US2018087081A1PendingUtilityA1

Protein expression enhancing polypeptides

Assignee: SOLA BIOSCIENCES LLCPriority: Dec 5, 2012Filed: Sep 12, 2017Published: Mar 29, 2018
Est. expiryDec 5, 2032(~6.3 yrs left)· nominal 20-yr term from priority
A61P 43/00A61P 25/16A61P 25/28A61P 25/14A61P 25/00A61P 11/00C07K 16/244C07K 14/315C07K 2319/35C07K 16/241C07K 14/8125C12N 9/6437C07K 19/00C07K 2317/14C07K 14/31C07K 7/06C07K 14/5437C12P 21/02C07K 14/47C07K 2319/30C07K 14/755C07K 14/7155C12N 9/644C07K 2319/70C07K 2319/43A61K 48/00C07K 14/705C07K 14/01C07K 2319/705C07K 16/22C07K 2319/00C07K 7/08
37
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Fusion proteins comprising a protein expression enhancing polypeptide linked to a target protein binding domain and nucleic acid molecules encoding such fusion proteins are described for use in enhancing expression and/or location of a targeted protein of interest, for restoring lost functions in cells, and for treating disease. Additional fusion proteins comprising a target protein of interest modified with a fusion partner comprising a protein expression enhancing polypeptide are also disclosed.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A fusion protein comprising:
 (1) an isolated protein expression enhancing polypeptide (PEEP) domain linked to (2) a target protein of interest,   wherein said isolated protein expression enhancing polypeptide domain (1) is selected from the group consisting of:   (a) an isolated J domain of a J protein comprising a polypeptide domain of a J protein comprising four α helices, helices I, II, III, and IV, and having a histidine, proline, and aspartic acid sequence motif (HPD motif) between helix II and helix III, or an active fragment of said J domain; and   (b) a J domain analog polypeptide comprises the amino acid sequence of formula I:
 (I) X1-X2-X3-X4-X5-X6-X7-X8-X9 (SEQ ID NO:47), wherein:
 X1 is isoleucine (I), leucine (L), valine (V), alanine (A), or methionine (M); 
 X2 and X3 are each independently any amino acid with the proviso that one or both are K or R; 
 X4 is any amino acid or X4 may be absent when X1 through X3 are present and X5 through X9 are present; 
 X5 is tyrosine (Y), tryptophan (W), or phenylalanine (F); 
 X6 and X7 are each independently any amino acid with the proviso that one or both are lysine (K) or arginine (R); or either one of X6 and X7 may be absent when the other is K or R and when X1 through X5 are present and X8 and X9 are present; and 
 X8 and X9 are any amino acid with the proviso that one or both are leucine (L) or alanine (A); or one of X8 and X9 may be absent when the other is L or A and when X1 through X7 are present; and 
 
   wherein said fusion protein is expressed in a host cell at an enhanced level as compared to the level of expression of the unmodified target protein of interest.   
     
     
         2 . The fusion protein according to  claim 1 , wherein the protein expression enhancing polypeptide domain (1) is an isolated J domain of a J protein having an amino acid sequence selected from any one of SEQ ID NOs:1-46. 
     
     
         3 . The fusion protein according to  claim 1 , wherein the protein expression enhancing polypeptide domain (1) comprises an amino acid sequence selected from the group consisting of: 
       
         
           
                 
               
                   (SEQ ID NO: 48) 
                 
                 
                 
               
                     
                   I-K-K-A-Y-R-K-L-A, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 49) 
                 
                 
                 
               
                     
                   I-K-K-A-Y-K-L-A-L-Q, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 50) 
                 
                 
                 
               
                     
                   I-K-K-A-Y-R-L-A-L-Q, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 51) 
                 
                 
                 
               
                     
                   I-K-K-A-Y-R-K-A-L-Q, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 52) 
                 
                 
                 
               
                     
                   I-K-K-A-Y-R-K-L-L-Q, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 83) 
                 
                 
                 
               
                     
                   I-R-K-A-Y-R-K-L-S-L-T-L, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 84) 
                 
                 
                 
               
                     
                   I-K-K-Q-Y-R-L-L-S-L-K-Y, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 85) 
                 
                 
                 
               
                     
                   I-K-K-A-F-H-K-L-A-M-K-Y, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 86) 
                 
