US2011033421A1PendingUtilityA1

Methods related to immunostimulatory nucleic acid-induced interferon

Assignee: COLEY PHARM GMBHPriority: Sep 27, 1999Filed: Jul 13, 2010Published: Feb 10, 2011
Est. expirySep 27, 2019(expired)· nominal 20-yr term from priority
C12N 2501/23A61P 35/00C12N 15/117C12N 2501/056C12N 2501/22A61P 31/18A61K 38/21A61P 31/20A61K 2039/55561A61P 31/14A61P 31/22A61K 40/4252A61K 40/4217A61K 40/421A61K 40/10C12N 5/0639
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Claims

Abstract

Methods and compositions are provided for extending the clinical utility of IFN-α in the treatment of a variety of viral and proliferative disorders. Among other aspects, the invention provides methods which increase the efficacy of IFN-α treatment and reduce IFN-α treatment-related side effects. In addition, methods are provided for supporting the survival and for activating natural interferon producing cells (IPCs) in vitro without exogenous IL-3 or GM-CSF. The invention is based on the discovery that certain CpG and non-CpG ISNAs promote survival and stimulation of IPCs.

Claims

exact text as granted — not AI-modified
1 - 46 . (canceled) 
     
     
         47 . A method of treating a subject to activate interferon-producing cells (IPCs) of the subject comprising
 isolating IPCs from a subject in need of such treatment,   culturing the IPCs in vitro,   contacting the IPCs in vitro with an effective amount of an isolated immunostimulatory nucleic acid, and   returning the contacted IPCs to the subject.   
     
     
         48 . The method of  claim 47 , further comprising contacting the IPCs in vitro with a growth factor. 
     
     
         49 . The method of  claim 47 , further comprising contacting the IPCs in vitro with IL-3. 
     
     
         50 . The method of  claim 47 , further comprising contacting the IPCs in vitro with GM-CSF. 
     
     
         51 . The method of  claim 47 , wherein the IPCs are cultured in vitro in the absence of IL-3. 
     
     
         52 . The method of  claim 47 , wherein the IPCs are cultured in vitro in the absence of GMCSF. 
     
     
         53 . The method of  claim 47 , wherein the immunostimulatory nucleic acid is modified. 
     
     
         54 . The method of  claim 47 , wherein the immunostimulatory nucleic acid comprises a backbone with at least one nuclease-resistant internucleotide linkage selected from the group consisting of: phosphorothioate, phosphorodithioate, methylphosphonate, and peptide. 
     
     
         55 - 121 . (canceled) 
     
     
         122 . A method of enhancing efficacy of IFN-α treatment in a subject in need of such treatment, comprising
 administering to a subject in need of such treatment an amount of a pharmaceutical composition comprising IFN-α effective for treating a condition of the subject; 
 isolating natural interferon-producing cells (IPCs) from a donor; 
 contacting the isolated IPCs ex vivo with an amount of a pharmaceutical composition comprising an immunostimulatory nucleic acid effective for inducing the IPCs-to release IFN-α; and 
 administering the contacted cells to the subject. 
 
     
     
         123 . The method of  claim 122 , wherein the donor is the subject. 
     
     
         124 . The method of  claim 122  further comprising contacting the isolated IPCs with an antigen. 
     
     
         125 . The method of  claim 122 , wherein the administering the contacted cells comprises local injection. 
     
     
         126 . The method of  claim 125 , wherein the local injection is via a blood vessel supplying a target tissue. 
     
     
         127 . The method of  claim 126 , wherein the blood vessel is selected from the group consisting of a hepatic artery, a portal vein, a celiac artery, and a splenic artery. 
     
     
         128 . The method of  claim 122 , wherein the immunostimulatory nucleic acid is modified. 
     
     
         129 . The method of  claim 122 , wherein the immunostimulatory nucleic acid comprises a backbone with at least one nuclease-resistant internucleotide linkage selected from the group consisting of: phosphorothioate, phosphorodithioate, methylphosphonate, and peptide. 
     
