Redesigning viral genomes

Following the successful completion of Phase 1 human trials in the U.K. in June 2021, Coleman’s single dose intranasal vaccine, COVI-VAC, from Codagenix—the biotech he cofounded and leads as CEO—is entering a global Phase 2 trial in healthy adults, targeting 6,000 volunteers—and potentially even larger efficacy trials by the fall.

“In addition, we have generated data recently in preclinical models showing the vaccine is efficacious against newly emerging variants,” Coleman says. “We’re hoping it can provide a much broader immune response.”

The vaccine candidate uses Codagenix’s Synthetic Attenuated Virus Engineering (SAVE) platform, which works by recoding genes of a target virus, turning it from pathogen into a safe and stable vaccine. The SAVE-designed live attenuated vaccine trains the body to recognize the whole virus—as opposed to just the spike protein as with a number of other vaccines, which Coleman says could be critical as new variants of the virus develop.

The live attenuated vaccine in the form of a nasal drop also has the potential to address key logistical challenges worldwide, especially in places with poor infrastructure and networking capabilities.

“The vaccine is designed to be self-administered, eliminating the need for a qualified medical person to deliver it, and it can be stored for several months in the refrigerator,” he adds.

“This is the most amenable for use in the developing world, where access and distribution has been daunting and even nonexistent in many places.”

For the U.S. market, Coleman is initially focusing on children ages 4 to 18. Clinical testing on this age group has a target date of late fall.

If proven to be safe, Coleman’s COVI-VAC could also serve as a booster in the U.S., where a majority of the adult population is expected to be inoculated this summer with currently authorized vaccines from Pfizer, Moderna, and Johnson & Johnson.

Infectious disease specialists increasingly expect periodic boosters will be needed to extend the duration of protection from the new coronavirus and to build defenses against variants. They are also looking into whether giving a person doses of two different vaccines can improve their effectiveness.

Of the 93 vaccine trials that were under way in May, the number of companies trying to create nasal spray and oral COVID-19 vaccines is still small compared with the dozens working to introduce new injectable versions. According to the World Health Organization, two of the studies were for oral tablets and seven for nasal sprays.

Yet even if only a few are approved by regulators in various countries, Coleman stresses the impact would be huge on the world’s ability to rein in a virus that has wreaked global economic havoc.

“We’re always thinking about the big picture,” he says. “While things might feel like they’re getting better here in the U.S., there are still many places in the world in critical need of vaccines. We think we have a transformative technology, and its potential to provide longer-lasting immune responses and be more potent against newer and multiple variants could help meet current and future global needs.”

August 17, 2021

Redesigning viral genomes

by Rita Savard

Categories: Alumni, Magazine

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