CoronaTcP

Emergex received authorisation from the Philippines FDA to launch a Phase I-II clinical trial of CoronaTcP, its T cell-priming immune set-point candidate against Betacoronaviruses. Emergex is progressing trial initiation plans, with an anticipated start date in Q2 2024. ABINGDON, United Kingdom, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced that the Philippines Food & Drug Administration has authorised the initiation of a Phase I-II clinical trial of CoronaTcP™1, Emergex’s T cell-priming set-point product, designed to be broadly effective against disease caused by Betacoronaviruses, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2. The naNO-COVID 2 trial (NCT05633446) is a randomized, double-blind, placebo-controlled Phase I-II trial in the Philippines, which will investigate the safety and immunogenicity of CoronaTcP. The study is expected to enrol 110 healthy volunteers (18–75 years of age), who will each receive either one or two doses of CoronaTcP or placebo. All participants will be followed up for six months. This study follows completion of the naNO-COVID trial (NCT05113862), a Phase I clinical trial in Switzerland which demonstrated that CoronaTcP had a favourable safety pro successfully induced virus-specific CD8+ memory subsets. Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented: “We thank the Philippines FDA for rapidly approving this trial after a successful Phase I clinical trial in Switzerland. Coronaviruses are susceptible to high mutation rates, and cellular immunity is critical for long-lasting protection. We look forward to evaluating our T cell-based approach, which has the potential to improve any previous immune status. Emergex is rapidly moving forward with plans for the trial, and we expect to start enrolling volunteers in Q2 2024.” The naNO-COVID 2 trial The naNO-COVID 2 trial (NCT05633446) is a Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell-priming immune set-point candidate for coronavirus disease in healthy adults. The clinical study will enrol 110 participants, who will be randomized into the following groups: Group 1: one vaccination on Day 0 (n=55): 44 CoronaTcP + 11 placebo; Group 2: two vaccinations on Day 0 and Day 21 (n=55): 44 CoronaTcP + 11 placebo. Overall, 88 participants will receive CoronaTcP (7.5 nmol peptide per dose) and 22 will receive placebo (water for injection). Safety and immunogenicity of CoronaTcP (cellular and humoral immune responses) during the six-month post-vaccination period will be evaluated. About Emergex 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. Find out more online at . Visit our LinkedIn page or Twitter account for updates.

ABINGDON, United Kingdom, Nov. 17, 2023 (GLOBE NEWSWIRE) -- 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 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 CHIKV 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 is 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. About ChikungunyaChikungunya 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, Chikungunya virus (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 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). About Emergex 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 illnesses associated with infectious diseases. Visit our LinkedIn page or Twitter account for updates. For further information, please contact: Emergex Media InquiriesStorme Moore-Thornicroft, Executive DirectorPhone: +44 (0) 1235 527589Email: smt@emergexvaccines.comRachelle Babb, Account ExecutivePhone: +1 (929) 325-7559Email: rachelle.babb@russopartnersllc.com 1 Trademark application submitted 2 https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON448