Emergex Announces Approval to initiate Phase 1 Clinical Trial of Its Next-Generation COVID-19 Vaccine Candidate

Emergex Vaccines Holding Limited recently announced it has received the necessary regulatory approvals to initiate a Phase 1 clinical trial to evaluate the safety and tolerability of its vaccine candidate for SARS-CoV-2, the virus which causes COVID-19.

The Phase 1 trial is a double-blind, randomized and comparator-controlled study of two groups of 13 volunteers at high and low doses. In addition to providing safety and tolerability data, early data on CD8+ T-Cell mediated immune responses as a surrogate of protection against COVID-19 will be provided. The trial will be conducted by Professor Blaise Genton, Principal Investigator, from the Center for Primary Care and Public Health at the University of Lausanne, Switzerland. The first patient is anticipated to receive their first dose of Emergex vaccine candidate at the start of January 2022.

A Phase 1 clinical trial (NCT04935801), named naNO-DENGUE, testing Emergex’s Dengue vaccine candidate is currently underway in Switzerland with all patients having received two vaccine doses.

Robin Cohen, Chief Commercial Officer at Emergex Vaccines, said “Our T-Cell priming vaccines may offer significant benefits over current COVID-19 vaccines including longer lasting immunity and broader protection against new variants. We are proud to announce the initiation of this trial and look forward to gathering data to support the development of this important next generation vaccine.”

Professor Blaise Genton, Principal Investigator for the trial from the Center for Primary Care and Public Health (Unisante) at the University of Lausanne, Switzerland, added “Although current COVID-19 vaccines have made significant progress in reducing mortality and morbidity challenges still remain, especially with the development of new variants. This exciting new scientific approach to developing a vaccine against SARS-CoV-2 addresses the need to generate a T-Cell response to elicit long term immunity. We look forward to evaluating the results as when they are available.”

Emergex’s vaccines aim to prime naive CD8+ T-Cells to generate virus specific CTLs (CD8+ T-cells/Cytotoxic T Lymphocytes) to kill viral infected cells, preventing viral replication and disease and reducing symptoms and the transmissibility between infected and non-infected individuals. As a result, Emergex’s T-Cell priming vaccines have the potential to be more effective in targeting rapidly mutating viruses such as SARS-CoV-2 and eliminate the need for seasonal booster vaccines in comparison to current vaccine technologies, which primarily rely on an antibody immune response. In addition, Emergex’s vaccine is raised against antigens that are highly conserved so may provide cross reactive immunity to SARS-CoV-1 infection and all SARS-CoV-2 variants and strains of the virus, offering broad immune protection from two pandemic viruses in one vaccine.

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

Emergex, a biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, is pioneering the development of synthetic vaccines which prime the T-Cell immune response to address some of the world’s most immediate health threats such as COVID-19, Dengue Fever, Zika, Ebola, pandemic flu and serious intra-cellular bacterial infections.

These set-point vaccines modify the initial immune status of recipients in a way that ‘primes’ their immune systems to recognize subsequent infectious agents much like a natural infection would do, preventing an acute or severe manifestation of the disease.

Emergex uses a synthetic nano gold carrier system to deliver a specific set of peptides to the body’s immune system, generating a robust T-Cell response that has the potential to provide a rapid and broad immune response that may last for decades.

The company has a growing pipeline of vaccine candidates. The most advanced development programmes are a vaccine for Dengue Fever. The vaccine technology offers the potential for cross-reactive immune responses for other Flaviviruses such as the Zika and Yellow Fever viruses. Emergex has programs in development for a universal Influenza vaccine, a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programs for a Yellow Fever Booster vaccine, a therapeutic Hepatitis B vaccine and a Chikungunya vaccine.

Emergex has partnered with the Institute of Molecular and Cell Biology (IMCB) of Singapore to develop a vaccine for the emerging threat of Hand, Foot and Mouth (HFM) disease. The Company also has a collaboration in place with Brazil-based Bio-Manguinhos/Fiocruz for the development of several vaccine candidates, including a potential vaccine for COVID-19. For more information, visit www.emergexvaccines.com.