Providence Therapeutics and Everest Medicines announces that PTX-COVID19-B, a mRNA Vaccine for COVID-19, has received approval for inclusion in WHO Solidarity Trial Vaccines (STV) Program
Calgary, Alberta and Shanghai, China December 20, 2021 – Providence Therapeutics and Everest Medicines announced today that their COVID-19 vaccine, PTX-COVID19-B, has been recommended by an independent advisory group to be part of the Solidarity Trial Vaccines (“STV”) clinical trial. PTX-COVID19-B is a potentially best-in-class lipid nanoparticle-formulated mRNA vaccine with strong immunogenicity and tolerability profiles. The STV is an international, randomized clinical trial designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines. Vaccines are selected by an independent vaccine prioritization advisory group composed of leading scientists and experts based on pre-defined criteria, including their safety and proven potential for effectiveness, stability of the vaccine, whether they can be produced quickly for global distribution, and the ease with which they can be given to individuals.
“We are very excited to participate in the STV trial program and to address a global health crisis in collaboration with the WHO.” says Brad Sorenson, CEO of Providence Therapeutics.
“The STV trial complements the joint efforts of Everest and Providence in generating a robust safety and immunogenicity data set design,” added Kerry Blanchard, CEO of Everest Medicines. “We hope this can help accelerate approval with regulatory bodies around the world.”
STV trials have started recruitment in selected sites in the Philippines, Mali, and Colombia. A principal investigator, nominated by the Ministry of Health in each country, will lead the national team in respective countries administrating the study. The trial will be sponsored by and paid for by WHO.
*See https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-trial-of-covid-19-vaccines for more information on the STV program.
PTX-COVID19-B is an mRNA vaccine in Phase 2 development for the treatment of COVID-19, which is designed to encode the S protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (LNP). Interim data from Providence’s Phase 1 study showed that PTX-COVID19-B demonstrated strong virus neutralization capability and produced a level of antibodies in participants in the treatment arm that compare favorably to those produced by other mRNA vaccines that have been approved for use against COVID-19. The treatment was generally safe and well tolerated.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
About Providence Therapeutic
Providence is a leading Canadian clinical stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, Alberta and Toronto, Ontario. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a mRNA vaccine for COVID-19. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs. For more information, please visit providencetherapeutics.com