A next-generation COVID-19 vaccine, developed by British biotech Emergex, designed to prime T-Cells to rapidly remove viral-infected cells and offer broad long-lasting immunity, is entering Phase I clinical studies with the first patients expected to be dosed in January 2022.
Emergex Vaccines Holding Limited, or the company known to develop 100 percent synthetic T Cell priming vaccines to combat major global infectious disease threats, announced this week that it has secured the required regulatory clearances to begin a Phase I clinical trial to examine the safety and tolerability of its vaccine candidate for the SARS-CoV-2 virus that causes COVID-19.
The Phase I trial is a double-blind, randomized, and comparator-controlled investigation in which two groups of 13 volunteers at high and low doses. Early data on CD8+ T-Cell mediated immune responses as a surrogate of protection against COVID-19 will be presented in addition to safety and tolerability data.
Professor Blaise Genton, Principal Investigator from the University of Lausanne’s Center for Primary Care and Public Health, Switzerland, will lead the study. The study participants are expected to get their first dose of the Emergex vaccine candidate at the beginning of January 2022.
Currently, also in Switzerland, a Phase I clinical study (NCT04935801) assessing Emergex’s Dengue vaccine is ongoing, with all patients receiving two vaccine doses.
Robin Cohen, Chief Commercial Officer at Emergex Vaccines, commented:
“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 commented:
“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.”
The T-Cell priming vaccine could remove the need for booster immunizations
The vaccines developed by Emergex are engineered to prime naive CD8+ T-cells to generate virus-specific CTLs (CD8+ T-cells/Cytotoxic T Lymphocytes) that kill virally infected cells, stopping viral replication the disease, its transmission and symptoms. Versus current vaccine technologies, which predominantly rely on an antibody immune response, Emergex’s T-Cell priming vaccines have the potential to be more successful in targeting rapidly mutating viruses such as SARS-CoV-2 and eliminate the need for booster immunizations.
Potential to offer broad immune protection with one vaccine
Emergex’s vaccine is engineered against highly conserved antigens and it is considered potentially to provide cross-reactive immunity to both SARS-CoV-1 infection as well as all SARS-CoV-2 variants of the virus, providing broad immune protection against two pandemic viruses in one vaccine.
Emergex vaccines are designed to be delivered percutaneous(via the skin) with tiny needles and to be stable at room temperature for more than three months, allowing for faster and more efficient global distribution and vaccine administration that is patient-friendly
Emergex, a biotechnology company based in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is leading the way in the development of synthetic vaccines that prime the T-Cell immune response to meet some of the global health threats, including COVID-19, Dengue Fever, Zika, Ebola, pandemic flu, and serious intra-cellular bacterial infections. These set-point vaccines modify recipients’ initial immunological state in such a way that their immune systems are ‘primed’ to identify subsequent infectious invaders, just like they would in a natural infection, preventing an acute or severe disease presentation.
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 programmes in development for a universal Influenza vaccine, a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programmes 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.
Find out more online at www.emergexvaccines.com.