US2021338811A1PendingUtilityA1

Combination Therapy of Immunotoxin and Checkpoint Inhibitor

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Assignee: UNIV DUKEPriority: Nov 4, 2015Filed: Jul 15, 2021Published: Nov 4, 2021
Est. expiryNov 4, 2035(~9.3 yrs left)· nominal 20-yr term from priority
Inventors:Darell BignerVidyalakshmi ChandramohanSmita NairMatthias GromeierXuhui BaoIra H. Pastan
A61K 39/3955C07K 16/30A61K 47/6849A61K 2039/505C07K 2317/624C07K 2317/622A61K 47/6829C07K 2319/55A61P 35/00C07K 16/2818A61K 2039/507C07K 16/2863A61K 47/6851C07K 2317/73C07K 2317/76A61K 38/164A61K 39/395A61K 45/06
65
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Claims

Abstract

Regional, tumor-targeted, cytotoxic therapy, such as D2C7-immunotoxin (D2C7-IT), not only specifically target and destroy tumor cells, but in the process initiate immune events that promote an in situ vaccine effect. The antitumor effects are amplified by immune checkpoint blockade which engenders a long-term systemic immune response that effectively eliminates all tumor cells.

Claims

exact text as granted — not AI-modified
1 . A method of treating a tumor in a patient, comprising:
 administering to the patient an immunotoxin comprising a single chain variable region antibody fused to a PE38 truncated  Pseudomonas  exotoxin, wherein the single chain variable region antibody has CDR1, CDR2, and CDR3 regions as shown in SEQ ID NO: 6-11; and   administering an immune checkpoint inhibitor to the patient.   
     
     
         2 . The method of  claim 1  wherein the tumor is a malignant glioma. 
     
     
         3 . The method of  claim 1  wherein the tumor is breast cancer. 
     
     
         4 . The method of  claim 1  wherein the tumor is head and neck squamous cell carcinoma. 
     
     
         5 . The method of  claim 1  wherein the tumor is lung cancer. 
     
     
         6 . The method of  claim 1  wherein the immunotoxin is administered directly to the tumor. 
     
     
         7 . The method of  claim 1  wherein the immune checkpoint is selected from the group consisting of PD-1, PD-L1, CTLA-4, LAG-3, TIM-3, and CSF-1R. 
     
     
         8 . The method of  claim 1  wherein the checkpoint inhibitor is an anti-PD-1 antibody. 
     
     
         9 . The method of  claim 1  wherein the checkpoint inhibitor is an anti-PD-L1 antibody. 
     
     
         10 . The method of  claim 1  wherein the checkpoint inhibitor is an anti-CTLA4 antibody. 
     
     
         11 . The method of  claim 1  wherein the checkpoint inhibitor is an anti-LAG-3 antibody. 
     
     
         12 . The method of  claim 1  wherein the checkpoint inhibitor is an anti-TIM-3 antibody. 
     
     
         13 . The method of  claim 1  wherein the checkpoint inhibitor is an anti-CSF-1R antibody. 
     
     
         14 . The method of  claim 1  wherein the checkpoint inhibitor is a small molecule inhibitor of IDO. 
     
     
         15 . The method of  claim 1  wherein the checkpoint inhibitor is a small molecule inhibitor of CSF-1R. 
     
     
         16 . The method of  claim 1  wherein the immune checkpoint inhibitor is administered within 30 days of administering the immunotoxin. 
     
     
         17 . The method of  claim 1  wherein the immune checkpoint inhibitor is administered within 7 days of administering the immunotoxin. 
     
     
         18 . The method of  claim 1  wherein the PE38 truncated  Pseudomonas  exotoxin is fused to a KDEL peptide. 
     
     
         19 . A kit for treating a tumor, comprising:
 an immunotoxin comprising a single chain variable region antibody fused to a PE38 truncated  Pseudomonas  exotoxin, wherein the single chain variable region antibody has CDR1, CDR2, and CDR3 regions as shown in SEQ ID NO: 6-11; and   an immune checkpoint inhibitor.   
     
     
         20 . The kit of  claim 19  wherein the checkpoint inhibitor is an anti-PD-1 antibody. 
     
     
         21 . The kit of  claim 19  wherein the checkpoint inhibitor is an anti-PDL-1 antibody. 
     
     
         22 . The kit of  claim 19  wherein the checkpoint inhibitor is an anti-CTLA4 antibody. 
     
     
         23 . The kit of  claim 19  wherein the checkpoint inhibitor is an anti-LAG-3 antibody. 
     
     
         24 . The kit of  claim 19  wherein the checkpoint inhibitor is an anti-TIM-3 antibody. 
     
     
         25 . The kit of  claim 19  wherein the checkpoint inhibitor is an anti-CSF-R1 antibody. 
     
     
         26 . The kit of  claim 19  wherein the checkpoint inhibitor is a small molecule inhibitor of IDO. 
     
     
         27 . The kit of  claim 19  wherein the checkpoint inhibitor is a small molecule inhibitor of CSF-R1. 
     
     
         28 . The kit of  claim 19  wherein the PE38 truncated  Pseudomonas  exotoxin is fused to a KDEL peptide.

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