Kyle Flannigan and the Kinder COVID Vaccine

US Specialty Formulations is working to create an oral, thermo-stable COVID vaccine

By Alex Keown
February 14, 2023

Kyle Flanigan, Ph.D., always enjoyed tinkering and exploring new technologies. His first love was the U.S. space program and technologies that could benefit exploration. Later in life, he became an explorer of new paths, the development of shelf-stable, oral vaccines for multiple viral threats.

A graduate of Howard University with a degree in chemistry, Flanigan dreamed of working in the space program. He spent time in the astronaut candidate program before pivoting to develop computer chips for Intel Corp. From there, his career took him to Honeywell and then to Malinckrodt. There, he got a glimpse of the pharmaceutical world and his career trajectory changed.

It changed even further during a conversation with longtime friend and business partner Garry Morefield. The two men discussed the need for faster and easier vaccine delivery. Morefield, founder of Bethlehem, Penn.-based VaxForm LLC, had been working on a strep throat vaccine. The two men believed the development timeline could be accelerated if they did it on their own. That conversation sparked the formation of Allentown-based US Specialty Formulations (USSF), an African-American owned pharmaceutical manufacturing company.

Flanigan and Morefield launched USSF in 2013. The mission was to produce clinical materials that could support drug development for clients, as well as for the strep program.

When COVID-19 spread across the globe, Flanigan and his colleagues, like many companies, quickly pivoted the strep vaccine program to tackle the new viral threat. The situation was dire and there was a need for new therapeutics and vaccines to be developed. Flanigan, who now serves as chief executive officer of USSF, said the vaccine technology developed by USSF was ideal for respiratory infections. What’s more, USSF’s approach was aimed at manufacturing an oral vaccine.

“There are people out there afraid of needles, myself included. They don’t want to get stuck but they wouldn’t object taking something orally,” Flanigan said.

That alleviation of a fear of needles sparked the company’s name for the vaccine candidate, QYNDR, pronounced “kinder.”

USSF, alongside VaxForm, developed a liquid vaccine, something Flanigan said is easy to swallow. The experimental vaccine recently completed Phase I testing in New Zealand. Flanigan said the company team is currently evaluating the trial data. USSF intends to present the full findings in the second quarter of the year. However, Flanigan said the preliminary findings are promising.

The Phase I was designed for safety and not efficacy. However, Flanigan said there is evidence to show some efficacy against different strains of the SARS-Cov-2 virus.

“The preliminary data shows the vaccine could be as effective as existing approved vaccines. It also suggests it could make a good potential option for a booster (shot),” Flanigan said.

While there are effective vaccines against the SARS-CoV-2 virus on the market, such as those developed by Moderna, Pfizer/BioNTech, and Novavax, they are injectables that require special cold storage. Flanigan believes USSF’s oral vaccine technology could be a “game-changer” if it comes to market.

The experimental vaccine would not only be easier to administer – no needle means people can self-administer, Flanigan noted. Beyond that though, Flanigan said the vaccine has great thermal resistance. He said someone could load the medication into a car or plane and transport it to warmer climates or to places that do not have ready access to the cold-storage units necessary for the mRNA vaccines.

Flanigan noted that so far, much of USSF’s work has been self-financed. Larger trials will require significant investment. In order to move the vaccine program forward, Flanigan said USSF will look for investors or partnerships with larger companies that will enable them to move the vaccine into Phase II and Phase III studies.

Beyond the possibility of developing their own oral vaccine, Flanigan said USSF’s proprietary technology has the ability to stabilize other vaccines, particularly RNA-based options. If applied to the current mRNA vaccines, Flanigan said USSF’s technology could improve the cold-storage issues. He suggested the required need for specialty freezers could be eliminated and the vaccines could be stored long-term in normal refrigerator units. Or, going one step farther, Flanigan said the technology could even eliminate the need for refrigeration.

“As the industry comes along, oral vaccination is the way of the future,” he said, adding the company’s technology has the potential to turn an existing vaccine into an oral formulation.