What’s an oral vaccine?

Oral vaccines are designed to generate immune responses, including mucosal and systemic responses. Administration is far easier, as this type of vaccine just has to be swallowed through the mouth.

How are oral vaccines different, and in some cases more advantageous, than injectables?

Like injectable vaccines, Oral vaccines provide systemic protection which includes antibodies in the blood serum. Oral vaccines also provide an additional level of protection in that they also stimulate production of high levels of mucosal antibodies. Common mucosal locations are nose, throat and intestinal tract. Having a high level of antibodies in the nose and throat are thought to reduce the spread of the vaccine by reducing levels of nasal shedding. Additionally, the virus is being attacked by antibodies prior to entering the blood stream, while injectable vaccines require a person to become infected before the serum-based antibodies can attack the virus.

Oral vaccines are also easier to produce and distribute than injectable vaccines. USSF platform also offers enhanced thermal stability (up to 143oF) and does not require a healthcare professional to deliver the vaccine.

USSF’s oral vaccine is a solution to global vaccine demand, which is higher than the current U.S. suppliers of injectables can meet. Having an oral vaccine on the market will ensure more people can get vaccinated worldwide.

Does USSF’s oral vaccine need to be refrigerated in cold chain storage to work, like injectables or some other oral medications?

No, USSF’s oral vaccine does not require cold chain storage, which is why it is so easy to transport, distribute and store to places, even hard to reach ones, around the globe. Studies have shown it is stable beyond 60˚C or 143˚F

How would someone take USSF’s oral vaccine?

The oral vaccine does not require medical administering to use, so any adult can administer to themselves or someone they care for.

Can taking the USSF mucosal vaccine make me sick?

Historically, oral vaccines have very mild side effects and users do not experience the wide range of unpleasant side-effects observed from the mRNA injectable. They may also offer longer protection. Clinical trial data of the USSF vaccine indicated a much more pleasant user experience post vaccination.

When will USSF’s COVID-19 vaccine be available?

USSF completed most of the Phase One clinical trials, the initial 75-person human clinical trial demonstrated safety in humans as well as preliminary efficacy of this oral vaccine as a standalone.

Before going to market, oral vaccines require three phases of clinical trials, which will demonstrate USSF vaccine’s use as a booster to the other vaccines already approved and on the market. USSF is seeking partnerships to initiate Phase II/III human clinical trials globally.

To learn more about US Specialty Formulations LLC (USSF), please visit its website.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Exceptas required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date ofthis press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966- 0024 or pam@trentandcompany.com.

ALLENTOWN, Pennsylvania – From a small bio-tech 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 less side effects. Dr. Kyle Flanigan and Dr. Garry Morefield co-founded US Specialty Formulations LLC (USSF) through a series of discussions while watching their daughters compete in gymnastics. With just $100,000 and the ambition to grow their site into a successful biotech and pharmaceutical facility. Today, the 41,000 sq. ft. manufacturing facility spans over 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.

USSF is a minority-controlled business that is a certified Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical and specialty pharmaceuticals. It manufactures its own branded prescription products, in addition to providing clinical materials for investigational new drug applications. specialty formulations, adjuvants and fermentation and purification services requested by a variety of biotech companies.

The USSF team applies Agile High-Performance Teams system to facilitate collaboration and problem solving – ensuring each of their and their clients’ products go to market efficiently and seamlessly. From initial stages of development to commercial manufacture, they leverage their proven methods, analytics, scale-up technologies and technology transfer to guide both small compound and vaccine development.

With a credentialed portfolio that includes a range of vaccine candidates and small molecule formulations along with botanical pharmaceutical grade extracts, Dr. Flanigan and Dr. Morefield have the expertise and equipment to bring their safe, accessible mucosal COVID-19 vaccine to market. Their formula was pivoted from an oral DTaP (Diphtheria), a childhood vaccine most of the population has received that was originally targeted for human clinical trials in early 2020.

About the founders

Co-Founder and CEO Dr. Kyle Flanigan, Ph.D

With more than 25 years of experience, Dr. Kyle Flanigan, Co-founder and CEO of US Specialty Formulations LLC (USSF), is an expert in all pharmaceutical and medical performance materials development stages. He consults with several companies, providing robust and stable solutions and services for formulation, scale-up technology, contingency planning, supply-chain issues, quality systems implementation and new facility design. He brings this knowledge and guidance to USSF’s manufacturing and development teams enabling their clients’ and their pharmaceutical and medical developments on the best path to market.

