(10) Patent No.: US 9.284.543 B2 Wei Et Al
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USOO9284543B2 (12) United States Patent (10) Patent No.: US 9.284.543 B2 Wei et al. (45) Date of Patent: Mar. 15, 2016 (54) NEUTRAL ACTIVE SOLUBLE TRUNCATED 5,643,575 A 7/1997 Martinez et al. ........... 424,194.1 PH2O POLYPEPTDES AND USES THEREOF 5,665,069 A 9/1997 Cumer et al. ..... ... 604,116 5,672,662 A 9, 1997 Harris et al. .. 525/408 5,674,533 A 10/1997 Santus et al. ...... ... 424/493 (75) Inventors: GeWei, San Diego, CA (US); 5,705.364 A 1/1998 Etcheverry et al. .......... 435/70.3 Krishnasamy Panneer Selvam, Poway, 5,721,348 A 2/1998 Primakoff ..... 536,221 CA (US); Louis Bookbinder, San 5,733,566 A 3, 1998 Lewis ........ ... 424/426 Diego, CA (US); Gregory I. Frost, Del 5,766,581 A 6/1998 Bartley et al. 424/85.1 MaCA (US) s s 5,795,569 A 8/1998 Bartley et al. 424/85.1 s 5,808.096 A 9/1998 Zalipsky ........... 548,520 5,854,046 A 12/1998 Au-Young et al. ... 435,201 (73) Assignee: Halozyme, Inc., San Diego, CA (US) 5,900.461 A 5/1999 Harris .................. 525,54.11 5,919,455 A 7/1999 Greeninnwald et al. .... 424,178.1 (*) Notice: Subject to any disclaimer, the term of this 5,932,462 A 8/1999 Harris et al. .................. 435.188 patent is extended or adjusted under 35 E. A 3: CCCling al. ......et al. 5. U.S.C. 154(b) by 449 days. 5.990.237 A 1 1/1999 Bentley et al. ... 525,542 6,057,110 A 5/2000 Au-Young et al. ................ 435/6 (21) Appl. No.: 13/385,527 6,103.525. A 8/2000 Stern et al. ........ ... 435,326 6,113,906 A 9, 2000 Greenwald et al. ........ 424,194.1 (22) Filed: Feb. 21, 2012 6,123,938 A 9, 2000 Stern et al. .... ... 424/94.62 6,193,963 B1 2/2001 Stern et al. 424/94.6 O O 6,214,966 B1 4/2001 Harris ... 528,322 (65) Prior Publication Data 6,258,351 B1 7/2001 Harris ... 424/78.3 US 2012/0213767 A1 Aug. 23, 2012 6,340,742 B1 1/2002 Burg et al. 530,351 6,413.507 B1 7/2002 Bentley et al. ... 42478 US 2013/0101577 A9 Apr. 25, 2013 6.420,339 B1 7/2002 Gegg et al. ... 514/12 6,437,025 B1 8/2002 Harris et al. .. 523,406 Related U.S. Application Data 6,448,369 B1 9/2002 Bentley et al. ... 528/425 6,461,802 B1 10/2002 Van Thillo et al. ... 430,336 (63) Continuation of application No. 127653.245, filed on 6,461,863 B1 10/2002 Jarvis ......................... 435/320.1 Dec. 9, 2009. (Continued) (60) Provisional application No. 61/281,240, filed on Nov. 13, 2009, provisional application No. 61/201,384, FOREIGN PATENT DOCUMENTS filed on Dec. 9, 2008. CA 23.18356 T 2000 EP O400472 12/1990 (51) Int. Cl. CI2N 9/26 (2006.01) (Continued) A6 IK 47/48 (2006.01) A61 K38/00 (2006.01) OTHER PUBLICATIONS (52) U.S. Cl. Letter/Written Disclosure of the Supplemental Information Disclo CPC .......... CI2N 9/2408 (2013.01); A61 K47/4823 sure Statement for the above-referenced application, mailed on Nov. (2013.01); A61 K47/48215 (2013.01); A61 K 13, 2013, 2 pages. 47/48292 (2013.01); C12N 9/2474 (2013.01); Dyson et al., “Production of soluble mammalian proteins in A61 K38/00 (2013.01) Escherichia coli: identification of protein features that correlate with (58) Field of Classification Search successful expression.” BMC Biotechnol. 4:32 (2004). Gayle et al., “Identification of regions in interleukin-1 alpha impor CPC ............................ C12N 9/2408; C12N 9/2474 tant for activity.” J Biol Chem. 268(29): 22105-221 11 (1993). See application file for complete search history. Moran et al., “Glycophospholipid membrane anchor attachment. Molecular analysis of the cleavage attachment site.” J Biol Chem. (56) References Cited 266(2): 1250-1257 (1991). Vigdorovich et al., “Expression and characterization of a soluble, U.S. PATENT DOCUMENTS active form of the jaagsiekte sheep retrovirus receptor, Hyal2. J 3,536,809 A 10/1970 AppleZweig .................... 424,28 Virol. 79(1):79-86 (2005). 3,710,795 A 1/1973 Higuchi et al. ... 424/424 (Continued) 4,002,531 A 1/1977 Royer .......... ... 435,188 4,364,923 A 12/1982 Cook et al. ...................... 424/46 4,952.496 A 8, 1990 Studier et al. 435,9141 Primary Examiner — Sheridan Swope $835 A 88: as: . .3.26 (74) Attorney, Agent, or Firm — Dentons US LLP: 5,059,595 A 10/1991 Le Grazie ... 