(51) International Patent Classification: A61K 8/66 (2006.01) A61Q 11/00

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(51) International Patent Classification: A61K 8/66 (2006.01) A61Q 11/00 ( (51) International Patent Classification: A61K 8/66 (2006.01) A61Q 11/00 (2006.01) (21) International Application Number: PCT/EP20 19/08 1186 (22) International Filing Date: 13 November 2019 (13. 11.2019) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 18206133.3 14 November 2018 (14. 11.2018) EP (71) Applicant: NOVOZYMES A/S [DK/DK]; Krogshoejvej 36, 2880 Bagsvaerd (DK). (72) Inventors: DURHUUS, Thomas, Thomasen; Krogshoe¬ jvej 36, 2880 Bagsvaerd (DK). PALMEN, Lorena, Gonzalez,; Krogshoejvej 36, 2880 Bagsvaerd (DK). REISER, Anna, Verena,; Krogshoejvej 36, 2880 Bagsvaerd (DK). STREICHER, Werner, W,; Krogshoe¬ jvej 36, 2880 Bagsvaerd (DK). (81) Designated States (unless otherwise indicated, for every kind of national protection available) : AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available) : ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, Cl, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) — with sequence listing part of description (Rule 5.2(a)) (54) Title: ORAL CARE COMPOSITION COMPRISING A POLYPEPTIDE HAVING DNASE ACTIVITY (57) Abstract: The invention provides relates to oral care compositions comprising a polypeptide having DNase activity and at least one oral care component. ORAL CARE COMPOSITION COMPRISING A POLYPEPTIDE HAVING DNASE ACTIVITY REFERENCE TO SEQUENCE LISTING This application contains a Sequence Listing in computer readable form. The computer readable form is incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to oral care compositions comprising a polypeptide having DNase activity and at least one oral care component. BACKGROUND OF THE INVENTION: Biofilms are communities of bacteria that are found on solid surfaces in many different environments, including surfaces of the oral cavity. Oral biofilm, or dental plague, contains many of the bacteria that are associated with oral health issues such as oral malodor, demineralization, dental caries, tooth decay, potential loss of teeth and gum disease (gingivitis and periodontitis). The formation of oral biofilm occurs in three stages known as the lag phase, growth phase, and steady state, respectively. In the lag phase, glycoproteins from saliva bind to an oral surface such as teeth and create a structure termed the pellicle that functions as attachment site for bacteria. In the growth phase, co-aggregation occurs, i.e., secondary bacterial colonizers attach to the primary bacterial colonizers, causing the diversity of the biofilm to increase and the biofilm to grow and mature. In the steady state, the biofilm growth slows down and eventually stops. This stage-based formation cycle causes biofilms to exist in several consecutive layers, which makes physical abrasion of biofilm more difficult. Within a biofilm, the residing bacterial cells are distributed in an extracellular polymeric matrix that consists primarily of water, proteins, exopolysaccharides, lipopolysaccharides, lipids, surfactants, and extracellular DNA (eDNA). eDNA is an important component of the extracellular polymeric matrix and plays a vital role in both the formation and stability of biofilm and in the antimicrobial properties of its embedded bacteria. eDNA in biofilm is known to influence the initial attachment and adhesion of biofilm to surfaces as well as the subsequent buildup, and eDNA also has a stabilizing effect on biofilms as it coats the surface of the biofilm. Moreover, eDNA derived from lysed bacteria may contain genes conferring resistance to anti-microbial agents. In case such DNA fragments are transferred within the biofilm and integrated into the chromosome of living bacterial cells, this may lead to new phenotypes with improved anti-microbial resistance profiles. Because of the increased resistance to anti-microbial agents as well as the mechanical properties of biofilm, many current oral care products are rather inefficient in addressing biofilm formation and alleviating the associated oral health issues. The main focus for biofilm removal has been on mechanical abrasion. However, this approach is difficult due to the multilayered nature of biofilms and is further compromised by the fact that mechanical removal of biofilm, e.g., by brushing the teeth, expands and deepens the areas in the oral cavity where biofilms attach and expand, thus potentially increasing the severity of the problem rather than reducing it. In view of the important role