Claims for Patent: 9,993,530

Summary for Patent: 9,993,530

Title:	Fragments of P97 and uses thereof
Abstract:	Provided are fragments of human p97 (melanotransferrin) polypeptides having blood-brain barrier (BBB) transport activity, including variants and combinations thereof, conjugates comprising the p97 fragments, and related methods of use thereof, for instance, to facilitate delivery of therapeutic or diagnostic agents across the BBB.
Inventor(s):	Vitalis; Timothy Z. (Vancouver, CA), Gabathuler; Reinhard (Montreal, CA)
Assignee:	Bioasis Technologies, Inc. (Guilford, CT)
Application Number:	15/153,074
Patent Claims:	1. A conjugate, comprising a p97 fragment that is conjugated to an antibody or antigen-binding fragment thereof optionally via a peptide linker, to form a p97-antibody conjugate, wherein the p97 fragment consists essentially of DSSHAFTLDELR (SEQ ID NO: 13), and wherein the antibody or antigen-binding fragment thereof specifically binds to human Her2/neu. 2. The conjugate of claim 1, wherein the p97 fragment has one or more terminal cysteines and/or tyrosines. 3. The conjugate of claim 1, wherein the antibody or antigen-binding fragment thereof is trastuzumab, or a fragment or variant thereof that specifically binds to human Her2/neu. 4. The conjugate of claim 3, wherein the antibody is trastuzumab. 5. The conjugate of claim 1, wherein the p97 fragment has one or more terminal cysteines and/or tyrosines, and wherein the antibody or antigen-binding fragment thereof is trastuzumab, or a fragment or variant thereof that specifically binds to human Her2/neu. 6. The conjugate of claim 5, wherein the antibody is trastuzumab. 7. A method of treating a subject in need thereof, wherein the subject has a Her2/neu-expressing cancer which is metastatic to the CNS, comprising administering to the subject a conjugate of claim 1. 8. The method of claim 7, wherein the Her2/neu-expressing cancer is a breast cancer. 9. A conjugate, comprising a p97 fragment that is conjugated to trastuzumab, to form a p97-trastuzumab conjugate, wherein the p97 fragment consists of DSSHAFTLDELR (SEQ ID NO: 13) with a C-terminal tyrosine, and wherein the p97 fragment and trastuzumab are separated by a peptide linker of about 1-10 amino acids in length. 10. A method of treating a subject in need thereof, wherein the subject has a Her2/neu-expressing cancer which is metastatic to the CNS, comprising administering to the subject a conjugate of claim 9. 11. The method of claim 10, wherein the Her2/neu-expressing cancer is a breast cancer.

Details for Patent 9,993,530

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2033-03-13
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2033-03-13
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2033-03-13