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  • Writer's pictureLehigh Valley Business

Allentown pharma firm hopes to soon have oral vaccine to market

By: Stacy Wescoe July 20, 2022 2:53 pm

Kyle Flanigan of U.S. Specialty Formulations, right, poses with Garry Morefield of VaxForm at the Ben Franklin Tech Ventures in Bethlehem.
Kyle Flanigan of U.S. Specialty Formulations, right, poses with Garry Morefield of VaxForm at the Ben Franklin Tech Ventures in Bethlehem.

With Phase 1 testing now complete and showing positive results, U.S. Specialty Formulations of Allentown is moving forward with the oral COVID-19 vaccine that it is producing.

The company is working with VaxForm of Bethlehem, to bring a vaccine to market that company leaders believe will be easier to tolerate and more effective than the current injection vaccines on the market.

Kyle Flanigan, founder, CEO and president of U.S. Specialty Formulations said his company is now looking to attract venture capitalists to help fund Phase 2 and Phase 3 trials, which he will be conducting while attempting to get Emergency Use Authorization from the U.S. government, as well as other governments around the globe.

“It is in our best interest to make sure other countries have vaccines too, so they don’t bring that disease here,” he said.

He is looking for between $5 million and $15 million in funding depending on what the regulatory bodies want to see in the next level of testing.

He said, so far, much of the federal funding for vaccine research has gone to the “Big Five” pharmaceutical companies, like Moderna and Johnson & Johnson.

That’s leaving smaller developers looking for private funding.

But what they found in Phase 1, he said, is promising enough that he believes investors will be easy to attract.

“We’ve already generated the data that a venture capitalist would want to look at,” he said. Phase 1 testing, which was conducted in New Zealand because of its relatively isolated population and high vaccine rate, showed the vaccine U.S. Specialty Formulations is developing could be a highly desirable addition to the vaccine options currently available.

“It’s been really exciting,” Flanigan said. “The vaccine we adapted for COVID-19 seems to perform better than some of the platforms that are already on the market.”

He said the testing showed his oral vaccine was about 43% more effective for subjects who took it compared to those who took other vaccines on the market.

Also, the oral vaccine has shown that it fights all three major variants of COVID-19, and Flanigan hopes to show that it can fight all variants of the disease.

“That’s the Holy Grail in this,” he said.

The oral vaccine is also showing that it is easier to tolerate than the injectable vaccines currently available on the market.

With no injection, Flanigan said it may attract those that were avoiding the vaccine to avoid the needle stick.

He also said it’s showing less general side effects, like muscle soreness.

One of the biggest benefits, he said, is that the oral vaccine is proving to be extremely shelf stable and can tolerate high heat, which would make it easier to transport, store and deliver to hotter regions around the globe.

And because it can be taken orally, no health care professional is needed to provide the vaccine, which makes distribution to more remote regions much easier.

Flanigan said he hopes to receive Emergency Use Authorization to begin distribution of the vaccine while the second and third phase trials are underway. He said the fact that it has been proven to be safe will help his company’s case.

If things go well, he hopes to have the vaccine to market this fall.


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