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Preclinical evaluation of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B

Jun Liu, Patrick Budylowski, Reuben Samson, Bryan D. Griffin, Giorgi Babuadze, Bhavisha Rathod, Karen Colwill, Jumai A. Abioye, Jordan A Schwartz, Ryan Law, Lily Yip, Sang Kyun Ahn, Serena Chau, Maedeh Naghibosadat, Yuko Arita, Queenie Hu, Feng Yun Yue, Arinjay Banerjee, Karen Mossman, Samira Mubareka, Robert A. Kozak, Michael S. Pollanen, Natalia Martin Orozco, Anne-Claude Gingras, Eric G. Marcusson, Mario A. Ostrowski
doi: https://doi.org/10.1101/2021.05.11.443286
Jun Liu
1Department of Medicine, University of Toronto; Toronto, ON, Canada
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  • For correspondence: junut.liu@gmail.com mario.ostrowski@gmail.com eric@providencetherapeutics.com
Patrick Budylowski
1Department of Medicine, University of Toronto; Toronto, ON, Canada
2Institute of Medical Science, University of Toronto; Toronto, ON, Canada
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Reuben Samson
3Department of Molecular Genetics, University of Toronto; Toronto, ON, Canada
4Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System; Toronto, ON, Canada
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Bryan D. Griffin
5Sunnybrook Research Institute; Toronto, ON, Canada
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Giorgi Babuadze
5Sunnybrook Research Institute; Toronto, ON, Canada
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Bhavisha Rathod
4Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System; Toronto, ON, Canada
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Karen Colwill
4Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System; Toronto, ON, Canada
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Jumai A. Abioye
6Providence Therapeutics Holdings, Inc.; Calgary, Alberta, Canada
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Jordan A Schwartz
6Providence Therapeutics Holdings, Inc.; Calgary, Alberta, Canada
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Ryan Law
7Department of Immunology, University of Toronto; Toronto, ON, Canada
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Lily Yip
5Sunnybrook Research Institute; Toronto, ON, Canada
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Sang Kyun Ahn
3Department of Molecular Genetics, University of Toronto; Toronto, ON, Canada
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Serena Chau
7Department of Immunology, University of Toronto; Toronto, ON, Canada
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Maedeh Naghibosadat
5Sunnybrook Research Institute; Toronto, ON, Canada
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Yuko Arita
6Providence Therapeutics Holdings, Inc.; Calgary, Alberta, Canada
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Queenie Hu
4Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System; Toronto, ON, Canada
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Feng Yun Yue
1Department of Medicine, University of Toronto; Toronto, ON, Canada
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Arinjay Banerjee
8Vaccine and Infectious Disease Organization, University of Saskatchewan; Saskatoon, SK, Canada
9Department of Veterinary Microbiology, University of Saskatchewan; Saskatoon, SK, Canada
10Department of Biology, University of Waterloo; Waterloo, ON, Canada
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Karen Mossman
11Department of Medicine, McMaster University; Hamilton, ON, Canada
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Samira Mubareka
5Sunnybrook Research Institute; Toronto, ON, Canada
12Department of Laboratory Medicine and Pathology, University of Toronto; Toronto, ON, Canada
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Robert A. Kozak
5Sunnybrook Research Institute; Toronto, ON, Canada
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Michael S. Pollanen
12Department of Laboratory Medicine and Pathology, University of Toronto; Toronto, ON, Canada
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Natalia Martin Orozco
6Providence Therapeutics Holdings, Inc.; Calgary, Alberta, Canada
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Anne-Claude Gingras
3Department of Molecular Genetics, University of Toronto; Toronto, ON, Canada
4Lunenfeld-Tanenbaum Research Institute at Mount Sinai Hospital, Sinai Health System; Toronto, ON, Canada
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Eric G. Marcusson
6Providence Therapeutics Holdings, Inc.; Calgary, Alberta, Canada
13Marcusson Consulting, San Francisco, CA, USA
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  • For correspondence: junut.liu@gmail.com mario.ostrowski@gmail.com eric@providencetherapeutics.com
Mario A. Ostrowski
1Department of Medicine, University of Toronto; Toronto, ON, Canada
7Department of Immunology, University of Toronto; Toronto, ON, Canada
14Keenan Research Centre for Biomedical Science of St. Michael’s Hospital, Unity Health Toronto; Toronto, ON, Canada
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  • For correspondence: junut.liu@gmail.com mario.ostrowski@gmail.com eric@providencetherapeutics.com
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Abstract

