Delonix Bioworks Announces Initiation of Phase 1 First-in-Human Clinical Trial of a Next-Generation MenB OMV Vaccine DX-104

Delonix Bioworks, a clinical-stage biotechnology company pioneering genetically engineered bacterial vaccines, announced the initiation of first-in-human (FIH) dosing in a Phase 1 clinical trial of DX-104. DX-104 is an innovative Group B meningococcal (MenB) vaccine candidate developed using the company’s proprietary OMV Plus™ platform.

The Phase 1 trial is a randomized, double-blinded, positive-controlled study evaluating the safety and immunogenicity of DX-104 in healthy adult participants. The trial is currently underway in Perth, Australia. Following successful completion of the preliminary safety assessment by initial sentinel participants, the study has proceeded to broader enrollment as planned.

"The initiation of this Phase 1 trial is a transformative milestone for Delonix," said Dr. Qiubin Lin, Founder and CEO of Delonix Bioworks. "Beyond advancing our MenB program, this study serves as a critical clinical validation of our OMV Plus™ platform. We are rapidly advancing our OMV-based pipeline—targeting Pertussis, N. gonorrhoeae, and K. pneumoniae—to deliver breakthrough solutions against the global threat of antimicrobial resistance (AMR)."

About MenB (Meningococcal Group B)

Invasive meningococcal disease (IMD) remains a devastating, rapid-onset bacterial infection that primarily threatens infants, adolescents, and young adults. Globally, Serogroup B has become the dominant driver of IMD, now responsible for approximately 50% of cases with a steadily rising prevalence. While established vaccines such as GSK's Bexsero^® and Pfizer's Trumenba^® have validated the significant clinical and commercial demand—with Bexsero reporting approximately $1.58 billion in sales in 2025—critical gaps remain regarding global strain coverage, manufacturing complexity, and equitable access.

About DX-104

DX-104 is an investigational Group B meningococcal (MenB) vaccine candidate. Built on the OMV Plus™ platform, it utilizes genetically engineered outer membrane vesicles (OMVs) to ensure precise antigen presentation. The candidate aims to address the significant global unmet need for more consistent and broadly protective vaccines against serogroup B meningococcal disease.

About Delonix Bioworks

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.

For more information, please contact BD@delonixbio.com.

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