IP Library Granted Patent US 8,828,381
Granted Patent B2
US 8,828,381 · App. 12/559,839 · Granted Sep 9, 2014

Co-administration of CG250 and IL-2 or IFN-alpha for treating cancer such as renal cell carcinomas

Inventors: Sven Ole Warnaar (Leiden, NL); Stefan Ullrich (Starnberg, DE)
Assignee: Wilex AG
C07K16/3038A61K38/212A61K38/00A61K39/395A61K38/2013A61K2039/545A61K39/39558A61K2039/505
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Quick Facts
Patent No.
US 8,828,381
App. No.
12/559,839
Granted
Sep 9, 2014
Kind
B2
Abstract

A method for enhancing the therapeutic effect of cytokine treatment is disclosed. More specifically the present invention relates to a method for administering to a tumor patient a therapeutic dose of cytokine in combination with antibodies directed against the tumor associated antigen carbonic anhydrase IX (CAIX/G250/MN). The improved treatment method is characterized in a significantly reduced cytokine-related toxicity combined with potentiated effectiveness of anti-G250 antibody alone, resulting in a positive therapeutic response with respect to that observed with single anti-tumor agents alone.

Claims (20)

1. A method for the treatment of a renal cell cancer comprising co-administering an anti-tumor antibody directed against the MN (G250) antigen and a cytokine to a subject in need thereof, wherein the cytokine is administered repeatedly in a low-dose form as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is interleukin-2 (IL-2), and wherein the IL-2 is the only cytokine which is administered.

2. A method for the treatment of a renal cell cancer comprising co-administering an anti-tumor antibody directed against the MN (G250) antigen and a cytokine to a subject in need thereof, wherein the method comprises:

(a) a first treatment stage comprising administering a low-dose cytokine as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is interleukin-2 (IL-2), and

(b) a second treatment stage comprising co-administering said anti-tumor antibody and a low-dose cytokine, wherein the cytokine is administered as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is IL-2, and wherein the IL-2 is the only cytokine which is administered.

3. The method of claim 1 or 2 , wherein the low-dose cytokine comprises a dose which is pharmaceutically effective in the substantial absence of NIC CTC toxicity grade 3 or higher.

4. The method of claim 1 or 2 , wherein the cytokine is administered in a substantially constant dose during the treatment.

5. The method of claim 1 or 2 , wherein the cytokine is administered in a variable dose during the treatment.

6. The method of claim 1 or 2 , wherein the cytokine is administered subcutaneously.

7. The method of claim 1 or 2 , wherein the anti-tumor antibody is a chimeric or humanized G250 antibody or an antigen binding fragment thereof.

8. The method of claim 1 or 2 , wherein the anti-tumor antibody is administered in intervals of from 5-20 days.

9. The method of claim 2 , wherein the first treatment stage comprises 5-20 days.

10. The method of claim 2 , wherein the second treatment stage comprises 5-200 days.

11. The method of claim 1 or 2 , wherein the renal cell cancer is metastatic renal cell carcinoma.

12. The method of claim 2 , wherein the second treatment stage comprises about 70-120 days.

13. A method for the treatment of a renal cell cancer, said method comprising co-administering an anti-tumor antibody directed against the MN (G250) antigen and a cytokine to a subject in need thereof, wherein the cytokine is administered repeatedly in a low-dose form as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is interleukin-2 (IL-2), and wherein the anti-tumor antibody and the IL-2 are the only active ingredients which are administered.

14. The method of claim 13 , wherein the anti-tumor antibody is a chimeric or humanized G250 antibody or an antigen binding fragment thereof.

15. The method of claim 13 , wherein the renal cell cancer is metastatic renal cell carcinoma.

16. A method for the treatment of metastatic renal cell carcinoma comprising co-administering an anti-tumor antibody directed against the MN (G250) antigen and a cytokine to a subject in need thereof, wherein the cytokine is administered repeatedly in a low-dose form as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is interleukin-2 (IL-2), and wherein the IL-2 is the only cytokine which is administered.

17. A method for the treatment of a renal cell cancer comprising co-administering an anti-tumor antibody directed against the MN (G250) antigen and a cytokine to a subject in need thereof, wherein the subject is in the terminal stage of the disease, wherein the cytokine is administered repeatedly in a low-dose form as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is interleukin-2 (IL-2), and wherein the IL-2 is the only cytokine which is administered.

18. A method for the treatment of a renal cell cancer comprising co-administering an anti-tumor antibody directed against the MN (G250) antigen and a cytokine to a subject in need thereof, wherein the cytokine is administered subcutaneously and repeatedly in a low-dose form as a single daily dose in the range of from 1-10 MIU daily, wherein the cytokine is interleukin-2 (IL-2), and wherein the IL-2 is the only cytokine which is administered.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2014
From: PROMETHEUS IP HOLDINGS LLC
To: WILEX AG
Reel/Frame 033402/0739 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2011
From: WARNAAR, SVEN OLE; ULLRICH, STEFAN
To: WILEX AG
Reel/Frame 027231/0530 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 4, 2011
From: WILEX AG
To: PROMETHEUS IP HOLDINGS LLC
Reel/Frame 026226/0580 →
Continuity (3)
Division 10517338
Provisional Application 60392311 · Jul 1, 2002
Related Publication 20100008888A1 · Jan 14, 2010