Claims for Patent: 9,555,126

Summary for Patent: 9,555,126

Title:	Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of B-cell malignancies symptoms
Abstract:	An anti-CD19 maytansinoid immunoconjugate is used for treating B-cell malignancies symptom, in particular Non-Hodgkin\'s lymphoma.
Inventor(s):	Morariu; Rodica (Paris, FR)
Assignee:	Sanofi (Paris, FR)
Application Number:	14/117,806
Patent Claims:	1. A method of treating CD19+ B-cell malignancies symptom in a human patient in need thereof, said method comprising a) administering to said patient an initial dose of 55 mg/m.sup.2 of an anti-CD19 maytansinoid immunoconjugate, b) administering to the patient at least 3 subsequent doses of 55 mg/m.sup.2 of the anti-CD19 maytansinoid immunoconjugate separated in time from each other by about one week, and c) administering to the patient at least 3 further subsequent doses of 55 mg/m.sup.2 of the anti-CD19 maytansinoid immunoconjugate separated in time from each other by about two weeks, wherein said anti-CD19 maytansinoid immunoconjugate comprises an antibody that specifically binds to a CD19 antigen comprising: a) a heavy chain CDR1 comprising SNWMH (SEQ ID NO.4); a heavy chain CDR2 comprising EIDPSDSYTN (SEQ ID NO.5); and a heavy chain CDR3 comprising GSNPYYYAMDY (SEQ ID NO.6); and b) a light chain CDR1 comprising SASSGVNYMH (SEQ ID NO:1); a light chain CDR2 comprising DTSKLAS (SEQ ID NO:2); and a light chain CDR3 comprising HQRGSYT (SEQ ID NO:3), wherein the maytansinoid is DM4; and wherein the antibody is conjugated to DM4 through N-succinimidyl 4-(2-pyridyldithio)butanoate (SPDB) linker. 2. The method according to claim 1, wherein the method minimizes eye related adverse events. 3. The method according to claim 2, wherein the occurrence of all grades of eye related adverse events is below 40%. 4. The method according to claim 2, wherein the occurrence of grade 3 or 4 eye related adverse events is below 13%. 5. The method according to claim 1, wherein said CD19+ B-cell malignancies symptom is a leukemia or a lymphoma. 6. The method according to claim 5, wherein said lymphoma is Non-Hodgkin's lymphoma (NHL). 7. The method according to claim 5, wherein said leukemia is Acute lymphoblastic leukemia (ALL). 8. The method according to claim 6, wherein said Non-Hodgkin's lymphoma is Diffuse Large B-cell lymphoma (DLBCL), a follicular lymphoma (FL), a Mantle cell lymphoma (MCL), a Marginal zone lymphoma (MZL), a Small lymphocytic lymphoma (SLL), or a Waldenstrom macroglobulinemia (WM). 9. The method according to claim 6, wherein said NHL is a relapsed or refractory NHL. 10. The method according to claim 6, wherein said NHL is a NHL expressing CD19. 11. The method according to claim 6, wherein said patient has already been treated for the NHL. 12. The method according to claim 6, wherein said patient has failed rituximab therapy. 13. The method according to claim 6, wherein said NHL is rituximab resistant. 14. The method according to claim 6, wherein said patient has received an autologous or allogeneic stem cell transplant. 15. The method according to claim 1, wherein the anti-CD19 maytansinoid immunoconjugate is administered intravenously. 16. The method according to claim 1, wherein the anti-CD19 maytansinoid immunoconjugate comprises an huB4 antibody conjugated to DM4 through an SPDB linker. 17. The method according to claim 1, wherein the anti-CD19 maytansinoid immunoconjugate has the following formula: ##STR00002## 18. The method according to claim 1, wherein the antibody comprises a light chain having the sequence of SEQ ID NO.7 and a heavy chain having the sequence of SEQ ID NO.8. 19. The method according to claim 16, wherein 3.5 molecules of DM4 are bound through the SPDB linker to each huB4 antibody molecule. 20. A method of treating CD19+ B-cell malignancies symptom in a human patient in need thereof, wherein the method comprises administering to the patient 4 doses of 55 mg/m.sup.2 of an anti-CD19 maytansinoid immunoconjugate separated in time from each other by one week, and administering to the patient 4 subsequent doses of 55 mg/m.sup.2 of the anti-CD19 maytansinoid immunoconjugate separated in time from each other by two weeks, wherein said anti-CD19 maytansinoid immunoconjugate comprises an antibody that specifically binds to a CD19 antigen comprising: a) a heavy chain CDR1 comprising SNWMH (SEQ ID NO.4); a heavy chain CDR2 comprising EIDPSDSYTN (SEQ ID NO.5); and a heavy chain CDR3 comprising GSNPYYYAMDY (SEQ ID NO.6); and b) a light chain CDR1 comprising SASSGVNYMH (SEQ ID NO:1); a light chain CDR2 comprising DTSKLAS (SEQ ID NO:2); and a light chain CDR3 comprising HQRGSYT (SEQ ID NO:3), wherein the maytansinoid is DM4; and wherein the antibody is conjugated to DM4 through N-succinimidyl 4-(2-pyridyldithio)butanoate (SPDB) linker. 21. The method of claim 20, wherein the antibody comprises a light chain having the sequence of SEQ ID NO.7 and a heavy chain having the sequence of SEQ ID NO.8. 22. The method of claim 20, wherein the antibody is HuB4 antibody.

Details for Patent 9,555,126

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2031-05-17
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2031-05-17
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2031-05-17