Delonix Bioworks, a clinical-stage biotechnology company developing genetically engineered bacterial vaccines, announced on Monday 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 Delonix Bioworks' proprietary OMV Plus platform.
The Phase 1 trial is a randomised, 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 enrolment 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)."
Delonix Bioworks launches Phase 1 trial of next-generation MenB OMV vaccine DX-104
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