• Both studies fully recruited, with data from the Dengue Fever study anticipated in the summer
  • Preclinical data for Emergex’s Coronavirus vaccine candidate suggests that it could provide heterologous immunity to viruses from the same family

ABINGDON, UK I April 18, 2022 I Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines, today provided an update on its first-in-human clinical trials of its Dengue and Coronavirus T cell Adaptive Vaccine candidates.

As part of the clinical development of its novel T cell Adaptive Vaccines, Emergex has introduced an innovative clinical trial design where two vaccine candidates based on the same platform technologies, one against Dengue fever and one against Coronavirus disease, are assessed in two stages of a
Phase I clinical trial at a single site in Switzerland (Unisanté, Lausanne) with 52 participants. The two stages of the trial are designed to evaluate the safety and tolerability of the vaccine candidates in a double-blind, randomised, dose-ranging, and comparator-controlled setting. An independent Data Safety Monitoring Board has been monitoring the clinical trial.

naNO-Dengue study: The Company has successfully completed the Phase I clinical trial for its novel CD8+ T cell Dengue vaccine candidate. The Last Participant Last Visit per clinical trial protocol for the trial (NCT04935801) was performed on 11 March 2022. In the trial, two dose levels of the Emergex CD8+ T cell Dengue vaccine candidate were evaluated in 26 healthy adults aged 18 to 45 years. Follow up with trial participants has taken place over a six-month period following first injection and the final clinical trial report is nearing completion. The results are expected to be announced in the summer.

naNO-COVID study: The Phase I clinical trial (NCT05113862) for the Company’s novel CD8+ T cell Coronavirus vaccine candidate is ongoing with first participant dosed on 10 January 2022. All 26 healthy adults aged 18 to 45 years in the ‘naNO-COVID’ trial have received vaccinations (lower-dose or higher-dose) of the Emergex CD8+ T cell vaccine against Coronavirus disease and are now in the follow-up period per the clinical trial protocol. The Lausanne-based trial coincided with the January-March Omicron wave of SARS-CoV-2 in Switzerland. During this time, the seven-day average of new cases peaked at 30-40,000 new cases per day, representing a significant increase over prior time periods. The trial remains blinded (comparator controlled) and participants are being monitored for virologically confirmed symptomatic disease.

Preclinical data for the Company’s novel CD8+ T cell Coronavirus vaccine candidate in HLA transgenic mice has confirmed that after vaccination with the Company’s T cell Coronavirus vaccine candidate and subsequent SARS-CoV-1 intranasal challenge, no lung inflammation was detected which suggests that the vaccine candidate demonstrates heterologous protection for both viruses from the same family.

Future Studies: Phase I/II and II/III Clinical trials for both vaccine candidates are planned, in the near-term, for South-East Asia, USA, South America and Middle East.

Dr. Athanasios Papadopoulos, Chief Medical Officer, commented: “Over the past year, Emergex has made substantial progress in advancing its clinical programmes with a platform that is designed to boost T cell immunity against any infectious agent. The 52 participants enrolled in the naNO-Dengue and naNO-COVID Phase I trials represent a significant milestone for the Company, and I remain optimistic for when the data from these studies is unblinded. Both of these vaccines are a direct result of Emergex’ work to advance its CD8+ T cell Adaptive Vaccine platform to address a diversity of viral and bacterial disease threats. As it becomes available, I look forward to reporting the data from these ongoing clinical studies as well as our future clinical programme plans.”

About Emergex

Emergex, a clinical-stage, privately-held biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells for protection against some of the world’s most pressing health threats: [i] viral infectious diseases, amongst which are Dengue, Coronaviruses, and pandemic Influenza, as well as [ii] serious intracellular bacterial infectious diseases.

Emergex has a growing proprietary pipeline of innovative CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease. Emergex has a number of Phase I clinical trials underway, of which the most advanced programmes in development are [i] Dengue (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and [ii] Coronaviruses. Other programmes in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.

Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via micro-needles in order to elicit a robust, adaptive CD8+ T cell response. With potential stability at ambient temperatures, the vaccine candidates as intended reduce the burden and logistics of vaccine administration.

Find out more online at www.emergexvaccines.com.

SOURCE: Emergex