IP Library › Granted Patent US 12,383,637
Granted Patent B2
US 12,383,637 · App. 17/570,933 · Granted Aug 12, 2025

Therapeutic agents and uses thereof

Inventors: Sven-Erik Strand (Lund, SE); Amanda Thuy Tran (Stockholm, SE); Sven-Niklas Anders Axelsson (Bjarred, SE)
Assignee: Janssen Biotech, Inc.
A61K51/1072A61K47/6803A61K49/16A61K49/221A61K51/1018A61K51/1075A61K51/1093A61K51/1096C07K16/18C07K16/3069C07K16/40G01N33/57434C07K2317/565G01N2333/96455
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Quick Facts
Patent No.
US 12,383,637
App. No.
17/570,933
Granted
Aug 12, 2025
Kind
B2
Abstract

The present application provides an agent comprising or consisting of a binding moiety with specificity for a kallikrein protein (for example, PSA or hK2) for use in the treatment of prostate cancer, and a method for the treatment of prostate cancer in a patient, the method comprising the step of administering a therapeutically effective amount of an agent comprising or consisting of a binding moiety with specificity for a kallikrein protein to the patient.

Claims (21)

1. A method for the treatment of castration-resistant prostate cancer (CRPC) in a patient, the method comprising administering a therapeutically effective amount of an agent comprising

(a) an antibody or antigen-binding fragment thereof with specificity for human glandular kallikrein (hK2) and

(b) a cytotoxic moiety comprising 225 Ac,

wherein the antibody or antigen-binding fragment thereof with specificity for hK2 comprises the six complementarity determining regions (CDRs) of antibody 11B6, wherein the heavy chain of the 11B6 antibody comprises SEQ ID NO: 4 and the light chain of the 11B6 antibody comprises SEQ ID NO: 5.

2. The method of claim 1 , wherein the antibody or antigen-binding fragment thereof with specificity for hK2 is selected from the group consisting of 11B6 and antigen-binding fragments thereof, wherein the heavy chain of the 11B6 antibody comprises SEQ ID NO: 4 and the light chain of the 11B6 antibody comprises SEQ ID NO: 5.

3. The method of claim 1 , wherein the antibody or the antigen-binding fragment thereof comprises human framework residues.

4. The method of claim 1 , wherein the antibody or antigen-binding fragment thereof with specificity for hK2 comprises at least a portion of an antibody constant region derived from a human antibody.

5. The method of claim 1 , wherein the antibody or antigen-binding fragment thereof with specificity for hK2 is linked indirectly to the cytotoxic moiety.

6. The method of claim 1 , wherein the antibody or antigen-binding fragment thereof with specificity for hK2 is linked directly to the cytotoxic moiety.

7. The method of claim 1 , wherein the agent displays tumor uptake characteristics substantially equivalent to the tumor uptake characteristics of the antibody or antigen-binding fragment thereof with specificity for hK2 alone.

8. The method of claim 1 , wherein the prostate cancer is metastatic CRPC.

9. The method of claim 1 , wherein the patient has prostate cancer and is less than 70 years old at the time of diagnosis of prostate cancer and/or at the time of treatment.

10. The method of claim 1 , wherein the patient is characterized in that a family member has been previously diagnosed with prostate cancer.

11. The method of claim 1 , wherein the patient has previously been treated with one or more prostate cancer therapies.

12. The method of claim 1 , wherein the cytotoxic moiety is linked to the antibody or antigen-binding fragment thereof via a non-phenolic linker.

13. The method of claim 1 , wherein the cytotoxic moiety is linked to the antibody or antigen-binding fragment thereof via a chelating moiety.

14. The method of claim 13 , wherein the chelating moiety comprises a derivatives of 1,4,7,10-tetraazacyclododecane-1,4,7,10, tetraacetic acid (DOTA), a derivative of diethylenetriaminepentaacetic acid (DTPA), a derivative of S-2-(4-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (NOTA), or a derivatives of 1,4,8,11-tetraazacyclodocedan-1,4,8,11-tetraacetic acid (TETA).

15. The method of claim 13 , wherein the chelating moiety comprises 1,4,7,10-tetraazacyclododecane-1,4,7,10, tetraacetic acid (DOTA).

16. The method of claim 1 , wherein the method reduces the rate of growth of prostatic cancer cells in the patient by at least 10% compared to the observed rate of growth of prostatic cancer cells in the patient prior to the treatment.

17. The method of claim 1 , wherein the method reduces the rate growth of prostatic cancer cells in the patient by at least 20%, 30%, 40%, 50%, 60%, 70%, 80% or 90% compared to the observed rate of growth of prostatic cancer cells in the patient prior to the treatment.

18. The method of claim 1 , wherein the agent is administered at a dose of about 1 mg/kg.

Continuity (5)
Continuation 16679778 · Nov 11, 2019
Continuation 15135028 · Apr 21, 2016
Continuation 14354617
Provisional Application 61552796 · Oct 28, 2011
Related Publication 20220125961A1 · Apr 28, 2022
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