You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 25, 2024

Claims for Patent: 8,158,129

✉ Email this page to a colleague

« Back to Dashboard

Summary for Patent: 8,158,129

Title:	Dimeric alpha interferon PEGylated site-specifically shows enhanced and prolonged efficacy in vivo
Abstract:	The present invention concerns methods and compositions for forming PEGylated complexes of defined stoichiometry and structure. In preferred embodiments, the PEGylated complex is formed using dock-and-lock technology, by attaching a therapeutic agent to a DDD sequence and attaching a PEG moiety to an AD sequence and 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. In alternative embodiments, 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:	13/178,092
Patent Claims:	1. A method of treating cancer or a viral infection comprising: a) obtaining a PEGylated interferon-.alpha. (IFN-.alpha.) or interferon-.beta. (IFN-.beta.) complex comprising; i) a PEG (polyethylene glycol) moiety covalently attached to a first peptide; ii) a fusion protein comprising IFN-.alpha. or IFN-.beta. and a second peptide; and b) administering the PEGylated IFN-.alpha. or IFN-.beta. complex to a subject with cancer, a viral infection or autoimmune disease; wherein two copies of the second peptide form a dimer that binds to the first peptide to form a PEGylated complex, 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, SEQ ID NO:7, SEQ ID NO:8 and SEQ ID NO:9. 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 PEGylated complex has a higher anti-proliferative effect on cancer cells in vitro than Peginterferon alfa-2b. 7. 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.. 8. The method of claim 1, wherein the PEGylated complex has greater anti-tumor efficacy in vivo than Peginterferon alfa-2b. 9. The method of claim 1, wherein the PEG moiety is capped at one end with a methoxy group. 10. The method of claim 1, wherein the viral infection is hepatitis B, hepatitis C, dengue virus, influenza virus, rhinovirus, cytomegalovirus, herpes simplex, vaccinia virus or encephalomyocarditis virus.

Details for Patent 8,158,129

Subscribe to access the full database, or Try a Trial
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
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.