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Providence announces PTX-COVID19-B, its mRNA vaccine for Covid-19, neutralizes SARS-CoV-2 and variants of concern, including delta

Calgary, Alberta
Tuesday, September 14, 2021, 18:00 Hrs  [IST]

Providence Therapeutics announced additional results from its phase 1 study, PRO-CL-001, of PTX-Covid19-B. Previously, Providence Therapeutics announced that the primary endpoints of safety, tolerability, and immunogenicity were met for the first in human placebo controlled, observer-blinded, randomized, ascending dose study in 60 healthy seronegative adults aged 18-64 for PTX-COVID19-B vaccine.

Today's announcement extends the immunogenicity data to include pseudovirus neutralization assays which are becoming the preferred standard for predicting efficacy of Covid-19 vaccines. Sera from all subjects dosed with PTX-COVID19-B demonstrated neutralizing activity by day 28 after only a single dose while none of the subjects dosed with a placebo generated neutralizing antibodies. The titers increased both with higher dose levels and over time when measured two weeks after the second dose. The neutralization titers by day 42 are over 1000 NT50 (50% inhibition neutralization titer) and more than tenfold higher than the neutralization levels of Covid19 recovered patients as indicated by the validated neutralization assay.

Providence Therapeutics Reports PTX-COVID19-B, its mRNA Vaccine for Covid-19, Neutralizes SARS-CoV-2 and Variants of Concern, Including Delta (CNW Group/Providence Therapeutics)

The current wave of infections in Canada and worldwide is being driven by variants of SARS-CoV-2, particularly the recently emerged Delta variant which has been named a variant of concern (VOC) along with the Alpha, Beta and Gamma variants. Providence worked with the laboratory of Anne-Claude Gingras at Mount Sinai, Toronto to investigate the neutralizing capacity of the sera from subjects in the phase 1 trial against three of the current VOCs; Alpha, Beta and Delta. The Inhibitory Dilution 50% (ID50) values of the sera were highest against the pseudovirus for the original strain, which is what the vaccine was designed against G614.

PTX-COVID19-B mRNA vaccine can induce a robust neutralization against the original, Alpha, Beta and Delta variants. As such, the 40 µg dose level is now being evaluated in a phase 2 clinical trial. The study will recruit 525 subjects and have important endpoints related to safety and immunogenicity.

Providence developed, manufactured, and tested this world-class vaccine in Canada. It licensed supporting lipid nanoparticle intellectual property that was invented in Canada from Genevant. The company looks forward to progressing through late-stage trials and is advancing business development discussions with partners globally, to ensure the access of affordable high-quality vaccines in countries where the need is greatest.

 

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