NG-350A + capecitabine

NG-350A + capecitabine is an investigational combination regimen consisting of NG-350A, an intravenously delivered oncolytic adenoviral-vector gene therapy, and capecitabine, an approved oral small-molecule fluoropyrimidine chemotherapy. Developed by Akamis Bio, NG-350A is derived from the company's Tumor-Specific Immuno-Gene (T-SIGn) platform and is engineered to drive intratumoral expression of a CD40 agonist monoclonal antibody. This antibody activates antigen-presenting cells (APCs) within solid tumors and their draining lymph nodes, which subsequently recruit T cells to stimulate a potent anti-tumor immune response. Capecitabine acts as a prodrug of 5-fluorouracil, inhibiting thymidylate synthase to block DNA synthesis. The combination is being evaluated alongside radiotherapy (chemoradiotherapy) in the Phase 1b FORTRESS study (NCT06459869) for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), for which the FDA has granted NG-350A Fast Track designation.

Other names

NG-350A and capecitabineNG350A and capecitabineNG 350A and capecitabineNG-350A plus capecitabineNG350A plus capecitabineNG 350A plus capecitabinecapecitabine + NG-350A