Co-Founder and CEO Dr. Kyle Flanigan, Ph.D

• Startup USSF bringing oral COVID vaccine to market, Labiotech
• The Future of Travel in the Post-COVID World, Medium.com
• White Paper: Vaccine Trend Report: The Latest Challenges and Opportunities, BioPharma Dive

Before becoming one of the few Black Ph.D.’s to co-found and own a biotech firm, Dr. Flanigan’s former positions include serving as the Director of Electronic Materials with Avantor (formerly Mallinckrodt/Baker, Inc.) and Sr. Staff Scientist within Technology and Manufacturing, Fab Materials (Intel Corporation).

When he is not at the USSF facility or spending time with his wife, two daughters and two dogs, Dr. Flanigan loves travel, exploration, aerospace and is a semi-active private pilot. He was a member of the Bison and Husky Ski/Snowboard Teams and enjoys drone photography.

Co-founder and COO Dr. Garry Morefield, Ph.D.

In addition to co-founding USSF, Dr. Garry Morefield founded VaxForm LLC. He brings more than two decades of experience in all stages of development and production in the biologics and pharmaceutical industries. Before joining Dr. Flanigan in creating their own facility for consulting and product development in their local city, he served as deputy director of formulation and stability at Sanofi-Pasteur. Inc.

Dr. Morefield has been closely involved in various industrial collaborations that have led to breakthrough innovations with Sanofi Pasteur; Pfizer; Astellas; Janssen; Serum Institute of India; Lundbeck; Affinivax; and Advanced Bioscience Laboratories (ABL). Throughout his career, he has also worked on the treatment and prevention of numerous diseases, including: Group A Strep; Covid-19; Pertussis; Group B Strep; Meningococcus; Influenza, C. Difficle; Hepatitis B; Rabies; Diphtheria; Tetanus; S. Aureus; HIV; Anthrax, Plague, Botulinum toxin and combination products.

To learn more about US Specialty Formulations LLC (USSF), please visit its website

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966- 0024 or pam@trentandcompany.com.

How one small bio-tech company started from the ground-up to develop a safer, easier oral COVID-19 Vaccine

ALLENTOWN, Pennsylvania – Injectable vaccines were administered as an initial solution to help protect people from COVID-19. But the race to bring an oral vaccine to the market continues. In that hurdle to the finish line, is Dr. Kyle Flanigan, Ph.D. and his small bio-tech company, US Specialty Formulations LLC (USSF). Since the onset of the pandemic, he, along with Co-Founder Dr. Garry Morefield, Ph.D. and their team have worked tirelessly to develop an easy to administer oral vaccine that will offer not only protection against COVID-19, but with less side effects with more accessible storage and transport options than existing injectable vaccines.

Dr. Flanigan is one of the very few Black owners of a biotech company. Since co-founding USSF with just $100,000, he has grown the site into a successful biotech and pharmaceutical facility. With a credentialed portfolio that includes a range of vaccine candidates and small molecule formulations along with botanical pharmaceutical grade extracts, Dr. Flanigan and Dr. Morefield have the expertise and equipment to bring their safe, accessible mucosal vaccine to market. Their formula is pivoted from an oral DTaP (Diphtheria), a childhood vaccine most of the population has received that was originally targeted for human clinical trials in early 2020.

How will USSF’s oral vaccine help the fight against COVID-19?

• Protect against mutations:Every COVID-19 infection provides an opportunity for the virus to mutate. Mutations will have a high chance to breakthrough previous rounds of vaccines so it’s imperative we be ready with new and improved vaccines. USSF’s oral vaccine is uniquely positioned to update thoroughly as new variants are identified.
• Reduce Risk of Transmission: Recent data shows that even immunized people ‘shed’ live virus after exposure into their surroundings. This mucosal type vaccine also acts to significantly reduce the quantity of virus in the mucosal cavities, thus reducing the ‘shedding’ effect and risk of transmission.
• Less side effects and longer-lasting protection: Conventional mRNA (Messenger RNA) injectable vaccines can be developed and made to work quickly, but they can be full of side effects. While there are high levels of protection early on, the levels drop off. Initially it was important to get a vaccine on the market; speed was important. This oral vaccine has shown that the acceptable levels of antibodies persist for a significant time and that after administration of the vaccine no meaningful side effects are observed. Adding a mucosal oral vaccine to the worlds vaccine mRNA arsenal allows populations to protect against COVID-19 for much longer due to ease of use and less discomfort to those taking the vaccine.
• Supplying the demand: USSF’s oral vaccine is a solution to global vaccine demand, which is higher than the current three U.S. suppliers can meet. The components used in producing the oral vaccine come from a separate supply chain extending from conventional pharma markets, which is why it is not constrained by persisting supply chain issues. The manufacturing requirements to produce this vaccine safely are also significantly different, thus allowing USSF to ramp to significant quantiles quickly as various organizations place orders. It doesn’t require cold chain storage (refrigeration) to be transported and distributed, making it far more accessible for remote locations in the USA as well as global populations.
• Convenience: USSF’s oral vaccine doesn’t require medical administering in order for it to be issued. To administer the vaccine, one merely has to open the bottle and drink.