424/468 Stephanie Seidman 5,073,543 A 12/1991 Marshall et al. 514/21 5,116,615 A 5/1992 Gokcen et al. ...... ... 424/94.2 5, 120,548 A 6, 1992 McClelland et al. ... 424/473 (57) ABSTRACT 5,122,614 A 6/1992 Zalipsky ......... ... 548,520 Soluble PH20 polypeptides are provided, including extended 5,292,509 A 3/1994 Hageman . 424/94.61 5,323,907 A 6/1994 Kalvelage ..................... 206,531 soluble PH20 polypeptides, and uses thereof. Also provided 5,324,844 A 6/1994 Zalipsky ....................... 548,520 are other C-terminally truncated PH20 polypeptides and par 5,446,090 A 8, 1995 Harris ...... 525,54.1 tially deglycosylated PH20 polypeptides and uses thereof. 5,591,767 A 1/1997 Mohr et al. ... 514,413 5,612.460 A 3/1997 Zalipsky ...... 530.391.9 5,639,476 A 6, 1997 Oshlack et al. ............... 424/468 22 Claims, 6 Drawing Sheets US 9,284.543 B2 Page 2 (56) References Cited 2012fO294.830 A1 11/2012 Bookbinder et al. ........ 424/85.2 2013, OO11378 A1 1/2013 Yang et al. ...... ... 424/94.3 U.S. PATENT DOCUMENTS 2013/0022.588 A1 1/2013 Yang et al. ... ... 424/94.3 2013/0022592 A1 1/2013 Vaughn et al. ............. 424/94.62 6,495,659 B2 12, 2002 Bentley et al. ................ 528/425 2013,0058893 A1 3/2013 Bookbinder et al. ......... 435/200 6,552,170 B1 4, 2003 Thompson et al. 530,351 2013/0202583 A1 8/2013 Jiang et al. ...... 424/94.62 6,737,505 B2 5, 2004 Bentley et al. ................ 528/425 2013/0251786 A1 9/2013 Li et al. .... ... 424/94.62 2013/0302275 A1 11, 2013 Wei et al. ..... 424/94.62 6,745,776 B2 6, 2004 Soll ............................... 128/898 6,828.401 B2 12, 2004 Nho et al. ... 526,333 2013/0302400 A1 11/2013 Maneval et al. .............. 435/195 6,828,431 B1 12, 2004 Frudakis et al. 536,231 2014/0037613 A1 2/2014 Bookbinder et al. ...... 424/94.62 6,858,736 B2 2, 2005 Nho et al. .......... 546,290 2014,0199282 A1 7/2014 Bookbinder et al. ......... 435/200 7,015,253 B2 3, 2006 Escandon et al. .. 514,724 2014/0248237 A1 9/2014 Bookbinder et al. ...... 424/94.62 7,105,330 B2 9, 2006 Stern et al. ..... 435/200 7,148,201 B2 12, 2006 Stern et al. .. 514,44 R FOREIGN PATENT DOCUMENTS 7,368, 108 B2 5/2008 DeFrees et al. .... 424/94.5 7,601,335 B2 10, 2009 McCutcheon et al. ......... 424.9.2 EP O822199 9, 2004 7,767.429 B2 8, 2010 Frost et al. .................... 435,201 JP A-2008-531017 8, 2008 7,781,397 B2 8, 2010 Stern et al. ......... 424/94.62 JP 5-670913 2, 2015 7,829,081 B2 11, 2010 Bookbinder et al. 424/94.62 WO WO 88,02261 4f1988 7,846,431 B2 12, 2010 Bookbinder et al. ...... 424/94.62 WO WO 2004/078140 9, 2004 7,871,607 B2 1, 2011 Bookbinder et al. ...... 424/94.62 WO WO 2006/09 1871 8, 2006 7.914,542 B2 3, 2011 Lamson et al. ....... ... 606,139 WO WO 2006,133553 12/2006 8, 105,586 B2 1, 2012 Bookbinder et al. 424/94.3 WO WO 2008.101.098 8, 2008 8, 187,855 B2 5, 2012 Baker et al. ........... ... 435,201 WO WO 2009/128917 10/2009 8,257,699 B2 9, 2012 Bookbinder et al. ...... 424/94.62 WO WO 201O/O77297 T 2010 8,343,487 B2 1, 2013 Baker et al. ................ 424/94.62 8,431,124 B2 4, 2013 Bookbinder et al. ...... 424/94.62 OTHER PUBLICATIONS 8,431,380 B2 4, 2013 Bookbinder et al. ......... 435/201 Whisstock, J. and A. Lesk, “Prediction of protein function from 8.450,470 B2 5, 2013 Bookbinder et al. ........ 536,232 protein sequence and structure.” Q Rev Biophys. 36(3):307-340 8,580,252 B2 11, 2013 Bookbinder et al. 424/85.2 (2003). 8,765,685 B2 T/2014 Bookbinder et al. 514, 20.9 Willard et al., “Expression, purification, and characterization of the 8,772.246 B2 T/2014 Bookbinder et al. ......... 435/200 human receptor activator of NF-kappaB ligand (RANKL) extracel 8,846,034 B2 9, 2014 Jiang et al. ......... 424/94.62 8,927,249 B2 1/2015 Wei et al. ... 424/450 lular domain.” Protein Expr Purif. 2001);48-57 (2000). 2001/OO21763 A1 9, 2001 Harris ...... 528,75 Halozyme Therapeutics Investor Presentation, "Halozyme Thera 2001/0044526 A1 11, 2001 Shen ........... 530/409 peutics, Inc.: Thinking outside the cell.” Presented on Oct. 2, 2012 2001 0046481 A1 11/2001 Bentley et al. 424/78.18 online retrieved on Oct. 11, 2012 Retrieved from:<URL: sec.gov/ 2002fOO52430 A1 5, 2002 Harris et al. .................. 523,406 Archives/edgar/data 1159036/0001 19312512412748/ 20O2/OO72573 A1 6, 2002 Bentley et al.