Emergex’s dengue vaccine candidate receives regulatory approval for its first phase clinical trial

UK – A company tackling major global infectious disease threats through the development of 100% synthetic ‘set point’ vaccines, Emergex Vaccines Holding has received regulatory approval for its phase 1 clinical trials of its Dengue Vaccine, pepGNP-Dengue.

With approval from Swiss regulatory agencies, Emergex is set to enroll its first participants for the trial phase.

The naNO-DENGUE phase 1 trials will evaluate Emergex’s novel T-Cell priming vaccine, which has been designed to deliver broad and long-lasting immunity by priming the body’s T-Cell response to provide rapid clearance of infected cells in the event of an infection.

This study’s main agenda is to evaluate the safety of the investigational vaccine, pepGNP-Dengue and additionally provide proof-of-concept for a rapidly scalable modular peptide vaccine platform against emerging viral pathogens.

Dengue is a mosquito-borne viral disease that has rapidly spread in all regions of WHO in recent years through a viral transmission initiated by the female mosquitoes.

The incidence of dengue has grown dramatically around the world in recent decades and a vast majority of cases are asymptomatic or mild and self-managed, hence the actual numbers of dengue cases are under-reported.

According to WHO, one modelling estimate indicates 390 million dengue virus infections per year (95% credible interval 284–528 million), of which 96 million (67–136 million) manifest clinically (with any severity of disease).

Another study on the prevalence of dengue estimates that 3.9 billion people are at risk of infection with dengue viruses and despite a risk of infection existing in 129 countries, 70% of the actual burden is in Asia.

The number of dengue cases reported to WHO increased over 8-fold over the last two decades, from 505,430 cases in 2000, to over 2.4 million in 2010, and 5.2 million in 2019.

This alarming increase in case numbers is partly explained by a change in national practices to record and report dengue to the Ministries of Health, and to the WHO.

Just in 2020 alone, dengue affected several countries, with increased number of cases in Bangladesh, Brazil, Cook Islands, Ecuador, India, Indonesia, Maldives, Mauritania, Mayotte (Fr), Nepal, Singapore, Sri Lanka, Sudan, Thailand, Timor-Leste and Yemen.

In 2021, dengue continues to affect Brazil, Cook Islands, Colombia, Fiji, Kenya, Paraguay, Peru and Reunion island.

This alarming number prompted pharma companies to act swiftly on finding a vaccine to help curb the disease and hence the first dengue vaccine, Dengvaxia (CYD-TDV) developed by Sanofi Pasteur and licensed in December 2015 with approvals from approximately 20 countries.

Emergex is hopeful to join Sanofi in the fight against dengue with its newly developed vaccine as the company anticipates for positive feedback from the phase 1 trials.

PepGNP-Dengue vaccines have been designed to be administered via the skin using micro needles and to be stable at ambient room temperature for beyond 3 months, facilitating rapid and efficient distribution across the world and making administration of the vaccine more patient friendly.

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