Xuanzhu Biopharmaceutical Announces Promising Preliminary Results from Phase 1b FORTRESS Study of NG-350A at AACR 2026

Key Points for Investors

• Promising Early Efficacy: The Phase 1b FORTRESS study of NG-350A, an oncolytic immunotherapy, showed a composite response rate of 50% (cCR + ncCR) in the first 10 patients with pMMR locally advanced rectal cancer (LARC) – doubling the historical benchmark of 25% for chemoradiotherapy (CRT) alone.
• Favorable Safety Profile: No serious adverse events or new safety signals related to NG-350A were observed in the study, supporting the safety and tolerability of the candidate therapy.
• Strategic Licensing: Xuanzhu Biopharmaceutical holds exclusive Greater China rights to develop, manufacture, and commercialize NG-350A, which was in-licensed from Akamis Bio, Inc., a notable clinical-stage oncology company.
• Potential Market Impact: These early, positive data suggest NG-350A could significantly improve outcomes for a large subgroup of rectal cancer patients, potentially positioning Xuanzhu as a leader in the colorectal cancer treatment field in Greater China.

Detailed Report

Xuanzhu Biopharmaceutical Co., Ltd. (Stock Code: 2575) has announced encouraging preliminary results from its ongoing Phase 1b FORTRESS clinical trial of NG-350A. The data was presented at the prestigious 2026 Annual Meeting of the American Association for Cancer Research (AACR) on April 20, 2026.

NG-350A is an innovative, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn^®) therapy designed to trigger a targeted immune response against solid tumors. Specifically, it induces intratumoral expression of a CD40 agonist monoclonal antibody, which activates antigen-presenting cells (APCs) in the tumor and its draining lymph nodes. This activation is intended to recruit T cells to the tumor microenvironment, unleashing a potent anti-tumor immune response.

Clinical Study Highlights

• The FORTRESS study (NCT06459869) is an open-label, single-arm, multi-center trial evaluating NG-350A in combination with standard chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), who have at least one risk factor for recurrence or have oligometastatic disease.
• The key efficacy endpoint is the composite response rate at 12 weeks, defined as the proportion of patients achieving either a clinical complete response (cCR) or near clinical complete response (ncCR).
• Results: The composite response rate in the first 10 patients who completed the 12-week treatment was 50% — significantly higher than the approximately 25% seen with CRT alone.
• Safety: No serious adverse events or new safety signals attributable to NG-350A were noted, adding to the growing evidence of a favorable risk-benefit profile.

Strategic and Commercial Implications

• NG-350A was in-licensed from Akamis Bio, Inc., a clinical-stage oncology company headquartered in Cambridge, Massachusetts, that specializes in systemically administered oncolytic immunotherapies for colorectal cancer.
• Xuanzhu Biopharmaceutical possesses exclusive development, manufacturing, and commercialization rights for NG-350A in Greater China, and is actively advancing the regulatory application for clinical trials within the People’s Republic of China.
• The Group’s prospectus (October 6, 2025) contains further details regarding the in-licensing agreement and development strategy for this asset.

Potential Price-Sensitive Information for Shareholders

• Market Differentiation: Doubling the composite response rate compared to standard CRT in an early-stage trial positions NG-350A as a potentially game-changing therapy in the rectal cancer space.
• Pipeline Progress: The absence of serious adverse events or new safety signals de-risks the asset and underpins its advancement into larger, pivotal trials.
• Licensing Leverage: Exclusive Greater China rights provide Xuanzhu with a powerful competitive edge and commercialization opportunity if later-stage studies confirm these early results.

Leadership and Corporate Governance

As of this announcement, the Board of Xuanzhu Biopharmaceutical is led by Chairperson Ms. Xu Yanjun, with a combination of executive, non-executive, and independent non-executive directors, underpinning strong corporate governance and industry expertise.

Conclusion

The preliminary Phase 1b FORTRESS study results suggest that NG-350A, in combination with CRT, could significantly enhance clinical outcomes for patients with pMMR LARC, relative to the current standard of care. These findings, if confirmed in larger studies, could be highly accretive to Xuanzhu Biopharmaceutical’s valuation and growth prospects in the oncology sector, making this a potentially price-moving development for shareholders.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should perform their own due diligence and consult professional advisors before making investment decisions. Past performance and early clinical results are not indicative of future outcomes.

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