Claims for Patent: 7,534,431

Summary for Patent: 7,534,431

Title:	Methods and compositions for administering therapeutic and diagnostic agents
Abstract:	Methods and compositions are described for targeting therapeutic and diagnostic molecules to particular types of cells using targeting antibodies or other targeting moeities.
Inventor(s):	McBride; William J. (Boonton, NJ), Hansen; Hans J. (Picayune, MS), Chang; Chien-Hsing Ken (Downington, PA), Goldenberg; David M. (Mendham, NJ)
Assignee:	Immunomedics, Inc. (Morris Plains, NJ)
Application Number:	10/768,707
Patent Claims:	1. A method for treating or diagnosing cancer in a subject, comprising: a) administering to said subject (i) a bispecific antibody comprising a target binding moiety that binds to a tumor-associated marker selected from the group consisting of carcinoembryonic antigen (CEA), colon-specific antigen-p (CSAp), CD4, CD5, CD8, CD14, CD15, CD19, CD20, CD22, CD40, CD40L, CD74, B7, HLA-DR, EGFR, HER 2/neu, TAG-72, EGP-1, HCG, HCG-beta, PSMA, PSA, VEGF, IL-2 and MAGE, and at least one targetable construct binding moiety that binds to a first hapten comprising HSG (histamine succinyl glycine), DTPA (diethylenetriaminepentaacetic acid) or Tscg-Cys (thiosemi-carbazonylglyoxylcysteine); (ii) a targetable construct comprising Ac-Lys(DTPA)-Tyr-Lys(DTPA)-Lys(Tscg-Cys)-NH.sub.2 (SEQ TD NO:1), or DTPA-Gln-Ala-Lys(HSG)-D-Tyr-Lys(HSG)-NH.sub.2 (IMP 272), said targetable construct comprising a therapeutic or diagnostic moiety; and (iii) a clearing agent comprising one or more second antibody or antigen binding fragment thereof that binds to a second hapten comprising HSG, DTPA or Tscg-Cys, wherein said first and second haptens are orthogonal to each other and said clearing agent enhances retention of said targetable construct at a target site. 2. The method of claim 1, wherein said tumor-associated marker is CEA, CD74, HLA-DR, CD20, CD22 or EGP-1. 3. The method of claim 2, wherein said target binding moiety is a humanized, chimeric, human or murine anti-CEA MN14, anti-CD74 LL1, anti-CD20 A20, anti-CD22 LL2 or anti-EGP-1 RS7 antibody or antigen binding fragment thereof. 4. A method for treating or diagnosing cancer in a subject, comprising: a) administering to said subject (i) a bispecific antibody comprising a target binding moiety that binds to a tumor-associated marker selected from the group consisting of carcinoembryonic antigen (CEA), colon-specific antigen-p (CSAp), CD4, CD5, CD8, CD14, CD15, CD19, CD20, CD22, CD40, CD40L, CD74, B7, HLA-DR, EGFR, HER 2/neu. TAG-72, EGP-1, HCG, HCG-beta, PSMA, PSA, VEGF, IL-2 and MAGE, and at least one targetable construct binding moiety that binds to a first hapten comprising HSG (histamine succinyl glycine); (ii) a targetable construct comprising DTPA-Gln-Ala-Lys(HSG)-D-Tyr-Lys(HSG)-NH.sub.2 (IMP 272), said targetable construct comprising a therapeutic or diagnostic moiety; and (iii) a clearing agent comprising one or more second antibody antigen binding fragment thereof that binds to a second hapten comprising In-DTPA, wherein said first and second haptens are orthogonal to each other and said clearing agent enhances retention of said targetable construct at a target site. 5. The method of claim 4, wherein said binding moiety that binds to said first hapten HSG is an antibody designated 679 and said second antibody that binds to said second hapten comprising In-DPTA is antibody designated 734. 6. The method of claim 1, wherein binding of said clearing agent to said targetable construct stabilizes binding of said targetable construct to said bispecific antibody and enhances clearance of said targetable construct not bound to said bispecific antibody. 7. The method of claim 1, wherein said bispecific antibody and said targetable construct are administered simultaneously, and said clearing agent is administered subsequently or at the same time of said simultaneous administration. 8. The method of claim 1, wherein said bispecific antibody or antigen binding fragment thereof and second antibody or antigen binding fragment thereof are selected from the group consisting of a humanized antibody, a chimeric antibody, a human antibody, a murine antibody and an antigen binding fragment thereof. 9. The method of claim 8, wherein said second antibody is an IgG antibody. 10. The method of claim 9, wherein said IgG antibody of said clearing agent is an IgG antibody with a CH.sub.2 deletion that enhances clearance from circulation. 11. The method of claim 1, wherein said second antibody or antigen binding fragment thereof is conjugated to an internalization moiety selected from the group consisting of folic acid, methotrexate, HIV-1 tat, transportan, Model Amphipathic Peptide (MAP) penetratin, somatostatin, LHRH, bombesin, CCKB, substance P and VIP. 12. The method of claim 11, wherein said internalization moiety is folic acid. 13. The method of claim 1, wherein said target binding moiety is an anti-CEA antibody or antigen binding fragment thereof. 14. The method of claim 13, wherein the anti-CEA antibody or antigen binding fragment thereof is an hMN-14 antibody or antigen binding fragment thereof. 15. The method of claim 4, wherein said tumor-associated marker is CEA, said bispecific antibody is hMN14.times.m679 that binds to CEA and hapten HSG and said clearing agent is a highly galactosylated m734 IgG with two binding arms for In DTPA. 16. A method for treating or diagnosing cancer in a subject, comprising: a) administering to said subject (i) a bispecific antibody comprising hA20Fab-679scFv that binds to CD20 and hapten HSG; (ii) a targetable construct comprising In-DTPA-Gln-Ala-Lys(HSG)-D-Tyr-Lys(HSG)-NH.sub.2, said targetable construct comprising a therapeutic or diagnostic moiety; and (iii) a clearing agent comprising (c734scFv).sub.2-hLL1 IgG that binds to In-DTPA and CD74, wherein said clearing agent enhances retention of said targetable construct at a target site. 17. The method of claim 1, wherein said tumor-associated marker is CD74 and said target binding moiety is a humanized, chimeric or murine LL1 antibody or antigen-binding LL1 antibody fragment thereof that binds to CD74. 18. The method of claim 1, wherein said tumor-associated marker is CD20 and said target binding moiety is a humanized, chimeric or murine A20 antibody or antigen-binding A20 antibody fragment thereof that binds to CD20. 19. The method of claim 1, wherein said tumor-associated marker is CD22 and said target binding moiety is a humanized, chimeric or murine LL2 antibody or antigen-binding LL2 antibody fragment thereof that binds to CD22. 20. The method of claim 1, wherein said tumor-associated marker is EGP-1 and said target binding moiety is a humanized, chimeric or murine RS7 antibody or antigen-binding RS7 antibody fragment thereof that binds to EGP-1.

Details for Patent 7,534,431

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2023-01-31