                 
                 
               
                     
                   I-R-Q-A-F-K-K-L-A-L-K-L, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 87) 
                 
                 
                 
               
                     
                   I-I-K-A-Y-R-K-L-A-L-Q-W, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 88) 
                 
                 
                 
               
                     
                   I-A-R-A-Y-R-Q-L-A-R-R-Y, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 89) 
                 
                 
                 
               
                     
                   I-K-R-A-Y-R-R-Q-A-L-R-Y, 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 90) 
                 
                 
                 
               
                     
                   I-K-K-S-Y-R-K-L-A-L-K-Y, 
                 
                     
                   and 
                 
                     
                     
                 
                 
               
                   (SEQ ID NO: 91) 
                 
                 
                 
               
                     
                   I-K-K-A-Y-K-R-L-A-M-K-Y. 
                 
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
               
            
             
                
               
            
             
                
                
                
               
            
             
                
               
            
             
                
               
            
           
         
       
     
     
         4 . The fusion protein according to  claim 1 , wherein the protein expression enhancing polypeptide domain (1) is an isolated J domain of an Erdj protein selected from the group consisting of: Erdj1, Erdj2, Erdj3, Erdj4, Erdj5, Erdj6, and Erdj7. 
     
     
         5 . The fusion protein according to  claim 4 , wherein the protein expression enhancing polypeptide domain (1) is an isolated J domain of Erdj3 (SEQ ID NO:4). 
     
     
         6 . The fusion protein according to  claim 1 , wherein the protein expression enhancing polypeptide domain (1) is a J domain analog polypeptide that comprises the amino acid sequence of formula I. 
     
     
         7 . The fusion protein according to  claim 6 , wherein said J domain analog polypeptide comprises the amino acid sequence (SEQ ID NO:326) wherein:
 X1 is I, L, V, A, or M;   the dipeptide X2-X3 is selected from the group consisting of: KR, KK, RK, RR, AK, AR, KA, IK, NK, KQ, RQ, and RD;   X4 is A, S, T, R, S, Q, E, F, C, or I;   X5 is Y or F;   the dipeptide X6-X7 is selected from the group consisting of: KR, KK, RK, RR, RQ, FR, RL, KL, HK, LK, QK, and KV; and   the dipeptide X8-X9 is selected from the group consisting of: LA, LL, AL, AA, LC, LV, QA, KA, LS, LI, LY, and RA.   
     
     
         8 . The fusion protein according to  claim 1 , wherein said protein expression enhancing polypeptide domain (1) comprises one of the following amino acid sequences: 
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                     
                   Amino Acid Sequence 
                 
                     
                   Sequence Identifier 
                   123456789012345 
                 
                     
                     
                 
                     
                   SEQ ID NO: 48 
                   IKKAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 49 
                   IKKAYKLALQ 
                 
                     
                     
                 
                     
                   SEQ ID NO: 50 
                   IKKAYRLALQ 
                 
                     
                     
                 
                     
                   SEQ ID NO: 51 
                   IKKAYRKALQ 
                 
                     
                     
                 
                     
                   SEQ ID NO: 52 
                   IKKAYRKLLQ 
                 
                     
                     
                 
                     
                   SEQ ID NO: 53 
                   IKKYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 54 
                   IKKAYKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 55 
                   IKKAYRLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 56 
                   IKKAYRKA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 57 
                   LKKAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 58 
                   VKKAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 59 
                   MKKAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 60 
                   AKKAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 61 
                   IAKAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 62 
                   IKAAYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 63 
                   IKKRYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 64 
                   IKKSYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 65 
                   IKKQYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 66 
                   IKKEYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 67 
                   IKKFYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 68 
                   IKKCYRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 69 
                   IKKAFRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 70 
                   IKKAWRKLA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 71 
                   IKKAYRKQA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 72 
                   IKKAYRKMA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 73 
                   IKKAYRKIA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 74 
                   IKKAYRKAA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 75 
                   IKKAYRKVA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 76 
                   IKKAYRKRA 
                 
                     
                     
                 
                     
                   SEQ ID NO: 77 
                   IKKAYRKLM 
                 
                     
                     
                 
                     
                   SEQ ID NO: 78 
                   IKKAYRKLI 
                 
                     
                     
                 
                     
