CAMBRIDGE, Mass. — Akamis Bio, a clinical-stage oncology company developing novel immunotherapies through its proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NG-350A for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC).
NG-350A is an intravenously delivered oncolytic immunotherapy designed to induce intratumoral expression of a CD40 agonist monoclonal antibody, activating antigen-presenting cells (APCs) within solid tumors and nearby lymph nodes. This activation stimulates T-cell recruitment and drives a robust anti-tumor immune response. The candidate is currently being evaluated in combination with chemoradiotherapy in the ongoing Phase 1b FORTRESS trial (NCT06459869), which is actively recruiting patients with pMMR LARC.
“The NG-350A Fast Track designation from FDA is a recognition of the significant unmet need for new therapies to treat locally advanced rectal cancer,” said Oliver Rosen, M.D., chief medical officer at Akamis Bio. “The global incidence of LARC continues to rise, with a particularly alarming increase among younger populations. Patients with mismatch repair-proficient tumors represent about 90 percent of all LARC cases and face the greatest need for advances in standard care, including therapies that may help them avoid surgical interventions.”
Fast Track designation is intended to accelerate the development and review of new drugs that address serious or life-threatening conditions with unmet medical needs. The designation allows for more frequent FDA communication, rolling review of applications, and potential eligibility for Accelerated Approval and Priority Review if certain criteria are met, potentially enabling earlier patient access to new therapies.