Safe and effective vaccines are needed to end the COVID-19 pandemic caused by SARS-CoV-2. Here we report the preclinical development of a lipid nanoparticle (LNP) formulated SARS-CoV-2 mRNA vaccine, PTX-COVID19-B. PTX-COVID19-B was chosen among three candidates after the initial mouse vaccination results showed that it elicited the strongest neutralizing antibody response against SARS-CoV-2. Further tests in mice and hamsters indicated that PTX-COVID19-B induced robust humoral and cellular immune responses and completely protected the vaccinated animals from SARS-CoV-2 infection in the lung. Studies in hamsters also showed that PTX-COVID19-B protected the upper respiratory tract from SARS-CoV-2 infection. Mouse immune sera elicited by PTX-COVID19-B vaccination were able to neutralize SARS-CoV-2 variants of concern (VOCs), including the B.1.1.7, B.1.351 and P.1 lineages. No adverse effects were induced by PTX-COVID19-B in both mice and hamsters. These preclinical results indicate that PTX-COVID19-B is safe and effective. Based on these results, PTX-COVID19-B was authorized by Health Canada to enter clinical trials in December 2020 with a phase 1 clinical trial ongoing (ClinicalTrials.gov number: NCT04765436).

One Sentence Summary PTX-COVID19-B is a SARS-CoV-2 mRNA vaccine that is highly immunogenic, safe, and effective in preventing SARS-CoV-2 infection in mice and hamsters and is currently being evaluated in human clinical trials.

Competing Interest Statement

MAO, RAK, SM and A-CG receive funds from a research contract with Providence Therapeutics Holdings, Inc. EGM is a co-founder of Providence Therapeutics Holdings, Inc. JAA was, and JAS, YA, NMO are employees of Providence Therapeutics Holdings, Inc. JAA, YA, NMO and EGM are inventors on patents and patent applications on SARS-CoV-2 mRNA vaccines. All other authors declare that they have no competing interests.

Footnotes

  • ↵† Co-first author

  • ↵‡ Co-senior corresponding author

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Preclinical evaluation of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B
Jun Liu, Patrick Budylowski, Reuben Samson, Bryan D. Griffin, Giorgi Babuadze, Bhavisha Rathod, Karen Colwill, Jumai A. Abioye, Jordan A Schwartz, Ryan Law, Lily Yip, Sang Kyun Ahn, Serena Chau, Maedeh Naghibosadat, Yuko Arita, Queenie Hu, Feng Yun Yue, Arinjay Banerjee, Karen Mossman, Samira Mubareka, Robert A. Kozak, Michael S. Pollanen, Natalia Martin Orozco, Anne-Claude Gingras, Eric G. Marcusson, Mario A. Ostrowski
bioRxiv 2021.05.11.443286; doi: https://doi.org/10.1101/2021.05.11.443286
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Preclinical evaluation of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B
Jun Liu, Patrick Budylowski, Reuben Samson, Bryan D. Griffin, Giorgi Babuadze, Bhavisha Rathod, Karen Colwill, Jumai A. Abioye, Jordan A Schwartz, Ryan Law, Lily Yip, Sang Kyun Ahn, Serena Chau, Maedeh Naghibosadat, Yuko Arita, Queenie Hu, Feng Yun Yue, Arinjay Banerjee, Karen Mossman, Samira Mubareka, Robert A. Kozak, Michael S. Pollanen, Natalia Martin Orozco, Anne-Claude Gingras, Eric G. Marcusson, Mario A. Ostrowski
bioRxiv 2021.05.11.443286; doi: https://doi.org/10.1101/2021.05.11.443286

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