                   SEQ ID NO: 79 
                   IKKAYRKLV 
                 
                     
                     
                 
                     
                   SEQ ID NO: 80 
                   IKKAYRKLC 
                 
                     
                     
                 
                     
                   SEQ ID NO: 81 
                   IKKAYRKLS 
                 
                     
                     
                 
                     
                   SEQ ID NO: 82 
                   IKKAYRKLY 
                 
                     
                     
                 
                     
                   SEQ ID NO: 83 
                   IRKAYRKLSLTL 
                 
                     
                     
                 
                     
                   SEQ ID NO: 84 
                   IKKQYRLLSLKY 
                 
                     
                     
                 
                     
                   SEQ ID NO: 85 
                   IKKAFHKLAMKY 
                 
                     
                     
                 
                     
                   SEQ ID NO: 86 
                   IRQAFKKLALKL 
                 
                     
                     
                 
                     
                   SEQ ID NO: 87 
                   IIKAYRKLALQW 
                 
                     
                     
                 
                     
                   SEQ ID NO: 88 
                   IARAYRQLARRY 
                 
                     
                     
                 
                     
                   SEQ ID NO: 89 
                   IKRAYRRQALRY 
                 
                     
                     
                 
                     
                   SEQ ID NO: 90 
                   IKKSYRKLALKY 
                 
                     
                     
                 
                     
                   SEQ ID NO: 91 
                   IKKAYKRLAMKY 
                 
                     
                     
                 
             
                
                
                
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         9 . The fusion protein according to  claim 1 , wherein the target protein of interest (2) is selected from the group consisting of: a soluble protein, a membrane-associated protein, a secreted protein, an extracellular domain of a transmembrane protein, an extracellular binding domain of a cell surface receptor fused to an Fc domain, an antibody or antigen-binding fragment thereof, a cytokine, a peptide hormone, an enzyme, and a morphogenetic protein. 
     
     
         10 . An isolated nucleic acid molecule comprising a nucleic acid sequence encoding a fusion protein according to  claim 1 . 
     
     
         11 . A nucleic acid vector molecule comprising the isolated nucleic acid molecule according to  claim 10 . 
     
     
         12 . A host cell comprising the nucleic acid vector molecule according to  claim 11 . 
     
     
         13 . A method of expressing a fusion protein comprising (1) a protein expression enhancing polypeptide (PEEP) domain linked to (2) a target protein of interest comprising culturing a host cell according to  claim 12  under conditions sufficient to produce the fusion protein. 
     
     
         14 . A method of expressing a fusion protein comprising (1) a protein expression enhancing polypeptide (PEEP) domain linked to (2) a target protein of interest comprising transfecting a host cell with an expression vector comprising a structural gene encoding a fusion protein according to  claim 1  and culturing said transfected host cell under conditions causing the expression said fusion protein. 
     
     
         15 . A method of expressing a fusion protein comprising (1) a protein expression enhancing polypeptide (PEEP) domain linked to (2) a target protein of interest (2) comprising the steps of:
 1) constructing a recombinant gene sequence encoding a fusion protein according to  claim 1 ;   2) inserting the recombinant gene sequence into an expression vector to form a recombinant expression vector wherein said recombinant gene sequence is operably linked to a transcriptional promoter sequence;   3) transfecting said recombinant expression vector into host cells that are compatible with said promoter sequence; and   4) culturing said transfected host cells under conditions that permit expression of said fusion protein.   
     
     
         16 . A method of restoring a protein function in cells of a mammalian subject that are deficient in the secretion of a native secreted protein that provides said protein function comprising inserting into cells of the subject an exogenous nucleic acid molecule encoding a fusion protein according to  claim 1  comprising (1) a protein expression enhancing polypeptide (PEEP) domain linked to (2) a target protein of interest, wherein said target protein of interest is the secreted protein, wherein expression of the fusion protein provides the function of the native secreted protein whose secretion is deficient in cells of the subject in the absence of the exogenous nucleic acid. 
     
     
         17 . The method according to  claim 16 , wherein the subject has a disease associated with the deficient secretion of a native secreted protein in the subject. 
     
     
         18 . The method according to  claim 17 , wherein said disease is selected from the group consisting of a prion-associated disease, Alzheimer's disease, Parkinson's disease, Huntington's disease, cystic fibrosis (CF), and al-antitrypsin (AAT) deficiency. 
     