     
         130 - 139 . (canceled) 
     
     
         140 . The method of  claim 122 , wherein the subject has a condition selected from the group consisting of a proliferative disorder and a viral infection. 
     
     
         141 . The method of  claim 122 , wherein the subject has a proliferative disorder selected from the group consisting of: hairy cell leukemia, chronic myelogenous leukemia, cutaneous T-cell leukemia, multiple myeloma, follicular lymphoma, malignant melanoma, squamous cell carcinoma, AIDS-related Kaposi's sarcoma, renal cell carcinoma, prostate carcinoma, bladder cell carcinoma, cervical dysplasia, and colon carcinoma. 
     
     
         142 . The method of  claim 122 , wherein the subject has a viral infection selected from the group consisting of: hepatitis B, hepatitis C, condyloma acuminatum, human immunodeficiency virus, herpes, cytomegalovirus, Epstein-Barr virus, and papillomavirus. 
     
     
         143 . A method of supporting survival of natural interferon-producing cells (IPCs) in vitro, comprising
 isolating IPCs from a subject;   culturing the IPCs in a sterile medium suitable for tissue culture; and   contacting the IPCs in vitro with an amount of immunostimulatory nucleic acid effective to support the growth of the IPCs in the absence of interleukin 3 (IL-3).   
     
     
         144 - 200 . (canceled) 
     
     
         201 . An isolated nucleic acid having a sequence selected from the group consisting of: 
       
         
           
                 
                 
                 
               
                   tcgtcgttttgtcgttttgtcgtt 
                   ODN 2022 
                   SEQ ID NO: 2 
                 
                     
                 
                   ggggtegtegttttgggggg 
                   ODN 2184 
                   SEQ ID NO: 3 
                 
                     
                 
                   tcgtcgttttgtcgttttgggggg 
                   ODN 2185 
                   SEQ ID NO: 4 
                 
                     
                 
                   ggggtcgacgtcgagggggg 
                   ODN 2192 
                   SEQ ID NO: 5 
                 
                     
                 
                   ggggtcatcgatgagggggg 
                   ODN 2204 
                   SEQ ID NO: 6 
                 
                     
                 
                   ggGGGACGATCGTCgggggG 
                   ODN 2216 
                   SEQ ID NO: 7 
                 
                     
                 
                   gggggtcgtacgacgggggg 
                   ODN 2217 
                   SEQ ID NO: 8 
                 
                     
                 
                   ggGGGACGATATCGTCgggggG 
                   ODN 2245 
                   SEQ ID NO: 9 
                 
                     
                 
                   ggGGGACGACGTCGTCgggggG 
                   ODN 2246 
                   SEQ ID NO: 10 
                 
                     
                 
                   ggGGGACGAGCTCGTCgggggG 
                   ODN 2247 
                   SEQ ID NO: 11 
                 
                     
                 
                   ggGGGACGTACGTCgggggG 
                   ODN 2248 
                   SEQ ID NO: 12 
                 
                     
                 
                   ggGGGACGATCGTTGggggG 
                   ODN 2252 
                   SEQ ID NO: 13 
                 
                     
                 
                   ggGGAACGATCGTCgggggG 
                   ODN 2253 
                   SEQ ID NO: 14 
                 
                     
                 
                   ggGGGGACGATCGTCgggggG 
                   ODN 2254 
                   SEQ ID NO: 15 
                 
                     
                 
                   ggGGGACGATCGTCGgggggG 
                   ODN 2255 
                   SEQ ID NO: 16 
                 
                     
                 
                   ggGGGTCATCGATGAgggggG 
                   ODN 2260 
                   SEQ ID NO: 17 
                 
                     
                 
                   ggGGTCGTCGACGAgggggG 
                   ODN 2293 
                   SEQ ID NO: 18 
                 
                     
                 
                   ggGGTCGTTCGAACGAgggggG 
                   ODN 2294 
                   SEQ ID NO: 19 
                 
                     
                 
                   ggGGACGTTCGAACGTgggggG 
                   ODN 2295 
                   SEQ ID NO: 20 
                 
