Invikafusp Alfa (STAR0602) Receives US FDA Fast Track Designation for Treatment of Unresectable, Locally Advanced, or Metastatic TMB-H CRC

“The FDA’s Fast Track designation is an important milestone for the STAR0602 program and further positions our unique selective dual T cell agonist platform as a promising solution to address key challenges that perpetuate significant unmet needs in oncology,” said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. “This recognition specifically validates the promise of STAR0602 as a novel treatment option for patients with TMB-H metastatic colorectal cancer, which is insensitive to PD-1 treatment.”

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