USSF completed the first stage of clinical trials and is proceeding into the second and third stages, which often requires government funding. Succeeding in these trials will prove Dr.Flanigan and his team’s oral vaccine provides equivalent or better protection than that of injectable vaccines through use of two lines of defense, (IgA Mucosal and IgG blood stream delivery), plus, less side effects – another step closer to a safer population in the USA and abroad.

To learn more about USSF, please visit its website.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966- 0024 or pam@trentandcompany.com.

Bio-tech leader honored for its quality pharmaceutical manufacturing, state-of-theart processes, and development of game changing oral COVID vaccine

ALLENTOWN, Pennsylvania – US Specialty Formulations of Allentown, Pennsylvania, co-founded by Dr. Kyle Flanigan and Dr. Garry Morefield, will be recognized by the Ben Franklin Technology Partners of Northeastern Pennsylvania (BFTP_NEPA) during its annual iXchange event, to be held virtually this year at 3:30-5:00 PM on Wednesday, May 18. The event honors early-stage technology companies, established manufacturers, and individuals who have helped advance the technology economy in northeastern Pennsylvania. US Specialty Formulations will receive the R. Chadwick Paul, Jr. Incubator Graduate Award for its success in providing state-of-the-art quality processes to pharmaceutical manufacturing and development, and effectively overcoming challenges in the development of its game-changing oral COVID vaccine.

This new oral vaccine platform and oral COVID-19 vaccine candidate help better reduce the transmission of the COVID virus. In addition, it provides a better safety profile with a more pleasant user experience post vaccination, and is additionally more easily distributed due to its high temperature stability (up to 145˚F) when compared to existing injectable vaccines. Ben Franklin has been an ongoing supporter of this bio-tech company since its establishment in 2013.

“We are grateful to the Ben Franklin Technology Partners for its faith in the vision I articulated from the very beginning, as well as the support it has continuously provided to us through its financial investments in US Specialty Formulations,” said Dr. Flanigan. “Ben Franklin’s support has helped us fulfill our mission in revolutionizing the pharmaceutical manufacturing industry. Ben Franklin also supported our pivoting this technology from other oral vaccine development efforts into the new oral COVID vaccine, developed in conjunction with VaxForm. Bringing this oral vaccine to the market is essential as we continue to see additional variants emerge.

US Specialty Formulations Co-Founder Dr. Morefield added, “Through the development of our oral platform and validation using the oral COVID vaccine, we have achieved a huge leap in vaccine technology. US Specialty Formulations now has a pipeline beyond COVID for creating oral vaccines, to address other respiratory diseases and enteric diseases that continue to afflict populations worldwide.”

Dr. Flanigan and Dr. Morefield co-founded US Specialty Formulations in 2013 with just $100,000, building the company’s first clean room in Ben Franklin TechVentures, BFTP_NEPA’s business technology incubator in Bethlehem, Pennsylvania, from a kit. Since then, they have grown it into one of today’s up-and-coming boutique bio-tech pharmaceutical development and manufacturing companies, known by its customers for high quality and flexibility.

With a credentialed portfolio that includes a range of vaccine candidates and small molecule formulations, along with botanical pharmaceutical grade extracts, Dr. Flanigan and Dr. Morefield have the expertise and equipment to bring their safe, accessible mucosal oral vaccine to market. Their formula was developed after the company pivoted from its efforts in developing an oral DTaP (Diphtheria, Tetanus, and acellular-Pertusis), a childhood vaccine most of the population has received that was originally targeted for human clinical trials in early 2020.

US Specialty Formulations has completed the first-stage human clinical trials of its oral COVID vaccine and plans to roll out its second-stage human trials in the U.S. and abroad. Despite there being several injectable vaccines already approved, there is still a great need for more vaccines in areas of the world with poor distribution infrastructure and/or faltering vaccination programs.

USSF is seeking $60 million in funding for this trial. Succeeding in these trials will further prove that US Specialty Formulations’ oral vaccine provides better protection than that of injectable vaccines through use of two lines of defense, (IgA Mucosal and IgG blood stream delivery), with the benefit of fewer side effects. In leading this oral vaccine to market, this brings us another step closer to a safer population for our nation and the world.

