From a small biotech start-up firm in Allentown, Pennsylvania, two scientists are leading their team to bring an oral COVID-19 vaccine to market – one that will be easier to use, longer lasting and with fewer side effects. \n\n\n\nKyle Flanigan and Garry Morefield co-founded US Specialty Formulations LLC (USSF) through discussions while watching their daughters compete in gymnastics. This came with just $100,000 and the ambition to grow their site into a thriving biotech and pharmaceutical facility. Today, the 41,000-square-foot manufacturing facility spans more than two acres and has become a hub of experts creating diverse solutions, applications and approaches to help clients overcome hurdles in drug discovery and development.\n\n\n\nUS Specialty Formulations is a minority-controlled business and certified Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical and specialty pharmaceuticals. It manufactures its own branded prescription products and provides clinical materials for investigational new drug applications, specialty formulations, adjuvants and fermentation and purification services requested by various biotech companies. \n\n\n\nThe US Specialty Formulations team applies agile high-performance teams system to facilitate collaboration and problem solving – ensuring clients’ products go to market efficiently and seamlessly. From initial stages of development to commercial manufacture, they leverage their methods, analytics, scale-up technologies and technology transfer to guide small compound and vaccine development. \n\n\n\nWith a portfolio that includes a range of vaccine candidates, small molecule formulations and botanical pharmaceutical grade extracts, Flanigan and Morefield are bringing their mucosal COVID-19 vaccine to market. They pivoted their formula from an oral DTaP (diphtheria), a childhood vaccine most of the population received, initially targeted for human clinical trials in early 2020. \n\n\n\nHow has US Specialty Formulations been able to adapt the DTaP vaccine for COVID? \n\n\n\nIn the early pre-clinical development work, we looked at extending the shelf life of existing vaccines using this oral technology. For those experiments, we used an expired DTap vaccine. The experiments showed that after applying our technology to the expired DTap vaccine, it generated immune responses on par with a ‘fresh’ vaccine vs. a poor immune response from the unmodified and expired stock DTap vaccine. The current oral platform benefited from these early experiments and the learnings incorporated into the COVID vaccine.\n\n\n\nIs the oral vaccine similar to other vaccines in that it doesn’t necessarily prevent people from catching it, just reduces the severity, or does it prevent COVID completely? \n\n\n\nOral vaccines (mucosal vaccines) produce antibodies in both the serum (blood), as well as the mucosal systems (eyes, nasal cavity, ears and throat). Various studies lend strong evidence that mucosal antibodies provide much greater protection from infection than serum antibodies. The antibodies in the mucosa also tend to reduce the amount of virus shedding, further limiting the spread of the virus to another person. \n\n\n\nBoth features reduce the chance of a person contracting a virus, but we cannot say it completely eliminates the risk. In our recent clinical trial, fewer people contracted COVID than was statistically expected when compared to other approved serum-based vaccines. Those who did contract COVID reported none or mild symptoms. Several people were surprised they tested positive. \n\n\n\nAnd does it work against the new BQ.1.1 sub-variant that is causing such concern currently? \n\n\n\nThe clinical trial formulations were based upon the original strain, however, during the past 12 months were exposed to the delta and omicron (BA.5) with BQ.1/BQ1.11 appearing at the tail end of the study. In our recent clinical trial, fewer people contracted COVID than was statistically expected when compared against other approved serum-based vaccines based upon the original strain. What is way cool about our vaccine is the ease with which we can add additional vaccine particles into the formulation as new strains or configure a dose for the strains prevalent in a specific country.\n\n\n\nWhere is US Specialty Formulations at with trials of the oral vaccine? \n\n\n\nThe Human Phase I clinical trial just ended the third week in November. We are processing the participant samples now and compiling data for the final report. To date, the vaccine was well tolerated, with no significant AE attributed to the vaccine. We are designing the Phase II clinical trial and are seeking collaborative partners to move the trial forward. It is an exciting time at US Specialty Formulations as this is our lead vaccine for this amazing oral platform.\n\n\n\nWhat else is in the pipeline, and what stage are these at? \n\n\n\nWe have several other vaccines using this oral platform. Specifically, we are ready to begin a clinical trial for Group A strep. In parallel, we are completing the pre-clinical work for the pandemic flu but with appropriate support, the program could be made into a conventional flu-style platform. \n\n\n\nIn the spirit of continuous improvement, we have created 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 liquid oral technology. The capsule technology is in pre-clinical assessment and if all goes well, we could link to our next clinical phase trials.