SHANGHAI, China, July 13, 2026
Delonix Bioworks, a clinical-stage biotechnology company specializing in genetically engineered bacterial vaccines, has announced that the first participant has been dosed in its Phase 1 clinical trial evaluating DX-104, the company’s next-generation Group B meningococcal (MenB) outer membrane vesicle (OMV) vaccine candidate, in China. The milestone marks another important advancement in the company’s global clinical development strategy following the initiation of its First-in-Human Phase 1 study in Australia. Developed using Delonix Bioworks’ proprietary OMV Plus® technology platform, DX-104 is designed to deliver broader strain protection, improved tolerability, simplified manufacturing, and enhanced global accessibility compared with existing MenB vaccines. The Phase 1 program represents a significant step toward addressing one of the world’s most serious bacterial infectious diseases while expanding access to innovative vaccines in regions where no approved MenB vaccine is currently available.
Phase 1 Trial Evaluates Safety and Immune Response
The Phase 1 clinical study in China is designed as a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and immunogenicity of DX-104 in healthy participants aged 2 to 59 years. Running alongside the ongoing Australian Phase 1 study, the dual-country clinical strategy enables researchers to generate safety and immune response data across diverse populations while strengthening the global clinical development program. Company leaders noted that conducting simultaneous trials in different geographic regions provides broader validation of the OMV Plus® platform, supporting future international regulatory development and commercialization opportunities. By collecting clinical evidence from multiple populations early in development, Delonix aims to accelerate the advancement of its next-generation vaccine candidate toward larger efficacy studies.
DX-104 Targets Significant Global Public Health Need
Invasive meningococcal disease (IMD) remains a rapidly progressing and potentially life-threatening bacterial infection that can cause meningitis, bloodstream infections, permanent neurological damage, and death. Serogroup B (MenB) is now responsible for approximately half of all invasive meningococcal disease cases worldwide, creating a substantial unmet medical need despite the availability of existing vaccines in selected markets. DX-104 has been engineered using genetically modified outer membrane vesicles (OMVs) that allow precise antigen presentation designed to improve immune protection while overcoming limitations associated with current MenB vaccines, including restricted strain coverage, manufacturing complexity, and limited accessibility.
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Importantly, China currently has no approved MenB vaccine, representing a significant healthcare gap. Industry projections estimate that the Chinese MenB vaccine market could reach RMB 4.7 billion by 2035, highlighting both the medical importance and commercial opportunity for innovative vaccine technologies.
OMV Plus® Platform Expands Next-Generation Vaccine Pipeline
The advancement of DX-104 further validates Delonix Bioworks’ proprietary OMV Plus® platform, a genetically engineered bacterial vaccine technology designed to produce high-yield, precisely engineered outer membrane vesicles capable of delivering enhanced immunogenicity with scalable manufacturing. Beyond meningococcal disease, the company is applying the same platform to develop a diversified pipeline targeting additional infectious diseases with significant global health burdens, including pertussis, gonorrhea, and Klebsiella pneumoniae infections. Company executives emphasized that the concurrent Phase 1 studies in China and Australia represent an important milestone in demonstrating the platform’s global development potential. As vaccine innovation continues to play a critical role in infectious disease prevention, Delonix Bioworks aims to deliver next-generation bacterial vaccines capable of improving public health, increasing global vaccine accessibility, and addressing long-standing unmet needs in infectious disease prevention through advanced genetically engineered OMV technology.
Source: Delonix Bioworks press release
