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(12) United States Patent (10) Patent No.: US 9,005,612 B2 Ledbetter Et Al

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(12) United States Patent (10) Patent No.: US 9,005,612 B2 Ledbetter Et Al US009005612B2 (12) United States Patent (10) Patent No.: US 9,005,612 B2 Ledbetter et al. (45) Date of Patent: *Apr. 14, 2015 (54) BINDING DOMAIN-IMMUNOGLOBULIN 5,455,030 A 10/1995 Ladner et al. FUSION PROTEINS $599. A 3: BestInsley et al. al. (75) Inventors: Jeffrey A. Ledbetter, Seattle, WA (US); 5,530,101 A 6/1996 Queen et al. Martha S. Hayden-Ledbetter, Seattle, 5,580,756. A 12/1996 Linsley et al. WA (US) 5,595,7215,585,089 A 1431/1997 SAS,Kaminski et al.1 (73) Assignee: Emergent Product Development 5,597,707 A 1/1997 Marken et al. Seattle, LLC, Seattle, WA (US) 3.W - A 3.87 EaCee ea. (*) Notice: Subject to any disclaimer, the term of this 5,645,835 A 7/1997 Fell, Jr. et al. patent is extended or adjusted under 35 $22.9 A ck 8. 3. Earl 530,387.1 U.S.C. 154(b) by 0 days. 5,693,762.w A 12/1997 QueenOCC et Cal. al. ............ This patent is Subject to a terminal dis- 5,709,859 A 1/1998 Aruffo et al. claimer 5,714,147 A 2, 1998 Capon et al. 5,721, 108 A 2f1998 Robinson et al. (21) Appl. No.: 13/451,641 5,736,137 A 4, 1998 Anderson et al. 5,770,197 A 6/1998 Linsley et al. (22) Filed: Apr. 20, 2012 5,773.253 A 6/1998 Linsley et al. O O 5,776.456 A 7/1998 Anderson et al. (65) Prior Publication Data 5,795,572 A 8/1998 Diegel et al. US 2013/O142793 A1 Jun. 6, 2013 5,843,3985,807,734. A 12/19989/1998 DiegelKaminski et al.et al. O O 5,843,439 A 12/1998 Anderson et al. Related U.S. Application Data 5,844,093 A 12/1998 Kettleborough et al. (63) Continuation of application No. 12/901.297, filed on (Continued) Oct. 8, 2010, now Pat. No. 8,197,810, which is a continuation of application No. 1 1/088.693, filed on FOREIGN PATENT DOCUMENTS Mar. 23, 2005, now Pat. No. 8,106,161, which is a continuation of application No. 10/053,530, filed on E. 85. i: A: 3. Jan. 17, 2002, now abandoned. EP O 332865 A2 9, 1989 (60) Pyal application No. 60/367,358, filed on Jan. (Continued) (51) Int. Cl. OTHER PUBLICATIONS g 9: 3.08: Belikov, V.G., Pharmaceutical Chemistry, Moscow: Vysshaya C07K I6/46 (2006.01) Shkola, 1993, pp. 43-47. A61 K39/00 (2006.01) Mashkovsky, M.D., Medicaments, Moscow: Novaya Volna, Part 1, p. 11 (2001). (52) U.S. Cl. O’Brien, S.O. “New Agents in the Treatment of CLL' 2008 Hema CPC ........... C07K 16/46 (2013.01); A6 IK 2039/505 tology Am. Soc. Hematol. Educ. Program pp. 457-464. (2013.01); C07K 16/2809 (2013.01); C07K "IUPAC-IUB commission on biochemical nomenclature rules for I6/2818 (2013.01); C07K 16/2878 (2013.01); naming synthetic modification of natural peptides tentative rules. J. C07K 16/2896 (2013.01); C07K 16/462 Biol. Chem. 242:555-557, 1967. (2013.01); C07K 231 7/22 (2013.01); C07K (Continued) 2317/24 (2013.01); C07K 2317/53 (2013.01); C07K 2317/622 (2013.01); C07K 2317/64 (2013.01); C07K 2317/732 (2013.01); C07K Primary Examiner — Laura B Goddard 2317/734 (2013.01); C07K 2319/00 (2013.01); Assistant Examiner — Meera Natarajan C07K 2319/30 (2013.01) (74) Attorney, Agent, or Firm — Cooley LLP (58) Field of Classification Search USPC .... - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 424/130.1 See application file for complete search history. (57) ABSTRACT (56) References Cited The invention relates to novel binding domain immunoglo bulin fusion proteins that feature a binding domain for a U.S. PATENT DOCUMENTS cognate structure Such as an antigen, a counterreceptor or the like, a hinge region polypeptide having either Zero or one 4,704,692 A 11, 1987 Ladner 4,816,567 A 3/1989 Cabilly et al. cysteine residue, and immunoglobulin CH2 and CH3 4,861,579 A 8/1989 Meyer, Jr. et al. domains, and that are capable of ADCC and/or CDC while 4,906,562 A 3, 1990 Hellstrom et al. occurring predominantly as monomeric polypeptides. The 4,935,495 A 6, 1990 Hellstrom et al. fusion proteins can be recombinantly produced at high 4.946,778 A 8, 1990 Ladner et al. 5,091,177 A 2f1992 Hellstrom et al. expression levels. Also provided are related compositions and 5,098,833. A 3/1992 Lasky et al. methods, including immunotherapeutic applications. 