Claims for Patent: 8,524,217

Summary for Patent: 8,524,217

Title:	MCP1-Ig fusion variants
Abstract:	The present invention provides, in part, MCP1-Ig fusion polypeptides exhibiting surprisingly beneficial properties as well as methods for treating various diseases (e.g., inflammatory diseases) by administering any of such fusions.
Inventor(s):	Presta; Leonard G. (San Francisco, CA), Chou; Chuan-Chu (Westfield, NJ)
Assignee:	Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	13/105,453
Patent Claims:	1. An isolated polypeptide comprising an MCP1 polypeptide that comprises the amino acid sequence set forth in SEQ ID NO: 17; fused to a polypeptide linker, that comprises an amino acid sequence which is a member selected from the group consisting of SEQ ID NOs: 1-13; fused to a human immunoglobulin gamma-1 polypeptide comprising the immunoglobulin hinge to the immunoglobulin CH3 region that comprises the amino acid sequence set forth in SEQ ID NO: 15. 2. The polypeptide of claim 1 comprising the amino acid sequence: TABLE-US-00020 (SEQ ID NO: 20) MKVSAALLCLLLIAATFIPQGLAQPDAINAPVTCCYNFTNRKISVQRLASYRRITSSKCPKEAVIFKTIVAKEI- C ADPKQKWVQDSMDHLDKQTQTPKT GGEPKSS DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVAVSHEDPEVKFNWYVDGVEVHNAKTKPREE- Q YNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLV- K GFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLS- P GK. 3. The polypeptide of claim 1 comprising the amino acid sequence: TABLE-US-00021 (SEQ ID NO: 16) QPDAINAPVT CCYNFTNRKI SVQRLASYRR ITSSKCPKEA VIFKTIVAKE ICADPKQKWV QDSMDHLDKQ TQTPKTGGEPKSSD KTHTCPPCPA PELLGGPSVF LFPPKPKDTL MISRTPEVTC VVVAVSHEDP EVKFNWYVDG VEVHNAKTKP REEQYNSTYR VVSVLTVLHQ DWLNGKEYKC KVSNKALPAP IEKTISKAKG QPREPQVYTL PPSRDELTKN QVSLTCLVKG FYPSDIAVEW ESNGQPENNY KTTPPVLDSD GSFFLYSKLT VDKSRWQQGN VFSCSVMHEA LHNHYTQKSL SLSPGK. 4. A pharmaceutical composition comprising the polypeptide of claim 1 and a pharmaceutically acceptable carrier. 5. A composition comprising the polypeptide of claim 1 in association with one or more further therapeutic agents. 6. The composition of claim 5 wherein the further therapeutic agent is a member selected from the group consisting of aspirin, diclofenac, diflunisal, etodolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, meclofenamate, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, phenylbutazone, piroxicam, salsalate, sulindac, tenoxicam, tiaprofenic acid, tolmetin, betamethasone benzoate, betamethasone valerate, clobetasol propionate, desoximetasone, fluocinolone acetonide, flurandrenolide, a topical steroid, alclometasone dipropionate, aloe vera, amcinonide, amcinonide, anthralin, betamethasone dipropionate, betamethasone valerate, calcipotriene, clobetasol propionate, coal tar, Dead Sea salts, desonide, desonide; betamethasone valerate, desoximetasone, diflorasone diacetate, epsom salts, fluocinolone acetonide, fluocinonide, flurandrenolide, fluticasone propionate, halcinonide, halobetasol propionate, hydrocortisone valerate, hydrocortisone, mometasone furoate, oilated oatmeal, petroleum jelly, prednicarbate, salicylic acid, tazarotene, triamcinolone acetonide, a mixture of hydrocortisone, dexamethasone, methylprednisolone and prednisolone, alefacept, etanercept, cyclosporine, methotrexate, acitretin, isotretinoin, hydroxyurea, mycophenolate mofetil, sulfasalazine, 6-Thioguanine, anakinra, injectable gold, penicillamine, azathioprine, chloroquine, hydroxychloroquine, sulfasalazine, oral gold, auranofin, gold sodium thiomalate, aurothioglucose, mesalamine, sulfasalazine, budesonide, metronidazole, ciprofloxacin, azathioprine, 6-mercaptopurine or dietary supplementation of calcium, folate, vitamin B12, celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, efalizumab, adalimumab, infliximab, rituximab, tocilizumab and ABX-IL8. 7. The polypeptide of claim 1 wherein the linker comprises the amino acid sequence set forth in SEQ ID NO: 12. 8. A method for decreasing MCP-1 mediated migration of MCP-1 receptor-bearing cells into inflamed tissue, in a subject with rheumatoid arthritis, comprising administering, to the subject, a therapeutically effective amount of the polypeptide of claim 1 or a pharmaceutical composition thereof optionally in association with a further therapeutic agent or procedure. 9. The method of claim 8 wherein the subject is a human. 10. The method of claim 8 wherein the further therapeutic agent or procedure is a member selected from the group consisting of denosumab, aspirin, diclofenac, diflunisal, etodolac, fenoprofen, floctafenine, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, meclofenamate, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, phenylbutazone, piroxicam, salsalate, sulindac, tenoxicam, tiaprofenic acid, tolmetin, betamethasone benzoate, betamethasone valerate, clobetasol propionate, desoximetasone, fluocinolone acetonide, flurandrenolide, a topical steroid, alclometasone dipropionate, aloe vera, amcinonide, amcinonide, anthralin, betamethasone dipropionate, betamethasone valerate, calcipotriene, clobetasol propionate, coal tar, Dead Sea salts, desonide, desonide; betamethasone valerate, desoximetasone, diflorasone diacetate, epsom salts, fluocinolone acetonide, fluocinonide, flurandrenolide, fluticasone propionate, halcinonide, halobetasol propionate, hydrocortisone valerate, hydrocortisone, mometasone furoate, oilated oatmeal, petroleum jelly, prednicarbate, salicylic acid, tazarotene, triamcinolone acetonide, a mixture of hydrocortisone, dexamethasone, methylprednisolone and prednisolone, alefacept, etanercept, cyclosporine, methotrexate, acitretin, isotretinoin, hydroxyurea, mycophenolate mofetil, sulfasalazine, 6-Thioguanine, anakinra, injectable gold, penicillamine, azathioprine, chloroquine, hydroxychloroquine, sulfasalazine, oral gold, auranofin, gold sodium thiomalate, aurothioglucose, mesalamine, sulfasalazine, budesonide, metronidazole, ciprofloxacin, azathioprine, 6-mercaptopurine or dietary supplementation of calcium, folate, vitamin B12, celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, efalizumab, adalimumab, infliximab, rituximab, tocilizumab, ABX-IL8 and phototherapy.

Details for Patent 8,524,217

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2030-05-11
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2030-05-11
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2030-05-11
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2030-05-11
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2030-05-11
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2030-05-11
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2030-05-11