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Last Updated: September 27, 2020

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Claims for Patent: 9,382,321

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Summary for Patent: 9,382,321
Title:Effector-deficient anti-CD32A antibodies
Abstract: Effector-deficient anti-CD32a monoclonal antibodies are encompassed, as are method and uses for treating CD32a-mediated diseases and disorders, including, thrombocytopenia, allergy, hemostatic disorders, immune, inflammatory, and autoimmune disorders.
Inventor(s): Francis; John (Longwood, FL), Amirkhosravi; Ali (Longwood, FL), Meyer; Todd (Longwood, FL), Robles-Carrillo; Liza (Rockledge, FL)
Assignee: Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL)
Application Number:14/555,556
Patent Claims:1. A method for inhibiting IgG-Fc ligand binding to CD32a in a human subject comprising: administering a therapeutically effective amount of an effector-deficient anti-CD32a monoclonal antibody to a human subject, wherein the antibody comprises two CD32a binding domains and at least a portion of a C.sub.H2 domain, and is effector-deficient, thereby inhibiting IgG-Fc ligand binding to CD32a.

2. The method of claim 1, wherein the effector-deficient antibody satisfies both the IgG Immune Complex Test and the Immobilized IgG Test, and wherein the FC region of the effector-deficient antibody has been altered so as to reduce or eliminate Fc-binding to CD16, CD32, and/or CD64 type IgG receptors.

3. The method of claim 1, wherein the subject has an IgG-mediated hemostatic disorder.

4. The method of claim 3, wherein the hemostatic disorder is thrombosis with or without thrombocytopenia.

5. The method of claim 3, wherein the hemostatic disorder is selected from the group consisting of IgG-mediated-thrombocytopenia, immune-mediated-thrombocytopenia (ITP), antiphospholipid syndrome (APS), anti-platelet-antibody disorders, heparin-induced thrombocytopenia (HIT), and heparin-induced thrombocytopenia with thrombosis (HITT).

6. The method of claim 1, wherein the subject has an IgG-mediated immune, autoimmune, or inflammatory disease or disorder.

7. The method of claim 6, wherein the IgG-mediated immune, autoimmune or inflammatory disorder is selected from the group consisting of rheumatoid arthritis (RA), psoriasis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease, ulcerative colitis, Crohn's disease, antiphospholipid syndrome (APS), osteoarthritis, systemic lupus erythematous (SLE), lupus nephritis, IgG antibody-induced anemia, and IgG-mediated cytopenia.

8. The method of claim 1, wherein the subject has an IgG immune complex-mediated disease or disorder.

9. The method of claim 8, wherein the IgG immune complex-mediated disease or disorder is an anti-therapeutic-antibody (ATA) response caused by administration of a non-anti-CD32a monoclonal antibody or fragment thereof.

10. The method of claim 9, wherein the non-anti-CD32a antibody is infliximab, adalimumab, certolizumab pegol (antibody-like), golimumab, etanercept (antibody-like), ustekinumab, omalizumab, or bevacizumab.

11. The method of claim 9, wherein the effector deficient anti-CD32a antibody is administered prior to, concurrently with, or following the non-anti-CD32a monoclonal antibody.

12. The method of claim 9, wherein the IgG immune complex-mediated disease or disorder occurs in a patient being treated with a non-anti-CD32a monoclonal antibody for the treatment of rheumatoid arthritis, systemic lupus erythematosus (SLE), lupus nephritis, or inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease.

13. The method of claim 1, wherein the subject has a disease or disorder characterized by IgG localized on the surface of cells circulating in the blood of the human subject.

14. The method of claim 13, wherein the circulating cell type is comprised of one or more of the following: platelets, erythrocytes, monocytes, neutrophils, basophils, eosinophils, B-lymphocytes, macrophages, mast cells, leukemia cells, or microbes.

15. The method of claim 13, wherein the disease or disorder is selected from one or more of the following: thrombocytopenia, leukopenia, neutropenia, lymphopenia, monocytopenia, anemia, hemolytic anemia, or sepsis.

16. A method for treating antibody-mediated allergic or hypersensitivity reactions of type I, type II, or type III in a human subject comprising: administering a therapeutically effective amount of an effector-deficient anti-CD32a monoclonal antibody to a human subject, wherein the antibody comprises two CD32 binding domains and at least a portion of a C.sub.H2 domain, and is effector-deficient, thereby treating the antibody-mediated allergic or hypersensitivity reactions of type I, type II, or type III.

17. The method of claim 16, wherein the allergic disorder is selected from the group consisting of atopy, contact dermatitis, allergic rhinitis, systemic anaphylaxis, localized anaphylaxis as exhibited in hay fever, asthma, hives, food allergies, and eczema, allergic reactions to vaccines, allergic reactions to foods, allergic reactions to, allergic reactions to insect products, allergic reactions to drugs, allergic reactions to mold spores, allergic reactions to animal hair and dander, allergic reactions to latex, blood transfusion reactions, platelet transfusion reactions, erythrocyte transfusion reactions, erythroblastosis fetalis, hemolytic anemia, serum sickness, infusion reactions, necrotizing vasculitis, glomerulonephritis, rheumatoid arthritis, systemic lupus erythematosus, and allergic reactions to microorganisms.

