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WO 2012/170438 A2 13 December 2012 (13.12.2012) P O P C T

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WO 2012/170438 A2 13 December 2012 (13.12.2012) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2012/170438 A2 13 December 2012 (13.12.2012) P O P C T (51) International Patent Classification: (74) Agent: BERNSTEIN, Scott; AMGEN INC., One Amgen A61K 39/00 (2006.01) Center Drive, Patent Operations/MS 28-2-C, Thousand Oaks, CA 91320-1799 (US). (21) International Application Number: PCT/US20 12/040941 (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (22) Date: International Filing AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, 5 June 2012 (05.06.2012) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, (25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, (26) Publication Language: English KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, (30) Priority Data: MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 61/493,933 6 June 201 1 (06.06.201 1) US OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, 61/501,133 24 June 201 1 (24.06.201 1) us SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, 61/537,998 22 September 201 1 (22.09.201 1) us TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. 13/487,061 1 June 2012 (01 .06.2012) us (84) Designated States (unless otherwise indicated, for every (71) Applicant (for all designated States except US) : AMGEN kind of regional protection available): ARIPO (BW, GH, INC. [US/US]; One Amgen Center Drive, Thousand Oaks, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, CA 91320-1799 (US). UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (72) Inventors; and EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (75) Inventors/Applicants (for US only): LI, Yang [US/US]; MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, 1142 Cuesta Drive, Mountain View, CA 94040 (US). TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, STEVENS, Jennitte [US/US]; 9820 West Olympic ML, MR, NE, SN, TD, TG). Boulevard, Beverly Hills, CA 90212 (US). KING, Chad- wick, Terence [CA/CA]; 1325 Moody Avenue, North Declarations under Rule 4.17 : Vancouver, British Columbia V7L 3T5 (CA). FOLTZ, Ian — as to applicant's entitlement to applyfor and be granted a [CA/CA]; 2108 Knightswood Place, Burnaby, British patent (Rule 4.1 7(H)) Columbia V5A 4B9 (CA). KANNAN, Gunasekaran [US/US]; 1168 Westlake Boulevard, Unit B, Westlake Vil Published: lage, CA 91361 (US). YIE, Junming [US/US]; 2623 — without international search report and to be republished Capella Way, Thousand Oaks, CA 91362 (US). HU, upon receipt of that report (Rule 48.2(g)) Shaw-Fen, Sylvia [US/US]; 986 Lynnmere Drive, Thou — with sequence listing part of description (Rule 5.2(a)) sand Oaks, CA 91360 (US). < (54) Title: HUMAN ANTIGEN BINDING PROTEINS THAT BIND TO A COMPLEX COMPRISING β-KLOTHO AND AN FGF RECEPTOR (57) Abstract: The present invention provides compositions and methods relating to or derived from antigen binding proteins cap o able of inducing B-Klotho, and or FGF21-like mediated signaling. In embodiments, the antigen binding proteins specifically bind to a complex comprising β-Klotho and at least one of (i) FGFRlc, (ii) FGFR2c and (iii) FGFR3c. In some embodiments the antigen binding proteins induce FGF2 1-like signaling. In some embodiments, an antigen binding protein is a fully human, humanized, or chimeric antibodies, binding fragments and derivatives of such antibodies, and polypeptides that specifically bind to a complex com - o prising β-Klotho and at least one of (i) FGFRlc, (ii) FGFR2c and (iii) FGFR3c. Other embodiments provide nucleic acids encoding such antigen binding proteins, and fragments and derivatives thereof, and polypeptides, cells comprising such polynucleotides, meth ods of making such antigen binding proteins, and fragments and derivatives thereof, and polypeptides, and methods of using such o antigen binding proteins, fragments and derivatives thereof, and polypeptides, including methods of treating or diagnosing subjects suffering from type 2 diabetes, obesity, NASH, metabolic syndrome and related disorders or conditions. HUMAN ANTIGEN BINDING PROTEINS THAT BIND TO A COMPLEX COMPRISING -KLOTHO AND AN FGF RECEPTOR This application claims priority to U.S. Application No. 13/487,061 (filed June 01, 2012), which claims benefit to U.S. Provisional applications 61/493,933 (filed June 6, 2011), 61/501,133 (filed June 24, 201 1), and 61/537,998 (filed September 22, 201 1), the contents of each of which are hereby incorporated in their entirety. SEQUENCE LISTING The instant application contains a Sequence Listing which has been submitted in ASCII format via EFS-Web and is hereby incorporated by reference in its entirety. Said ASCII copy, created on May 