Emergex Announces Authorisation from Philippines FDA to Initiate Phase I-II Clinical Trial of 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, 3 January 2024 – 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 profile and 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 www.emergexvaccines.com.

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1 Trademark application submitted

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com