San Diego-based Aegis Life, a biotechnology company developing vaccines and therapies for life-threatening diseases, has entered the race to combat COVID-19 with its DNA vaccine.
Earlier this year, the company spun out of Entos Pharmaceuticals, a health care biotechnology company with a mission to cure infectious diseases using a patient’s genetics.
In particular, the Fusogenix-encapsulated DNA vaccines fuse with cell membranes and instruct patients’ cells to create their own medicines.
Tapping its proprietary gene delivery technology called Fusogenix, Founder and CEO John Lewis said the technology will be used for gene therapies to develop cancer therapeutics and applying it to create a DNA vaccine for the novel coronavirus.
“Entos Pharmaceuticals developed the Fusogenix technology over the past decade, and has broadened Fusogenix’ adoption through multiple spinouts and partnerships. When COVID-19 hit, we realized that the technology is ideally suited to deliver DNA vaccines and therapeutics.” said Lewis. “We decided to spin out Aegis Life to focus on infectious diseases to leverage the Fusogenix technology, as we have done before for other diseases such as cancer.”
The flexibility of Fusogenix may enable Aegis’s investigational DNA vaccine to target and deliver simultaneously the Spike (S) protein and the Nucleocapsid (N) protein intracellularly.
This approach offers a number of potential advantages over traditional approaches, including the stimulation of both B- and T-cell responses, ease of large-scale manufacture, improved vaccine stability, and the absence of any infectious agent.
“We believe DNA vaccines have important inherent advantages over other approaches, including the potential to develop a single dose vaccine that induces a potent T cell response and therefore enhanced durability,” said Lewis.
Unlike traditional vaccines, a DNA-based vaccine involves the direct introduction of a plasmid encoding the antigen(s) against which an immune response is sought and relies on the production of the target antigen in the patient’s own cells.
A DNA vaccine is also different compared to traditional vaccines, like a flu shot where an inactivated virus is injected into the arm.
“Just like a software program, we’re going to encode several of the COVID-19 proteins, not the ones that make it dangerous, but the ones that are identified as unique,” Lewis said. “When your own cells, your body, produces those proteins, your body will recognize those as foreign, and then mount an immune response.”
One Year Turnaround
The vaccine candidates will first be tested in animal models before moving to human trials. Best case scenario, those could begin in three to four weeks, Lewis said, and they hope to start a trial in Edmonton. The company anticipated to start its phase III trials by 2021.
Lewis said they’re also hoping to find patients who have recovered from COVID-19 to look at the immune cells in their blood and see if they respond to the vaccine.
“We are rapidly mobilizing to start a clinical trial of our COVID-19 vaccine. We have the Canadian Centre for Vaccinology in Halifax, Nova Scotia, who are the key collaborators at Dalhousie (University),” Lewis said. “They ran clinical trials for the Ebola vaccine which was the first one in North America.”
In June, the company received a $4.2M grant from the Canadian Institutes of Health Research, Research Nova Scotia, and the Institute for Ageing. The funding was used to further develop its vaccine candidates through animal challenge studies and human clinical trials, according to the company.
“We think we are going to be very competitive once this rolls out,” said Lewis. “Now is the time for genetic medicine, all these viruses and bacteria that are affecting us, are all using their genetics to their advantage, it’s time for us to turn the tides.”