Abingdon, United Kingdom, 17 November 2023 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of 100% synthetic T cell-priming immune set-point candidates, today announced that it has signed a contract with the UK Department of Health and Social Care for £1,798,109 to advance a CD8 T cell-based vaccine candidate against Chikungunya virus (CHIKV).
CHIKV is a mosquito-transmitted alphavirus that causes epidemics of illness characterized by debilitating arthralgia and arthritis that can endure for months to years following infection. In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.
The milestone-based contract is designed such that Emergex will advance the development of a CD8 T cell-priming Chikungunya virus (CHIKV) vaccine candidate (PepGNP-ChikV) through preclinical studies, manufacture the vaccine candidate under Good Manufacturing Practice (cGMP) standards, and apply for MHRA regulatory submission for a Phase-1 clinical trial in the UK. The programme is intended to position Emergex for entry to the clinic by its completion, ready to begin a Phase-1 clinical trial.
Laurens Rademacher, Chief Technology Officer of Emergex commented, “We are greatly looking forward to continuing development of our novel T cell-priming solutions against leading and reemerging global health threats of epidemic potential. Through this meaningful contract, we are pleased that the UK government and its advisors recognize the potential of our innovative technology in contribution to global epidemic (and pandemic) preparedness. The focus of this opportunity on developing groundbreaking solutions targeted to entire families of viruses aligns well with Emergex’s core mission and capabilities. Our T cell-priming set-point candidates are designed to deliver robust and long-lasting protection against current and existing strains of RNA viruses, from Influenza to Chikungunya, and to ultimately increase vaccine accessibility in endemic regions.”
This news follows a previous announcement in February 2022, highlighting a contract awarded by UK government’s Department of Health and Social Care (‘DHSC’) in support of the development of Emergex’s Chikungunya vaccine candidate prototype stages of which included 1) identification of novel CHIKV peptide antigen epitopes (collectively constituting Emergex’s “ligandome”), 2) synthesis of a vaccine candidate, and 3) testing in in vitro efficacy models. Subsequently, Emergex achieved all milestones priming the CHIKV candidate for progression to the next stage of its preclinical development.
Dr Phil Packer, Innovation Lead, AMR and Vaccines, from UK Research and Innovation (UKRI) added: “Innovate UK are delivering a further (£40M) Programme for DHSC to develop vaccines against diseases that have outbreak potential. This exciting project, spearheaded by Emergex, will pave the way for development of a vaccine against Chikungunya Virus that will be ready for evaluation in human clinical trials. This brings us one step closer to providing a solution that, if successful, will have huge benefit for people in Low- and Middle- Income Countries where this disease is most prevalent.”
Using the Emergex T cell-priming platform, Emergex has successfully completed Phase I trials of Dengue and Betacoronavirus vaccine candidates (DengueTcPTM1 and CoronaTcP, respectively) under Swiss Medic, which were shown to be safe and capable of inducing desired T cell effector and memory responses. A Phase-2 trial for CoronaTcP and a Phase-1 trial for a Universal Influenza vaccine candidate are planned in H1 2024.
Chikungunya is an alphavirus (group of RNA viruses) and genus of the Togaviridae family of viruses. It is transmitted through the bite of an infected mosquito and can cause epidemics of infectious disease. The illness is characterized by fever, rash, debilitating joint stiffness (arthralgia) and arthritis, which can endure for months to years following infection. Endemic in most countries in Central and South America and the Caribbean with first local transmission identified over the past decade, CHIKV cases have been reported in Europe, Asia, the Pacific region, as well as the Americas. An increasing trend in CHIKV cases has been observed in the Americas in recent years; in this region collectively, a four-fold increase in CHIKV cases and deaths has been reported between 1 January and 4 March 2023, compared with the same time period in 2022.2 Epidemics of CHIKV can severely impact the economy. It was announced last week that the U.S. Food and Drug Administration (FDA) has approved under accelerated approval a single-dose, live-attenuated vaccine for individuals over 18 years of age at increased risk of exposure to chikungunya virus (CHIKV) for the prevention of disease based on anti-CHIKV neutralizing antibody titres, the clinical benefit of which is contingent upon verification in confirmatory studies.
About UK Vaccine Network (“UKVN”)
This research was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). It was delivered by Innovate UK.
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer. This investment is part of the UK Vaccine Network (UKVN). UKVN was established to provide funding to support the development of promising vaccines and vaccine technologies that will help combat infectious diseases that have epidemic potential in low and middle-income countries (LMICs). UKVN is an UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs).
Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic the body’s natural T cell immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.
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