# US 10,441,648 B2 · Mycobacterium antigenic composition > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,648 B2 - Document ID: US10441648B2 - Status: Granted - Kind: B2 - Application number: 15/643,084 - Filed: 2017-07-06 - Published: 2018-03-15 - Granted: 2019-10-15 - Earliest claimed: 2010-12-14 - Assignees: Glaxosmithkline Biologicals SA - Applicants: Glaxosmithkline Biologicals, SA - Inventors: Stéphane André Georges Godart; Amina Laanan; Dominique Ingrid Lemoine - Web page: https://patentgrep.com/patent/US10441648B2 ## CPC - A61K 39/04: Mycobacterium, e.g. Mycobacterium tuberculosis - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 31/04: Antibacterial agents - A61P 31/06: for tuberculosis - A61P 31/12: Antivirals - A61P 37/04: Immunostimulants - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers} - A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A} - A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Immunogenic compositions comprising an M72 related antigen, wherein the conductivity of the composition is 13 mS/cm or lower, or the concentration of salts of the composition is 130 mM or lower, and their use in medicine, are provided. ## Claims ### Claim 1 An immunogenic composition comprising an M72 related antigen, wherein the concentration of salts in said composition is 130 mM or lower. ### Claim 2 (depends on 1) The immunogenic composition according to claim 1, wherein the conductivity of the composition is 10 mS/cm or lower. ### Claim 3 (depends on 2) The immunogenic composition according to claim 2, wherein the conductivity of the composition is 3 mS/cm or lower. ### Claim 4 (depends on 1) The immunogenic composition according to claim 1, wherein the concentration of salts in said composition is 100 mM or lower. ### Claim 5 (depends on 4) The immunogenic composition according to claim 4, wherein the concentration of salts in said composition is 40 mM or lower. ### Claim 6 (depends on 1) The immunogenic composition according to claim 1, comprising sodium chloride in a concentration of 100 mM or lower. ### Claim 7 (depends on 6) The immunogenic composition according to claim 6, wherein the concentration of sodium chloride in said composition is 40 mM or lower. ### Claim 8 (depends on 1) The immunogenic composition according to claim 1, comprising CaCl2 in a concentration of 30 mM or lower. ### Claim 9 (depends on 1) The immunogenic composition according to claim 1, comprising MgSO4 in a concentration of 60 mM or lower. ### Claim 10 (depends on 1) The immunogenic composition according to claim 1, wherein the total concentration of NH4+, Mg2+, and Ca2+ ions is 40 mM or lower. ### Claim 11 (depends on 1) The immunogenic composition according to claim 1, further comprising a non-ionic tonicity agent. ### Claim 12 (depends on 11) The immunogenic composition according to claim 11, wherein the non-ionic tonicity agent is a polyol. ### Claim 13 (depends on 12) The immunogenic composition according to claim 12, wherein the polyol is sorbitol. ### Claim 14 (depends on 13) The immunogenic composition according to claim 13, wherein the concentration of sorbitol is between 4 and 6% (w/v). ### Claim 15 (depends on 1) The immunogenic composition according to claim 1, comprising sucrose in a concentration of between 4 and 6% (w/v). ### Claim 16 (depends on 1) The immunogenic composition according to claim 1, further comprising one or more immunostimulants. ### Claim 17 (depends on 16) The immunogenic composition according to claim 16, comprising a saponin immunostimulant and/or a TLR4 agonist immunostimulant. ### Claim 18 (depends on 16) The immunogenic composition according to claim 16, wherein at least one immunostimulant is in the form of liposomes. ### Claim 19 (depends on 16) The immunogenic composition according to claim 16, comprising QS21. ### Claim 20 (depends on 16) The immunogenic composition according to claim 16, comprising 3-de-O-acylated monophoshoryl lipid A. ### Claim 21 (depends on 1) The immunogenic composition according to claim 1, wherein the osmolality is 250 to 750 mOsm/kg. ### Claim 22 (depends on 1) The immunogenic composition according to claim 1, wherein the composition is provided as a unit dose of between 50 ul and 1 ml. ### Claim 23 (depends on 22) The immunogenic composition according to claim 22, wherein the unit dose is between 100 ul and 750 ul. ### Claim 24 (depends on 22) The immunogenic composition according to claim 22, wherein a unit dose contains 1 to 100 ug of M72 related antigen. ### Claim 25 (depends on 24) The immunogenic composition according to claim 24, wherein a unit dose contains 5 to 50 ug of M72 related antigen. ### Claim 26 (depends on 1) The immunogenic composition according to claim 1, wherein the pH of said composition is in the range 7.0 to 9.0. ### Claim 27 (depends on 1) The immunogenic composition according to claim 1, wherein the M72 related antigen comprises a sequence having at least 70% identity to SEQ ID No: 1. ### Claim 28 (depends on 27) The immunogenic composition according to claim 27, wherein the M72 related antigen consists of a sequence having at least 70% identity to SEQ ID No: 1. ### Claim 29 (depends on 27) The immunogenic composition according to claim 27, wherein the M72 related antigen comprises a sequence having at least 90% identity to SEQ ID No: 1. ### Claim 30 (depends on 29) The immunogenic composition according to claim 29, wherein the M72 related antigen consists of a sequence having at least 90% identity to SEQ ID No: 1. ### Claim 31 (depends on 1) The immunogenic composition according to claim 1, wherein the M72 related antigen comprises the amino acid sequence of SEQ ID No: 1. ### Claim 32 (depends on 1) The immunogenic composition according to claim 1, wherein the M72 related antigen comprises the amino acid sequence of SEQ ID No: 3. ### Claim 33 (depends on 31) The immunogenic composition according to claim 31, wherein the M72 related antigen consists of the amino acid sequence of SEQ ID No: 1. ### Claim 34 (depends on 32) The immunogenic composition according to claim 32, wherein the M72 related antigen consists of the amino acid sequence of SEQ ID No: 3. ### Claim 35 (depends on 1) The immunogenic composition according to claim 1, wherein at least 80% of the antigenicity of the immunogenic composition remains after storage at 25° C. for a period of 24 hours. ### Claim 36 (depends on 1) A process for the making an immunogenic composition according to claim 1 comprising the steps: a) lyophilising an M72 related antigen; and b) reconstituting the lyophilised M72 related antigen of step a) with an aqueous solution wherein the concentration of salts in said solution is 130 mM or lower. ### Claim 37 (depends on 1) A method for the manufacture of a stable immunogenic composition according to claim 1 comprising the steps: a) lyophilising an M72 related antigen; and b) reconstituting the lyophilised M72 related antigen of step a) with an aqueous solution wherein the concentration of salts in said solution is 130 mM or lower; wherein at least 80% of the antigenicity of the immunogenic composition remains after storage at 25° C. for a period of 24 hours. ### Claim 38 A kit comprising: a) a lyophilised M72 related antigen; and b) an aqueous solution wherein the concentration of salts in said solution is 130 mM or lower.