US2021380664A1PendingUtilityA1
Hcmv entry inhibitors
Assignee: AICURIS ANTI INFECTIVE CURES GMBHPriority: Jun 27, 2016Filed: Aug 6, 2021Published: Dec 9, 2021
Est. expiryJun 27, 2036(~9.9 yrs left)· nominal 20-yr term from priority
C12N 2310/14C07K 19/00A61K 39/0005A61K 38/179C12N 15/1138C07K 2319/74A61P 31/22C07K 2317/92C07K 14/71C07K 2319/30C07K 16/2863
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Claims
Abstract
Subject matter of the present invention is a soluble PDGFR-alpha-Fc chimera or a PDGFR-alpha derived peptide or an anti-PDGFR-alpha antibody or a PDGFR-alpha antibody fragment or anti-PDGFR-alpha non-Ig scaffold for inhibiting HCMV entry for use in a method of treatment in a subject that has been infected by HCMV or for use in a method of prophylaxis of HCMV infection in a subject that has not yet been infected by HCMV.
Claims
exact text as granted — not AI-modified1 . A method for treatment of a subject that has been infected by HCMV, comprising:
administering to said subject a soluble PDGFR-alpha-Fc chimera, wherein said soluble PDGFR-alpha-Fc chimera comprises a PDGFR-alpha sequence selected from the following group: I. SEQ ID No. 2 consisting of amino acides 24 to amino acids 524 of SEQ ID No. 1:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIRN
EENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYVPD
PDVAFVPLGMTDYLVIVEDDDSAIIPCRTTDPETPVTLHNSEGVVPASYD
SRQGFNGTFTVGPYICEATVKGKKFQTIPFNVYALKATSELDLEMEALKT
VYKSGETIVVTCAVFNNEVVDLQWTYPGEVKGKGITMLEEIKVPSIKLVY
TLTVPEATVKDSGDYECAARQATREVKEMKKVTISVHEKGFIEIKPTFSQ
LEAVNLHEVKHFVVEVRAYPPPRISWLKNNLTLIENLTEITTDVEKIQEI
RYRSKLKLIRAKEEDSGHYTIVAQNEDAVKSYTFELLTQVPSSILDLVDD
HHGSTGGQTVRCTAEGTPLPDIEWMICKDIKKCNNETSWTILANNVSNII
TEIHSRDRSTVEGRVTFAKVEETIAVRCLAKNLLGAENRELKLVAPTLRS
E,
II. a sequence having 90% or more identity to SEQ ID No. 2,
III. a sequence that is a truncated sequence of SEQ ID No. 2 with at least 45 amino acids or a sequence having 90% or more identity to said truncated SEQ ID No. 2, and
IV. variants of sequences according to items I., II., III. having substitutions atone or more of the following positions (numbering adhered to SEQ ID. No. 1): Ile-30, Glu-52, Ser-66, Ser-67, Asp-68, Leu-80, Ser-89, His-162, Pro-169, Asp-173, Ile-188, Val-193, Lys-194, Glu-213, Lys-304, Thr-320, His-334, Arg-340, Ile-373, Lys-378, Ala-396, Ala-401, Thr-436, Thr-440, Ile-453, Val-469, Ile-476, Ser-478, Asp-480, Ser-482, Arg-487.
2 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera has at least one of the following mutations or deletions within SEQ ID No. 2 (numbering adhered to SEQ ID. No. 1):
i. Deletion of aa 150-189, ii. SEQ ID No. 2 having at least one point mutation in the protein region as specified in the above item i.
3 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera has at least one of the following mutations or deletions within SEQ ID No. 2 (numbering is adhered to SEQ ID No. 1):
i) Deletion of amino acids M133-I139; ii) Deletion of amino acids V184-G185; iii) Deletion of amino acids N204-Y206; iv) Deletion of amino acids T259-E262; v) Deletion of amino acids Q294-E298; vi) SEQ ID No. 2 having at least one point mutation in at least one of the protein regions as specified above under items i., ii., iii., iv., or v.
4 . The method according to claim 1 , wherein said subject is: (a) a pregnant woman who is infected by HCMV, (b) a congenitally HCMV-infected child, (c) a bone marrow transplant recipient infected with HCMV, or (d) a solid organ transplant recipients infected with HCMV.