“Ben Franklin competitively selected USSF for our Incubator Graduate Award in recognition of the incredible skill and tenacity Dr. Flanigan and Dr. Morefield exhibited in developing and executing their product concept,” said Laura Eppler, Chief Marketing Officer of the Ben Franklin Technology Partners of Northeastern Pennsylvania. “Their products address real market needs. We have high hopes for USSF’s continued success in improving the human condition while creating highly paid, sustainable jobs.”

The iXchange is a premier business/technology event in northeastern Pennsylvania, during which the Ben Franklin Technology Partners of Northeastern Pennsylvania presents six innovation awards to early-stage technology companies, established manufacturers, and individuals who have helped Ben Franklin to advance the technology economy of northeastern Pennsylvania. Other awards presented at this event will include The Entrepreneurial Achievement Award, The Product Innovation Award, The Innovative Application of Technology Award, The Manufacturing Achievement Award, and The Frederick J. Beste III Partnership Award. The iXchange is presented virtually and free-of-charge to guests; register at https://ixchange.ticketmambo.com/index.cfm?e=home.

About US Specialty Formulations, LLC

The Ben Franklin Technology Partners of Northeastern Pennsylvania (BFTP_NEPA) creates and retains highly paid, sustainable jobs by investing in and linking companies with experts, universities, follow-on funding, and other resources to help them prosper through innovation. It is part of a four-center economic development initiative of the Pennsylvania Department of Community and Economic Development and is funded by the Ben Franklin Technology Development Authority. BFTP_NEPA owns, manages, and is headquartered in Ben Franklin TechVentures® , an awardwinning business incubator/post-incubator facility on Lehigh University’s campus in Bethlehem. BFTP_NEPA also owns and manages the Bloomsburg Regional Technology Center. Applying more than 38 years of experience and two international awards for excellence in business incubation, BFTP_NEPA leads a 14-member business incubator network that is among the largest in the nation.

About the Ben Franklin Technology Partners of Northeastern Pennsylvania

US Specialty Formulations, LLC (USSF) is both a bio-pharmaceutical contract manufacturing (CMO) and bio-pharmaceutical contract development organization (CDMO). USSF was founded in 2013 with friends and family funding as well as start-up loans from the Ben Franklin Technology Partners of Northeastern Pennsylvania. Initially the company consisted of only its two co-founders Drs. Flanigan and Morefield. The original facilities were built by the two of them from cleanroom kits and installed in the rented space within Ben Franklin TechVentures, a technology business incubator. The companies first contract fill was completed in November of 2014 and its first commercial product released for sale in January of 2015. In 2019, the firm relocated into its new 41,800 ft2 (3,888m2) facility. The company now employs 16 full-time staff with several consultants to support a variety of projects. USSF services customers in the USA as well as in EU, Canada, and UK. USSF supplies a variety of different finished injectable drugs to the market, including botanical distillates, small-molecule, and perfusion chemistries, as well as vaccines. USSF is providing formulation guidance and clinical materials into more than 11 clinical trials being conducted in the USA. Procedures, protocols, and infrastructure have been built up over the years, as these are critical to ensuring a new therapy successfully emerges from regulatory review processes. To learn more about USSF, please visit its website.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966- 0024 or pam@trentandcompany.com.

No needles or nasal administration – just a simple oral vaccine to protect against many common viruses

ALLENTOWN, Pennsylvania – Finding the most comfortable, convenient vaccine to protect against cold and flu season can be a feat with a limited pool of options. But there is a kinder vaccine platform in development at US Specialty Formulations™ (USSF): QYNDR. The cutting-edge oral vaccine was created in response to the U.S. government’s call for more COVID-19 vaccines and may be a successful yet versatile option against many viruses and illnesses, from common colds, flus and COVID to West Nile, MERS, Group A Strep and Nipah.

“QYNDR is a vaccine that we developed out of urgency but has, because of extensive clinical trials, become a feasible solution to better protection against not only SARS-CoV-2 but a range of viruses. In early 2020, our biotech firm was approaching the clinical trial stage of an oral DTaP vaccine and was able to pivot the development to create QYNDR. Through induction of mucosal IgA and serum IgG, this vaccine will make administration, adherence and protection better and more accessible for all,” said Co-Founder and CEO Dr. Kyle Flanigan, Ph.D.

