US SPECIALTY FORMULATIONS COMPLETES PHASE I OF CLINICAL TRIALS FOR THE QYNDR VACCINE
The promising results in phase I of clinical trials bring USSF one step closer to an adaptable, convenient oral vaccine for COVID-19, Group A Strep and flu
ALLENTOWN, PA, US, September 7, 2023/EINPresswire.com/ -- QYNDR (pronounced kinder), is a next-generation vaccine that addresses the challenges of the current COVID-19 vaccines. After completing phase I of clinical trials, US Specialty Formulations, LLC. (USSF) is another step closer to launching a new, multi-faceted oral vaccine that can be stored easily, administered needle-free with the ability to fight against a range of diseases and viruses.“The phase I clinical data3 showed strong evidence that this oral platform and vaccine is a revolutionary industry disruptor and will become the preferred method of vaccination in the future,” said USSF CEO and Co-founder Kyle Flanigan, Ph.D. “As we proceed into phase II and III, we are confident this next generation vaccine will be more effective than other mucosal vaccines in current development and testing.”
The human clinical phase I safety trial took place in New Zealand, which provided the opportunity to look at the efficacy of QYNDR compared to already approved vaccines in New Zealand. After administering and closely monitoring the results of the oral QYNDR vaccine1, the clinical results were excellent in terms of longevity and cross variant protection from multiple COVID-19 strains. The study may have identified a correlation of protection against the virus and other strains to be investigated further in an upcoming phase II clinical trial currently under development.
The protein-based oral vaccine (is a mucosal vaccine) is formulated by Co-founders Garry Morefield, Ph.D and his partner Kyle Flanigan, Ph.D . and their accomplished team of scientists at VaxForm and USSF. With decades of experience in the multiple stages of pharmaceutical development and medical performance materials, Dr. Morefield and Dr. Flanigan discovered an elegant solution for a simple-to-take vaccine supported by extensive research that oral vaccines boast numerous advantages over injectables. These include:
• Adaptable: Oral vaccines are uniquely positioned to be updated as viruses mutate.
• Reduced risk of transmission (shedding): Data shows that even immunized people ‘shed’ live viruses after exposure to their surroundings. In addition, this mucosal-type vaccine notably reduces the amount of virus in the mucosal cavities, thus reducing the risk of virus shedding.
• Supplying the demand: QYNDR can help meet the underserved demand for global vaccines, which is higher than the large suppliers in the U.S. can provide. It does not require a cold chain (refrigeration) to transport, distribute or store, thus making it more accessible.
• Fewer side effects and longer-lasting protection: After taking QYNDR, acceptable levels of antibodies persist for a significant amount of time without any observed negative side effects. By adding a mucosal oral vaccine to the world's vaccine mRNA arsenal, populations can be protected against viruses for a longer period of time due to its ease of use.
• Convenient: QYNDR is easy to administer, once prescribed – simply open the bottle and drink.
The required efficacy human trial of USSF’s next-generation COVID-19 vaccine is a step forward for the biotech firms to continue accelerating innovative medical solutions.
To learn more about USSF, VaxForm and the QYNDR vaccine, please visit its website2.
About USSF
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.
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.
Pamela Wadler
Trent and Company
email us here
1 https://qyndr.com/
2 https://qyndr.com/
3 https://classic.clinicaltrials.gov/ct2/show/NCT04893512