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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 (NCT05633446) trial is a randomized, double-blind, placebo-controlled, phase I-II trial in the Philippines that will investigate the protection and immunogenicity of CoronaTcP. The study is expected to enroll 110 healthy volunteers (ages 18). at 75 years of age), who will receive one or two doses of CoronaTcP or placebo. All participants will be followed for six months.
This follows the finishing touch of the naNO-COVID (NCT05113862) trial, a phase I clinical trial in Switzerland that demonstrated that CoronaTcP had a favorable protection profile and effectively induced virus-specific CD8 memory subsets.
Professor Thomas Rademacher, Co-Founder and Chief Executive Officer of Emergex, commented: “We thank the Philippine FDA for approving this trial after a successful Phase I clinical trial in Switzerland. Coronaviruses are vulnerable to high mutation rates and cellular immunity is a must. “for long-lasting protection. We hope to compare our T-cell-based approach, which has the potential to improve any past immune state. “Emergex is temporarily moving forward with its plans for the trial and we look forward to beginning recruiting volunteers. in the second quarter of 2024. “
The naNO-COVID 2 Trial The naNO-COVID 2 (NCT05633446) trial is a Phase I-II, double-blind, randomized, placebo-controlled study that examines the protection and immunogenicity of a candidate at a T-cell preparation immune setpoint for coronavirus. Disease in healthy adults. The clinical trial will enroll 110 participants, who will be randomly assigned to the following groups: Group 1: one vaccine on day 0 (n = 55): 44 CoronaTcP 11 placebo; Group 2: two vaccines on day 0 and day 21 (n=55): 44 CoronaTcP 11 placebo. A total of 88 participants will receive CoronaTcP (7. 5 nmol peptide consistent with dose) and 22 will receive placebo (water for injection). The protection and immunogenicity of CoronaTcP (cellular and humoral immune responses) will be evaluated six months after vaccination.
About EmergexEmergex 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 www.emergexvaccines.com. Visit our LinkedIn page or Twitter account for updates.
For information, please contact:
Emergex
Media Inquiries
Storme Moore-Thornicroft, CEO Telephone: (0) 1235 527589 Email: smt@emergexvaccines. com
Rachelle Babb, Senior Account Manager Phone: 1 (929) 325-7559 Email: rachelle. babb@russopartnersllc. com
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