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Last Updated: October 22, 2019

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Claims for Patent: 8,992,908

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Summary for Patent: 8,992,908
Title:Anti-IL-6 antibodies for the treatment of oral mucositis
Abstract: The present invention is directed to therapeutic methods using IL-6 antagonists such as anti-IL-6 antibodies and fragments thereof having binding specificity for IL-6 to prevent or treat mucositis (e.g., oral mucositis) including persons on a treatment regimen with a drug or chemotherapy and/or radiation for cancer (e.g., head and neck cancer) that is associated with increased risk of mucositis, including oral mucositis.
Inventor(s): Smith; Jeffrey T.L. (Bellevue, WA), Garcia-Martinez; Leon F. (Woodinville, WA), Feldhaus; Andrew L. (Lynnwood, WA)
Assignee: Alderbio Holdings LLC (Las Vegas, NV)
Application Number:13/304,173
Patent Claims:1. A method of treating or reducing the occurrence of mucositis in a subject in need thereof, comprising administering a composition comprising an effective amount of an anti-interleukin 1 (IL-6) antibody or antibody fragment thereof that binds IL-6, wherein said antibody or antibody fragment thereof comprises the variable light (V.sub.L) complementarity determining regions (CDRs) in SEQ ID NO:4, 5 and 6, and the variable heavy (V.sub.H) CDRs in SEQ ID NO:7, 8 or 120, and 9, respectively.

2. The method of claim 1, wherein said mucositis is oral mucositis.

3. The method of claim 1, wherein said mucositis is alimentary track mucositis.

4. The method of claim 1, wherein said mucositis is gastrointestinal tract mucositis.

5. The method of claim 1, wherein said mucositis is mucositis associated with chemotherapy.

6. The method of claim 5, wherein said chemotherapy comprises administration of a chemotherapy agent selected from the group consisting of Alemtuzumab (Campath.TM.), Asparaginase (Elspar.TM.), Bleomycin (Blenoxane.TM.), Busulfan (Myleran.TM., Busulfex.TM.), Capecitabine (Xeloda.TM.), Carboplatin (Paraplatin.TM.), Cisplatin (PLATINOL.TM.), Cyclophosphamide (Cytoxan.TM.), Cytarabine (Cytosar-U.TM.), Daunorubicin (Cerubidine.TM.), Docetaxel (Taxotere.TM.), Doxorubicin (Adriamycin.TM.), Epirubicin (Ellence.TM.), Etoposide (VePesid.TM.), Fluorouracil (5-FU.TM.), Gemcitabine (Gemzar.TM.), Gemtuzumab ozogamicin (Mylotarg.TM.), Hydroxyurea (Hydrea.TM.), Idarubicin (Idamycin.TM.), Interleukin 2 (Proleukin.TM.) Irinotecan (Camptosar.TM.), Lomustine (CeeNU.TM.), Mechlorethamine (Mustargen.TM.), Melphalan (Alkeran.TM.), Methotrexate (Rheumatrex.TM.), Mitomycin (Mutamycin.TM.), Mitoxantrone (Novantrone.TM.), Oxaliplatin (Eloxatin.TM.), Paclitaxel (Taxol.TM.), Pemetrexed (Alimta.TM.) Pentostatin (Nipent.TM.), Procarbazine (Matulane.TM.), Thiotepa (Thioplex.TM.), Topotecan (Hycamtin.TM.), Trastuzumab (Herceptin.TM.), Tretinoin (Vesanoid.TM.), Vinblastine (Velban.TM.), and Vincristine (Oncovin.TM.).

7. The method of claim 1, wherein said mucositis is mucositis associated with radiotherapy.

8. The method of claim 1, wherein said mucositis is mucositis associated with cancer.

9. The method of claim 1, wherein said mucositis is mucositis associated with hematopoietic stem cell transplant (HSCT).

10. The method of claim 1, wherein said anti-IL-6 antibody or antibody fragment thereof comprises at least one light chain selected from the group consisting of an amino acid sequence with at least about 90% sequence identity to an amino acid sequence of SEQ ID NO: 2, 20, 647, 648, 649, 650, 651, 655, 660, 666, 667, 671, 675, 679, 683, 687, 693, 699, 702, 706, or 709.

11. The method of claim 1, wherein said anti-IL-6 antibody or antibody fragment thereof comprises at least one heavy chain selected from the group consisting of an amino acid sequence with at least about 90% sequence identity to an amino acid sequence of SEQ ID NO: 3, 18, 19, 652, 653, 654, 655, 656, 657, 658, 661, 664, 665, 668, 672, 676, 680, 684, 688, 691, 692, 704, or 708.