                     
                 
                   ggGGAACGACGTCGTTgggggG 
                   ODN 2297 
                   SEQ ID NO: 21 
                 
                     
                 
                   ggGGAACGTACGTCgggggG 
                   ODN 2298 
                   SEQ ID NO: 22 
                 
                     
                 
                   ggGGAACGTACGTACGTTgggggG 
                   ODN 2299 
                   SEQ ID NO: 23 
                 
                     
                 
                   ggGGTCACCGGTGAgggggG 
                   ODN 2300 
                   SEQ ID NO: 24 
                 
                     
                 
                   ggGGTCGACGTACGTCGAgggggG 
                   ODN 2301 
                   SEQ ID NO: 25 
                 
                     
                 
                   ggGGACCGGTACCGGTgggggG 
                   ODN 2302 
                   SEQ ID NO: 26 
                 
                     
                 
                   ggGTCGACGTCGAgggggG 
                   ODN 2303 
                   SEQ ID NO: 27 
                 
                     
                 
                   ggGGTCGACGTCGagggg 
                   ODN 2304 
                   SEQ ID NO: 28 
                 
                     
                 
                   ggGGAACGTTAACGTTgggggG 
                   ODN 2305 
                   SEQ ID NO: 29 
                 
                     
                 
                   ggGGACGTCGACGTggggG 
                   ODN 2306 
                   SEQ ID NO: 30 
                 
                     
                 
                   ggGGGTCGTTCGTTgggggG 
                   ODN 2311 
                   SEQ ID NO: 31 
                 
                     
                 
                   ggGACGATCGTCGgggggG 
                   ODN 2328 
                   SEQ ID NO: 32 
                 
                     
                 
                   ggGTCGTCGACGAggggggG 
                   ODN 2329 
                   SEQ ID NO: 33 
                 
                     
                 
                   ggTCGTCGACGAGgggggG 
                   ODN 2330 
                   SEQ ID NO: 34 
                 
                     
                 
                   ggGGACGATCGTCGgggggG 
                   ODN 2332 
                   SEQ ID NO: 35 
                 
                     
                 
                   ggGGTCGACGTCGACGTCGAGgggggG, 
                   ODN 2334 
                   SEQ ID NO: 36 
                 
                   and 
                     
                     
                 
                     
                 
                   ggGGACGACGTCGTGgggggG, 
                   ODN 2336 
                   SEQ ID NO: 37 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       wherein each lower case letter represents phosphorothioate linkage and each upper case letter indicates phosphodiester linkage. 
     
     
         202 . A pharmaceutical composition comprising
 an isolated nucleic acid having a sequence selected from the group consisting of:   
       
         
           
                 
                 
                 
               
                   tcgtcgattttgtcgtillgtcgtt 
                   ODN 2022 
                   SEQ ID NO: 2 
                 
                     
                 
                   ggggtcgtcgttttgggggg 
                   ODN 2184 
                   SEQ ID NO: 3 
                 
                     
                 
                   tcgtcgttagtcgttttgggggg 
                   ODN 2185 
                   SEQ ID NO: 4 
                 
                     
                 
                   ggggtcgacgtcgagggggg 
                   ODN 2192 
                   SEQ ID NO: 5 
                 
                     
                 
                   ggggtcatcgatgagggggg 
                   ODN 2204 
                   SEQ ID NO: 6 
                 
                     
                 
                   ggGGGACGATCGTCgggggG 
                   ODN 2216 
                   SEQ ID NO: 7 
                 
                     
                 
                   gggggtcgtacgacgggggg 
                   ODN 2217 
                   SEQ ID NO: 8 
                 
                     
                 
                   ggGGGACGATATCGTCgggggG 
                   ODN 2245 
                   SEQ ID NO: 9 
                 
                     
                 
                   ggGGGACGACGTCGTCgggggG 
                   ODN 2246 
                   SEQ ID NO: 10 
                 