5 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera comprises a sequence of SEQ ID No. 3.
6 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera comprises a sequence of human Fc as depicted in SEQ ID No. 8.
7 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera is suitable for binding specifically to HCMV.
8 . A method for treatment of a subject that has been infected by HCMV comprising:
administering to said subject a PDGFR-alpha peptide fragment, wherein said peptide fragment is selected from: I. SEQ ID No. 9; II. SEQ ID No. 10; M. SEQ ID No. 11; IV. SEQ ID No. 12; V. SEQ ID No. 13; VI. a peptide fragment of SEQ ID No. 9, SEQ ID No. 10, SEQ ID No. 11, SEQ ID No. 12, or SEQ ID No. 13, any of them having at least 10 amino acids, and VII. a variant of the above items I to VI that exhibits at least 80% sequence identity to the peptide having the sequence of SEQ ID No. 9 or SEQ ID No. 10 or SEQ ID No. 11 or SEQ ID No. 12 or SEQ ID No. 13 that exhibits at least 80% sequence identity to the peptide fragment of SEQ ID No. 9 or SEQ ID No. 10 or SEQ ID No. 11 or SEQ ID No. 12 or SEQ ID No. 13, said variant having a length of at least 10 amino acids.
9 . The method according to claim 8 , wherein said subject is: (a) a pregnant woman that is infected by HCMV, (b) a congenitally HCMV-infected child, (c) a bone marrow transplant recipient infected with HCMV or at risk of HCMV infection, or (d) a solid organ transplant recipient infected with HCMV or at risk with HCMV infection.
10 . (canceled)
11 . (canceled)
12 . (canceled)
13 . (canceled)
14 . (canceled)
15 . A method for prophylaxis of HCMV infection in a subject that has not yet been infected by HCMV, comprising:
administering to said subject a soluble PDGFR-alpha-Fc chimera, wherein said soluble PDGFR-alpha-Fc chimera comprises a PDGFR-alpha sequence selected from the following group: I. SEQ ID No. 2 consisting of amino acids 24 to amino acids 524 of SEQ ID No. 1:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIR
NEENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYV
PDPDVAFVPLGMTDYLVIVEDDDSAIIPCRTTDPETPVTLHNSEGVVPA
SYDSRQGFNGTFTVGPYICEATVKGKKFQTIPFNVYALKATSELDLEME
ALKTVYKSGETIVVTCAVFNNEVVDLQWTYPGEVKGKGITMLEEIKVPS
IKLVYTLTVPEATVKDSGDYECAARQATREVKEMKKVTISVHEKGFIEI
KPTFSQLEAVNLHEVKHFVVEVRAYPPPRISWLKNNLTLIENLTEITTD
VEKIQEIRYRSKLKLIRAKEEDSGHYTIVAQNEDAVKSYTFELLTQVPS
SILDLVDDHHGSTGGQTVRCTAEGTPLPDIEWMICKDIKKCNNETSWTI
LANNVSNIITEIHSRDRSTVEGRVTFAKVEETIAVRCLAKNLLGAENRE
LKLVAPTLRSE,
II. a sequence having 90% or more identity to SEQ ID No. 2,
III. a sequence that is a truncated sequence of SEQ ID No. 2 with at least 45 amino acids or a sequence having 90% or more identity to said truncated SEQ ID No. 2, and
IV. variants of sequences according to items I., II., III. having substitutions atone or more of the following positions (numbering adhered to SEQ ID. No. 1): Ile-30, Glu-52, Ser-66, Ser-67, Asp-68, Leu-80, Ser-89, His-162, Pro-169, Asp-173, Ile-188, Val-193, Lys-194, Glu-213, Lys-304, Thr-320, His-334, Arg-340, Ile-373, Lys-378, Ala-396, Ala-401, Thr-436, Thr-440, Ile-453, Val-469, Ile-476, Ser-478, Asp-480, Ser-482, Arg-487.
16 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera, has an EC50 value lower than 100 ng/ml.
