US2023270850A1PendingUtilityA1

Hpv vaccine

70
Assignee: MERCK SHARP & DOHME LLCPriority: Feb 14, 2020Filed: Mar 10, 2023Published: Aug 31, 2023
Est. expiryFeb 14, 2040(~13.5 yrs left)· nominal 20-yr term from priority
Inventors:Andrew J. BettJohn BilelloAmy EspesethTong-Ming FuMarian Gindy
A61K 39/39A61P 31/20A61K 39/12C12N 7/00A61K 2039/5258C12N 2710/20034A61K 2039/70A61K 2039/55555A61K 2039/55505C12N 2710/20023A61K 2039/545C12N 2710/20071A61K 2039/55572
70
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

The present disclosure provides, among other things, a pharmaceutical composition that includes a lipid nanoparticle adjuvant and an anti-human papillomavirus (HPV) comprising HPV virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A pharmaceutical composition comprising:
 virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82,   a lipid nanoparticle (LNP) adjuvant, and   a pharmaceutically acceptable carrier.   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises VLPs of at least HPV types 16 and 18. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises VLPs of at least HPV types 6, 11, 16, and 18. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises VLPs of at least HPV types 31, 45, 52, and 58. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition comprises VLPs of at least HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. 
     
     
         6 . The pharmaceutical composition of any of  claims 1 - 5 , wherein the LNP adjuvant comprises a cationic lipid, a phospholipid, cholesterol, and a PEG-lipid. 
     
     
         7 . The pharmaceutical composition of any of  claims 1 - 6 , wherein the LNP adjuvant comprises 30-65 mole % cationic lipid, 5-30 mole % phospholipid, 10-40 mole % cholesterol, and 0.5-4 mole % PEG-lipid. 
     
     
         8 . The pharmaceutical composition of any of  claims 1 - 7 , wherein the LNP adjuvant comprises 55-65 mole % cationic lipid, 5-15 mole % phospholipid, 25-35 mole % cholesterol, and 1-2.5 mole % PEG-lipid. 
     
     
         9 . The pharmaceutical composition of any of  claims 1 - 8 , wherein the LNP adjuvant comprises DSPC, cholesterol, ePEG2000-DMG, and (13Z, 16Z)—N, N-dimethyl-3-nonyldocosa 13, 16-dien-1-amine. 
     
     
         10 . The pharmaceutical composition of any of  claims 1 - 9 , wherein the LNP adjuvant comprises 5-15 mole % DSPC, 25-35 mole % cholesterol, 1-2.5 mole % ePEG2000-DMG, and 55-65 mole % (13Z, 16Z)—N, N-dimethyl-3-nonyldocosa 13, 16-dien-1-amine. 
     
     
         11 . The pharmaceutical composition of any of  claims 1 - 10 , further comprising an aluminum adjuvant. 
     
     
         12 . A pharmaceutical composition comprising:
 (a) virus like particles (VLPs) of at least one type of human papillomavirus (HPV), wherein the at least one type of HPV is selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82;   (b) about 100 μg to about 900 μg of an aluminum adjuvant; and   (c) about 10 μg to about 200 mg of a lipid nanoparticle (LNP) adjuvant,   wherein each of the HPV VLPs comprise recombinant L1 or recombinant L1+L2 protein;   wherein each of the HPV VLPs are present in a concentration of about 10 μg to about 100 μg per 0.5 mL of the pharmaceutical composition;   wherein the total HPV VLP concentration is between 10 μg and 2000 μg per 0.5 mL of the pharmaceutical composition; and   wherein the HPV VLPs are adsorbed onto the aluminum adjuvant.   
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 16 and 18. 
     
     
         14 . The pharmaceutical composition of  claims 12 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 6, 11, 16, and 18. 
     
     
         15 . The pharmaceutical composition of  claims 12 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 31, 45, 52, and 58. 
     
     
         16 . The pharmaceutical composition of  claim 12 , wherein the pharmaceutical composition comprises HPV VLPs of at least HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. 
     
     
         17 . The pharmaceutical composition of any of  claims 12 - 16 , wherein the LNP adjuvant comprises a cationic lipid, a phospholipid, cholesterol, and a PEG-lipid. 
     
