US 12,227,565 B2
Method of formulating a pharmaceutical composition comprising administering an immune modulator to the small intestine
Mitchell Lawrence Jones, La Jolla, CA (US); Christopher Loren Wahl, San Diego, CA (US); Sharat Singh, Rancho Santa Fe, CA (US); Kevin David Howe, London (GB); and Arana Perera, San Diego, CA (US)
Assigned to Biora Therapeutics, Inc., San Diego, CA (US)
Appl. No. 17/253,804
Filed by Biora Therapeutics, Inc., San Diego, CA (US)
PCT Filed Jun. 19, 2019, PCT No. PCT/US2019/038063
§ 371(c)(1), (2) Date Dec. 18, 2020,
PCT Pub. No. WO2019/246317, PCT Pub. Date Dec. 26, 2019.
Claims priority of provisional application 62/687,766, filed on Jun. 20, 2018.
Prior Publication US 2023/0009902 A1, Jan. 12, 2023
Int. Cl. C07K 16/24 (2006.01); A61K 9/00 (2006.01); A61K 39/00 (2006.01); A61P 1/00 (2006.01); A61P 37/06 (2006.01); C07K 16/28 (2006.01)
CPC C07K 16/241 (2013.01) [A61K 9/0053 (2013.01); A61P 1/00 (2018.01); A61P 37/06 (2018.01); C07K 16/244 (2013.01); C07K 16/2842 (2013.01); A61K 2039/505 (2013.01)] 15 Claims
 
1. A method of formulating a pharmaceutical composition comprising an immune modulator, the method comprising:
(a) topically administering a dose of an immune modulator to a predetermined site in a small intestine or a predetermined site in a colon of a mammal;
(b) selecting an immune modulator whose topical administration in step (a) has been determined to result in:
(i) a decrease in the level of one or more of T cells, B cells, natural killer (NK) cells, macrophages, M cells, and dendritic cells, in MALT, GALT, Peyer's patches, mesenteric lymph nodes, paraaortic lymph nodes, or any of the other tissues originating from the endoderm, and/or
(ii) a decrease in the level of one or more of IL-1, IL-2, IL-6, IL-8, IL-12, IL-18, interferon-kappa, TGF-β, tumor necrosis factor, and GM-CSF, in MALT, GALT, Peyer's patches, mesenteric lymph nodes, paraaortic lymph nodes, or any of the other tissues originating from the endoderm, in the mammal, each as compared to the corresponding level in a control mammal systemically administered the same dose or a therapeutically effective dose of the immune modulator; and
(c) formulating a pharmaceutical composition comprising the selected immune modulator.