What's Happening?
Akamis Bio has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its NG-350A therapy, aimed at treating mismatch repair-proficient locally advanced rectal cancer (LARC). NG-350A is an oncolytic immunotherapy that drives
intratumoral expression of a CD40 agonist monoclonal antibody, activating antigen-presenting cells and recruiting T cells to deliver an anti-tumor immune response. The therapy is currently being evaluated in the Phase 1b FORTRESS study, which is actively recruiting patients. This designation is intended to expedite the development and review of NG-350A, potentially leading to earlier approval and access for patients.
Why It's Important?
The FDA's Fast Track designation for NG-350A highlights the urgent need for new treatments for LARC, particularly as the incidence of this cancer rises among younger populations. With approximately 90% of LARC cases being mismatch repair-proficient, NG-350A offers a promising alternative to surgical interventions, which are often the standard of care. This designation could accelerate the availability of NG-350A, providing patients with more effective treatment options and potentially improving survival rates and quality of life for those affected by LARC.
What's Next?
Akamis Bio will continue to advance the FORTRESS study, aiming to enroll around 30 patients to evaluate the efficacy and safety of NG-350A in combination with chemoradiotherapy. The study's outcomes could influence future treatment protocols for LARC, potentially leading to broader adoption of immunotherapy approaches in oncology. The Fast Track designation may also facilitate more frequent interactions with the FDA, ensuring the collection of necessary data for approval and possibly qualifying NG-350A for Accelerated Approval and Priority Review.
