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# Akamis Bio Gets Fast Track for Rectal Cancer Drug
- URL: https://www.fdaweb.com/akamis-bio-gets-fast-track-for-rectal-cancer-drug/
- Published: 2025-10-15T12:00:00.000Z
- Updated: 2026-09-14T15:24:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160048

FDA has granted Akamis Bio a fast-track designation to NG-350A for treating mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). The intravenously delivered oncolytic immunotherapy is designed to “drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes,” the company says. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. The therapy is currently being evaluated in combination with chemoradiotherapy in the Phase 1b FORTRESS study ([NCT06459869](https://clinicaltrials.gov/study/NCT06459869?ref=fdaweb.com)) in pMMR LARC patients.

Akamis has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. “Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression,” it says.