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Generated: September 22, 2017

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Title:Carrier-antibody compositions and methods of making and using the same
Abstract: Described herein are compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic. Also described are lyophilized compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic.
Inventor(s): Markovic; Svetomir N. (Rochester, MN), Nevala; Wendy K. (Rochester, MN)
Assignee: Mayo Foundation for Medical Education and Research (Rochester, MN)
Application Number:15/060,912
Patent Claims:1. A lyophilized nanoparticle composition comprising nanoparticles having an outside surface, wherein each of the nanoparticles comprises: a) albumin; b) between about 100 to about 1000 trastuzumab antibodies having an Fc portion and an antigen-binding portion; and c) paclitaxel; said nanoparticles being lyophilized, and wherein upon reconstitution with an aqueous solution antigen-binding portions of said antibodies are arranged on the outside surface of the nanoparticles and are capable of binding to HER2 in vivo and wherein the average size of the nanoparticles is between 130 nm and 800 nm.

2. The lyophilized nanoparticle composition of claim 1 that is stable at about 20.degree. C. to about 25.degree. C. for at least 3 months.

3. The lyophilized nanoparticle composition of claim 1, wherein each of the nanoparticles comprises between about 400 and about 800 antibodies and the antibodies arrange into a substantially single layer of antibodies on all or part of the outside surface of the nanoparticle.

4. The lyophilized nanoparticle composition of claim 3, wherein less than 0.01% of nanoparticles in the composition have a size greater than 800 nm.

5. The lyophilized nanoparticle composition of claim 1, wherein the average nanoparticle size in the composition is about 160 nm.

6. The lyophilized nanoparticle composition of claim 1, wherein the paclitaxel is located inside the nanoparticle, arranged on the outside surface of the nanoparticle, or both.

7. The lyophilized nanoparticle composition of claim 1, wherein the nanoparticles have a dissociation constant between about 1.times.10.sup.-11 M and about 1.times.10.sup.-9 M.

8. The lyophilized nanoparticle composition of claim 1, wherein the albumin is human serum albumin.

9. A lyophilized composition comprising nanoparticle complexes having an outside surface, wherein each of the nanoparticle complexes comprises: albumin; between about 100 to about 1000 trastuzumab antibodies, each having a Fc portion and a HER2-binding portion, wherein HER2-binding portions of the trastuzamab antibodies are arranged on the outside surface of the complex; and paclitaxel; said nanoparticle complexes being lyophilized, and wherein upon reconstitution with an aqueous solution the nanoparticle complexes remain capable of binding to HER2 in vivo and further wherein said complexes have an average size of from about 130 nm to about 800 nm; wherein the lyophilized composition does not contain a bulking agent.

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Inventors Patent Expiration Status Orphan Source
Genentech
HERCEPTIN
trastuzumab
VIAL; INTRAVENOUS1037920011998-09-25► Subscribe Mayo Foundation for Medical Education and Research (Rochester, MN) Markovic; Svetomir N. (Rochester, MN), Nevala; Wendy K. (Rochester, MN) ► SubscribeRXOrphansearch
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International Patent Family for Patent: ► Subscribe

Country Document Number Publication Date
African Regional IP Organization (ARIPO)201709771Feb 28, 2017
Argentina102307Feb 15, 2017
Australia2015328247Mar 30, 2017
South Korea20170035358Mar 30, 2017
Peru02422017Mar 30, 2017
Philippines12017500022May 15, 2017
Taiwan201707725Mar 01, 2017
United States of America2016095942Apr 07, 2016
United States of America2016184229Jun 30, 2016
United States of America2016184452Jun 30, 2016
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