WO2023064711A3 - Ultra-long acting insulin-fc fusion proteins and methods of use - Google Patents

Ultra-long acting insulin-fc fusion proteins and methods of use Download PDF

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Publication number
WO2023064711A3
WO2023064711A3 PCT/US2022/077752 US2022077752W WO2023064711A3 WO 2023064711 A3 WO2023064711 A3 WO 2023064711A3 US 2022077752 W US2022077752 W US 2022077752W WO 2023064711 A3 WO2023064711 A3 WO 2023064711A3
Authority
WO
WIPO (PCT)
Prior art keywords
insulin
fusion proteins
ultra
long acting
fungal strain
Prior art date
Application number
PCT/US2022/077752
Other languages
French (fr)
Other versions
WO2023064711A2 (en
Inventor
Thomas M. Lancaster
Todd C. Zion
Original Assignee
Akston Biosciences Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Akston Biosciences Corporation filed Critical Akston Biosciences Corporation
Publication of WO2023064711A2 publication Critical patent/WO2023064711A2/en
Publication of WO2023064711A3 publication Critical patent/WO2023064711A3/en

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/62—Insulins
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/80—Vectors or expression systems specially adapted for eukaryotic hosts for fungi
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

The present disclosure provides ultra-long acting insulin-Fc fusion proteins manufactured in a fungal strain for high yields and for use in treating canine and feline diabetes. The insulin-Fc fusion proteins comprise an insulin polypeptide linked via a peptide linker to an Fc-fragment of canine or feline origin. Based on the results obtained, creating a treatment that is exhibits sufficient in vivo bioactivity, displays extended duration of bioactivity, does not induce anti-drug antibodies, and substantially retains is potency over multiple administrations, requires a non-obvious combination of insulin polypeptide, peptide linkers, and species-specific Fc fragment, in addition to selective mutations on one or more of these components. Production of the insulin-Fc fusion protein in a fungal strain provides unexpectedly high yields enabling a significant reduction in manufacturing costs. Fungal strain manufactured exemplary ultra-long acting insulin-Fc fusion proteins, polynucleotides encoding these insulin-Fc fusion proteins, and pharmaceutical formulations of exemplary insulin-Fc fusion proteins are provided, in addition to methods of use and preparation.
PCT/US2022/077752 2021-10-14 2022-10-07 Ultra-long acting insulin-fc fusion proteins and methods of use WO2023064711A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163255629P 2021-10-14 2021-10-14
US63/255,629 2021-10-14

Publications (2)

Publication Number Publication Date
WO2023064711A2 WO2023064711A2 (en) 2023-04-20
WO2023064711A3 true WO2023064711A3 (en) 2023-06-01

Family

ID=85988953

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/077752 WO2023064711A2 (en) 2021-10-14 2022-10-07 Ultra-long acting insulin-fc fusion proteins and methods of use

Country Status (1)

Country Link
WO (1) WO2023064711A2 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200157169A1 (en) * 2018-06-29 2020-05-21 Akston Biosciences Corporation Ultra-long acting insulin-fc fusion proteins and methods of use
US20200261595A1 (en) * 2017-04-05 2020-08-20 Novo Nordisk A/S Oligomer Extended Insulin-FC Conjugates

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200261595A1 (en) * 2017-04-05 2020-08-20 Novo Nordisk A/S Oligomer Extended Insulin-FC Conjugates
US20200157169A1 (en) * 2018-06-29 2020-05-21 Akston Biosciences Corporation Ultra-long acting insulin-fc fusion proteins and methods of use

Also Published As

Publication number Publication date
WO2023064711A2 (en) 2023-04-20

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