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Last Updated: April 26, 2024

Claims for Patent: 9,636,412

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Summary for Patent: 9,636,412

Title:	Conjugates of an anti-TNF-alpha antibody
Abstract:	Conjugates of an anti-TNF antibody and one or more nonpeptidic water soluble polymers are provided. Typically, the nonpeptidic water soluble polymer is poly(ethylene glycol) or a derivative thereof. Also provided, among other things, are compositions comprising conjugates, methods of making conjugates, and methods of administering compositions to a patient.
Inventor(s):	Bossard; Mary J. (Madison, AL), Stephenson-Phillips; Gayle (Harvest, AL)
Assignee:	Nektar Therapeutics (San Francisco, CA)
Application Number:	14/819,212
Patent Claims:	1. A method for delivering a conjugate to a patient in need thereof, the method comprising subcutaneously administering a pharmaceutical composition, the pharmaceutical composition comprising a conjugate and a pharmaceutically acceptable excipient, the conjugate comprising a single water-soluble polymer covalently attached, either directly or through a spacer moiety of one to twenty atoms, to an amino group of an amino acid side chain or an N-terminal amine of a residue of a full length anti-TNF.alpha. antibody, wherein: (i) the one to twenty atoms within the spacer moiety, when present, correspond to the covalent attachment to the amino group of the full length anti-TNF.alpha. antibody and atoms derived from a water-soluble polymeric reagent used to attach the water-soluble polymer; (ii) the anti-TNF.alpha. antibody is neither galactosylated nor glycosylated; (iii) the water-soluble polymer is a polyethylene glycol terminally capped with a methoxy; and (iv) the water-soluble polymer has a weight-average molecular weight in the range of from about 10,000 Daltons to about 100,000 Daltons. 2. A The method of claim 1, wherein the conjugate has the following structure: ##STR00155## wherein: POLY is the water-soluble polymer; (a) is either zero or one; X, when present, is the spacer moiety of one to twenty atoms; R.sup.1 is H or an organic radical containing 1 to 3 carbon atoms; and ATA is the residue of the full length anti-TNF.alpha. antibody. 3. A The method of claim 1, wherein the conjugate has the following structure: ##STR00156## wherein: POLY is the water-soluble polymer; (a) is either zero or one; (j) is zero or an integer from 1 to about 20; (b) is zero or an integer from 1 to about 10; each R.sup.2, when present, is H or an organic radical; each R.sup.3, when present, is H or an organic radical; and ATA is the residue of the full length anti-TNF.alpha. antibody. 4. The method of claim 1, wherein the water-soluble polymer is branched. 5. The method of claim 1, wherein the water-soluble polymer is linear. 6. The method of claim 1, wherein the anti-TNF.alpha. antibody is not a dimer or trimer. 7. The method of claim 1, wherein the anti-TNF.alpha. antibody is monovalent. 8. The method of claim 1, wherein the anti-TNF.alpha. antibody is not CDR-grafted. 9. The method of claim 2, wherein the conjugate has the following structure: ##STR00157## wherein n ranges from about 225 to about 1930. 10. The method of claim 2, wherein the conjugate has the following structure: ##STR00158## wherein n ranges from about 225 to about 1930. 11. The method of claim 1, wherein the poly(ethylene glycol) has a weight-average molecular weight in the range of from about 10,000 Daltons to about 85,000 Daltons. 12. The method of claim 11, wherein the poly(ethylene glycol) has a weight-average molecular weight in the range of from about 20,000 Daltons to about 65,000 Daltons. 13. The method of claim 1, wherein the full length anti-TNF.alpha. antibody is either infliximab or adalimumab.

Details for Patent 9,636,412

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998	⤷ Try a Trial	2026-04-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2026-04-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2026-04-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2026-04-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2026-04-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015	⤷ Try a Trial	2026-04-07
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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