Lyophilized compositions comprising albumin-antibody paclitaxel nanoparticle complexes
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.
1. A lyophilized composition comprising nanoparticle complexes comprising:
albumin;
antibodies, each having an antigen-binding portion; and
paclitaxel;
said nanoparticle complexes being lyophilized, and wherein upon reconstitution with an aqueous solution the nanoparticle complexes have binding specificity for the antigen expressed by a cancer cell in vivo, wherein the cancer cell is a leukemia cell or a lymphoma cell, wherein said complexes have an average size of less than 1 μm, and wherein the antibodies are associated with the albumin through non-covalent bonds.
2. The lyophilized composition of claim 1 that is stable at about 20° C. to about 25° C. for at least 3 months.
3. The lyophilized composition of claim 1 , wherein each of the nanoparticle complexes comprises between about 400 and about 800 antibodies.
4. The lyophilized composition of claim 1 , wherein less than 0.01% of nanoparticle complexes have a size greater than 800 nm.
5. The lyophilized composition of claim 1 , wherein said nanoparticle complexes have an average size of about 160 nm.
6. The lyophilized composition of claim 1 , wherein the albumin is human serum albumin.
7. The lyophilized composition of claim 1 , wherein the nanoparticle complexes have a dissociation constant between about 1×10 −11 M and about 1×10 −9 M.
8. The lyophilized composition of claim 1 which does not contain a bulking agent.
9. The lyophilized composition of claim 1 , wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm.
10. The lyophilized composition of claim 1 , wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:1 and 10:30.
11. The lyophilized composition of claim 1 , wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:2 and 10:6.
12. The lyophilized composition of claim 1 , wherein the antibodies are alemtuzumab, brentuximab, blinatumomab, obinutuzumab, ibritumomab, ofatumumab, rituximab, or gemtuzumab.
13. The lyophilized composition of claim 1 , wherein the antibodies are alemtuzumab.
14. The lyophilized composition of claim 1 , wherein the antibodies are brentuximab.
15. The lyophilized composition of claim 1 , wherein the antibodies are blinatumomab.
16. The lyophilized composition of claim 1 , wherein the antibodies are gemtuzumab.
17. The lyophilized composition of claim 12 , wherein less than 0.01% of nanoparticle complexes have a size greater than 800 nm.
18. The lyophilized composition of claim 12 , wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm.
19. The lyophilized composition of claim 12 , wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:1 and 10:30.
20. The lyophilized composition of claim 12 , wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:2 and 10:6.
21. The lyophilizcd composition of claim 1 , wherein each of the nanoparticle complexes comprises between about 100 and about 1000 antibodies.
22. The lyophilized composition of claim 1 , further comprising at least one additional cancer therapeutic agent.
23. The lyophilized composition of claim 1 , wherein the paclitaxel is associated with the albumin through non-covalent bonds.
24. The lyophilized composition of claim 12 , wherein the paclitaxel is associated with the albumin through non-covalent bonds.
25. The lyophilized composition of claim 1 , wherein the antibodies are obinutuzunab.
26. The lyophilized composition of claim 1 , wherein the antibodies are ibritumomab.
27. The lyophilized composition of claim 1 , wherein the antibodies are ofatumumab.
28. The lyophilized composition of claim 1 , wherein the antibodies are rituximab.