The protein-based oral (mucosal) vaccine was formulated by Dr. Flanigan and Co-Founder and COO Dr. Garry Morefield, Ph.D. and their accomplished team of scientists. With decades of experience in pharmaceutical development and medical performance materials, they established a complex solution for a simple-to-take vaccine supported by extensive research that oral vaccines boast numerous advantages over injectables. These include:

• Fewer side effects and long-lasting protection: After taking QYNDR, acceptable levels of antibodies persist for a significant amount of time without negative side effects. By adding an oral vaccine to complement the world’s vaccine mRNA arsenal, larger populations can be protected against viruses due to its ease of use.
• Adaptable: Oral vaccines have shown cross-strain protection and are positioned to be updated as viruses mutate.
• Convenient: : QYNDR vaccines do not require medical administration, just open the bottle and drink.
• Reduced risk of transmission (shedding): Recent data shows that immunized people continue to ‘shed’ live viruses after exposure. This vaccine reduces the amount of virus in the mucosa, reducing the risk of virus shedding and stopping the spread.
• Supplying the demand: QYNDR can help meet the underserved demand for global vaccines, which is higher than what the large suppliers provide. It does not require refrigeration to transport, distribute or store, making it more accessible.

USSF has completed the first stage of clinical trials and has proceeded into the second and third stages. It will continue to undergo the final stages of clinical trials and funding initiatives before announcing QYNDR’s official launch date. With funding for additional testing, QYNDR has the potential to become an over-the-counter vaccine.

About USSF

A minority-controlled business and a 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 biotech companies.

To keep up to date on the latest about the QYNDR vaccine, please visit USSF.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966-0024 or pam@trentandcompany.com.

No needles or nasal administration – just a simple oral vaccine to protect against many common viruses

ALLENTOWN, Pennsylvania – Finding the most comfortable, convenient vaccine to protect against cold and flu season can be a feat with a limited pool of options. But there is a kinder vaccine platform in development at US Specialty Formulations™ (USSF): QYNDR. The cutting-edge oral vaccine was created in response to the U.S. government’s call for more COVID-19 vaccines and may be a successful yet versatile option against many viruses and illnesses, from common colds, flus and COVID to West Nile, MERS, Group A Strep and Nipah.

USSF will attend the JPMorgan Biotech Week from January 9th to 13th in San Francisco. Co-Founders Dr. Kyle Flanigan, Ph.D. and Dr. Garry Morefield, Ph.D. will be taking the opportunity to discuss their new vaccine, QYNDER, a ‘kinder’ vaccine with their peers, leading biotech executives, investors, and other industry stakeholders.

“QYNDR is a vaccine that we developed out of urgency but has demonstrated in its Phase I human clinical trial, feasibility as a solution to better protect against not only SARS-CoV-2 but a range of viruses. In early 2020, our biotech firm was approaching the clinical trial stage of an oral DTaP vaccine and was able to pivot the development to create QYNDR. Through induction of mucosal IgA and serum IgG, this vaccine will make administration, adherence and protection better and more accessible for all,” said Co-Founder and CEO Dr. Kyle Flanigan, Ph.D.

The protein-based oral (mucosal) vaccine was formulated by Dr. Flanigan and Co-Founder and COO Dr. Garry Morefield, Ph.D. and their accomplished team of scientists. With decades of experience in pharmaceutical development and medical performance materials, they established a complex solution for a simple-to-take vaccine supported by extensive research that oral vaccines boast numerous advantages over injectables. These include:

• Fewer side effects and long-lasting protection: After taking QYNDR, acceptable levels of antibodies persist for a significant amount of time without negative side effects. By adding an oral vaccine to complement the world’s vaccine mRNA arsenal, larger populations can be protected against viruses due to its ease of use.
• Adaptable: Oral mucosal vaccines have shown cross-strain protection and are positioned to be updated as viruses mutate.
• Convenient: QYNDR vaccines do not require medical administration, just open the bottle and drink. They are shelf stable, which means no refrigeration or other special handling
• Reduced risk of transmission (shedding): Recent data shows that immunized people continue to ‘shed’ live viruses after exposure. These mucosal vaccines are believed to reduce the amount of virus in the mucosa, reducing the risk of virus shedding and stopping the spread.
• Supplying the demand: QYNDR can help meet the underserved demand for global vaccines, which is higher than what the large suppliers provide. It does not require refrigeration to transport, distribute or store, making it more accessible.

“We are thrilled to be attending the JPM Biotech Week and to have the opportunity to meet with key players in the industry,” said Dr. Flanigan, Co-Founder and CEO of USSF. “We believe that this week will provide a valuable opportunity for us to discuss our innovative technology and to find additional resources to help us continue driving our QYNDR vaccine mission forward.” With more investments, QYNDR has the potential to become an over-the-counter vaccine. USSF has already completed the first stage of clinical trials.

USSF has completed the first stage of clinical trials and has proceeded into the second and third stages. It will continue to undergo the final stages of clinical trials and funding initiatives before announcing QYNDR’s official launch date. With funding for additional testing, QYNDR has the potential to become an over-the-counter vaccine.