12. The method of claim 1, wherein said antibody or antibody fragment thereof comprises a light chain comprising the amino acid sequence of SEQ ID NO: 2, 20, 647, 648, 649, 650, 651, 660, 666, 699, 702, 706, or 709.

13. The method of claim 1, wherein said antibody or antibody fragment thereof comprises a humanized light chain comprising the amino acid sequence of SEQ ID NO: 648, 649, or 650.

14. The method of claim 1, wherein said antibody or antibody fragment thereof comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 3, 18, 19, 652, 653, 654, 655, 656, 657, 658, 661, 664, 665, 704, or 708.

15. The method of claim 1, wherein said antibody or antibody fragment thereof comprises a humanized heavy chain comprising the amino acid sequence of SEQ ID NO: 653, 654, or 655.

16. The method of claim 1, wherein anti-IL-6 antibody or antibody fragment thereof is expressed from a recombinant cell.

17. The method of claim 16, wherein the cell is mammalian, yeast, bacterial, or insect cell.

18. The method of claim 17, wherein the cell is a yeast cell.

19. The method of claim 18, wherein the cell is a diploidal yeast cell.

20. The method of claim 19, wherein the yeast cell is a Pichia yeast.

21. The method of claim 1, wherein said antibody or antibody fragment thereof is asialated.

22. The method of claim 1, wherein said antibody fragment is a Fab, Fab', F(ab').sub.2, Fv, scFv, IgNAR, SMIP, camelbody, or nanobody.

23. The method of claim 1, wherein said antibody or antibody fragment thereof has an in vivo half-life of at least about 30 days.

24. The method of claim 1, wherein the antibody or antibody fragment thereof is aglycosylated.

25. The method of claim 1, wherein the antibody or antibody fragment thereof contains an Fc region that has been modified to alter effector function, half-life, proteolysis, and/or glycosylation.

26. The method of claim 1, wherein the antibody or antibody fragment thereof is a human, humanized, single chain, or chimeric antibody.

27. The method of claim 1, wherein the antibody or antibody fragment thereof further comprises a human F.sub.c.

28. The method of claim 1, wherein said anti-IL-6 antibody or antibody fragment thereof is administered prior to, concurrent with or after chemotherapy or radiotherapy.

29. The method of claim 1, wherein said subject is receiving concomitant chemotherapy.

30. The method claim 1, wherein said treated mucositis comprises oral or oropharyngeal mucositis induced by chemoradiation (CRT) regimens or hematopoietic stem cell transplant (HSCT) used for the treatment of cancers of the head and neck.

31. A method of treating or reducing the occurrence of emesis in a subject in need thereof, comprising administering a composition comprising an effective amount of an anti-interleukin 1 (IL-6) antibody or antibody fragment thereof that binds IL-6, wherein said antibody or antibody fragment thereof comprises the variable light (V.sub.L) complementarity determining regions (CDRs) in SEQ ID NO:4, 5 and 6, and the variable heavy (V.sub.H) CDRs in SEQ ID NO:7, 8 or 120, and 9, respectively.

32. The method of claim 31, wherein said emesis is emesis associated with chemotherapy.

33. The method of claim 31, wherein said emesis is emesis associated with radiotherapy.

34. The method of claim 31, wherein said emesis is emesis associated with hematopoietic stem cell transplant (HSCT).

35. A method for treating oral mucositis in a subject with head and neck cancer receiving concomitant chemotherapy, comprising administering an effective amount of a humanized monoclonal antibody that specifically binds interleukin-6 (IL-6), wherein said antibody or antibody fragment thereof comprises the variable light (V.sub.L) CDRs in SEQ ID NO: 4, 5 and 6, and the variable heavy (V.sub.H) CDRs in SEQ ID NO:7, 8 or 120, and 9, respectively.

Details for Patent 8,992,908

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Merck ELSPAR asparaginase VIAL 101063 001 1978-01-10   Start Trial Alderbio Holdings LLC (Las Vegas, NV) 2039-02-26 RX search
Genentech HERCEPTIN trastuzumab VIAL; INTRAVENOUS 103792 001 1998-09-25   Start Trial Alderbio Holdings LLC (Las Vegas, NV) 2039-02-26 RX Orphan search
Genzyme CAMPATH alemtuzumab VIAL; INTRAVENOUS 103948 001 2001-05-07   Start Trial Alderbio Holdings LLC (Las Vegas, NV) 2039-02-26 RX Orphan search
Genzyme CAMPATH alemtuzumab VIAL; INTRAVENOUS 103948 002 2001-05-07   Start Trial Alderbio Holdings LLC (Las Vegas, NV) 2039-02-26 RX Orphan search
Genzyme LEMTRADA alemtuzumab INJECTABLE;INJECTION 103948 003 2001-05-07   Start Trial Alderbio Holdings LLC (Las Vegas, NV) 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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