Startup USSF Launches Oral COVID Vaccine | Jobs Recent

Two scientists at a small biotech start-up in Allentown, Pennsylvania, are leading their team to bring an oral COVID-19 vaccine to market – one that is easier to use, more durable and with fewer side effects.

Kyle Flanigan and Garry Morefield co-founded U.S. Specialty Formulations LLC (USSF) through discussions while watching their daughters compete in gymnastics. It came with just $100,000 and the ambition to turn their site into a thriving biotech and pharmaceutical facility. Today, the 41,000-square-foot manufacturing facility covers more than two acres and has become a hub of experts creating a variety of solutions, applications and approaches to help customers overcome obstacles to drug discovery and development.

USSF is a minority controlled, Current Good Manufacturing Practice (cGMP) certified manufacturer of sterile injectable, topical and specialty pharmaceuticals. It manufactures its own branded prescription products and supplies clinical materials for use in research on new drugs, specialty formulations, adjuvants, and fermentation and purification services commissioned by various biotech companies.

The USSF team employs an agile, high-performance team system to facilitate collaboration and problem solving – ensuring customers get their products to market efficiently and seamlessly. From early development to commercial production, they use their methods, analyses, scale-up technologies and technology transfer to guide the development of small compounds and vaccines.

With a portfolio that includes a range of vaccine candidates, small molecule formulations and pharmaceutical grade botanical extracts, Flanigan and Morefield are launching their mucosal COVID-19 vaccine. They changed their formula from oral DTaP (diphtheria) vaccine, a pediatric vaccine that the majority of the population has received, initially intended for human clinical trials in early 2020.

How did you adapt the DTaP COVID vaccine?

In early preclinical development, we looked at extending the shelf life of existing vaccines using this oral technology. We used an expired DTap vaccine for these experiments. Experiments showed that when our technology was applied to an expired DTap vaccine, it generated an immune response comparable to the “fresh” vaccine compared to the poor immune response from the unmodified and expired DTap vaccine. The current oral platform has benefited from these early experiments and knowledge from the COVID vaccine.

Is the oral vaccine similar to other vaccines in that it doesn’t necessarily prevent infection, just reduces the severity or prevents COVID altogether?

Oral vaccines (mucosal vaccines) produce antibodies both in the serum (blood) and in the mucous membranes (eyes, nose, ears and throat). Various studies provide strong evidence that mucosal antibodies provide significantly better protection against infection than serum antibodies. The antibodies in the mucosa also tend to reduce the amount of virus shed, further limiting the spread of the virus to another person.

Both features reduce the risk of contracting the virus, but cannot be said to completely eliminate the risk. In our recent COVID-19 clinical trial, fewer people became ill than statistically expected compared to other approved serum-based vaccines. Those who contracted COVID reported no or mild symptoms. Several people were surprised by the positive test result.

And does it work against the new sub-option BQ.1.1 which currently causes such concern?

The clinical trial formulations were based on the original strain, however, they had been exposed to delta and omicron (BA.5) in the last 12 months, with BQ.1/BQ1.11 appearing at the end of the study. In our recent clinical trial, fewer people got sick from COVID than statistically expected compared to other approved serum-based vaccines based on the original strain. What is very cool about our vaccine is the ease with which we can add additional vaccine particles to the formulation as new strains or configure the dose for dominant strains in a given country.

How far are the trials of the oral vaccine?

The Phase I human clinical trial just ended in the third week of November. We are currently processing participants’ samples and compiling data for the final report. To date, the vaccine has been well tolerated and no significant adverse effects have been attributed to it. We are designing a phase II clinical trial and are looking for cooperation partners to move the study forward. It’s an exciting time at the USSF as this is our lead vaccine for this amazing oral platform.

What else is in preparation and at what stage are they?

We have several other vaccines using this oral platform. In particular, we are ready to start clinical trials on Group A Streptococcus. In parallel, we are completing pre-clinical work on pandemic influenza, but with the right support, the program could be turned into a conventional flu-like platform.

In the spirit of continuous improvement, we have developed a second-generation version of our vaccine technology and are looking at a COVID vaccine capsule. This technology has a better stability profile than our current oral liquid technology. The capsule technology is in the pre-clinical evaluation phase and if all goes well, we may link to our next clinical phase studies.

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