(10) Patent No.: US 9.284.543 B2 Wei Et Al

(10) Patent No.: US 9.284.543 B2 Wei Et Al

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.

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    81 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us