Claims for Patent: 9,856,323

Summary for Patent: 9,856,323

Title:	Anti-CD22 antibodies
Abstract:	Anti-CD22 antibodies, including isolated nucleic acids that encode at least one such anti-CD22 antibody, vectors, host cells, transgenic animals or plants, and methods of making and using thereof, including therapeutic compositions, methods and devices.
Inventor(s):	Short; Jay (Del Mar, CA), Frey; Gerhard (San Diego, CA), Chang; Hwai Wen (San Marcos, CA), Boyle; William (Malibu, CA)
Assignee:	BIOATLA, LLC (San Diego, CA)
Application Number:	14/396,869
Patent Claims:	1. An isolated antibody or antibody fragment that binds to human CD22, comprising: (a) a heavy chain variable region comprising three heavy chain complementarity determining regions (CDR1, CDR2, CDR3), wherein the complementarity determining region 1 (CDR1) has the amino acid sequence of complementary determining region 1 of SEQ ID NO: 49, the complementarity determining region 2 (CDR2) has the amino acid sequence of complementary determining region 2 of SEQ ID NO: 49, and the complementarity determining region 3 (CDR3) has the amino acid sequence of complementary placement determining region 3 of SEQ ID NO: 49; and (b) a light chain variable region comprising three light chain complementarity determining regions (CDR4, CDR5, CDR6), wherein the complementarity determining region 4 (CDR4) has the amino acid sequence of complementary determining region 4 of SEQ ID NO: 17 or 32, the complementarity determining region 5 (CDR5) has the amino acid sequence of complementary determining region 5 of SEQ ID NO: 17, and the complementarity determining region 6 (CDR6) has the amino acid sequence of complementary determining region 6 of SEQ ID NO: 17; wherein the heavy chain variable region and the light chain variable region each have human framework regions surrounding the complementarity determining regions (CDR1, CDR2, CDR3, CDR4, CDR5, CDR6) of the heavy chain and light chain variable regions; and (c) a heavy chain constant region and a light chain constant region derived from one or more human antibodies and wherein the heavy chain constant region is associated with the heavy chain variable region and the light chain constant region is associated with the light chain variable region. 2. The antibody or antibody fragment according to claim 1, wherein said antibody or antibody fragment has a heavy chain variable region having the amino acid sequence of SEQ ID NOS: 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, or 64; a light chain variable region having the amino acid sequence of SEQ ID NOS: 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, or 32. 3. The antibody or fragment according to claim 1, wherein said antibody or fragment competitively inhibits in vivo binding of an anti CD22 murine antibody to human CD22. 4. The antibody or antibody fragment according to claim 1, wherein said antibody or antibody fragment binds human CD22 with an affinity (K.sub.d) of at least 10.sup.-9 M. 5. The antibody or antibody fragment according to claim 1, wherein said antibody or antibody fragment substantially neutralizes at least one activity of said human CD22. 6. A composition, comprising said antibody or antibody fragment according to claim 1, and a carrier or diluent. 7. The antibody or antibody fragment of claim 1, wherein the complementary determining region 1 (CDR1) of the heavy chain variable region is at positions 26-35 of the amino acid sequence of SEQ ID NO: 49, the complementary determining region 2 (CDR2) of the heavy chain variable region is at positions 50-66 of the amino acid sequence of SEQ ID NO: 49, the complementary determining region 3 (CDR3) of the heavy chain variable region is at positions 99-105 of the amino acid sequence of SEQ ID NO: 49, the complementary determining region 4 (CDR4) of the light chain variable region is at positions 24-40 of the amino acid sequence of SEQ ID NO: 17 or 32, the complementary determining region 5 (CDR5) of the light chain variable region is at positions 56-62 of the amino acid sequence of SEQ ID NO: 17, and the complementary determining region 6 (CDR6) of the light chain variable region is at positions 95-102 of the amino acid sequence of SEQ ID NO: 17. 8. The antibody or antibody fragment according to claim 1, wherein said antibody or antibody fragment binds human CD22 with an affinity (K.sub.d) of at least 10.sup.