PTX-COVID19-B / Providence Therap, University of Toronto, Everest Medicines - LARVOL DELTA

Comparable safety and non-inferior immunogenicity of the SARS-CoV-2 mRNA vaccine candidate PTX-COVID19-B and BNT162b2 in a phase 2 randomized, observer-blinded study. (PubMed, Sci Rep) - P2 | "This study also shows induction of cell-mediated immune (CMI) responses by PTX-COVID19-B. In conclusion, the vaccine candidate PTX-COVID19-B demonstrated favourable safety profile along with immunogenicity similar to the active comparator BNT162b2 vaccine."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase I randomized, observer-blinded, placebo-controlled study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B. (PubMed, Sci Rep) - P1 | "The 40-µg dose showed fewer adverse reactions than the 100-µg dose, and therefore was selected for a Phase 2 trial, which is currently ongoing.Clinical Trial Registration number: NCT04765436 (21/02/2021). ( https://clinicaltrials.gov/ct2/show/NCT04765436 )."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine. (clinicaltrials.gov) - P2 | N=565 | Completed | Sponsor: Providence Therapeutics Holdings Inc. | Active, not recruiting ➔ Completed | N=890 ➔ 565

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease

Booster Superiority Study of PTX-COVID19-B Compared to Vaxzevria® in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Everest Medicines (Singapore) Pte. Ltd.

Head-to-Head • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Booster Study of PTX-COVID19-B in Adults Aged 18 Years and Older (clinicaltrials.gov) - P3 | N=3800 | Not yet recruiting | Sponsor: Everest Medicines (Singapore) Pte. Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[PREPRINT] Phase I study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B (medRxiv) - P1 | N=60 | NCT04765436 | Sponsor: Providence Therapeutics Holdings Inc. | “This Phase 1 observer-blinded, randomized, placebo-controlled, ascending dose study evaluated the safety, tolerability, and immunogenicity of two doses of PTX-COVID19-B vaccine in healthy seronegative adults….Participants received two intramuscular doses, 4 weeks apart, of 16-μg, 40-μg, or 100-μg PTX-COVID19-B. Adverse events were generally mild to moderate, self-resolving, and transient….All tested doses of PTX-COVID19-B were safe, well-tolerated, and provided a strong immunogenicity response. The 40-μg dose showed fewer adverse reactions than the 100-μg dose, supporting further investigation of the 40-μg dose.”

P1 data • Preprint • Infectious Disease • Novel Coronavirus Disease

PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64 (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Providence Therapeutics Holdings Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine. (clinicaltrials.gov) - P2 | N=890 | Active, not recruiting | Sponsor: Providence Therapeutics Holdings Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2022 ➔ Mar 2023

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Preclinical evaluation of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B. (PubMed, Sci Adv) - "No adverse effects were induced by PTX-COVID19-B in either mice or hamsters. Based on these results, PTX-COVID19-B was authorized by Health Canada to enter clinical trials in December 2020 with a phase 2 clinical trial ongoing."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine. (clinicaltrials.gov) - P2; N=890; Recruiting; Sponsor: Providence Therapeutics Holdings Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine. (clinicaltrials.gov) - P2; N=890; Active, not recruiting; Sponsor: Providence Therapeutics Holdings Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64 (clinicaltrials.gov) - P1; N=60; Active, not recruiting; Sponsor: Providence Therapeutics Holdings Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Apr 2021 ➔ Feb 2022

Clinical • Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • PCR

Providence Therapeutics Enters into Agreement with Government of Manitoba to Supply 2 Million Doses of its COVID-19 Vaccine (Canada Newswire) - "Providence Therapeutics is pleased to confirm that the Government of Manitoba has agreed to purchase 2 million doses of its proprietary mRNA (messenger RNA) COVID-19 vaccine, PTX-COVID19-B....In late January 2021, Providence Therapeutics' messenger RNA (mRNA) vaccine became the first fully made-in-Canada vaccine to begin Phase 1 human trials. The company plans to move into Phase 2 trials in May 2021, pending regulatory approval."

Commercial • New P2 trial • Infectious Disease • Novel Coronavirus Disease

PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64 (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Providence Therapeutics Holdings Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • PCR

Providence Therapeutics COVID-19 Vaccine Receives Health Canada Authorization to Begin Clinical Trials (Canada Newswire) - "Providence Therapeutics today announced that Health Canada has provided a Notice of Authorization for its Clinical Trial Application....PTX-COVID19-B is a messenger RNA (mRNA) vaccine and is the first fully made-in-Canada COVID vaccine...Health Canada's authorization means Phase I clinical trials will begin early in the New Year. Later phase clinical trials are expected to proceed in 2021, subject to regulatory approval....The Government of Canada, through the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) program is providing financial sponsorship and advice for the Phase 1 trial."

New P1 trial • Infectious Disease • Novel Coronavirus Disease