22, 2012, is named A-1650-US-NP_SeqListing.txt and is 340 KB in size. FIELD OF THE INVENTION The present disclosure relates to nucleic acid molecules encoding antigen binding proteins that bind to a complex comprising β-Klotho and at least one of (i) FGFRlc, (ii) FGFPv2c and (iii) FGFR3c, including antigen binding proteins that induce FGF21-like signaling, as well as pharmaceutical compositions comprising antigen binding proteins that bind to a complex comprising β-Klotho and at least one of (i) FGFRlc, (ii) FGFR2c and (iii) FGFR3c, including antigen binding proteins that induce FGF21-like signaling, and methods for treating metabolic disorders using such nucleic acids, polypeptides, or pharmaceutical compositions. Diagnostic methods using the antigen binding proteins are also provided. BACKGROUND Fibroblast Growth Factor 2 1 (FGF21) is a secreted polypeptide that belongs to a subfamily of Fibroblast Growth Factors (FGFs) that includes FGF 19, FGF21, and FGF23 (Itoh et ah, (2004) Trend Genet. 20:563-69). FGF21 is an atypical FGF in that it is heparin independent and functions as a hormone in the regulation of glucose, lipid, and energy metabolism. It is highly expressed in liver and pancreas and is the only member of the FGF family to be primarily expressed in liver. Transgenic mice overexpressing FGF21 exhibit metabolic phenotypes of slow growth rate, low plasma glucose and triglyceride levels, and an absence of age-associated type 2 diabetes, islet hyperplasia, and obesity. Pharmacological administration of recombinant FGF21 protein in rodent and primate models results in normalized levels of plasma glucose, reduced triglyceride and cholesterol levels, and improved glucose tolerance and insulin sensitivity. In addition, FGF21 reduces body weight and body fat by increasing energy expenditure, physical activity, and metabolic rate. Experimental research provides support for the pharmacological administration of FGF21 for the treatment of type 2 diabetes, obesity, dyslipidemia, and other metabolic conditions or disorders in humans. FGF21 is a liver derived endocrine hormone that stimulates glucose uptake in adipocytes and lipid homeostasis through the activation of its receptor. Interestingly, in addition to the canonical FGF receptor, the FGF21 receptor also comprises the membrane associated β-Klotho as an essential cofactor. Activation of the FGF21 receptor leads to multiple effects on a variety of metabolic parameters. In mammals, FGFs mediate their action via a set of four FGF receptors, FGFRl -4, that in turn are expressed in multiple spliced variants, e.g., FGFRlc, FGFR2c, FGFR3c and FGFR4. Each FGF receptor contains an intracellular tyrosine kinase domain that is activated upon ligand binding, leading to downstream signaling pathways involving MAPKs (Erkl/2), RAF1, AKT1 and STATs. (Kharitonenkov et al, (2008) BioDrugs 22:37-44). Several reports suggested that the "c"-reporter splice variants of FGFRl -3 exhibit specific affinity to β-Klotho and could act as endogenous receptor for FGF21 (Kurosu et al, (2007) J. Biol. Chem. 282:26687-95); Ogawa et al, (2007) Proc. Natl. Acad. Sci. USA 104:7432-37): Kharitonenkov et al., (2008) J. Cell Physiol. 215: 1-7). In the liver, which abundantly expresses both β-Klotho and FGFR4, FGF21 does not induce phosphorylation of MAPK albeit the strong binding of FGF21 to the P-Klotho-FGFR4 complex. In 3T3-L1 cells and white adipose tissue, FGFRl is by far the most abundant receptor, and it is therefore most likely that FGF21's main functional receptors in this tissue are the β-Klotho/FGFRlc complexes. The present disclosure provides a human (or humanized) antigen binding protein, such as a monoclonal antibody, that induces FGF21-like signaling, e.g., an agonistic antibody that mimics the function of FGF21. Such an antibody is a molecule with FGF21-like activity and selectivity but with added therapeutically desirable characteristics typical for an antibody such as protein stability, lack of immunogenicity, ease of production and long half-life in vivo. SUMMARY The instant disclosure provides antigen binding proteins that bind a complex comprising β-Klotho and at least one of (i) FGFRlc, (ii) FGFR2c and (iii) FGFR3c, including antigen binding proteins that induce FGF21-like signaling, as well as pharmaceutical compositions comprising antigen binding proteins that bind to a complex comprising β-Klotho and at least one of (i) FGFRlc, (ii) FGFR2c and (iii) FGFR3c, including antigen binding proteins that induce FGF21-like signaling. In another aspect, also provided are expression vectors and host cells transformed or transfected with the expression vectors that comprise the aforementioned isolated nucleic acid molecules that encode the antigen binding proteins disclosed herein.
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