-11M. 9. The antibody or antibody fragment according to claim 1, wherein said antibody or antibody fragment binds human CD22 with an affinity (K.sub.d) of at least 10.sup.-12 M. 10. A method for inhibiting binding or specific activity of CD22 in a cell, tissue, organ or animal having an immune condition, an immune disorder, an immune disease, or a cancerous disorder or cancerous condition, comprising: contacting or administering an effective amount of at least one antibody or antibody fragment according to claim 1 with, or to, said cell, tissue, organ or animal. 11. The method according to claim 10, wherein said immune condition, immune disorder or immune disease is at least one selected from rheumatoid arthritis/seronegativearthropathies, osteoarthritis, inflammatory bowel disease, systematic lupus erythematosis, and iridocyclitis/uvetis/optic neuritis. 12. The method according to claim 10, wherein said cancerous disorder or cancerous condition is at least one selected from leukemia, acute leukemia, acute lymphoblastic leukemia (ALL), B-cell, T-cell or FAB ALL, acute myeloid leukemia (AML), chronic myelocytic leukemia (CML), chronic lymphocytic leukemia (CLL), hairy cell leukemia, myelodyplastic syndrome (MDS), a lymphoma, Hodgkin's disease, a malignant lymphoma, non-hodgkin's lymphoma, Burkitt's lymphoma, and multiple myeloma. 13. The method according to claim 10 wherein said effective amount is 0.01-100 mg/kilogram of said cells, tissue, organ or animal for treating said immune condition, immune disorder or immune disease, or 0.0001-50 mg/kilogram of said cells, tissue, organ or animal for treating said cancerous disorder or cancerous condition. 14. The method according to claim 10, wherein said contacting or administering is by at least one mode selected from intravenous, intramuscular, bolus, subcutaneous, respiratory, inhalation, vaginal, rectal, buccal, sublingual, intranasal or transdermal. 15. A medical device, comprising at least one antibody or antibody fragment according to claim 1, wherein said device further comprising means for contacting or administering said at least one antibody or antibody fragment by at least one mode selected from intravenous, intramuscular, bolus, subcutaneous, respiratory, inhalation, vaginal, rectal, buccal, sublingual, intranasal, or transdermal. 16. A formulation comprising at least one antibody or antibody fragment according to claim 1, and at least one carrier selected from sterile water, sterile buffered water, or at least one preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, phenylmercuric nitrite, phenoxyethanol, formaldehyde, chlorobutanol, magnesium chloride, alkylparaben, benzalkonium chloride, benzethonium chloride, sodium dehydroacetate and thimerosal, and mixtures thereof, in an aqueous diluent. 17. The formulation according to claim 16, wherein the concentration of the antibody or antibody fragment in the formulation is from about 0.1 mg/ml to about 100 mg/ml. 18. A kit comprising at least one antibody or antibody fragment according to claim 1 in lyophilized form in a first container, and an optional second container comprising sterile water, sterile buffered water, or at least one preservative selected from the group consisting of phenol, m-cresol, p-cresol, o-cresol, chlorocresol, benzyl alcohol, phenylmercuric nitrite, phenoxyethanol, formaldehyde, chlorobutanol, magnesium chloride, alkylparaben, benzalkonium chloride, benzethonium chloride, sodium dehydroacetate, thimerosal, and mixtures thereof in an aqueous diluent. 19. The kit according to claim 18, wherein reconstituting contents of the first and second containers produces a solution with a concentration of said antibody or antibody fragment of from about 0.1 mg/ml to about 500 mg/ml. 20. A method of inhibiting binding or specific activity of CD22 in a patient having a B cell cancer or a B cell dependent autoimmune disease, comprising administering to the patient with the formulation according to claim 16. 21. An article of manufacture for human pharmaceutical use, comprising packaging material and a container comprising a solution or a lyophilized form of at least one antibody or antibody fragment according to claim 1. 22. The article of manufacture according to claim 21, wherein said container is a glass or plastic container having a stopper for multi-use administration.

Details for Patent 9,856,323

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-22