Claims for Patent: 9,957,321

Summary for Patent: 9,957,321

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:	14/672,392
Patent Claims:	1. A method of treating or reducing the occurrence of diarrhea associated with at least one of chemotherapy, radiotherapy or hematopoietic stem cell transplant ("HSCT") in a subject in need thereof, comprising administering a composition comprising an effective amount of an anti-interleukin 6 (IL-6) antibody or antibody fragment thereof that binds IL-6, wherein said antibody or fragment thereof comprises the variable light (VL) complementarity determining regions (CDRs) in SEQ ID NO:4, 5 and 6, and the variable heavy (VH) CDRs in SEQ ID NO:7, 8 or 120, and 9, respectively. 2. The method of claim 1, wherein said diarrhea is associated with chemotherapy. 3. The method of claim 2, 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.). 4. The method of claim 1, wherein said diarrhea is associated with radiotherapy. 5. The method of claim 1, wherein said diarrhea is associated with hematopoietic stem cell transplant (HSCT). 6. The method of claim 1, wherein said anti-IL-6 antibody or fragment thereof comprises at least one light chain comprising an amino acid sequence with at least about 90% sequence identity to an amino acid sequence of SEQ ID NO: 2, 20, 647, 651, 660, 666, 679, 687, 693, 699, 702, 706, or 709. 7. The method of claim 1, wherein said anti-IL-6 antibody or antibody fragment thereof comprises at least one heavy chain comprising an amino acid sequence with at least about 90% sequence identity to an amino acid sequence of SEQ ID NO: 3, 18, 19, 652, 654, 657, 658, 665, 668, 672, 676, 684, 688, 691, 692, 704, or 708. 8. The method of claim 1, wherein said antibody or fragment thereof comprises a light chain comprising the amino acid sequence of SEQ ID NO: 2, 20, 647, 651, 660, 666, 699, 702, 706, or 709. 9. The method of claim 1, wherein said antibody or fragment thereof comprises a humanized light chain comprising the amino acid sequence of SEQ ID NO: 702. 10. The method of claim 1, wherein said antibody or fragment thereof comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 3, 18, 19, 652, 654, 657, 658, 665, 704, or 708. 11. 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: 704. 12. The method of claim 1, wherein the antibody or fragment thereof is aglycosylated. 13. The method of claim 1, wherein the antibody or fragment thereof contains an Fc region that has been modified to alter effector function, half-life, proteolysis, and/or glycosylation. 14. The method of claim 1, wherein the antibody or fragment thereof is a human, humanized, single chain, or chimeric antibody. 15. The method of claim 1, wherein the antibody or fragment thereof further comprises a human Fc. 16. The method of claim 1, wherein said anti-IL-6 antibody or fragment thereof is administered prior to, concurrent with or after chemotherapy or radiotherapy or HSCT. 17. The method of claim 1, wherein said subject is receiving concomitant chemotherapy, radiotherapy or HSCT. 18. The method of claim 17, wherein said subject is receiving concomitant chemotherapy.

Details for Patent 9,957,321

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2030-11-23
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2030-11-23
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2030-11-23
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2030-11-23
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2030-11-23
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2030-11-23