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(12) United States Patent (10) Patent No.: US 8,431,124 B2 B00kbinder Et Al

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(12) United States Patent (10) Patent No.: US 8,431,124 B2 B00kbinder Et Al USOO8431124B2 (12) United States Patent (10) Patent No.: US 8,431,124 B2 B00kbinder et al. (45) Date of Patent: Apr. 30, 2013 (54) METHODS FOR TREATING ADISEASE (56) References Cited CHARACTERIZED BY AN EXCESS OF HYALURONAN BY ADMINISTERING A U.S. PATENT DOCUMENTS SOLUBLE HYALURONIDASE 3,536,809 A 10/1970 AppleZweig .................. 424/435 GLYCOPROTEIN (SHASEGP) 3,598,123 A 8, 1971 Zaffaroni ....... ... 424/435 3,630,200 A 12/1971 Higuchi ......... ... 424/427 (75) Inventors: Louis H. Bookbinder, San Diego, CA 3,710,795 A 1/1973 Higuchi et al. ... 424/424 (US); Anirban Kundu, San Diego, CA 3,845,770 A 11/1974 Theeuwes et al. ............ 424/427 (US); Gregory I. Frost, Del Mar, CA (Continued) (US) FOREIGN PATENT DOCUMENTS CA 1243,948 11, 1988 (73) Assignee: Halozyme, Inc., San Diego, CA (US) EP O13420 T 1980 (*) Notice: Subject to any disclaimer, the term of this (Continued) patent is extended or adjusted under 35 U.S.C. 154(b) by 543 days. OTHER PUBLICATIONS Baumgartner et al..."The impact of extracellular matrix on the (21) Appl. No.: 12/386,473 chemoresistancee of solid tumors—experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy. Cancer (22) Filed: Apr. 16, 2009 Lett. 131(1):85-99 (1998). (65) Prior Publication Data (Continued) US 2009/0214.505 A1 Aug. 27, 2009 Primary Examiner — Rosanne Kosson Related U.S. Application Data (74) Attorney, Agent, or Firm — McKenna Long & Aldridge LLP; Stephanie Seidman (63) Continuation of application No. 10/795,095, filed on Mar. 5, 2004, now Pat. No. 7,767, 429. (57) ABSTRACT (60) Provisional application No. 60/452,360, filed on Mar. Provided are soluble neutral active Hyaluronidase Glycopro 5, 2003. teins (shASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate (51) Int. C. glycosaminoglycan associated pathologies. Minimally active A6 IK38/47 (2006.01) polypeptide domains of the soluble, neutral active shASEGP A6 IK38/43 (2006.01) domains are described that include asparagine-linked Sugar A6 IK38/17 (2006.01) moieties required for a functional neutral active hyalu CI2N 9/26 (2006.01) ronidase domain. Included are modified amino-terminal CI2P 21/02 (2006.01) leader peptides that enhance secretion of shASEGP. Sialated (52) U.S. C. and pegylated forms of the shASEGPs also are provided. USPC ....... 424/94.62: 514/21.2: 435/201: 435/69.1 Methods of treatment by administering shASEGPs and (58) Field of Classification Search ............... 424/94.62; modified forms thereof also are provided. 514/21.2: 435/201, 69.1 See application file for complete search history. 21 Claims, 1 Drawing Sheet Sac-721 - GAGCTC Psi - 830 - CTGCAG Sca-13-AGTACT Nie-1052- GCTAG C Scal-Saa-AGTACT Ban-3967 - G'GATCC Cia-3960 - ATCG AT Not-3722- GCGGCC GC Mia-3693 - ACGCGT Not - 31.5-GCGGCC GC Sac-3389-G AGCTC S-38 - AGTACT US 8,431,124 B2 Page 2 U.S. PATENT DOCUMENTS 6,858,736 B2 2/2005 Chang-min et al. .......... 546,290 3,916,899 A 1 1/1975 Theeuwes et al. ............ 424/424 $325; R. 39 Star 32. RE28,819 E 5/1976 Thompson ..... 514,174 7,148,201 B2 12/2006 Stern et al. ...................... 514,44 4,002,531. A 1/1977 Royer ............ 435,188 7.368,108 B2 5/2008 DeFrees et al. .............. 424,945 4,008,719 A 2f1977 Theeuwes et all 424/427 7,544.499 B2 6/2009 Frost et al. .......... ... 435/200 4,044,126 A 8, 1977 Cook et al. 514,180 7,767.429 B2 8/2010 Bookbinder et al. 435,201 4,179,337 A 12/1979 Davis et al. 435/181 7,781,397 B2 8/2010 Stern et al. ........................ 514/2 4.328,245. A 5/1982 Yu et al. ... 514,530 7,829,081 B2 11/2010 Bookbinder et al. ...... 424/94.62 4,358,603 A 1 1/1982 Yu ..................................... 560.2 7,846,431 B2 12/2010 Bookbinder et al. ...... 