Posted by Michael Wonder on 09 Jan 2025
Marengo’s first in class invikafusp alfa (STAR0602) receives US FDA fast track designation for treatment of unresectable, locally advanced, or metastatic colorectal cancers with high tumour mutational burden
8 January 2025 - Initial safety and efficacy data from Phase 1 STARt-001 trial showed promising single agent clinical activity in patients with different types of PD-1 resistant tumours including TMB-H colorectal cancer.
Marengo Therapeutics today announced that the US FDA has granted fast track designation to invikafusp alfa (STAR0602), Marengo’s first in class selective dual T cell agonist being studied as a potential new treatment for advanced colorectal cancer with TMB-H.