of biofilm in oral disease, there is a need in the art for oral care compositions that can effectively target oral biofilm. In particular, there is a need for oral care formulations that can target biofilm by removing the eDNA. However, this would require agents such as enzymes that at the same time are effective against biofilm as well as stable under conditions suitable for oral care, including in oral care formulations. WO 201 1/098579 relates to NucA/NucB-type deoxyribonucleases and methods for biofilm disruption and prevention. SUMMARY OF THE INVENTION In a first aspect, the present invention relates to an oral care composition comprising a polypeptide having DNase activity and at least one oral care component. In a second aspect, the present invention relates to a composition according to the first aspect for use as a medicament. In a third aspect, the present invention relates to a composition according to the first aspect for use in the treatment of oral disease. In a fourth aspect, the present invention relates to use of a composition according to the first aspect for treatment or prophylactic treatment of a human or animal subject. In a fifth aspect, the present invention relates to a method of treatment of a human or animal subject, the method comprising administering a composition according to the first aspect to a human or animal subject. In a sixth aspect, the present invention relates to a kit of parts comprising: a) a composition according to the first aspect; and b) instructions for use. BRIEF DESCRIPTION OF DRAWINGS Fig. 1 shows an example of the thermal stability data generated using the nanoDSF instrument. Panel A is an example of the data obtained (the ratio of the fluorescence emission at 350 nm to 330 nm) in triplicate for SEQ ID NO: 32 (for clarity only every fifth data point is shown) as a function of temperature. Panel B shows the first derivative of the raw data in Panel A . The peak maximum in the first derivative plot corresponds to the mid-point of the thermal unfolding transition, referred to as Td. In this example the Td corresponds to 58°C and is highly reproducible within the three replicates. Fig. 2 shows the average thermal stability of DNases in 1 mM EDTA (black bars) or 5 mM EDTA (grey bars). The dotted line represents the average for all Td values measured in EDTA. Fig. 3 shows thermal stability of DNases in the presence of 1 or 5% sodium dodecyl sulphate (SDS). The dotted line represents the average for all Td values measured in SDS. Fig. 4 shows thermal stability of DNases in the presence of 45 or 90% Plax COOL MINT (Colgate®) mouthwash. The dotted line represents the average for all Td values measured in mouthwash Plax COOL MINT (Colgate®). Fig. 5 shows thermal stability of DNases in the presence of 1 or 10% (w/v) Cavity Protection Caries toothpaste (Colgate®, Colgate-Palmolive). The dotted line represents the average for all Td values measured in Cavity Protection Caries toothpaste (Colgate ® , Colgate- Palmolive). DEFINITIONS: Clade: The term “clade” means a group of polypeptides clustered together on the basis of homologous features traced to a common ancestor. Polypeptide clades can be visualized as phylogenetic trees and a clade is a group of polypeptides that consists of a common ancestor and all its lineal descendants. Polypeptides forming a group within the clade (a subclade) of the phylogenetic tree can also share common properties and are more closely related than other polypeptides in the clade. Dentures: The term “dentures” is meant to cover dentures as such as well as braces, aligners, retainers, and the like. Polypeptide having DNase activity: The term “polypeptide having DNase activity” means a polypeptide with DNase (deoxyribonuclease) activity that catalyzes the hydrolytic cleavage of phosphodiester linkages in a DNA backbone, thus degrading DNA. Exodeoxyribonuclease cut or cleaves residues at the end of the DNA back bone where endo-deoxyribonucleases cleaves or cut within the DNA backbone. A DNase may cleave only double-stranded DNA or may cleave double stranded and single stranded DNA. The term “DNases” and the expression “a polypeptide with DNase activity” are used interchangeably throughout this application. For purposes of the present invention, DNase activity is determined according to the procedure described in the Assay I or Assay II. Nomenclature For purposes of the present invention, the nomenclature [G/N] means that the amino acid at this position may be a glycine (Gly, G) or an asparagine (Asn, N).
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