Akamis Bio (IP Group plc) Receives FDA Fast Track Designation for NG-350A in Locally Advanced Rectal Cancer

Reuters10-14
Akamis Bio (IP Group plc) Receives FDA <a href="https://laohu8.com/S/FTRK">Fast Track</a> Designation for NG-350A in Locally Advanced Rectal Cancer

Akamis Bio, a portfolio company of IP Group plc, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy NG-350A. This designation is for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), which represents about 90% of LARC cases. NG-350A is an intravenously delivered oncolytic immunotherapy developed to stimulate a targeted immune response in tumors by inducing expression of a CD40 agonist monoclonal antibody. The therapy is currently being assessed in combination with chemoradiotherapy in the ongoing Phase 1b FORTRESS study. The FDA's Fast Track designation is intended to expedite the development and review process for promising treatments addressing serious unmet medical needs.

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