Marengo Therapeutics, Inc.

FDA Grants Fast Track Designation to Invikafusp Alfa for Advanced Colorectal Cancer

5 months ago

• The FDA granted Fast Track designation to invikafusp alfa (STAR0602) for advanced colorectal cancer with high tumor mutational burden (TMB-H). • Phase 1 data showed invikafusp alfa yielded a 50% disease control rate and tumor shrinkage in 32% of patients across six tumor types. • The Phase 2 clinical trial is ongoing, evaluating invikafusp alfa monotherapy in PD-1 resistant tumors across multiple sites in Europe. • Invikafusp alfa selectively targets Vβ T cells, offering a novel approach for PD-1 insensitive or resistant tumors like colorectal cancer.

Marengo Therapeutics Advances Invikafusp Alfa into Phase 2 for PD-1 Resistant Tumors, Expands Trial to Europe

5 months ago

• Marengo Therapeutics has dosed the first patient in the Phase 2 portion of the STARt-001 trial, evaluating invikafusp alfa in advanced anti-PD-1 resistant solid tumors. • Phase 1 data showed a 25% Overall Response Rate and a 50% Disease Control Rate in patients with PD-1 resistant tumors with high tumor mutation burden. • The Phase 2 study expands to premier European oncology centers in France and Spain, enhancing patient enrollment and understanding of invikafusp alfa's mechanism. • Invikafusp alfa (STAR0602) is a T cell activator generated from Marengo's STAR platform, targeting a common Vβ T cell subset to promote durable anti-tumor responses.

Marengo's Invikafusp Alfa Shows Promise in Anti-PD-1 Resistant Solid Tumors

7 months ago

• Marengo Therapeutics' invikafusp alfa (STAR0602) demonstrates tumor shrinkage across multiple tumor types in heavily pre-treated, anti-PD-1 resistant patients. • The Phase 1 STARt-001 trial shows a manageable safety profile for invikafusp alfa, supporting its potential in high tumor mutational burden cancers. • Invikafusp alfa achieves sustained and selective in vivo expansion of TCRVβ6/Vβ10 T cells, with disease control observed in 50% of patients. • The recommended Phase 2 dose (0.08 mg/kg) was selected based on safety, PK/PD data, and preliminary anti-tumor activity, with Phase 2 expansion underway.