By JON HARRIS
THE MORNING CALL | DEC 03, 2020 AT 3:54 PM
Pharmaceutical executives Kyle Flanigan and Garry Morefield first met in 2011 on the sidelines of their daughters’ gymnastics program.
“As parents sitting on the sideline watching kids do death-defying feats, we started talking to avert our eyes from what could have been catastrophe,” Flanigan said. “That’s where the partnership began initially.”
Today, the Lehigh Valley duo have their eyes firmly fixed on developing and producing an oral COVID-19 vaccine that people would drink, a formulation that wouldn’t require the same cold storage requirements as the injectable vaccines that appear to be speeding toward market release.
Toward those efforts, the company they co-founded in 2013, US Specialty Formulations LLC, joined with state officials Thursday to announce plans to invest more than $5 million and create nearly 100 high-paying jobs at a 41,000-square-foot facility at 101 E. Lexington St. in Allentown.
USSF and VaxForm LLC, a vaccine consulting firm headed by Morefield, have been partnering on the vaccine since earlier this year, a formulation that produced antibodies in 100% of mice in preclinical trials. Flanigan, USSF CEO, said the human trial is to begin in February.
He anticipates that trial will be complete by May, after which USSF will apply to the U.S. Food and Drug Administration for emergency use authorization. The goal is to get the vaccine into the market by mid-2021.
“During that time, however, USSF starting in January will begin scaling up our production,” Flanigan said. “So we’ll have a stockpile of vaccine to release as soon as we’re given the OK from the FDA to begin distribution.”
The initial target, he said, is to produce 300,000 doses per month by March. USSF, which has 14 employees, hopes to begin staffing up the building as soon as possible.
Since the pandemic began, hundreds of drugs and vaccines have been under development. The United Kingdom gave emergency authorization to Pfizer’s coronavirus vaccine this week, and the U.S. FDA is expected to make a determination on the pharmaceutical giant’s vaccine later this month. Biotech firm Moderna also has applied for FDA emergency use authorization for its vaccine.
“Our belief is there will be many vaccines needing to be administered globally over the course of several years before the bulk of the population is vaccinated properly,” Flanigan said. “So this is a clear need.”
USSF and VaxForm are clients of Ben Franklin Technology Partners of Northeastern Pennsylvania. Both companies got started at Ben Franklin TechVentures, a business technology incubator in Bethlehem.
Aiding USSF’s expansion is a funding proposal from the state Department of Community and Economic Development that includes a $291,000 Pennsylvania First grant. USSF also received more than $225,000 in funding from DCED through the COVID-19 Vaccines, Treatments and Therapies program.
That program also has issued $300,000 to VaxForm for the vaccine, state records show.
VaxForm President Morefield said his firm, which has five employees at TechVentures, has been working on its oral vaccine technology since 2017. The oral delivery platform technology, he said, is not reliant on cold-chain storage for distribution and not dependent on medical professionals for administration, making it easier for a vaccine to reach rural or remote places.
The challenge with oral vaccines, Morefield said, is getting them to remain intact after being swallowed, since the body is naturally good at digestion. But, he said, he feels the partnership has overcome those challenges, though they also evaluated the vaccine as an injection.
“We think sticking with the oral, we’re able to have a much larger advantage down the road than some of the traditional vaccines,” Morefield said.
While the partnership’s focus is getting a liquid vaccine to market, Morefield said the plan is to follow those efforts with a capsule, or pill, version.
At USSF’s Allentown facility, which it acquired in March 2019 for $1 million, records show, renovations are ongoing.
Flanigan said the company has completed the move of its analytical lab from Ben Franklin TechVentures to the new building and has finished installing its initial cleanrooms. Those temporary cleanrooms will be converted to hard-wall, permanent ones, he added.
At the facility, Flanigan said USSF also will be able to support other vaccine formulation companies fighting the pandemic. In addition to making its own branded prescription products, USSF provides clinical materials for investigational new drug applications as well as specialty formulations requested by health networks and health care providers worldwide.
From the state’s perspective, Gov. Tom Wolf said in a news release Pennsylvania is eager to support the growth of companies that are “stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe.”
In August, state officials joined with another Lehigh Valley company, OraSure Technologies Inc., to announce the Bethlehem firm would expand and create 177 full-time jobs to produce a rapid antigen self-test that would detect a COVID-19 infection within minutes.
OraSure said last month it expects to apply to the FDA for emergency use authorization for the self-test in the first quarter.
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Morning Call reporter Jon Harris can be reached at 484-280-2866 or at jon.harris@mcall.com.
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