The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Jun. 13, 2023

Filed:

Sep. 29, 2021
Applicant:

Akston Biosciences Corporation, Beverly, MA (US);

Inventors:

Thomas M. Lancaster, Wenham, MA (US);

Todd C. Zion, Marblehead, MA (US);

Assignee:

Akston Biosciences Corporation, Beverly, MA (US);

Attorney:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
C07K 14/62 (2006.01); A61P 3/10 (2006.01); A61K 9/00 (2006.01); C07K 16/28 (2006.01); C12N 15/62 (2006.01); A61K 47/65 (2017.01); C07K 1/22 (2006.01); C07H 21/04 (2006.01); A61K 38/00 (2006.01);
U.S. Cl.
CPC ...
C07K 14/62 (2013.01); A61K 9/0019 (2013.01); A61K 47/65 (2017.08); A61P 3/10 (2018.01); C07H 21/04 (2013.01); C07K 1/22 (2013.01); C07K 16/2869 (2013.01); C12N 15/62 (2013.01); A61K 38/00 (2013.01); C07K 2317/94 (2013.01); C07K 2319/30 (2013.01);
Abstract

The present disclosure provides recombinantly manufactured ultra-long acting insulin-Fc fusion proteins 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 amenable to low cost manufacturing, 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. 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.


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