17 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera comprises a PDGFR-alpha sequence having at least one of the following mutations or deletions within SEQ ID No. 2 (numbering is adhered to SEQ ID No. 1):
i. Deletion of amino acids M133-I139 optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids; further it is possible also to delete one or two or three or four or five amino acids less than amino acids M133-I139 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids M133-I139, ii. Deletion of amino acids V184-G185 optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids, wherein each of the respective combinations of additional deletions; Furthermore, it is possible also to delete one amino acid less than amino acids V184-G185 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids V184-G185, iii. Deletion of amino acids N204-Y206 optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids; furthermore, it is possible also to delete one or two amino acid less than amino acids N204-Y206 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids N204-Y206; iv. Deletion of amino acids N240-L245 (optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids; further it is possible also to delete one or two or three or four or five amino acids less than amino acids N240-L245 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids N240-L245, v. Deletion of amino acids T259-E262 optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids, wherein each of the respective combinations of additional deletions; further it is possible also to delete one or two or three or four amino acids less than amino acids T259-E262 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids T259-E262; vi. Deletion of amino acids K270-T273 optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids, wherein each of the respective combinations of additional deletions; further it is possible also to delete one or two or three amino acids less than amino acids K270-T273 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids K270-T273; vii. Deletion of amino acids Q294-E298 optionally having additional deletions at the N- and/or C-termini of at least one or at least two or at least three N-terminal amino acids and/or at least one or at least two or at least three or at least four or at least five C-terminal amino acids; further it is possible also to delete one or two or three or four amino acids less than amino acids Q294-E298 at the N-terminus and/or the C-terminus, wherein all possible combinations of fewer deleted amino acids are possible, provided that at least one amino acid remains deleted in the stretch of amino acids Q294-E298; and viii. SEQ ID No. 2 having at least one point mutation in at least one of the protein regions as specified above under items i., ii., iii., iv., v., vi, or vii.
18 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera comprises a PDGFR-alpha sequence selected from the following group:
I. a sequence having 90% or more identity to SEQ ID No. 2, II. a sequence that is a truncated sequence of SEQ ID No. 2 or a sequence having 90% or more identity to said truncated SEQ ID No. 2 said sequence having at least 45 amino acids, and III. variants of sequences according to the yet aforementioned items I. and II., with substitutions at one or more of the following positions (numbering is adhered to SEQ ID. No. 1):
Ile-30, Glu-52, Ser-66, Ser-67, Asp-68, Lu-80, Ser-89, His-162, Pro-169, Asp-173, Ile-188, Val-193, Lys-194, Glu-213, Lys-304, Thr-320, His-334, Arg-340, Ile-373, Lys-378, Ala-396, Ala-401, Thr-436, Thr-440, Ile-453, Val-469, Ile-476, Ser-478, Asp-480, Ser-482, Arg-487.
