Patronus Biotech Receives Ethical Approval to Begin First-in-Human Phase 1 Trial of Three Multi-Stage Vaccines Against Malaria in Australia
Bellberry Limited Research Ethics Committee approves first-in-human study in Australia of Patronus Biotech's novel multi-stage virus-like-particle (VLP)-based malaria vaccine candidates targeting Plasmodium falciparum and Plasmodium vivax
GUANGZHOU, China, Oct. 20, 2026 /PRNewswire/ -- Patronus Biotech, a biotechnology company that develops next-generation vaccines to address unmet global needs, today announced that its Phase I first-in-human clinical trial NCT07831226 of three novel multi-stage VLP-based investigational vaccine candidates for malaria has received ethical approval from Bellberry Limited on 19 October 2026. LYB014 targets 3 key stages of the Plasmodium falciparum malaria parasite lifecycle; LYB017 targets 3 key stages of the Plasmodium vivax malaria parasite lifecycle; and LYB027 targets these 3 key life stages of both the P. falciparum and P. vivax lifecycles. These vaccines will be tested with the proprietary A02 adjuvant, a novel liposomal adjuvant containing fully synthetic active ingredients. The randomised, double-blinded, controlled, dose-escalation trial will evaluate the safety and immunogenicity of these vaccines in healthy adult volunteers at Nucleus Network Pty Ltd., in Melbourne, Australia; with first participant enrolment expected December 2026. The immunogenicity analysis is being conducted in collaboration with the Draper Lab, based at the Department of Paediatrics at the University of Oxford.
These vaccines were developed at Patronus Biotech and were designed to address the need for a next-generation vaccine for malaria that can target the three key stages of the malaria life cycle, with the ambition of contributing to future efforts to eliminate malaria by preventing infection, disease and transmission.
Despite significant progress, malaria remains a major global health threat causing an estimated 282 million cases and 610,000 deaths in 2024. The two key malaria species accounting for the majority of these cases are P. falciparum and P. vivax. Both have complex life cycles beginning as sporozoites transmitted by the bite of an infected mosquito, where they travel to the liver (1), before emerging into the bloodstream where they invade and replicate within red blood cells (2). A portion of these parasites become the sexual-stage which is then taken up by another mosquito (3) to progress the lifecycle and allow transmission to the next person. The currently WHO-approved RTS,S/AS01 and R21/Matrix-M vaccines target the 1st stage of the P. falciparum parasite lifecycle only and demonstrated partial efficacy against clinical malaria in previous Phase 2/3 field trials in paediatric populations. LYB014/017/027 are designed to test whether additionally targeting the remaining stages of the life-cycle and/or targeting multiple parasite species, can provide complementary, layered protection, a hypothesis that will be assessed in future efficacy trials.
Simon Draper, Professor of Vaccinology and Translational Medicine at the Department of Paediatrics, said: "We are pleased to be collaborating with Patronus Biotech on the immunogenicity analysis for this first-in-human study. Malaria remains a major global health challenge, and there is an ongoing need to explore new vaccine approaches that could provide broader protection across different stages of the parasite's life cycle."
"Our scientific approach has the potential to transform the fight against malaria," said Dr. Jin, Chief Executive Officer of Patronus Biotech. "Our goal with our malaria vaccines and the A02 adjuvant is not just to prevent infection, but to create a more robust and affordable shield that can combat the parasite's complex biology. This could be a critical step toward eventual malaria elimination."
Media Contact:
Rebecca Dabbs, Chief Alliance Officer
rebecca.dabbs@patronusbio.com
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