     
         18 . The pharmaceutical composition of  claim 17 , wherein the LNP adjuvant comprises 30-65 mole % cationic lipid, 5-30 mole % phospholipid, 10-40 mole % cholesterol, and 0.5-4 mole % PEG-lipid. 
     
     
         19 . The pharmaceutical composition of  claim 18 , wherein the LNP adjuvant comprises DSPC, cholesterol, ePEG2000-DMG, and (13Z, 16Z)—N, N-dimethyl-3-nonyldocosa 13, 16-dien-1-amine. 
     
     
         20 . The pharmaceutical composition of  claim 19 , wherein the LNP adjuvant comprises 5-15 mole % DSPC, 25-35 mole % cholesterol, 1-2.5 mole % ePEG2000-DMG, and 55-65 mole % (13Z, 16Z)—N, N-dimethyl-3-nonyldocosa 13, 16-dien-1-amine. 
     
     
         21 . The pharmaceutical composition of any of  claims 1 - 20 , wherein the HPV VLPs comprise HPV L1 protein and do not comprise HPV L2 protein. 
     
     
         22 . The pharmaceutical composition of any of  claims 1 - 20 , wherein the HPV VLPs consists of HPV L1 protein. 23. A single-dose vaccine composition comprising:
 a lipid nanoparticle (LNP) adjuvant, wherein the adjuvant comprises 30-65 mole % cationic lipid, 5-30 mole % phospholipid, 10-40 mole % cholesterol, and 0.5-4 mole % PEG-lipid,   virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82,   wherein the single-dose vaccine composition provides an elevated or comparable anti-HPV immune response relative to multiple doses of the same composition formulated without an LNP adjuvant.   
     
     
         24 . The single-dose vaccine composition of claim  23 , wherein the vaccine further comprises an aluminum adjuvant. 
     
     
         25 . The single-dose vaccine composition of  claim 24 , wherein the HPV VLPs are adsorbed onto the aluminum adjuvant. 
     
     
         26 . The single-dose vaccine composition of any of claims  23 - 25 , wherein each of the HPV VLPs are present in a concentration of about 10 μg to about 100 μg per 0.5 mL of the pharmaceutical composition and wherein the total HPV VLP concentration is between 10 μg and 2000 μg per 0.5 mL of the pharmaceutical composition. 
     
     
         27 . A method of inducing an immune response to a human papillomavirus (HPV) in a human patient comprising administering to the patient the pharmaceutical composition of any of  claims 1 - 22  or the single-dose vaccine composition of any of claims  23 - 26 . 
     
     
         28 . A method of inducing an immune response to a human papillomavirus (HPV) in a human patient comprising co-administering to the patient (a) a pharmaceutical composition comprising virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82 and (b) an LNP adjuvant. 
     
     
         29 . A method of preventing infection of a human patient by a human papillomavirus (HPV) comprising administration to the patient the pharmaceutical composition of any of  claim 1 - 22  or the single-dose vaccine composition of any of claims  23 - 26 . 
     
     
         30 . A method of preventing infection of a human patient by a human papillomavirus (HPV) comprising co-administering to the patient (a) a pharmaceutical composition comprising virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82 and (b) an LNP adjuvant. 
     
     
         31 . A kit comprising:
 (a) a human papilloma virus (HPV) vaccine; and   (b) an LNP adjuvant.   
     
     
         32 . The kit of  claim 31 , further comprising instructions for administering to a human patient the HPV vaccine and the LNP adjuvant. 
     
     
         33 . The kit of any of  claims 25  and  26 , wherein the HPV vaccine comprises virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82. 
     
     
         34 . A method of delivering a pharmaceutical composition that induces a neutralizing titer against an HPV antigen in a host comprising:
 (a) administering a pharmaceutical composition comprising:   a lipid nanoparticle (LNP) adjuvant, and   virus-like particles (VLPs) of at least one type of human papillomavirus (HPV) selected from the group consisting of HPV types: 6, 11, 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 55, 56, 58, 59, 66, 68, 73, and 82,   and   (b) inducing a neutralizing titer against the HPV antigen in the host, where a single dose of the pharmaceutical composition provides enhanced or comparable neutralizing titers when compared to multiple doses of the same pharmaceutical composition when the anti-HPV composition is formulated without an adjuvant.   
     
     
         35 . The method of  claim 34 , further comprising an aluminum adjuvant.

Join the waitlist — get patent alerts

Track US2023270850A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.