Delonix Bioworks, a clinical-stage biotechnology company developing next-generation bacterial vaccines, recently announced that its Group B meningococcal (MenB) vaccine candidate, DX-104, has received Investigational New Drug (IND) clearance from China's National Medical Products Administration (NMPA). This follows the successful completion of Clinical Trial Notification (CTN) procedures and ethics committee approval in Australia in January 2026. Delonix plans to initiate Phase I clinical trials in the near term to evaluate the safety and immunogenicity of DX-104 in human subjects.

Invasive meningococcal disease (IMD) is a life-threatening bacterial infection that disproportionately impacts infants, adolescents, and young adults. Serogroup B has emerged as a predominant cause of IMD globally, accounting for approximately 50% of cases with a rising prevalence trend. While vaccines like GSK's Bexsero® and Pfizer's Trumenba® have established the commercial and clinical value of MenB prevention—with Bexsero recording approximately $1.58 billion in sales in 2025—significant global gaps in access and strain coverage remain.

DX-104 is an engineered MenB vaccine candidate developed using Delonix's proprietary OMV Plus® platform. The platform leverages precisely engineered outer membrane vesicles (OMVs) with intrinsic adjuvant properties to optimize immunogenicity. In preclinical studies, DX-104 induced robust serum bactericidal antibody (SBA) responses without the need for external adjuvants. Furthermore, DX-104 has achieved commercial-scale production with high batch-to-batch consistency, ensuring a reliable global supply chain as the candidate advances toward potential commercialization.

"The dual regulatory clearances in China and Australia mark a transformative milestone for Delonix Bioworks as we transition into a clinical-stage company," said Qiubin Lin, CEO and Founder of Delonix Bioworks. "This is a crucial step in our global strategy to deploy engineered bacterial vaccines that are designed to be highly immunogenic, well-tolerated, and scalable. We are committed to addressing the urgent unmet medical needs of patients worldwide."