Claims for Patent: 9,150,846

Summary for Patent: 9,150,846

Title:	P97-antibody conjugates and methods of use
Abstract:	The present invention provides p97-antibody conjugates and related compositions and methods, which may be used in any of a variety of therapeutic methods, including methods for the treatment of cancers such as Her2/neu-expressing and Her1/EGFR-expressing cancers.
Inventor(s):	Jefferies; Wilfred (South Surrey, GB), Vitalis; Timothy Z. (Vancouver, CA), Gabathuler; Reinhard (Montreal, CA)
Assignee:	biOasis Technologies, Inc. (Richmond, CA)
Application Number:	13/542,435
Patent Claims:	1. A conjugate comprising a p97 polypeptide covalently or operatively linked to an antibody or antigen-binding fragment thereof that specifically binds the human Her2/neu protein, wherein the p97 polypeptide is a soluble p97 polypeptide that has a deletion of all or a portion of the hydrophobic domain as defined by residues 710-738 of SEQ ID NO: 1, and where the p97 polypeptide is effective for transporting the anti-Her2/neu antibody across the blood brain barrier. 2. The conjugate of claim 1, wherein the p97 polypeptide consists of residues 20-711 of SEQ ID NO: 1 or differs from residues 20-711 of SEQ ID NO: 1 by substitution, deletion, addition, and/or insertion of five amino acids or fewer. 3. The conjugate of claim 1, wherein the p97 polypeptide and the antibody or antigen-binding fragment are covalently linked as a fusion polypeptide. 4. The conjugate of claim 1, wherein the p97 polypeptide is covalently linked to the antibody or antigen-binding fragment with a linker. 5. The conjugate of claim 1, wherein the p97 polypeptide is (a) covalently linked to the antibody or antigen-binding fragment with a polymeric cross-linker, (b) covalently linked to the antibody or antigen-binding fragment via a nanoparticle, or (c) operatively linked to the antibody or antigen-binding fragment thereof via a liposome. 6. The conjugate of claim 1, wherein the p97 polypeptide is covalently linked to the antibody or antigen-binding fragment with a polymeric cross-linker comprising a thioether linkage. 7. The conjugate of claim 1, wherein the p97 polypeptide is covalently linked to the antibody or antigen-binding fragment with a polymeric cross-linker comprising polyethylene glycol. 8. The conjugate of claim 1, wherein the antibody or antigen-binding fragment thereof is specific for a human Her2/neu protein having a sequence set forth in SEQ ID NO: 2. 9. The conjugate of claim 1, wherein the antibody is trastuzumab or an antigen-binding fragment thereof. 10. A pharmaceutical composition comprising a conjugate of claim 1 or 9 and a pharmaceutically acceptable carrier, diluent, or excipient. 11. A method for the treatment of a subject with a Her2/neu-expressing cancer comprising administering to the subject a pharmaceutical composition of claim 10. 12. The method of claim 11, wherein the Her2/neu-expressing cancer is breast cancer, or a metastatic brain cancer. 13. The conjugate of claim 1, where the conjugate is covalently linked to a cytotoxic agent. 14. The conjugate of claim 13, where the conjugate is covalently linked to the cytotoxic agent via the antibody. 15. The conjugate of claim 14, where the cytotoxic agent is covalently linked to the antibody with a linker. 16. The conjugate of claim 13, where the conjugate is covalently linked to the cytotoxic agent via the p97 polypeptide. 17. The conjugate of claim 16, where the cytotoxic agent is covalently linked to the p97 polypeptide with a linker.

Details for Patent 9,150,846

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2031-07-05
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2031-07-05
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2031-07-05