Formulation containing TLR agonist and methods of use
AssigneeAccess To Advanced Health Institute
InventorChristopher B. Fox
Life of this patent
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Abstract
Stable aqueous formulations of adjuvant comprising a TLR7/8 agonist or a TLR4 agonist with a helper lipid that are adsorbed to alum are provided. Compositions and methods of using the formulations for stimulating an immune response are also provided.
Claims12
A method of stimulating an immune response in a subject comprising administering a composition to the subject and thereby stimulating the immune response in the subject, wherein the composition comprises:
- (a) a TLR7/8 agonist, wherein the TLR7/8 agonist is 3M-052;
- (b) a helper lipid;
- and
- (c) an aluminum salt,
- wherein the helper lipid is DSTAP and the aluminum salt is aluminum phosphate, or
- wherein the helper lipid is DLPG, DMPG, DPPG, DSPG, or DOPG and the aluminum salt is aluminum hydroxide, and
- wherein a molar ratio of the TLR7/8 agonist to the helper lipid is about 1:2.
A method for preparing an aqueous formulation comprising a TLR7/8 agonist and a helper lipid, wherein the TLR7/8 agonist is 3M-052 and (i) the helper lipid is DSTAP and the aluminum salt is aluminum phosphate or (ii) the helper lipid is DLPG, DMPG, DPPG, DSPG, or DOPG and the aluminum salt is aluminum hydroxide, wherein a molar ratio of the TLR7/8 agonist to the helper lipid is about 1:2, and wherein the aqueous formulation comprising the TLR7/8 agonist and the helper lipid comprises particles that are in a range of 1 nm to about 450 nm, the method comprising:
- (a) mixing the TLR7/8 agonist and the helper lipid in a solvent to make a solution;
- (b) removing the solvent from the solution to make a film composition;
- and
- (c) rehydrating the film composition to make a rehydrated composition;
- (d) subjecting the rehydrated composition to a high energy source to make a nanosuspension composition;
- and
- (e) mixing an aluminum salt with the nanosuspension composition.
Dependencies are inferred from the claim text.