IP Library Granted Patent US 11,597,775
Granted Patent B2
US 11,597,775 · App. 15/824,055 · Granted Mar 7, 2023

Preparations and methods for treating a GD2 positive cancer

Inventors: Hans Loibner (Vienna, AT); Oliver Mutschlechner (Wiener Neudorf, AT); Ruth Ladenstein (Vienna, AT); Isabel Klier (Vienna, AT)
Assignee: APEIRON BIOLOGICS AG
C07K16/3084A61K9/0019A61K2039/505A61K2039/545C07K2317/24C07K2317/734
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Quick Facts
Patent No.
US 11,597,775
App. No.
15/824,055
Granted
Mar 7, 2023
Kind
B2
Abstract

The present invention relates to preparations and methods for treating a GD2 positive cancer by administering a preparation comprising a chimeric or humanized anti-GD2 antibody to a patient, wherein the patient is not concomitantly treated with Interleukin-2 (IL-2 wherein a GD2 positive cancer is treated in the patient. Furthermore, the invention relates to preparations and methods for the treatment of a GD2 positive cancer in a patient, wherein a preparation comprising an anti-GD2 antibody is administered to the patient as a continuous infusion, without concomitantly administering IL-2. The present invention further relates to preparations and methods for the treatment of a GD2 positive cancer in a patient, wherein the one or more anti-GD2 antibody treatment periods is/are preceded, accompanied, and/or followed by one or more treatment periods with a retinoid.

Claims (14)

1. A method of treating a GD2 positive cancer in a patient comprising administering a preparation comprising an anti-GD2 antibody to the patient without concomitantly administering IL-2 within the same treatment cycle and/or within the same overall treatment period, wherein a GD2 positive cancer is treated in the patient, wherein the anti-GD2 antibody is a 14.18 antibody, and wherein the preparation is administered to the patient in a dose of 10 mg/m 2 /day for 10 consecutive days or in a dose of 15, 20, or 25 mg/m 2 /day for 4 consecutive days.

2. The method of claim 1 , wherein the anti-GD2 antibody is a chimeric or humanized anti-GD2 antibody.

3. The method of claim 1 , further comprising treating the patient one or more times with a retinoid within the same treatment cycle preceding, accompanying, and/or following the administration of the anti-GD2 antibody.

4. The method of claim 1 , wherein the anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0.

5. The method of claim 1 , wherein the anti-GD2 antibody has the light chain amino acid sequence of amino acid residues 21 to 240 of SEQ ID NO:3 and the heavy chain amino acid sequence of amino acid residues 21 to 462 SEQ ID NO:4.

6. The method of claim 1 , wherein the anti-GD2 antibody is administered to the patient in a dose of 50 to 150 mg/m 2 /cycle.

7. The method of claim 1 , wherein the preparation is administered to the patient in a dose of 50, 60, 65, 68, 70, 75, 80, 100, 120, or 150 mg/m 2 /cycle.

8. The method of claim 1 , wherein the anti-GD2 antibody is administered to the patient for two or more treatment cycles.

9. The method of claim 1 , wherein the patient is not concomitantly treated with GM-CSF within the same treatment cycle and/or within the same overall treatment period.

10. The method of claim 1 , wherein the patient is not concomitantly treated with a cytokine within the same treatment cycle and/or within the same overall treatment period.

11. The method of claim 1 , wherein the GD2 positive cancer is neuroblastoma, glioblastoma, medulloblastoma, astrocytoma, melanoma, small-cell lung cancer, desmoplastic small round cell tumor, osteosarcoma, rhabdomyosarcoma, or another soft tissue sarcoma.

12. The method of claim 1 , wherein the patient suffers from primary refractory or relapsed high-risk neuroblastoma, or from minimal residual disease in high-risk neuroblastoma.

13. The method of claim 1 , wherein a morphine dose of the overall treatment time is lower than a morphine dose of the overall treatment time in an according administration schedule wherein the anti-GD2 antibody is administered to a patient in a dose of 1 to 25 mg/m 2 /day and 50 to 150 mg/m 2 /cycle as a continuous infusion for 24 hours per day concomitantly with IL-2, GM-CSF, and/or another cytokine.

14. The method of claim 1 , wherein a dose of one or more analgesics is reduced within the overall treatment time, within a treatment cycle, during the antibody treatment period within a treatment cycle, from one antibody treatment day to the next antibody treatment day within a treatment cycle, and/or from one treatment cycle to the next.

Assignments (4)
SECURITY INTEREST Recorded Dec 23, 2024
From: APEIRON BIOLOGICS GMBH
To: CITIBANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 069669/0908 →
CHANGE OF NAME Recorded Dec 10, 2024
From: APEIRON BIOLOGICS AG
To: APEIRON BIOLOGICS GMBH
Reel/Frame 069584/0365 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 7, 2017
From: LOIBNER, HANS; MUTSCHLECHNER, OLIVER; LADENSTEIN, RUTH; KLIER, ISABEL
To: APEIRON BIOLOGICS AG
Reel/Frame 044331/0772 →
LICENSE Recorded Dec 7, 2017
From: APEIRON BIOLOGICS AG
To: EUSA PHARMA (UK) LIMITED
Reel/Frame 044801/0254 →
Priority Claims (2)
CA CA 2834000 · Nov 21, 2013 · national
EP 13193953 · Nov 21, 2013 · regional
Continuity (4)
Continuation 15036519
Continuation In Part 14182776 · Feb 18, 2014
Continuation In Part 14086696 · Nov 21, 2013
Related Publication 20180258183A1 · Sep 13, 2018