Clinical development of DIOS-HFVac3: A pre-clinically effective multivalent vaccine for Lassa fever virus, Marburg virus, and Sudan ebolavirus

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DIOSynVax, a clinical-stage biotechnology company based in Cambridge, UK, is working on a groundbreaking project to develop a novel vaccine against four diseases which cause outbreaks of high consequence to human health including Ebola, Lassa, Marburg and mpox . The primary goal of our project is to protect populations in low and middle-income countries (LMICs), where the risk and impact of these epidemic diseases are highest.The DIOS-HFVac3 candidate vaccine delivers RNA- and codon optimised sequences encoding engineered antigens derived from 3 different viruses - the glycoproteins of Ebola- and Marburg virus and the nucleoprotein of lassaviruses - via a poxviral vaccine vector, shown to protect from mpox infection and/or disease.Our vaccine candidate has demonstrated (Fig 1, Appendix Q2) promising results in preclinical trials, demonstrating a robust immune response protecting relevant animal models from challenge with Ebola-Sudan, Marburg, and Lassa virus induced disease, making it a promising candidate in the fight against these important epidemic disease threats.This project will undertake five distinct work packages important to ensure that the clinical vaccine manufacturing process is performed at the very highest specifications to ensure that the vaccine meets all the regulatory and safety criteria prior to GMP manufacturing and in preparation for Phase 1 Clinical studies and future manufacturing scaleup. These include CMC management comprising the qualification of the seed material and technology transfer, engineering batch run for physicochemical stability analysis, confirmation of vaccine immunogenicity as well as formal toxicology study, and planning of a Phase 1 clinical study and eventually the generation of a business plan and technical case. Each of these work packages is designed to advance the DIOS-HFVac3 vaccine towards clinical trials and regulatory approval.This project is not just about creating a vaccine, but also about ensuring it can be produced and distributed effectively where it is most needed. We are working on manufacturing processes that will allow us to produce the vaccine at scale, including future manufacturing and subsequent advanced clinical testing in Africa.This project represents a significant step forward in the fight against epidemic diseases, leveraging cutting-edge technology, multidisciplinary expertise, and a proven track record in vaccine development, bringing our innovative vaccine candidate closer to clinical development, regulatory approval, and ultimately, implementation to protect people at greatest risk.