About USSF

A minority-controlled business and 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 biotech companies.

To keep up to date on the latest about the QYNDR vaccine, please visit USSF.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966-0024 or pam@trentandcompany.com.

QYNDR Vaccine Can Survive the Acidity of the Stomach and Reduces Viral Shedding

Allentown, PA – Human clinical and pre-clinical data has shown that QYNDR, the oral-mucosal COVID vaccine particle, can survive stomach acidity and train the lymphatic system to recognize and respond to vaccine targets, in this case, COVID strains. As a mucosal vaccine, it also reduces the amount of vial ‘shedding,’ which is how an infected person spreads the live COVID-19 and many other respiratory viruses through nasal or oral secretions. This is possible because mucosal vaccines are delivered to the body via the oral route rather than injected into the bloodstream providing more “bang for the buck” in terms of protection.

Having an oral vaccine that can survive the acidity of the stomach and reduce viral shedding is a significant development for two reasons:

1) Once the oral vaccine passes the stomach and into the intestines, it can deliver the antigen to the lymphatic system, which starts the body’s process of anti-body generations, thus assisting in ‘preventing’ the virus from taking hold in the host. If the virus is able to overwhelm the immune system, then the effects/host should not suffer life-threatening trauma.

2) A person who receives an injectable vaccine can continue to ‘shed’ the live virus as their body fights the internal infection. However, having an effective oral mucosal vaccine is believed to reduce the amount of shedding, leading to a reduction in outbreaks and the development of variants. This is a key point to global infectious disease and health departments attempting to halt the spread of disease.

“There are several additional advantages to an oral mucosal-based vaccine over conventional injectable vaccines, such as fewer side effects, they can be self-administered and they do not need to be refrigerated. In fact, the QYNDR vaccine can withstand temperatures up to 143°F/60°C. This makes the vaccine easier to transport to remote locations since it does not require special handling, a perfect vaccine platform for any serious vaccination campaign.

Additionally, the QYNDR vaccine is 10ml of a drinkable liquid, much like water, without a taste or smell.Dr. Kyle Flanigan, US Specialty Formulations (USSF) CEO and Co-founder, describes it as a “swish and swallow” method. Future variations could contain a cocktail of several different vaccine particles. For example, it could include two (2) flu strains and six (6) COVID variants.

“swish and swallow” method. Future variations could contain a cocktail of several different vaccine particles. For example, it could include two (2) flu strains and six (6) COVID variants. The proprietary technology available to USSF allows the company to tailor the platform – or vaccine targets – to a variety of different targets as USSF is looking for additional collaborations for just this purpose.

USSF completed the first stage of clinical trials and is proceeding into the second and third stages. Due to the magnitude of participants and global reach of these trials, USSF is seeking government and corporate funding. Succeeding in these trials will demonstrate the flexibility and power the oral QYNDR delivery technology provides, while the evidence concludes the vaccine may provide better overall protection than that of injectable vaccines – thus providing another tool in safeguarding domestic populations and internationally.

About USSF

A minority-controlled business and 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 biotech companies.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966-0024 or pam@trentandcompany.com.

The drinkable vaccine platform changes the vaccination landscape

Allentown, Pa – At the most important vaccine event of the year, biotech firm US Specialty Formulations™ (USSF™) will highlight QYNDR™, a cutting-edge oral vaccine created in response to the U.S. government’s call for alternative COVID-19 vaccines. This oral platform may be a successful yet versatile option against many viruses and illnesses, from common colds, flus and COVID to West Nile, MERS, Group A Strep and Nipah.

USSF will attend the World Vaccine Congress, the premiere event for R&D and strategic partnering for the global vaccine industry, April 4 – 6, 2023, at the Walter E. Washington Convention Center in Washington, D.C. USSF Co-Founders Kyle Flanigan, Ph.D. and Garry Morefield, Ph.D. will discuss their new mucosal vaccine, QYNDER, a ‘kinder’ vaccine with their peers, leading biotech executives, investors and other industry stakeholders.

“We are thrilled to be attending the World Vaccine Congress and to have the opportunity to meet with key players in the industry,” said CEO Dr. Flanigan. “This week will provide a valuable opportunity for us to discuss our innovative technology and to find additional resources to help us continue driving our QYNDR vaccine mission forward.

“QYNDR is a vaccine we developed out of urgency but has demonstrated in its Phase I human clinical trial, feasibility as a solution to better protect against not only SARS-CoV-2 but a range of viruses. In early 2020, our biotech firm was approaching the clinical trial stage of an oral DTaP vaccine and was able to pivot the development to create QYNDR. Through induction of mucosal IgA and serum IgG, this vaccine will make administration, adherence and protection better and more accessible for all,” said Dr. Flanigan.