424/94.62 4,364,923. A 12/1982 Cook et al. ... 424/46 7,871,607 B2 1/2011 Bookbinder et al. ...... 424/94.62 4,409,239 A 10/1983 Yu ............ 514,530 8,105,586 B2 1/2012 Bookbinder et al. ...... 424/94.62 4.410,545. A 10/1983 Yu et al. ... 514,530 2001/0021763 A1 9, 2001 Harris ............................. 528,75 4.414,209 A 1 1/1983 Cook et al... 514,180 2001/0044526 A1 11/2001 Shen ............................. 530/409 4,522,811 A 6/1985 Eppstein et al. ............ 514/2 2001/0046481 A1 1 1/2001 Bentley et al. 424/78.18 4,687,610 A 8, 1987 Vassilatos ................ 264/211.14 2002fOO52430 A1 5, 2002 Harris et al. .... ... 523,406 4,769,027 A 9/1988 Baker et al. ... 424/493 2002/0072573 A1 6/2002 Bentley et al. 525/409 4.820,516 A 4, 1989 Sawyer et al. ... 424/96.2 2002fO156047 A1 10, 2002 Zhao ..... 514/58 4,952,496 A 8/1990 Studier et al. .. 435,9141 2003/0114647 A1 6/2003 Harris et al. 530/402 4,980.286 A 12/1990 Morgan et al. 435/371 2003/0143596 A1 7/2003 Bentley et al. .................... 435/6 5,041.292 A 8/1991 Feijen ...... 424/484 2003/0158333 A1 8/2003 Roberts et al. ............. 525,54.11 5,052,558 A 10, 1991 Carter ... 206,439 2003/0170243 A1 9, 2003 Stern et al. ... ... 424,146.1 5,059,595 A 10/1991 Le Grazie ... 424/468 2003/0220447 A 11/2003 Harris. 525,541 5,073,543 A 12/1991 Marshall et al. ................ 514, 21 2004/0013637 A1 1/2004 Bentley et al. 424/78.17 5,120,548. A 6/1992 McClelland et al. ......... 424/473 2004/0096.921 A1 5/2004 Stern et al. ... 435/7.92 5,122,614 A 6/1992 Zalipsky ............ 548,520 2004/O151714 A1 8, 2004 SO11 et al. 424/94.61 5, 183,550 A 2f1993 Mattiessen .. 204,415 2004/O157787 A1 8/2004 Or et al. .............. 514, 28 5.215,899 A 6/1993 Dattagupta ....................... 435/6 2004/0224012 A1 1 1/2004 Suvanprakorn et al. ... 424/450 5,292,509 A 3/1994 Hageman ... 424/94.61 2004/0224023 A1 11/2004 Hunter et al. .......... 424/486 5,323.907. A 6/1994 Kalvelage ... ... 206,531 2004/0268425 A1 12/2004 Bookbinder et al. ........... 800, 18 5,324,844. A 6/1994 Zalipsky ..... 548,520 2005.0002865 A1 1/2005 Klaveness et al. ........... 424/9.52 5,354,566. A 10, 1994 Addesso et al. .................. 426.9 2005, 0004.095 A1 1/2005 Glinka et al. ... ... 514,204 5,436,128 A 7/1995 Harpold et al. ................ 435/6 2005/01 14037 A1 5/2005 Desjarlais et al. 702/19 5,446,090 A 8/1995 Harris .......................... 525,54.1 2005, 0171328 A1 8, 2005 Harris .......... 528,322 5,591,767 A 1/1997 Mohr et al. ... 514,413 2005/0209416 A1 9, 2005 Harris ........................... 525,523 5,612.460 A 3, 1997 Zalipsky ...... 530,391.9 2005/0260186 A1 11/2005 Bookbinder et al. ...... 424/94.61 5,631,018 A 5/1997 Zalipsky et al. ... 424/450 2005/0287.134 A1 12/2005 Klein ......................... 424.94.61 5,639,476 A 6/1997 Oshlack et al. ... 424/468 2006/0.104968 A1 5/2006 Bookbinder et al. ...... 424/94.61 5,643,575 A 7/1997 Martinez et al. 424,194.1 2007/0134228 A1 6/2007 Stern et al. ...... ... 424/94.61 5,665.069 A 9, 1997 Cumer et al. ... 604f116 2007. 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A 2, 1998 Primakoff. 536,221 2009/0253175 A1 10, 2009 Bookbinder et al. ........ 435/69.1 5,723, 147 A 3/1998 Kim et al. 424/450 2009/0304665 A1 12/2009 Frost et al. ................... 424,945 5,733,566 A 3/1998 Lewis ........................... 424/426 20090311237 A1 12/2009 Frost ........ 424/94.62 5,747.027 A 5/1998 Stern et al. .............. 424/94.62 2010.0003238 A1 1/2010 Frost et al. ... 424/94.62 5,766,581 A 6/1998 Bartley et al... ... 424/85.1 2010.0015698 A1 1/2010 Frost et al. ................. 435/320.1 5,766,627 A 6/1998 Sankaram et al. 424/450 2010, 0074885 A1 3, 2010 Schiff et al. .. 424,130.1 5,795,569 A 8, 1998 Bartley et al. 424,85.1 2010.01434.57 A1 6, 2010 Wei et al. ........ ... 424/450 5,808,096 A 9/1998 Zalipsky ..... 548,520 2010/0172892 A1 7, 2010 Uvarkina et al. 424/94.62 5,827,721. 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