                     
                 
                   ggGGGACGAGCTCGTCgggggG 
                   ODN 2247 
                   SEQ ID NO: 11 
                 
                     
                 
                   ggGGGACGTACGTCggggg0 
                   ODN 2248 
                   SEQ ID NO: 12 
                 
                     
                 
                   ggGGGACGATCGTTGggggG 
                   ODN 2252 
                   SEQ ID NO: 13 
                 
                     
                 
                   ggGGAACGATCGTCgggggG 
                   ODN 2253 
                   SEQ ID NO: 14 
                 
                     
                 
                   ggGGGGACGATCGTCgggggG 
                   ODN 2254 
                   SEQ ID NO: 15 
                 
                     
                 
                   ggGGGACGATCGTCGgggggG 
                   ODN 2255 
                   SEQ ID NO: 16 
                 
                     
                 
                   ggGGGTCATCGATGAgggggG 
                   ODN 2260 
                   SEQ ID NO: 17 
                 
                     
                 
                   ggGGTCGTCGACGAgggggG 
                   ODN 2293 
                   SEQ ID NO: 18 
                 
                     
                 
                   ggGGTCGTTCGAACGAgggggG 
                   ODN 2294 
                   SEQ ID NO: 19 
                 
                     
                 
                   ggGGACGTTCGAACGTgggggG 
                   ODN 2295 
                   SEQ ID NO: 20 
                 
                     
                 
                   ggGGAACGACGTCGTTgggggG 
                   ODN 2297 
                   SEQ ID NO: 21 
                 
                     
                 
                   ggGGAACGTACGTCgggggG 
                   ODN 2298 
                   SEQ ID NO: 22 
                 
                     
                 
                   ggGGAACGTACGTACGTTgggggG 
                   ODN 2299 
                   SEQ ID NO: 23 
                 
                     
                 
                   ggGGTCACCGGTGAgggggG 
                   ODN 2300 
                   SEQ ID NO: 24 
                 
                     
                 
                   ggGGTCGACGTACGTCGAgggggG 
                   ODN 2301 
                   SEQ ID NO: 25 
                 
                     
                 
                   ggGGACCGGTACCGGTgggggG 
                   ODN 2302 
                   SEQ ID NO: 26 
                 
                     
                 
                   ggGTCGACGTCGAgggggG 
                   ODN 2303 
                   SEQ ID NO: 27 
                 
                     
                 
                   ggGGTCGACGTCGagggg 
                   ODN 2304 
                   SEQ ID NO: 28 
                 
                     
                 
                   ggGGAACGTTAACGTTgggggG 
                   ODN 2305 
                   SEQ ID NO: 29 
                 
                     
                 
                   ggGGACGTCGACGTggggG 
                   ODN 2306 
                   SEQ ID NO: 30 
                 
                     
                 
                   ggGGGTCGTTCGTTgggggG 
                   ODN 2311 
                   SEQ ID NO: 31 
                 
                     
                 
                   ggGACGATCGTCGgggggG 
                   ODN 2328 
                   SEQ ID NO: 32 
                 
                     
                 
                   ggGTCGTCGACGAggggggG 
                   ODN 2329 
                   SEQ ID NO: 33 
                 
                     
                 
                   ggTCGTCGACGAGgggggG 
                   ODN 2330 
                   SEQ ID NO: 34 
                 
                     
                 
                   ggGGACGATCGTCGgggggG 
                   ODN 2332 
                   SEQ ID NO: 35 
                 
                     
                 
                   ggGGTCGACGTCGACGTCGAGgggggG, 
                   ODN 2334 
                   SEQ ID NO: 36 
                 
                   and 
                     
                     
                 
                     
                 
                   ggGGACGACGTCGTGgggggG, 
                   ODN 2336 
                   SEQ ID NO: 37 
                 
             
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
       wherein each lower case letter represents phosphorothioate linkage and each upper case letter indicates phosphodiester linkage; and
 a pharmaceutically acceptable carrier. 
 
     
     
         203 . The pharmaceutical composition of  claim 202 , further comprising IFN-α.

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