US2023277640A1PendingUtilityA1

Whole-cell cancer vaccines and methods for selection thereof

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Assignee: BRIACELL THERAPEUTICS CORPPriority: Feb 25, 2016Filed: Dec 9, 2022Published: Sep 7, 2023
Est. expiryFeb 25, 2036(~9.6 yrs left)· nominal 20-yr term from priority
Inventors:Markus Daniel LacherJoseph WagnerCharles Louis WisemanWilliam V. Williams
G01N 33/57515G01N 33/5758A61K 39/00112A61K 39/001139A61K 39/001129A61K 39/00114A61K 2039/5152A61K 39/0011A61K 2039/5156C07K 14/70539A61K 9/0019G01N 33/57415G01N 33/57484A61K 2039/55522A61P 35/00A61P 35/02A61P 37/04A61P 43/00
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Claims

Abstract

The present invention provides a modified human cancer cell comprising a recombinant polynucleotide encoding an allele of a human leukocyte antigen gene. The present invention also provides methods for selecting a whole-cell cancer vaccine for a subject having cancer and methods of treating cancer using whole-cell cancer vaccines of the present invention. In addition, the present invention provides a method of determining the HER2 status of a cell. Compositions and kits are also provided herein.

Claims

exact text as granted — not AI-modified
1 - 21 . (canceled) 
     
     
         22 . A method for selecting a whole-cell cancer vaccine for a subject having cancer, the method comprising:
 (a) detecting the presence or absence of one or more alleles of one or more human leukocyte antigen (HLA) genes in a sample obtained from the subject to generate an HLA allele profile of the subject;   (b) comparing the HLA allele profile of the subject to an HLA allele profile of the whole-cell cancer vaccine based on the presence or absence of the one or more alleles of one or more of the HLA genes in the whole-cell cancer vaccine; and   (c) selecting the whole-cell cancer vaccine for the subject when the HLA allele profile of the subject matches the HLA allele profile of the whole-cell cancer vaccine.   
     
     
         23 . The method of  claim 22 , wherein the one or more HLA genes comprise an HLA class I gene, an HLA class II gene, or a combination thereof. 
     
     
         24 . The method of  claim 23 , wherein the HLA class I gene comprises an HLA-A gene, an HLA-B gene, an HLA-C gene, an HLA-E gene, an HLA-F gene, an HLA-G gene, a beta-2-microglobulin (B2M) gene, or a combination thereof. 
     
     
         25 . The method of  claim 24 , wherein the allele of the HLA-A gene comprises HLA-A*11:01, HLA-A*01:01, HLA-A*02:01, HLA-A*03:01, HLA-A*26:01, HLA-A*29:02, HLA-A*32:01, HLA-A*24:02, HLA-A*33:03, HLA-A*68:01, HLA-A*31:01, HLA-A*02:06, or a combination thereof. 
     
     
         26 . The method of  claim 24 , wherein the allele of the HLA-B gene comprises HLA-B*13:02, HLA-B*41:01, HLA-B*18:03, HLA-B*44:02, HLA-B*07:02, HLA-B*35:01, HLA-B*40:01, HLA-B*35:08, HLA-B*55:01, HLA-B*51:01, HLA-B*44:03, HLA-B*58:01, HLA-B*08:01, HLA-B*18:01, HLA-B*15:01, HLA-B*52:01, or a combination thereof. 
     
     
         27 . The method of  claim 24 , wherein the allele of the HLA-C gene comprises HLA-C*04:01, HLA-C*07:02, HLA-C*07:01, HLA-C*06:02, HLA-C*03:04, HLA-C*01:02, HLA-C*02:02, HLA-C*08:02, HLA-C*15:02, HLA-C*03:03, HLA-C*05:01, HLA-C*08:01, HLA-C*16:01, HLA-C*12:03, HLA-C*14:02, or a combination thereof. 
     
     
         28 . The method of  claim 23 , wherein the HLA class II gene comprises an HLA class II alpha subunit gene, an HLA class II beta subunit gene, or a combination thereof. 
     
     
         29 . The method of  claim 23 , wherein the HLA class II gene comprises an HLA-DP gene, an HLA-DM gene, an HLA-DOA gene, an HLA-DOB gene, an HLA-DQ gene, an HLA-DR gene, or a combination thereof. 
     
     
         30 . The method of  claim 29 , wherein the HLA-DM gene comprises an HLA-DMA gene, an HLA-DMB gene, or a combination thereof. 
     
     
         31 . The method of  claim 29 , wherein the HLA-DR gene comprises HLA-DRA gene, an HLA-DRB1 gene, an HLA-DRB3 gene, an HLA-DRB4 gene, an HLA-DRB5 gene, or a combination thereof. 
     
