Delonix Bioworks Doses First Participant in China Phase 1 Trial of Next-Generation MenB OMV Vaccine DX-104
核心洞察
Delonix Bioworks (搜索) announced the first participant has been dosed in its Phase 1 clinical trial of DX-104 (搜索), a next-generation MenB vaccine candidate, in China.
The randomized, double-blind, placebo-controlled study will evaluate safety and immunogenicity in healthy participants aged 2 to 59 years.
DX-104 (搜索) leverages the proprietary OMV Plus® platform using genetically engineered outer membrane vesicles for precise antigen presentation and broader strain coverage.
Delonix Bioworks (搜索), a clinical-stage biotechnology company pioneering genetically engineered bacterial vaccines, announced today that the first participant has been dosed in its Phase 1 clinical trial of DX-104 (搜索) in China. DX-104 is an innovative Group B meningococcal (MenB) vaccine candidate developed using the company's proprietary OMV Plus® platform. This milestone marks a significant step in the concurrent global development of DX-104, following the initiation and ongoing progress of the DX-104 First-in-Human Phase 1 trial in Australia.
"The concurrent execution of Phase 1 trials in Australia and China enables the generation of clinical data across diverse populations, providing robust validation of our OMV Plus® platform's distinct advantages and global development potential," said Dr. Qiubin Lin, Founder and CEO of Delonix Bioworks (搜索). "As MenB remains a significant global health threat, DX-104 (搜索) is designed to deliver a next-generation vaccine with broader protection, improved tolerability, and enhanced global accessibility."
Trial Design and Objectives
The Phase 1 trial in China is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of DX-104 (搜索) in healthy participants aged 2 to 59 years. The study runs concurrently with the company's First-in-Human Phase 1 trial already underway in Australia, reflecting a deliberate strategy to generate clinical data across ethnically and geographically diverse populations.
The Unmet Need in MenB Prevention
Invasive meningococcal disease (搜索) (IMD) is a devastating, rapidly progressing bacterial infection. Globally, serogroup B (MenB) has become the leading cause of IMD, responsible for approximately 50% of cases with a steadily rising prevalence. While established global vaccines have validated significant market demand, critical gaps remain regarding strain coverage, manufacturing complexity, and equitable access.
Currently, no MenB vaccine is approved in China, representing a critical public health gap. According to Frost & Sullivan, the market potential for MenB vaccines in China is projected to reach RMB 4.7 billion by 2035.
DX-104 (搜索) and the OMV Plus® Platform
DX-104 (搜索) is a Group B meningococcal OMV vaccine candidate that leverages Delonix's proprietary OMV Plus® technology platform. The platform utilizes genetically engineered outer membrane vesicles (OMVs) to enable precise antigen presentation. DX-104 is designed to address the limitations of existing MenB vaccines in strain coverage, manufacturing complexity, and global accessibility, aiming to fulfill the significant global unmet medical need in MenB prevention.
Delonix Bioworks (搜索) is advancing a robust pipeline of first-in-class and best-in-class programs addressing critical unmet needs, including vaccines for Meningococcal B (搜索), pertussis, gonorrhoeae, and K. pneumoniae. The company's OMV Plus™ platform produces high-yield, cost-effective, and precisely engineered OMVs designed for superior antigen presentation and immunogenicity.