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Last Updated: April 16, 2024

Claims for Patent: 8,435,540

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Summary for Patent: 8,435,540

Title:	Dimeric alpha interferon PEGylated site-specifically shows enhanced and prolonged efficacy in VIVO
Abstract:	The present invention concerns methods and compositions for PEGylated complexes of defined stoichiometry and structure. Preferably, the PEGylated complex is formed using dock-and-lock technology, by attaching a therapeutic agent to a DDD sequence and a PEG moiety to an AD sequence, allowing the DDD sequence to bind to the AD sequence in a 2:1 stoichiometry, to form PEGylated complexes with two therapeutic agents and one PEG moiety. Alternatively, the therapeutic agent may be attached to the AD sequence and the PEG to the DDD sequence to form PEGylated complexes with two PEG moieties and one therapeutic agent. In more preferred embodiments, the therapeutic agent may comprise any peptide or protein of physiologic or therapeutic activity, preferably a cytokine, more preferably interferon-.alpha.2b. The PEGylated complexes exhibit a significantly slower rate of clearance when injected into a subject and are of use for treatment of a wide variety of diseases.
Inventor(s):	Chang; Chien-Hsing (Downingtown, PA), Goldenberg; David M. (Mendham, NJ), McBride; William J. (Boonton, NJ), Rossi; Edmund A. (Woodland Park, NJ)
Assignee:	IBC Pharmaceuticals, Inc. (Morris Plains, NJ)
Application Number:	13/412,816
Patent Claims:	1. A method of treating an autoimmune disease comprising: a) obtaining a PEGylated interferon complex comprising; i) a PEG (polyethylene glycol) moiety covalently attached to a first peptide; and ii) a fusion protein comprising interferon-.alpha. (IFN-.alpha.) or IFN-.beta. and a second peptide; and b) administering the PEGylated interferon complex to a subject with an autoimmune disease wherein two copies of the second peptide form a dimer that binds to the first peptide to form a PEGylated complex and wherein the amino acid sequence of the second peptide is selected from the group consisting of SEQ ID NO:1 and SEQ ID NO:2, and the amino acid sequence of the first peptide is selected from the group consisting of SEQ ID NO:3, SEQ ID NO:4, and wherein the autoimmune disease is selected from the group consisting of multiple sclerosis and ulcerative colitis. 2. The method of claim 1, wherein the second peptide is attached to the C-terminal end of IFN-.alpha. or IFN-.beta.. 3. The method of claim 1, wherein the IFN-.alpha. is IFN-.alpha.2b. 4. The method of claim 1, wherein the first peptide, or the first peptide covalently attached to the PEG moiety, is selected from the group consisting of: TABLE-US-00018 IMP350 (SEQ ID NO: 21) CGQIEYLAKQIVDNAIQQAGC(SS-tbu)-NH.sub.2; IMP360 (SEQ ID NO: 22) CGQIEYLAKQIVDNAIQQAGC(SS-tbu)-G-EDANS; IMP362 (SEQ ID NO: 22) PEG.sub.20k-CO-CGQIEYLAKQIVDNAIQQAGCG-NH--(CH.sub.2).sub.2-EDANS; IMP413 (SEQ ID NO: 22) mPEG.sub.30K-CGQIEYLAKQIVDNAIQQAGCG-NH--(CH.sub.2).sub.2-EDANS; IMP421 (SEQ ID NO: 22) Ac-C-PEG.sub.3-C(SStBu)GQIEYLAKQIVDNAIQQAGCG-NH.sub.2 and IMP457 (SEQ ID NO: 22) Ac-C(mPEG2-Suc 40K)-PEG.sub.3-CGQIEYLAKQIVDNAIQQAGCG-NH.sub.2. 5. The method of claim 1, wherein the PEGylated complex has a higher anti-viral specific activity than Peginterferon alfa-2b and Peginterferon alfa-2a. 6. The method of claim 1, wherein the clearance rate of the PEGylated complex from serum is at least an order of magnitude slower than the clearance rate of the unPEGylated IFN-.alpha.. 7. The method of claim 1, wherein the PEG moiety is capped at one end with a methoxy group. 8. The method of claim 1, wherein the autoimmune disease is multiple sclerosis. 9. The method of claim 1, further comprising administering one or more therapeutic agents to the subject.

Details for Patent 8,435,540

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	PEGINTRON	peginterferon alfa-2b	Injection	103949	01/19/2001	⤷ Try a Trial	2025-04-06
Merck Sharp & Dohme Corp.	SYLATRON	peginterferon alfa-2b	For Injection	103949	03/29/2011	⤷ Try a Trial	2025-04-06
Zr Pharma& Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	10/16/2002	⤷ Try a Trial	2025-04-06
Zr Pharma& Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	01/07/2004	⤷ Try a Trial	2025-04-06
Zr Pharma& Gmbh	PEGASYS	peginterferon alfa-2a	Injection	103964	09/29/2011	⤷ Try a Trial	2025-04-06
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	06/04/2004	⤷ Try a Trial	2025-04-06
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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