     
         32 . The method of  claim 31 , wherein the allele of the HLA-DRB3 gene comprises HLA-DRB3*02:02, HLA-DRB3*01:01, HLA-DRB3*03:01, or a combination thereof. 
     
     
         33 . The method of  claim 23 , wherein the allele of the HLA class I gene comprises HLA-A*11:01 or HLA-A*24:02 and the allele of the HLA class II gene comprises HLA-DRB3*02:02 or HLA-DRB3*01:01. 
     
     
         34 . The method of  claim 22 , wherein the whole-cell cancer vaccine is selected for the subject when one or more alleles in the HLA allele profile of the subject match the HLA allele profile of the whole-cell cancer vaccine. 
     
     
         35 . The method of  claim 34 , wherein the whole-cell cancer vaccine is selected for the subject when two or more alleles in the HLA allele profile of the subject match the HLA allele profile of the whole-cell cancer vaccine. 
     
     
         36 - 127 . (canceled) 
     
     
         128 . The method of  claim 34 , wherein the whole-cell cancer vaccine is selected for the subject when one or more HLA class I alleles and one of more HLA class II alleles in the HLA allele profile of the subject match the HLA allele profile of the whole-cell cancer vaccine. 
     
     
         129 . The method of  claim 128 , wherein the whole-cell cancer vaccine is selected for the subject when one or more HLA-A alleles and one of more HLA-DR alleles in the HLA allele profile of the subject match the HLA allele profile of the whole-cell cancer vaccine. 
     
     
         130 . The method of  claim 129 , wherein the one or more HLA-A alleles comprise HLA-A*11:01, HLA-A*01:01, HLA-A*02:01, HLA-A*03:01, HLA-A*26:01, HLA-A*29:02, HLA-A*32:01, HLA-A*24:02, HLA-A*33:03, HLA-A*68:01, HLA-A*31:01, HLA-A*02:06, or a combination thereof. 
     
     
         131 . The method of  claim 129 , wherein the one of more HLA-DR alleles comprise an HLA-DRB3 allele, an HLA-DRB4 allele, an HLA-DRB5 allele, or a combination thereof. 
     
     
         132 . The method of  claim 131 , wherein the HLA-DRB3 allele comprises HLA-DRB3*02:02, HLA-DRB3*01:01, HLA-DRB3*03:01, or a combination thereof. 
     
     
         133 . The method of  claim 129 , wherein the one or more HLA-A alleles comprise an HLA-A*02:01 allele and an HLA-A*11:01 allele. 
     
     
         134 . The method of  claim 133 , wherein the one of more HLA-DR alleles comprise an HLA-DRB3 allele and an HLA-DRB4 allele. 
     
     
         135 . The method of  claim 134 , wherein the HLA-DRB3 allele comprises an HLA-DRB3*03:01 allele or an HLA-DRB3*01:01 allele. 
     
     
         136 . The method of  claim 129 , wherein the one or more HLA-A alleles comprise an HLA-A*01:01 allele and an HLA-A*68:01 allele. 
     
     
         137 . The method of  claim 136 , wherein the one of more HLA-DR alleles comprise (i) an HLA-DRB3 allele and an HLA-DRB4 allele or (ii) an HLA-DRB3 allele and an HLA-DRB5 allele. 
     
     
         138 . The method of  claim 137 , wherein the HLA-DRB3 allele comprises an HLA-DRB3*02:02 allele. 
     
     
         139 . The method of  claim 129 , wherein the one or more HLA-A alleles comprise an HLA-A*03:01 allele. 
     
     
         140 . The method of  claim 139 , wherein the one of more HLA-DR alleles comprise an HLA-DRB3 allele and an HLA-DRB5 allele. 
     
     
         141 . The method of  claim 140 , wherein the HLA-DRB3 allele comprises an HLA-DRB3*01:01 allele or an HLA-DRB3*03:01 allele. 
     
     
         142 . The method of  claim 129 , wherein the one or more HLA-A alleles comprise an HLA-A*24:02 allele and an HLA-A*33:03 allele. 
     
     
         143 . The method of  claim 142 , wherein the one of more HLA-DR alleles comprise (i) an HLA-DRB5 allele or (ii) an HLA-DRB3 allele and an HLA-DRB5 allele. 
     
     
         144 . The method of  claim 22 , wherein the cancer is selected from the group consisting of breast cancer, ovarian cancer, cervical cancer, prostate cancer, pancreatic cancer, colorectal cancer, gastric cancer, lung cancer, skin cancer, liver cancer, brain cancer, eye cancer, soft tissue cancer, renal cancer, bladder cancer, head and neck cancer, mesothelioma, acute leukemia, chronic leukemia, medulloblastoma, multiple myeloma, sarcoma, and a combination thereof.

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