19 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera comprises a sequence selected from the following group:
SEQ ID No. 3:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIR
NEENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYV
PDPDVAFVPLGMTDYLVIVEDDDSAIIPEATVKGKKFQTIPFNVYALKA
TSELDLEMEALKTVYKSGETIVVTCAVFNNEVVDLQWTYPGEVKGKGIT
MLEEIKVPSIKLVYTLTVPEATVKDSGDYECAARQATREVKEMKKVTIS
VHEKGFIEIKPTFSQLEAVNLHEVKHFVVEVRAYPPPRISWLKNNLTLI
ENLTEITTDVEKIQEIRYRSKLKLIRAKEEDSGHYTIVAQNEDAVKSYT
FELLTQVPSSILDLVDDHHGSTGGQTVRCTAEGTPLPDIEWMICKDIKK
CNNETSWTILANNVSNIITEIHSRDRSTVEGRVTFAKVEETIAVRCLAK
NLLGAENRELKLVAPTLRSE,
SEQ ID No. 4:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIR
NEENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYV
PDPDVAFVPLGMTDYLVIVEDDDSAIIPCAVFNNEVVDLQWTYPGEVKG
KGITMLEEIKVPSIKLVYTLTVPEATVKDSGDYECAARQATREVKEMKK
VTISVHEKGFIEIKPTFSQLEAVNLHEVKHFVVEVRAYPPPRISWLKNN
LTLIENLTEITTDVEKIQEIRYRSKLKLIRAKEEDSGHYTIVAQNEDAV
KSYTFELLTQVPSSILDLVDDHHGSTGGQTVRCTAEGTPLPDIEWMICK
DIKKCNNETSWTILANNVSNIITEIHSRDRSTVEGRVTFAKVEETIAVR
CLAKNLLGAENRELKLVAPTLRSE,
SEQ ID No. 5:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIR
NEENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYV
PDPDVAFVPLGMTDYLVIVEDDDSAIIPAARQATREVKEMKKVTISVHE
KGFIEIKPTFSQLEAVNLHEVKHFVVEVRAYPPPRISWLKNNLTLIENL
TEITTDVEKIQEIRYRSKLKLIRAKEEDSGHYTIVAQNEDAVKSYTFEL
LTQVPSSILDLVDDHHGSTGGQTVRCTAEGTPLPDIEWMICKDIKKCNN
ETSWTILANNVSNIITEIHSRDRSTVEGRVTFAKVEETIAVRCLAKNLL
GAENRELKLVAPTLRSE,
SEQ ID No. 6:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIR
NEENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYV
PDPDVAFVPLGMTDYLVIVEDDDSAIIP,
SEQ ID No. 7:
YYNHTQTEENELEGRHIYIYVPDPDVAFVPLGMTDYLVIVEDDDSAIIP.
20 . The method according to claim 1 , wherein said soluble PDGFR-alpha-Fc chimera further comprises the sequence of human Fc that is SEQ ID No. 8:
LTVAGSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVV
DVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWL
NGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVS
LTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDK
SRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK.
21 . A method for inhibiting HCMV entry into a cell, comprising:
bringing said cell into contact with a soluble PDGFR-alpha-Fc chimera, wherein said soluble PDGFR-alpha-Fc chimera comprises a PDGFR-alpha sequence selected from the following group:
I. SEQ ID No. 2 consisting of amino acids 24 to amino acids 524 of SEQ ID No. 1:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIRNE
ENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYVPDP
DVAFVPLGMTDYLVIVEDDDSAIIPCRTTDPETPVTLHNSEGVVPASYDS
RQGFNGTFTVGPYICEATVKGKKFQTIPFNVYALKATSELDLEMEALKTV
YKSGETIVVTCAVFNNEVVDLQWTYPGEVKGKGITMLEEIKVPSIKLVYT
LTVPEATVKDSGDYECAARQATREVKEMKKVTISVHEKGFIEIKPTFSQL
EAVNLHEVKHFVVEVRAYPPPRISWLKNNLTLIENLTEITTDVEKIQEIRY
RSKLKLIRAKEEDSGHYTIVAQNEDAVKSYTFELLTQVPSSILDLVDDHH
GSTGGQTVRCTAEGTPLPDIEWMICKDIKKCNNETSWTILANNVSNIITEI
HSRDRSTVEGRVTFAKVEETIAVRCLAKNLLGAENRELKLVAPTLRSE,
II. a sequence having 90% or more identity to SEQ ID No. 2,
III. a sequence that is a truncated sequence of SEQ ID No. 2 with at least 45 amino acids or a sequence having 90% or more identity to said truncated SEQ ID No. 2, and
IV. variants of sequences according to items I., II., III. having substitutions atone or more of the following positions (numbering adhered to SEQ ID. No. 1): Ile-30, Glu-52, Ser-66, Ser-67, Asp-68, Leu-80, Ser-89, His-162, Pro-169, Asp-173, Ile-188, Val-193, Lys-194, Glu-213, Lys-304, Thr-320, His-334, Arg-340, Ile-373, Lys-378, Ala-396, Ala-401, Thr-436, Thr-440, Ile-453, Val-469, Ile-476, Ser-478, Asp-480, Ser-482, Arg-487.
