Claims for Patent: 7,837,995

Summary for Patent: 7,837,995

Title:	Immunotherapy of B-cell malignancies using anti-CD22 antibodies
Abstract:	B-cell malignancies, such as the B-cell subtype of non-Hodgkin\'s lymphoma and chronic lymphocytic leukemia, are significant contributors to cancer mortality. The response of B-cell malignancies to various forms of treatment is mixed. Traditional methods of treating B-cell malignancies, including chemotherapy and radiotherapy, have limited utility due to toxic side effects. Immunotherapy with anti-CD20 antibodies have also provided limited success. The use of antibodies that bind with the CD22 or CD19 antigen, however, provides an effective means to treat B-cell malignancies such as indolent and aggressive forms of B-cell lymphomas, and acute and chronic forms of lymphatic leukemias. Moreover, immunotherapy with anti-CD22 and/or anti-CD19 antibodies requires comparatively low doses of antibody protein, and can be used effectively in multimodal therapies.
Inventor(s):	Goldenberg; David M. (Mendham, NJ)
Assignee:	Immunomedics, Inc. (Morris Plains, NJ)
Application Number:	10/314,330
Patent Claims:	1. A method of treating a B-cell malignancy, comprising (i) administering an anti-CD20 monoclonal antibody or fragment thereof; and (ii) administering an anti-CD22 antibody or fragment thereof; wherein said anti-CD20 antibody or fragment and said anti-CD22 antibody or fragment are administered separately or in combination, and in either order and wherein the antibody fragment is a synthetic, genetically engineered or naturally occurring isolated antibody fragment selected from the group consisting of F(ab'), F(ab).sub.2, Fab', Fab, Fv, and sFv. 2. A method according to claim 1, wherein said anti-CD20 monoclonal antibody or fragment is non-radiolabeled and said anti-CD22 monoclonal antibody or fragment is radiolabeled. 3. A method according to claim 2, comprising (i) administering a non-radiolabeled anti-CD20 intact monoclonal antibody; and (ii) administering a radiolabeled anti-CD22 antibody or fragment thereof; wherein said anti-CD20 intact monoclonal antibody and said radiolabeled anti-CD22 antibody or fragment are administered separately or in combination, and in either order and wherein the CD22 antibody fragment is a synthetic, genetically engineered or naturally occurring isolated antibody fragment selected from the group consisting of F(ab'), F(ab).sub.2, Fab', Fab, Fv, and sFv. 4. A method according to claim 2, comprising (i) administering a therapeutically effective amount of non-radiolabeled anti-CD20 monoclonal antibody; and (ii) administering a therapeutically effective amount of a radiolabeled anti-CD22 antibody or fragment thereof; wherein said anti-CD20 antibody and said radiolabeled anti-CD22 antibody or fragment are administered separately or in combination, and in either order. 5. A method according to claim 4, wherein said anti-CD20 antibody is rituximab. 6. The method of claim 4, which is used to treat a B-cell malignancy selected from the group consisting of leukemia and lymphoma. 7. The method of claim 4, which is used to treat a B-cell malignancy selected from the group consisting of indolent forms of B-cell lymphomas, aggressive forms of B-cell lymphomas, chronic lymphatic leukemias, and acute lymphatic leukemias. 8. The method of claim 6, wherein said B-cell lymphoma is a non-Hodgkin's lymphoma. 9. The method of claim 4, wherein the amount of said anti-CD20 antibody ranges from 20-1500 mg/dose. 10. The method of claim 4, wherein the amount of said anti-CD20 antibody ranges from 20-500 mg/dose. 11. The method of claim 4, wherein the amount of said anti-CD20 antibody ranges from 20-100 mg/dose. 12. The method of claim 4, wherein said radiolabeled anti-CD22 antibody or fragment is an yttrium-90 labeled anti-CD22 antibody or fragment. 13. The method of claim 4, wherein said radiolabeled anti-CD22 antibody fragment is a F(ab).sub.2, F(ab').sub.2, Fab, Fab' or Fv. 14. The method of claim 4, wherein said anti-CD22 antibody is a .sup.90Y labeled humanized LL2 antibody. 15. The method of claim 14, wherein the dosage of said radiolabeled antibody ranges from 10 to 30 mCi. 16. The method of claim 4, further comprising administering a chemotherapeutic agent. 17. The method of claim 4, further comprising administering a cytokine. 18. The method of claim 4, wherein said anti-CD20 antibody is a humanized antibody. 19. The method of claim 4, wherein said anti-CD20 antibody is a human antibody. 20. The method of claim 1, wherein said anti-CD20 antibody or fragment is a humanized antibody or antibody fragment. 21. The method of claim 1, wherein said anti-CD20 antibody or fragment is a human antibody or antibody fragment. 22. The method according to claim 1, wherein the anti-CD20 antibody is administered before the anti-CD22 antibody. 23. The method according to claim 1, wherein the anti-CD20 antibody is administered concurrently with the anti-CD22 antibody. 24. The method according to claim 1, wherein the anti-CD22 antibody is administered before the anti-CD20 antibody.

Details for Patent 7,837,995

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2017-03-24
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2017-03-24
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2017-03-24