Can Synthetic Vaccines Change The World’s Approach To Infectious Disease Crises?
Executive Summary
Emerging Company Profile: Emergex Vaccines will use its nanobody technology to develop entirely synthetic immunizations against the world’s most concerning infectious diseases, including Ebola; evolving current options for vaccine stockpiling and national repositories.
Emergex Vaccines, a company built on nanobody technology from Midatech Pharma PLC, wants to tackle emerging epidemics with novel, purely synthetic vaccines.
Emergex is pursuing a novel approach to vaccine development, using 100% synthetic components to activate T-cells so that the immune system can destroy virus-infected human cells. The company’s technology is based on a library of immunogenic peptides and a gold nanoparticle delivery system.
Emergex’s CEO and Chief Scientific Officer Thomas Rademacher believes the company’s technology means it can develop and manufacture vaccines faster and at a fraction of the cost of traditional vaccines.
Founded in 2016, Emergex is funded through private financing and government grants, but it plans to raise more cash soon to take three programs into clinical testing. Emergex expects to get these assets to Phase I before selling them for stockpiling or licensing the vaccines to another company for further clinical trials.
The company is focused on vaccines for flavivirus, filovirus and influenza. Its lead program of these three is EMX-001, which is cross-reactive against Zika, dengue and yellow fever. Emergex will initiate a Phase I trial for EMX-001 in the final quarter of this year or early in the first quarter of 2019.
Emergex’s vaccine candidate against filovirus is targeting Ebola and Marburg, and the company hopes to take its influenza vaccine into studies for the use against new pandemic strains of flu at the time they move from an animal species into humans. The Oxford, UK-based company also is initiating earlier-stage programs for vaccines against meningitis and bacterial pneumonia.
Emergex received a grant of £979,318 from Innovate UK in May to progress its universal flu asset. The grant will cover 70% of the cost of developing the flu vaccine program over a period of two years. As such, clinical batches of the vaccine will be ready for Phase I testing by 2020.
Emergex Vaccines
Location: Oxford, UK
R&D Focus: vaccine development
Disease Area(s): flavivirus, filovirus and influenza
Founding Date: 2016
Investors: private investors and government grants
Employees: 5
The company licensed its platform from Midatech, which discovered the nanobody vaccine technology, but had no plans to enter the world of infectious disease R&D. Midatech, a preclinical-stage company that went public in 2014, is focused on oncology, immunotherapy and ophthalmology.
Emergex was formed in 2015 to potentially move forward with a vaccine against Ebola during an outbreak of the disease in West Africa at that time.
A few vaccines were being developed by pharma and government initiatives at the time of the 2014-2015 Ebola outbreak, but these were live viral vaccines that took around two years to get into the clinic.
“By the time these vaccines were ready to be tried there were no more Ebola patients, because health workers had contained the Ebola crisis,” Rademacher told Scrip.
“The world woke up and realized that to deal with these nasties coming from mosquitoes or bats, etc., we need investigational vaccines that can go into efficacy-driven clinical trials at the time of the epidemic, not two years later,” he said.
Rademacher noted that Emergex was not needed at the time of the Ebola epidemic, but that the company’s technology could see vaccines developed very quickly.
The company started its development plans with a list of the 12 most concerning viruses and infectious diseases, which included dengue and Zika.
Business Model
Emergex’s business model is to take its vaccine candidates as far as Phase Ia studies, at which point the immunizations would be ready to enter Phase III field trials. After Phase Ia, Emergex will look to sell the vaccines for repositories or to other companies for testing in larger, pivotal studies.
“This repository option was something completely lacking in the Ebola situation and even today no one knows if any of the vaccines created at the time have any prophylactic use,” Emergex’s CEO said.
“We were the first to recognize the issue of having these ‘vaccines-on-demand,'” he added. “There is huge interest in these types of vaccines now because of problems such as bioterrorism and the increase in tropical diseases moving into developed cities.”
For example, Emergex is working with agencies in Brazil on options for synthetic vaccines; Brazil has more than 60 active flaviviruses including dengue, Zika, West Nile disease, yellow fever and Japanese encephalitis.
Rademacher noted that only five countries handle vaccine repositories, because of the cost of maintaining them. Emergex wants to expand this model by making vaccine candidates that are cheaper to develop, and easier to store and maintain. “It will be selling the rights to prescriptions for vaccines that are ready to go out the door,” Rademacher said.
New Approach
Rademacher said one of the biggest issues was the difficulty of diagnosing patients with a particular virus, which means specific vaccines do not always work. “Current vaccine technology, by-and-large, goes after antibody-type responses, but antibodies are serotype-specific. We are looking at a disruptive, new approach to dealing with pandemics,” he highlighted. Rademacher noted that the company's vaccine programs are aimed at whole virus families, not single diseases within a group.
Emergex plans to validate its technology by showing the investigational vaccines are safe in Phase Ia studies. However, if the company is able to produce efficacy results in a larger field trial for at least one of its vaccines, that could change the rules for its other pipeline candidates. Rademacher noted it was a positive sign that Midatech had already moved one of its own pipeline assets, which is based on the same nanobody technology platform, into early clinical studies.
“We are hoping to rewrite the rules with our technology. This is a brand-new approach and new guides will be needed,” he said.
Rademacher noted that DNA and RNA technologies are other novel approaches being tried for vaccine development, but he does not believe these will yield strong results. “I think there will be a global resistance to putting DNA into people and I believe the DNA vaccines that have been tried in monkeys with Ebola did not work.”
The only other company developing a synthetic vaccine is Moderna Therapeutics LLC, Rademacher said. However, he did not consider the RNA-focused company a direct competitor to Emergex.
Despite Rademacher expecting Emergex’s technology to be disruptive in vaccine development, he doesn’t expect any pushback from pharmas in the market. “I think it’s an area that big pharma would prefer someone else to do. A lot of the vaccines we have today come from research in the 50s and 60s, or earlier, and the way these things were tested you just cannot do today.” He cited polio as an example, where in the past children who were given an investigational vaccine were exposed to live polio virus to test its effects.
Looking ahead, Rademacher would like to see the company establish vaccine options in flavivirus, filovirus and influenza before expanding its technology into intracellular bacterial pathogens, such as gonorrhea and Legionnaires' disease. The first step though, will be a successful Phase I trial readout for EMX-001 in 2019.