa across PD-1-resistant cancers.
- **2025-10** — Presented initial Phase 2 results at ESMO 2025 showing broad single-agent activity across multiple PD-1-refractory/resistant solid tumors.
- **2025-03** — Announced multi-year collaboration with the University of Pennsylvania Institute for Immunology and Immune Health.
- **2025-01** — Invikafusp alfa received FDA Fast Track designation for TMB-H metastatic colorectal cancer.
- **2024-11** — Unveiled first-in-human data for invikafusp alfa in a late-breaking oral presentation at SITC 2024.
- **2024-09** — Announced clinical study collaboration with Gilead Sciences (invikafusp alfa + Trodelvy in breast cancer).

## Links

- Website: https://marengotx.com
- LinkedIn: https://www.linkedin.com/company/marengo-therapeutics
- Twitter/X: https://twitter.com/marengotx

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Profile page: https://yespress.io/marengo-therapeutics
Published by YesPress — https://yespress.io
Last updated: 2026-06-13