22 . A method for inhibiting HCMV entry into a cell, comprising:
bringing said cell into contact with a PDGFR-alpha peptide fragment, wherein said peptide fragment is selected from: I. SEQ ID No. 9; II. SEQ ID No. 10; III. SEQ ID No. 11; IV. SEQ ID No. 12; V. SEQ ID No. 13, VI. a peptide fragment of SEQ ID No. 9, SEQ ID No. 10, SEQ ID No. 11, SEQ ID No. 12, or SEQ ID No. 13, any of them having at least 10 amino acids, and VII. a variant of the above items I to VI that exhibits at least 80% sequence identity to the peptide having the sequence of SEQ ID No. 9 or SEQ ID No. 10 or SEQ ID No. 11 or SEQ ID No. 12 or SEQ ID No. 13 that exhibits at least 80% sequence identity to the peptide fragment of SEQ ID No. 9 or SEQ ID No. 10 or SEQ ID No. 11 or SEQ ID No. 12 or SEQ ID No. 13, said variant having a length of at least 10 amino acids.
23 . A method for inhibiting HCMV entry into a cell, comprising:
bringing said cell into contact with a delivery vector for transferring a nucleic acid sequence encoding a PDGFR-alpha derived peptide or fragment thereof suitable for inhibiting HCMV entry, wherein the peptide or fragment is releasable from the delivery vector to bind to HCMV and inhibit infection of said cell.
24 . The method according to claim 23 , wherein said nucleic acid sequence comprises a PDGFR-alpha sequence selected from the following group:
I. SEQ ID No. 2 consisting of amino acids 24 to amino acids 524 of SEQ ID No. 1:
QLSLPSILPNENEKVVQLNSSFSLRCFGESEVSWQYPMSEEESSDVEIRNE
ENNSGLFVTVLEVSSASAAHTGLYTCYYNHTQTEENELEGRHIYIYVPDP
DVAFVPLGMTDYLVIVEDDDSAIIPCRTTDPETPVTLHNSEGVVPASYDS
RQGFNGTFTVGPYICEATVKGKKFQTIPFNVYALKATSELDLEMEALKTV
YKSGETIVVTCAVFNNEVVDLQWTYPGEVKGKGITMLEEIKVPSIKLVYT
LTVPEATVKDSGDYECAARQATREVKEMKKVTISVHEKGFIEIKPTFSQL
EAVNLHEVKHFVVEVRAYPPPRISWLKNNLTLIENLTEITTDVEKIQEIRY
RSKLKLIRAKEEDSGHYTIVAQNEDAVKSYTFELLTQVPSSILDLVDDHH
GSTGGQTVRCTAEGTPLPDIEWMICKDIKKCNNETSWTILANNVSNIITEI
HSRDRSTVEGRVTFAKVEETIAVRCLAKNLLGAENRELKLVAPTLRSE,
II. a sequence having 90% or more identity to SEQ ID No. 2,
III. a sequence that is a truncated sequence of SEQ ID No. 2 with at least 45 amino acids or a sequence having 90% or more identity to said truncated SEQ ID No. 2, and
IV. variants of sequences according to items I., II., III. having substitutions atone or more of the following positions (numbering adhered to SEQ ID. No. 1): Ile-30, Glu-52, Ser-66, Ser-67, Asp-68, Leu-80, Ser-89, His-162, Pro-169, Asp-173, Ile-188, Val-193, Lys-194, Glu-213, Lys-304, Thr-320, His-334, Arg-340, Ile-373, Lys-378, Ala-396, Ala-401, Thr-436, Thr-440, Ile-453, Val-469, Ile-476, Ser-478, Asp-480, Ser-482, Arg-487.
25 . The method according to claim 23 , wherein said nucleic acid sequence comprises a PDGFR-alpha sequence selected from the following group:
I. SEQ ID No. 9; II. SEQ ID No. 10; III. SEQ ID No. 11; IV. SEQ ID No. 12; V. SEQ ID No. 13, VI. a peptide fragment of SEQ ID No. 9, SEQ ID No. 10, SEQ ID No. 11, SEQ ID No. 12, or SEQ ID No. 13, any of them having at least 10 amino acids, and VII. a variant of the above items I to VI that exhibits at least 80% sequence identity to the peptide having the sequence of SEQ ID No. 9 or SEQ ID No. 10 or SEQ ID No. 11 or SEQ ID No. 12 or SEQ ID No. 13 that exhibits at least 80% sequence identity to the peptide fragment of SEQ ID No. 9 or SEQ ID No. 10 or SEQ ID No. 11 or SEQ ID No. 12 or SEQ ID No. 13, said variant having a length of at least 10 amino acids.Join the waitlist — get patent alerts
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