18. The method of claim 1, wherein the monoclonal antibody is humanized.

19. The method of claim 1, wherein the antibody comprises: a. a heavy chain variable region CDR1 sequence comprising a sequence that is identical to the sequence YYWMN (SEQ ID NO: 1) or GFTFSYYW (SEQ ID NO: 73 and SEQ ID NO: 88); b. a heavy chain variable region CDR2 sequence comprising a sequence that is identical to the sequence EIRLKSNNYATHYAESVKG (SEQ ID NO: 2) or IRLKSNNYAT (SEQ ID NO: 74 and SEQ ID NO: 89); c. a heavy chain variable region CDR3 sequence comprising a sequence that is identical to the sequence RDEYYAMDY (SEQ ID NO: 3) or NRRDEYYAMDY (SEQ ID NO: 75 and SEQ ID NO: 90); d. a light chain variable region CDR1 sequence comprising a sequence that is identical to the sequence RASESVDNFGISFMN (SEQ ID NO: 4) or ESVDNFGISF (SEQ ID NO: 76 and SEQ ID NO: 91); e. a light chain variable region CDR2 sequence comprising a sequence that is identical to the sequence GASNQGS (SEQ ID NO: 5) or GAS (SEQ ID NO: 77 and SEQ ID NO: 92); and f. a light chain variable region CDR3 sequence comprising a sequence that is identical to the sequence QQSKEVPWT (SEQ ID NO: 6) or QQSKEVPWT (SEQ ID NO:78 and SEQ ID NO: 93).

20. The method of claim 19, wherein the antibody comprises a variable heavy chain sequence comprising a sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 8 or SEQ ID NO: 12, and a variable light chain sequence comprising a sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 10 or SEQ ID NO: 14.

21. The method of claim 19, wherein the antibody comprises: a. a heavy chain sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 16, SEQ ID NO: 18, or SEQ ID NO: 20; and b. a light chain sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 22, or SEQ ID NO: 24.

22. The method of claim 1, wherein the antibody comprises: a. a heavy chain variable region CDR1 sequence comprising a sequence that is identical to the sequence NYGMN (SEQ ID NO: 25) or GYTFTNYG (SEQ ID NO: 79); b. a heavy chain variable region CDR2 sequence comprising a sequence that identical to the sequence WLNTYTGESIYPDDFKG (SEQ ID NO: 26) or LNTYTGES (SEQ ID NO: 80); c. a heavy chain variable region CDR3 sequence comprising a sequence that is identical to the sequence GDYGYDDPLDY (SEQ ID NO: 27) or ARGDYGYDDPLDY (SEQ ID NO: 81); d. a light chain variable region CDR1 sequence comprising a sequence that is identical to the sequence RSSKSLLHTNGNTYLH (SEQ ID NO: 28) or KSLLHTNGNTY (SEQ ID NO: 82 and SEQ ID NO: 100); e. a light chain variable region CDR2 sequence comprising a sequence identical to the sequence RMSVLAS (SEQ ID NO: 29) or RMS (SEQ ID NO: 83 SEQ ID NO: 101); and a light chain variable region CDR3 sequence comprising a sequence that is identical to the sequence MQHLEYPLT (SEQ ID NO: 30 and SEQ ID NO: 84 and SEQ ID NO: 102).

23. The method of claim 22, wherein the antibody comprises: a. a variable heavy chain sequence comprising a sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 32, SEQ ID NO: 36, or SEQ ID NO: 38; and b. a variable light chain sequence comprising a sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 34, SEQ ID NO: 41 or SEQ ID 85.

24. The method of claim 22, wherein the antibody comprises: a. a heavy chain sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 43, SEQ ID NO: 45, SEQ ID NO: 47, or SEQ ID NO: 49; and b. a light chain sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 51, SEQ ID NO: 53 or SEQ ID NO: 87.

25. The method of claim 1, wherein the antibody comprises: a. a heavy chain variable region CDR1 sequence comprising a sequence that is identical to the sequence SYGMH (SEQ ID NO: 54) or GFTFSSYG (SEQ ID NO: 94); b. a heavy chain variable region CDR2 sequence comprising a sequence that is identical to the sequence VIWYDGSNYYYTDSVKG (SEQ ID NO: 55) or IWYDGSNY (SEQ ID NO: 95); c. a heavy chain variable region CDR3 sequence comprising a sequence that is identical to the sequence DLGAAASDY (SEQ ID NO: 56) or ARDLGAAASDY (SEQ ID NO: 96); d. a light chain variable region CDR1 sequence comprising a sequence that is identical to the sequence RASQGINSALA (SEQ ID NO: 57) or QGINSA (SEQ ID NO: 97); e. a light chain variable region CDR2 sequence comprising a sequence that is identical to the sequence DASSLES (SEQ ID NO: 58) or DAS (SEQ ID NO: 98); and f. a light chain variable region CDR3 sequence comprising a sequence that is identical to the sequence QQFNSYPHT (SEQ ID NO: 59) or QQFNSYPHT (SEQ ID NO: 99).

26. The method of claim 25, wherein the antibody comprises: a. a variable heavy chain sequence comprising a sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 61; and b. a variable light chain sequence comprising a sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 63.

27. The method of claim 25, wherein the antibody comprises: a. a heavy chain sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 65 or SEQ ID NO: 67; and b. a light chain sequence that is at least 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% identical to the sequence shown in SEQ ID NO: 69.

Details for Patent 9,382,321

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Centocor Inc REMICADE infliximab VIAL 103772 001 1998-08-24   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX Orphan search
Immunex ENBREL etanercept VIAL; SUBCUTANEOUS 103795 001 1998-11-02   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX Orphan search
Immunex ENBREL etanercept SYRINGE 103795 002 1998-11-02   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX Orphan search
Genentech XOLAIR omalizumab VIAL 103976 001 2003-06-20   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX search
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX search
Genentech AVASTIN bevacizumab VIAL; INTRAVENOUS 125085 001 2004-02-26   Start Trial Adventis Health System/Sunbelt, Inc. (Altamonte Springs, FL) 2039-02-26 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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