July 13, 2026 -- Delonix Bioworks, a clinical-stage biotechnology company pioneering genetically engineered bacterial vaccines, today announced that the first participant has been dosed in its Phase 1 clinical trial of DX-104 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 Phase 1 trial in China is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and immunogenicity of DX-104 in healthy participants aged 2 to 59 years.
"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. "As MenB remains a significant global health threat, DX-104 is designed to deliver a next-generation vaccine with broader protection, improved tolerability, and enhanced global accessibility.
Invasive meningococcal disease (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 the 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 is a Group B meningococcal OMV vaccine candidate leveraging Delonix's proprietary OMV Plus® technology platform. It 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 is a clinical-stage biotechnology company at the forefront of developing next-generation genetically engineered bacterial vaccines. Leveraging its proprietary OMV Plus™ platform, the company produces high-yield, cost-effective, and precisely engineered outer membrane vesicles (OMVs) designed for superior antigen presentation and immunogenicity. Delonix is dedicated to advancing a robust pipeline of first-in-class and best-in-class programs addressing critical unmet needs, including vaccines for Meningococcal B, pertussis, gonorrhoeae, and K. pneumoniae.
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