	US 11,896,648 B2
	Interleukin-2 variant proteins fused to human IgG4 Fc and uses thereof
Manuel Baca, Lexington, MA (US); Sarah A. Gilmore, San Mateo, CA (US); Hassan Javanbakht, San Francisco, CA (US); and Prasenjit K. Mukherjee, South San Francisco, CA (US)
Assigned to GILEAD SCIENCES, INC., Foster City, CA (US)
Filed by Gilead Sciences, Inc., Foster City, CA (US)
Filed on Oct. 20, 2021, as Appl. No. 17/506,483.
Claims priority of provisional application 63/181,075, filed on Apr. 28, 2021.
Claims priority of provisional application 63/104,376, filed on Oct. 22, 2020.
Prior Publication US 2022/0125884 A1, Apr. 28, 2022
Int. Cl. A61K 38/20 (2006.01); A61P 35/00 (2006.01); A61K 39/395 (2006.01); C07K 14/55 (2006.01); A61K 38/00 (2006.01); A61P 31/20 (2006.01)

CPC A61K 38/2013 (2013.01) [A61K 39/3955 (2013.01); A61P 31/20 (2018.01); A61P 35/00 (2018.01); C07K 14/55 (2013.01); A61K 38/00 (2013.01); C07K 2319/30 (2013.01)]

14 Claims

1. A heterodimer comprising a human IgG4 Fc-IL-2v fusion protein comprising (i) a first amino acid sequence of SEQ ID NO: 114 comprising a first Fc domain; and (ii) a second Fc domain comprising an amino acid sequence of SEQ ID NO: 46.

7. A polynucleotide or multiple polynucleotides encoding the Fc-IL-2v fusion protein and the second Fc domain of the heterodimer of claim 1.

11. A method of producing an Fc-IL-2 fusion protein heterodimer, the method comprising:

a) culturing a cell or population of cells transformed with the polynucleotide or polynucleotides of claim 7, in a cell culture under conditions sufficient to express the Fc-IL-2 fusion protein heterodimer molecules; and

b) isolating or purifying the Fc-IL-2 fusion protein heterodimer molecules from the cell culture.

13. A method of preventing, reducing and/or inhibiting the recurrence, growth, proliferation, migration and/or metastasis of a cancer cell or population of cancer cells in a subject in need thereof, comprising administering to the subject an effective amount of the heterodimer of claim 1, wherein the cancer cell or population of cancer cells are selected from melanoma and colon cancer.