     
         19 . The method according to  claim 18 , wherein the subject is a human subject deficient in the secretion of cystic fibrosis transmembrane conductance regulator protein and the disease is cystic fibrosis. 
     
     
         20 . An isolated protein expression enhancing polypeptide selected from the group consisting of:
 (a) an active fragment of a J domain of a J protein; and   (b) a J domain analog polypeptide comprising the amino acid sequence of formula I:
 (I) X1-X2-X3-X4-X5-X6-X7-X8-X9 (SEQ ID NO:47), wherein:
 X1 is isoleucine (I), leucine (L), valine (V), alanine (A), or methionine (M); 
 X2 and X3 are each independently any amino acid with the proviso that one or both are K or R; 
 X4 is any amino acid or X4 may be absent when X1 through X3 are present and X5 through X9 are present; 
 X5 is tyrosine (Y), tryptophan (W), or phenylalanine (F); 
 X6 and X7 are each independently any amino acid with the proviso that one or both are lysine (K) or arginine (R); or either one of X6 and X7 may be absent when the other is K or R and when X1 through X5 are present and X8 and X9 are present; and 
 X8 and X9 are any amino acid with the proviso that one or both are leucine (L) or alanine (A); or one of X8 and X9 may be absent when the other is L or A and when X1 through X7 are present and wherein said J domain analog polypeptide is smaller than a J domain of a J protein; and 
 
   wherein a fusion protein comprising said protein expression enhancing polypeptide linked to a target protein of interest is expressed in a host cell at an enhanced level as compared to the level of expression of the unmodified target protein of interest; or   wherein co-expression in a host cell of a target protein of interest and a fusion protein comprising said protein expression enhancing polypeptide linked to a target protein binding domain that binds said target protein of interset results in an enhanced level of expression of said target protein of interest as compared to the level of expression of said target protein of interest in the absence of said fusion protein.   
     
     
         21 . The protein expression enhancing polypeptide according to  claim 20 , wherein said protein expression enhancing polypeptide is an active fragment of an isolated J domain of a J protein, wherein said J domain has an amino acid sequence selected from any one of SEQ ID NOs:1-46. 
     
     
         22 . The protein expression enhancing polypeptide according to  claim 20 , wherein said protein expression enhancing polypeptide has any amino acid sequence selected from any one of SEQ ID NOs: 48-91. 
     
     
         23 . The protein expression enhancing polypeotide according to  claim 1 , wherein the protein expression enhancing polypeptide is an active fragment of an isolated J domain of an Erdj protein selected from the group consisting of: Erdj1, Erdj2, Erdj3, Erdj4, Erdj5, Erdj6, and Erdj7. 
     
     
         24 . The protein expression enhancing fusion protein according to  claim 23 , wherein the protein expression enhancing polypeptide is a fragment of an isolated J domain of Erdj3. 
     
     
         25 . The protein expression enhancing polypeptide according to  claim 1 , wherein the protein expression enhancing polypeptide is a J domain analog polypeptide that comprises the amino acid sequence of formula I. 
     
     
         26 . The protein expression enhancing polypeptide according to  claim 25 , wherein said J domain analog polypeptide comprises the amino acid sequence (SEQ ID NO:326) wherein:
 X1 is I, L, V, A, or M;   the dipeptide X2-X3 is selected from the group consisting of: KR, KK, RK, RR, AK, AR, KA, IK, NK, KQ, RQ, and RD;   X4 is A, S, T, R, S, Q, E, F, C, or I;   X5 is Y or F;   the dipeptide X6-X7 is selected from the group consisting of: KR, KK, RK, RR, RQ, FR, RL, KL, HK, LK, QK, and KV; and   the dipeptide X8-X9 is selected from the group consisting of: LA, LL, AL, AA, LC, LV, QA, KA, LS, LI, LY, and RA.   
     
     
         27 . An isolated nucleic acid molecule comprising a nucleic acid sequence encoding a protein expression enhancing polypeptide according to  claim 20 . 
     
     
         28 . A nucleic acid vector molecule comprising the isolated nucleic acid molecule according to  claim 27 . 
     
     
         29 . A host cell comprising the nucleic acid vector molecule according to  claim 28 .

Join the waitlist — get patent alerts

Track US2018087081A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.