Xuanzhu Biopharmaceutical Co., Ltd. (Xuanzhu Biopharm) reported preliminary data from the ongoing Phase 1b FORTRESS study evaluating NG-350A combined with chemoradiotherapy (CRT) in patients with mismatch repair-proficient locally advanced rectal cancer (pMMR LARC). The results were presented on 20 April 2026 at the American Association for Cancer Research (AACR) annual meeting.

Study snapshot • Design: Open-label, single-arm, multi-center Phase 1b trial (NCT06459869). • Population: Adult pMMR LARC patients with at least one risk factor for local or distant recurrence or with oligometastatic disease. • Treatment: Intravenous NG-350A plus standard CRT over a 12-week active treatment period. • Objective: Evaluate composite response rate—clinical complete response (cCR) plus near clinical complete response (ncCR)—versus the historical ~25% rate for CRT alone.

Key interim findings (first 10 patients completing 12 weeks) • Composite response rate reached 50%, doubling the benchmark for CRT monotherapy. • No serious adverse events or new safety signals attributable to NG-350A were observed.

Therapeutic profile NG-350A is a Tumor-Specific Immuno-Gene (T-SIGn®) therapy engineered to deliver a CD40 agonist monoclonal antibody directly within tumors, activating resident antigen-presenting cells and recruiting T-cells to mount an anti-tumor immune response. Prior monotherapy (FORTITUDE) and combination (FORTIFY with pembrolizumab) studies have shown consistent safety, tumor-selective replication and transgene expression.

Commercial framework Xuanzhu Biopharm holds exclusive development, manufacturing and commercialization rights for NG-350A in Greater China under a licensing agreement with Akamis Bio, Inc., a Cambridge, Massachusetts-based oncology company. The company is advancing regulatory submissions to initiate clinical trials of NG-350A in mainland China.

The FORTRESS study continues to enroll, and further data will be needed to confirm these early efficacy and safety observations.