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. 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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. 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