The protein-based mucosal vaccine was formulated by Dr. Flanigan and COO Dr. Morefield and their accomplished team of scientists. The teams created a simple-to-take vaccine supported by extensive research. It is known that oral vaccines boast numerous advantages over injectables, and this vaccine has all of these including:

• Fewer side effects and long-lasting protection: After ingesting QYNDR, acceptable levels of antibodies persist for a significant amount of time without negative side effects. By adding an oral vaccine to complement the world’s vaccine mRNA arsenal, larger populations can be protected against viruses due to its ease of use.
• Adaptable: Oral mucosal vaccines have shown cross-strain protection and are positioned to be updated as viruses mutate.
• Convenient: QYNDR vaccines do not require medical administration, just open the bottle and drink. They are shelf stable, which means no refrigeration or other special handling
• Reduced risk of transmission (shedding): Recent data shows that immunized people continue to ‘shed’ live viruses after exposure. These mucosal vaccines are believed to reduce the amount of virus in the mucosa, reducing the risk of virus shedding and stopping the spread.
• Supplying the demand: QYNDR can help meet the underserved demand for global vaccines, which is higher than what the large suppliers provide. It does not require refrigeration to transport, distribute or store, making it more accessible.

USSF has completed the first stage of clinical trials and is proceeding into the second and third stages. With funding for additional testing, QYNDR has the potential to become an over-the-counter vaccine. USSF is continues to accept investors to accompany them on their journey to bring this revolutionary technology to the market and change the vaccine landscape forever.

About USSF

A minority-controlled business and 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 biotech companies.

To keep up to date on the latest about the QYNDR vaccine, please visit USSF.

This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.

EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966-0024 or pam@trentandcompany.com.

300,000 Doses Per Month Could Be Available By Mid-2021

Bethlehem, Pennsylvania, December 14, 2020 — The first of two oral Covid-19 vaccines is slated for mid-2021 distribution by US Specialty Formulations, a cGMP pharmaceutical manufacturing company. 300,000 doses will be available monthly for worldwide distribution by mid-2021 pending federal approval.

US Specialty Formulations (USSF) is securing funding to scale-up manufacturing and regulatory infrastructure with a $5.2 million incentive package from the state of Pennsylvania. The first generation of the oral virus is a drinkable liquid that can be stored at ambient temperatures and doesn’t require medical staff to administer. A second form of the vaccine in capsule form is also being developed for future release.

The company received a $291,000 Pennsylvania First grant from the state Department of Community and Economic Development. In addition, USSF has been encouraged by Pennsylvania Governor Tom Wolf to apply for a $2.4 million Pennsylvania Industrial Development Authority loan to help with the expansion.

“There is a global shortage of pharmaceutical manufacturing capacity, made worse by the Covid-19 pandemic, and limited capacity for clinical investigators to obtain appropriately documented clinical grade materials. USSF has been able to address both of these challenges,” said Governor Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe,” he added.

Clinical trials of the first version of the oral vaccine are scheduled to begin in February of 2021. USSF is ramping up production with a distribution goal of 300,000 doses per month. An FDA Emergency Use Approval for the release of a Covid-19 oral vaccine may be granted by by mid-2021.

“We are eager to develop an oral vaccine program that doesn’t require cold chain distribution or medical personnel for remote locations with limited resources. There will be many vaccines needed in the coming years to properly vaccinate the entire world against Covid-19. This funding will allow USSF to meet the growing demand for oral vaccines as well as support development of our other pharmaceutical products,” said Dr. Kyle Flanigan, CEO of USSF.

USSF partnered with VaxForm, a vaccine development company, to develop the oral vaccines. In 2017, Vaxform began working on an oral vaccination program for worldwide pandemics. When Covid-19 struck in 2020, the focus shifted to Covid-19. The partnership has developed two forms of an oral COVID-19 vaccine that have shown positive results in pre-clinical trials.

About US Specialty Formulations, LLC

US Specialty Formulations LLC (USSF) is a Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical, and specialty pharmaceuticals. The company is headquartered in at Ben Franklin TechVentures in Bethlehem, Pennsylvania with a 14,000 sq. ft. full cGMP manufacturing facility also in Bethlehem.

USSF manufactures its own branded prescription products in addition to providing clinical materials for investigational new drug applications (INDs) and specialty formulations requested by health networks and healthcare providers worldwide. US Specialty Formulations is a Black-Owned Business.

About VaxForm LLC

VaxForm LLC is an advanced research company focused on vaccine development. As part of its R&D efforts, VaxForm has developed formulation platforms for oral administration (liquid suspensions and capsules) as well as the traditional injectable immunization. Additionally, VaxForm provides contract development and consulting services to many of the world’s leading vaccine manufacturers.

