Patent List of Moderna relating to insertional mutagenesis

The residual plasmid DNA in the mRNA vaccine causes the insertional mutagenesis as well as the integration into the human genome.

The descriptions relating to the insertional mutagenesis in the Moderna patents can be broadly classified into the following four patterns.

1. e.g. WO2017070601A1

   Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as VZV antigens. The direct injection of genetically engineered DNA (e.g., naked plasmid DNA) into a living host results in a small number of host cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.

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2. e.g. WO2017070618A1

   Most commercial or developing vaccines are based on whole microorganisms, protein antigens, peptides, polysaccharides or deoxyribonucleic acid (DNA) vaccines and their combinations. DNA vaccination is one technique used to stimulate humoral and cellular immune responses to antigens. The direct injection of genetically engineered DNA (e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems of DNA integration into the vaccine's genome, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.

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3. e.g. WO2019226650A1

   In some embodiments, ceDNA is less likely to result in insertional mutagenesis compared to other gene therapy vectors, e.g., plasmid DNA vectors, and therefore can have an improved safety profile when administered to a subject relative to other vectors.

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4. e.g. WO2017100551A1

   Messenger RNA (mRNA) is frequently used as a gene delivery molecule in the field of cancer immunotherapy and stem cell-based biomedical research as an alternative to plasmid DNA. As a direct source of gene products, mRNA has several advantages including a lack of requirement for nuclear entry, which poses a significant barrier to DNA delivery, especially in non-dividing cells. mRNA also has a negligible chance of integrating into the host genome, avoiding aberrant transcription and expression of oncogenes caused by insertional mutagenesis.

This International patent application WO2017100551A1 was filed by ALEXION PHARMACEUTICALS, INC, and assigned to Moderna TX thereafter. The WO2017100551A1 was transferred to the US and registered as US11389546B2. So, the current Assignee is Moderna TX.

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Here is a List of "Insertional mutagenesis" patents of Moderna. The patents are categorized by patent family. The number of patents included in the patent family indicates the importance of the family to which the patents belong.

NOTE: For convenience, I have extracted the International patents (WO), the European patents (EP), and the United States patents (US), and other patent families including Australian patent (AU), Japanese patent (JP), Chinese patent (CN), etc., are excluded from this list.

The patent search requires an advanced know-how (unfortunately I don’t have), so there is no guarantee that all patents are correctly extracted, and there may be patents missing from this list. If you find a Moderna patent relating to "Insertional mutagenesis," please let me know to create a list that serves the public interest. That will be reflected in the following list.

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[Family. 1]

WO2017070601A1 WO2017070616A2 WO2017070618A1 WO2017070620A2 WO2017070622A1 WO2017070623A1 WO2017070624A1 WO2017070626A2 EP3364980A1 EP3364982A2 EP3364949A1 EP3365007A2 EP3365008A1 EP3365009A1 EP3364950A1 EP3364983A2 EP3718565A1 EP4011451A1 EP4349405A2 EP4349404A2 US11643441B1 US20170340724A1 US20170340725A1 US20180289792A1 US2018311336A1 US20180271970A1 US2018303929A1 US20180318409A1 US20180008694A1 US20180296662A1 US20180326045A1 US20190008946A1 US20190008947A1 US20190216917A1 US20190240317A1 US20200197510A1 US20200289638A1 US20200289639A1 US20200282046A1 US20200405844A1 US20220257746A1 US20230303632A1 US20230346907A1 US20230390379A1 US20230374079A1

[Family. 2]

WO2017015463A2 WO2017020026A1 EP3324979A2 EP3328394A1 EP4218805A1 US20180280496A1 US20180344838A1 US20180344839A1 US20190060438A1 US20190008938A1 US20200368343A1 US20200368344A1 US20220152178A1 US20230020362A1

[Family. 3]

WO2018170245A1 EP3609534A1 US20210187097A1 US20230310576A1

[Family. 4]

WO2018170260A1 EP3595713A1 US20200129608A1 US20230114180A1

[Family. 5]

WO2018170270A1 US20200069793A1 US20220409720A1

[Family. 6]

WO2018200737A1 EP3641810A1 US2020054737A1

[Family. 7]

WO2019226650A1 EP3796893A1 US20210346306A1

[Family. 8]

WO2018144082A1 EP3576751A1 US20190351040A1

[Family. 9]

WO2017100551A1 US20180353618A1 US20230050143A1

[Family. 10]

WO2022240806A1 EP4337177A1

[Family. 11]

WO2018170256A1 US20200129615A1

[Family. 12]

WO2017015457A1

[Family. 13]

US20180243225A1