5,225,539 A 7, 1993 Winter 5,260,203 A 11/1993 Ladner et al. 5.434,131 A 7/1995 Linsley et al. 22 Claims, 26 Drawing Sheets US 9,005,612 B2 Page 2 (56) References Cited 2002fO155604 A1 10, 2002 Ledbetter et al. 2002fO1972.55 A1 12/2002 Anderson et al. U.S. PATENT DOCUMENTS 2002fO197256 A1 12/2002 Grewal 2003/0021781 A1 1/2003 Anderson et al. 5,844,095 A 12/1998 Linsley et al. 2003/0026801 A1 2/2003 Weiner et al. 5,849,898 A 12/1998 Seed et al. 2003/0044423 A1 3/2003 Gillies et al. ............... 424,192.1 5,869,049 A 2f1999 Noelle et al. 2003, OO88074 A1 5/2003 Hamers et al. 5,869,620 A 2f1999 Whitlow et al. 2003.0118592 A1 6/2003 Ledbetter et al. 5,876,718 A 3, 1999 Noelle et al. 2003. O133930 A1 7/2003 Goldenberg et al. 5,876,950 A 3, 1999 Siadak et al. 2003. O133939 A1 7/2003 Ledbetter et al. 5,888,773 A 3, 1999 Jost et al. 2003/0219433 A1 11/2003 Hansen et al. 5,892,019 A 4/1999 Schlom et al. 2003/0219436 A1 11/2003 Ledbetter et al. 5,916.560 A 6, 1999 Larsen et al. 2003/0219446 A1 1 1/2003 Linsley et al. 5,955,315 A 9, 1999 Lee et al. 2003/0219876 A1 11/2003 Ledbetter et al. 6,015,542 A 1/2000 Kaminski et al. 2004/0058445 A1 3/2004 Ledbetter et al. 6,015,695 A 1/2000 Casterman et al. 2005, OO84933 A1 4/2005 Schilling et al. 6,074,644 A 6, 2000 Pastan et al. 2005. O136049 A1 6/2005 Ledbetter et al. 6,074,655 A 6, 2000 Fowler et al. 2005/0175614 A1 8, 2005 Ledbetter et al. 6,087.329 A 7/2000 Armitage et al. 2005/O18097O A1 8, 2005 Ledbetter et al. 6,090,365 A 7/2000 Kaminski et al. 2005, 0186216 A1 8, 2005 Ledbetter et al. 6,090,914 A 7/2000 Linsley et al. 2005/0202012 A1 9, 2005 Ledbetter et al. 6,105,542 A 8, 2000 Efford 2005/0202023 A1 9, 2005 Ledbetter et al. 6,120,767 A 9, 2000 Robinson et al. 2005/0202028 A1 9, 2005 Ledbetter et al. 6,136,313 A 10, 2000 Stevenson 2005/0202534 A1 9, 2005 Ledbetter et al. 6,147,203 A 11/2000 Pastan et al. 2005/0238646 A1 10, 2005 Ledbetter et al. 6,150,584. A 1 1/2000 Kucherlapati et al. 3.339:1 A. 58. Styayever et etal al. 1 8.5% R 299; S. al. 2006/0051844 A1 3/2006 Heavner et al. 6,194.551 B1 2/2001 Idusogie et al. 388 3. A. (39. Black et al. tal g: R 38: Babyitem 2007/0237779 A1 10, 2007 LedbetterOSale et ea. al. 6.264,951 B1 7/2001 Armitage et al. 2008/0213273 A1 9/2008 Burge 6,284,536 B1 9, 2001 Morrison et al. 2008/027985.0 A1 1 1/2008 Brady et al. 6,287,537 B1 9/2001 Kaminski et al. 2009/0041765 A1 2/2009 Espling et al. 6,306,393 B1 10/2001 Goldenberg 2009,0088.346 A1 4/2009 Enzelberger et al. 6.312,692 B1 11/2001 Noelle et al. 2009, O148447 A1 6/2009 Ledbetter et al. 6,352.694 B 32002 Juneetal. 2009/0175867 A1 7/2009 Thompson et al. 6,368,596 B1 4/2002 Ghetie et al. 2009,0196.870 A1 8, 2009 Ledbetter et al. 6,376.459 B1 4/2002 Aruffo et al. 2009, 0214539 A1 8/2009 Grosmaire et al. 6,384, 198 B1 5/2002 Diegel et al. 2009,0274692 A1 11/2009 Tan et al. 6,399,061 B1 6/2002 Anderson et al. 2010.0034820 A1 2/2010 Ledbetter et al. 6,403,769 B1 6/2002 Larochelle et al. 2010, O135900 A1 6/2010 Cerveny et al. 6.410,319 B1 6, 2002 Raubitschek et al. 2010/02O3052 A1 8, 2010 Ledbetter et al. 6.410,391 B1 6, 2002 ZelSacher 2010/0279932 A1 11/2010 Ledbetter et al. 6,444,792 B1 9/2002 Gray et al. 2011 OO33483 A1 2/2011 Thompson et al. 6,455,043 B1 9/2002 Grillo-Lopez 2011/0091461 A1 4/2011 Ledbetter et al. 6,472,510 B1 10/2002 Aruffo et al. 2011/0105729 A1 5, 2011 Ledbetter et al. 6,482.919 B2 11/2002 Ledbetter et al. 2011/0171208 A1 7/2011 Tan et al. 6,515, 110 B1 2/2003 Whitlow et al. 2011/0223164 A1 9, 2011 Ledbetter et al. 6,518,277 B1 2/2003 Sadhu et al. 6,528,624 B1 3/2003 Idusogie et al. FOREIGN PATENT DOCUMENTS 6,538,124 B1 3/2003 Idusogie et al. 6,586.428 B2 7/2003 Geroni et al. 6,623,940 B1 9, 2003 Ledbetter et al.
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