Bethlehem, Pennsylvania, September 1, 2020 — Two promising new COVID-19 vaccines show positive results in pre-clinical trials, according to a new alliance formed by VaxForm LLC, a vaccine development company and US Specialty Formulations LLC, a cGMP pharmaceutical manufacturing company.

The alliance was formed in the Ben Franklin TechVentures business/technology incubator where both companies are headquartered. These new vaccines utilize novel delivery platforms for COVID-19 with one oral delivery and the other a conventional injectable. Both vaccine formulations produced antibodies in 100% of mice in pre-clinical trials.

The results of the pre-clinical trials are as follows:

• CoV2-OGEN1 incorporates a novel oral-delivery platform, allowing individuals to obtain immune response orally without injection.
• Creating immunity orally, in the mucous membranes, has the advantage of combating SARS-CoV-2 at the initial site of infection.
• 100% of mice receiving CoV2-OGEN1 produced mucosal and serum antibody titers against the SARS-CoV-2 protein.

• CoV2-PGEN1 incorporates a novel system to induce immune response following a vaccine injection.
• A mixed immune response reduces the risk of antibody-mediated disease enhancement, increasing the likelihood vaccine effectiveness would eventually be compromised.
• 100% of mice receiving CoV2-OGEN1 produced mucosal and serum antibody titers against the SARS-CoV-2 protein.

“This vaccine candidate has the potential to provide solutions to the many challenges brought on by the emergence of the SARS-CoV-2 virus and the resulting global pandemic,” says Elodie Burlet, PhD, Deputy Director of Process Development at VaxForm. “The oral delivery platform is not only the ideal route of administration to combat a COVID-19. It also offers the unique advantage of self-administration and provides the ability to stockpile the vaccine, facilitating manufacturing, storage, and distribution. The established relationship and proximity between VaxForm and USSF will be key in ensuring successful technology transfer and production scale up.”

Investigational New Drug enabling studies (ING) are ongoing for both vaccine platforms.

The Vaccine Development Process

VaxForm initiated the development of its COVID-19 vaccine candidate in April of 2020. The company’s strategy is to apply its oral delivery platform technology to the widely used and safe protein-based vaccine approach. The receptor-binding domain (RBD) of the SARS-CoV-2 spike protein has been shown by research laboratories around the world to be an optimal target for a COVID-19 vaccine.

A few months later in July of 2020, VaxForm successfully identified a purification and formulation process and initiated pre-clinical studies. At the same time, USSF began scaling-up its recently acquired 41K manufacturing facility to accommodate high-volume production in early 2021.

Months of R&D led to the optimization of the recombinant RBD protein production in-house and the selection of a lead formulation. The companies tested the two vaccine platforms in mice in July 2020. Both oral and injected COVID-19 vaccine formulations have shown positive results. The vaccines trigger antibody generation in both the mucosa (oral) and serum (blood), respectively, at levels which historically provide immunological protection. Further, mixed antibody titers were generated, which is what vaccine experts hope to see from safe and effective vaccines targeting COVID-19.

“The data from this study provides clear justification for USSF to increase its investments in manufacturing infrastructure to support global partners in immunizing their populations against COVID-19,” said Kyle Flanigan, Ph.D., Chief Executive Officer of US Specialty Formulations. “I am also confident that the platform will succeed and be adopted to combat additional viruses in the coming years.”

“US Specialty Formulations has the experience and expertise to rapidly scale CoV2-OGEN1 and CoV2-PGEN1 into Current Good Manufacturing Practice (cGMP) production, allowing clinical evaluation and global distribution of this critical vaccine,” said Garry Morefield, Ph.D., President of VaxForm.

Both VaxForm and USSF are clients of the Ben Franklin Technology Partners of Northeastern Pennsylvania and resident companies in the Ben Franklin TechVentures business/technology incubator, Bethlehem.

About VaxForm LLC

VaxForm LLC is an advanced research company focused on vaccine development. As part of its R&D efforts, VaxForm has developed formulation platforms for oral administration (liquid suspensions and capsules) as well as the traditional injectable immunization. Additionally, VaxForm provides contract development and consulting services to many of the world’s leading vaccine manufactures.

About US Specialty Formulations, LLC

US Specialty Formulations LLC (USSF) is a Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical, and specialty pharmaceuticals. USSF manufactures its own branded prescription products, provides clinical materials for investigational new drug applications (INDs), and specialty formulations requested by health networks and healthcare providers worldwide. US Specialty Formulations is a Black-Owned Business.