The meningococcal B vaccine space has been GSK territory for a long time. Bexsero has been the standard since 2013, and while Pfizer’s Trumenba carved out a piece of the market, there hasn’t been much genuine next-generation competition. Until now, apparently — and it’s coming from Shanghai.
Delonix Bioworks just initiated a Phase 1 first-in-human clinical trial of DX-104, a Group B meningococcal vaccine built on the company’s proprietary OMV Plus™ platform. The trial is running in healthy adults in Australia — randomized, double-blind, and positive-controlled, with Bexsero as the active comparator. Sentinel dosing is complete and broader enrollment is underway.
That trial design is ambitious for a Phase 1. Going head-to-head against the market leader right out of the gate tells you the company thinks they have something meaningfully different, not just a me-too.
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So what’s the OMV Plus platform? Traditional MenB vaccines use outer membrane vesicles — tiny blebs that bud off from the bacterial surface and carry antigens that train the immune system. It’s a proven approach, but natural OMVs have limitations in antigen consistency and coverage. Delonix’s platform genetically engineers the bacteria to precision-tune what those vesicles present to the immune system — essentially upgrading the antigen display to improve both breadth and potency of the immune response.
The company operates as Shanghai Yuguan Biotech in China and has already secured IND clearance from both China’s NMPA and Australian regulators — a dual-geography strategy that gives them flexibility. Running the Phase 1 in Australia makes sense: faster regulatory timelines, experienced clinical trial infrastructure for vaccines, and data that’s globally transferable.
No efficacy data yet, obviously — this is a Phase 1 safety and immunogenicity study. But the dual IND clearance, the head-to-head design against Bexsero, and the engineered OMV approach make this one worth tracking. The MenB market needs competition, and Delonix is making a real play.
