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      The promise of mRNA vaccines: a biotech and industrial perspective

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          Abstract

          mRNA technologies have the potential to transform areas of medicine, including the prophylaxis of infectious diseases. The advantages for vaccines range from the acceleration of immunogen discovery to rapid response and multiple disease target manufacturing. A greater understanding of quality attributes that dictate translation efficiency, as well as a comprehensive appreciation of the importance of mRNA delivery, are influencing a new era of investment in development activities. The application of translational sciences and growing early-phase clinical experience continue to inform candidate vaccine selection. Here we review the state of the art for the prevention of infectious diseases by using mRNA and pertinent topics to the biotechnology and pharmaceutical industries.

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          Oligoribonucleotide synthesis using T7 RNA polymerase and synthetic DNA templates.

          J. Milligan, D R Groebe, G Witherell … (1987)
          A method is described to synthesize small RNAs of defined length and sequence using T7 RNA polymerase and templates of synthetic DNA which contain the T7 promoter. Partially single stranded templates which are base paired only in the -17 to +1 promoter region are just as active in transcription as linear plasmid DNA. Runoff transcripts initiate at a unique, predictable position, but may have one nucleotide more or less on the 3' terminus. In addition to the full length products, the reactions also yield a large amount of smaller oligoribonucleotides in the range from 2 to 6 nucleotides which appear to be the result of abortive initiation events. Variants in the +1 to +6 region of the promoter are transcribed with reduced efficiency but increase the variety of RNAs which can be made. Transcription reaction conditions have been optimized to allow the synthesis of milligram amounts of virtually any RNA from 12 to 35 nucleotides in length.
          Article 0 comments Cited 317 times – based on 0 reviews     Review now
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            A Novel Amino Lipid Series for mRNA Delivery: Improved Endosomal Escape and Sustained Pharmacology and Safety in Non-human Primates

            Staci Sabnis, E. Kumarasinghe, Timothy Salerno … (2018)
            The success of mRNA-based therapies depends on the availability of a safe and efficient delivery vehicle. Lipid nanoparticles have been identified as a viable option. However, there are concerns whether an acceptable tolerability profile for chronic dosing can be achieved. The efficiency and tolerability of lipid nanoparticles has been attributed to the amino lipid. Therefore, we developed a new series of amino lipids that address this concern. Clear structure-activity relationships were developed that resulted in a new amino lipid that affords efficient mRNA delivery in rodent and primate models with optimal pharmacokinetics. A 1-month toxicology evaluation in rat and non-human primate demonstrated no adverse events with the new lipid nanoparticle system. Mechanistic studies demonstrate that the improved efficiency can be attributed to increased endosomal escape. This effort has resulted in the first example of the ability to safely repeat dose mRNA-containing lipid nanoparticles in non-human primate at therapeutically relevant levels. Sabnis et al. describe a novel amino lipid series for lipid nanoparticle-mediated delivery of mRNA. Enhanced delivery efficiency attributed to increased endosomal escape is demonstrated. An improved tolerability profile enables the first example of safe repeat dosing of mRNA containing lipid nanoparticles in non-human primate at therapeutically relevant levels.
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              Nucleoside-modified mRNA vaccines induce potent T follicular helper and germinal center B cell responses

              Norbert Pardi, Michael Hogan, Martin S Naradikian … (2018)
              Pardi and colleagues report on a vaccine platform in which purified, antigen-encoding, nucleoside-modified mRNA is encapsulated in lipid nanoparticles. Immunization with this vaccine elicits potent T follicular helper cell, germinal center B cell, and protective, neutralizing antibody responses.
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                Author and article information

                Contributors
                Nicholas A. C. Jackson: nick.jackson@cepi.net
                Journal
                Journal ID (nlm-ta): NPJ Vaccines
                Journal ID (iso-abbrev): NPJ Vaccines
                Title: NPJ Vaccines
                Publisher: Nature Publishing Group UK (London )
                ISSN (Electronic): 2059-0105
                Publication date (Electronic): 4 February 2020
                Publication date PMC-release: 4 February 2020
                Publication date Collection: 2020
                Volume: 5
                Electronic Location Identifier: 11
                Affiliations
                [1 ]Coalition for Epidemic Preparedness Innovations (CEPI), Gibbs building, 215 Euston Road, Bloomsbury, London, NW1 2BE UK
                [2 ]ISNI 0000 0000 8814 392X, GRID grid.417555.7, Sanofi Pasteur, ; 1 Discovery Dr, Swiftwater, PA 18370 USA
                [3 ]Translate Bio, 29 Hartwell Ave, Lexington, MA 02421 USA
                Author information
                http://orcid.org/0000-0002-5056-0802
                Article
                Publisher ID: 159
                DOI: 10.1038/s41541-020-0159-8
                PMC ID: 7000814
                PubMed ID: 32047656
                SO-VID: 5e49cbf9-f7a6-4dee-8a98-81e70aeec0a7
                Copyright © © The Author(s) 2020
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 9 October 2019
                Date accepted : 20 December 2019
                Categories
                Subject: Review Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2020

                Keywords: vaccines,infectious diseases
                Data availability:
                Keywords: vaccines, infectious diseases

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