	US 12,440,559 B2
	Formulation containing TLR agonist and methods of use
Christopher B. Fox, Sumner, WA (US)
Assigned to ACCESS TO ADVANCED HEALTH INSTITUTE, Seattle, WA (US)
Filed by ACCESS TO ADVANCED HEALTH INSTITUTE, Seattle, WA (US)
Filed on Apr. 28, 2022, as Appl. No. 17/731,671.
Application 17/731,671 is a division of application No. 16/098,615, granted, now 11,344,619, previously published as PCT/US2017/032287, filed on May 11, 2017.
Claims priority of provisional application 62/337,322, filed on May 16, 2016.
Prior Publication US 2022/0280640 A1, Sep. 8, 2022
Int. Cl. A61K 39/395 (2006.01); A61K 35/76 (2015.01); A61K 39/04 (2006.01); A61K 39/12 (2006.01); A61K 39/39 (2006.01); A61K 45/06 (2006.01); A61P 31/06 (2006.01); A61P 31/12 (2006.01); A61P 33/04 (2006.01); A61P 35/00 (2006.01); C07K 14/705 (2006.01); A61K 39/00 (2006.01)

CPC A61K 39/39 (2013.01) [A61K 35/76 (2013.01); A61K 39/04 (2013.01); A61K 39/12 (2013.01); A61K 45/06 (2013.01); A61P 31/06 (2018.01); A61P 31/12 (2018.01); A61P 33/04 (2018.01); A61P 35/00 (2018.01); C07K 14/705 (2013.01); C07K 14/70596 (2013.01); A61K 2039/552 (2013.01); A61K 2039/55505 (2013.01); A61K 2039/55511 (2013.01); A61K 2039/55572 (2013.01); A61K 2039/57 (2013.01); A61K 2039/572 (2013.01); C12N 2740/16134 (2013.01)]

10 Claims

1. A composition comprising:

(a) a TLR4 agonist, wherein the TLR4 agonist is GLA;

(b) a helper lipid; and

wherein the helper lipid is DPTAP and the aluminum salt is aluminum phosphate, or

wherein the helper lipid is DPPC and the aluminum salt is aluminum hydroxide,

wherein the composition is an aqueous formulation comprising a stable nanosuspension having a particle size of 400 nm or less, the TLR4 agonist is adsorbed to the aluminum salt at 25 percent or more of the aluminum salt, and the TLR4 agonist and the helper lipid are present in a molar ratio of about 1:2.