JP2021525770A - がんの治療での使用のためのccr5阻害剤 - Google Patents
がんの治療での使用のためのccr5阻害剤 Download PDFInfo
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Abstract
Description
[0036]本明細書で使用する場合、用語「CCR5阻害剤」は、CCR5によって誘導される1つ又は複数の生物学的及び/又は病理学的活性を阻害する分子又は化合物を意味する。CCR5阻害剤は、リガンド又は病原体が相互作用のために必要とするCCR5の1つ又は複数の部位の、部分的又は完全な占領を達成することによって、リガンド又は病原体の結合を防ぐことができる(オルソステリック阻害剤)。或いは、CCR5阻害剤は、CCR5の他の部位に結合し、CCR5がリガンド又は病原体によって認識されない1つ又は複数の構造を採用するように誘導することによってリガンド又は病原体の結合を防止することができる(アロステリック阻害剤)。CCR5阻害剤は、CCR5細胞内シグナル伝達経路の全レパートリー又はサブセットのみを阻害し得る。CCR5阻害剤は、CCR5の長期細胞内隔離を誘発することによっても作用することができ、それによりCCR5が細胞外リガンド又は病原体によって接近されない。CCR5阻害剤は、CCR5遺伝子の発現を特異的に阻害又は除去することによっても作用し得る。CCR5阻害剤は、1つ又は複数のリガンド又は病原体に結合することによっても作用することができ、それにより1つ又は複数のリガンド又は病原体はCCR5に結合できない。
配列番号 シグネチャー配列
配列番号2 QGPPLMALQS
配列番号3 QGPPLMWMQV
配列番号4 QGPPLMWLQV
配列番号5 QGPPLMWTQS
配列番号6 QGPPLMWLQT
配列番号7 QGPPLMWTQV
配列番号8 QGPPLMWMQS
配列番号9 QGPPLMATQS
配列番号10 QGPPLMWLQS
配列番号11 QGPPLMALQV
配列番号12 QGPPLMWLGG
配列番号13 QGPPLMWRGS
配列番号14 QGPLLMWLQV
配列番号15 QGPPLMQTTP
配列番号16 QGPPGDTVLW
配列番号17 QGPPGDIVLA
配列番号18 QGPPGSYDYS
配列番号19 QGPPGDGGSV
配列番号20 QGPLSGQSTP
配列番号21 QGPPGDWLQV
配列番号22 QGPPLMSFQS
配列番号23 QGPPLMSTQS
配列番号24 QGPPLMSLQV
配列番号25 QGPPLMGLQV
配列番号26 QGPLSGWLQV
配列番号27 QGPPLMSVLA
配列番号28 QGPPGSWSSV
配列番号29 QGPPLGSMGP
配列番号30 QGPPLSWLQV
配列番号31 QGPPLSWLQS
配列番号32 QGPPGQWSQV
配列番号33 QGPPMMAGLS
配列番号34 QGPPLSWQQS
配列番号35 QGPPGMWSQS
配列番号36 QGPPLQWRQS
配列番号37 QGPPLMGTQS
配列番号38 QGPPLMQLQV
配列番号39 QGPPLSWSQV
配列番号40 QGPPMSWSQS
配列番号41 QGPPLMNLQV
配列番号42 QGPPMSAYQV
配列番号43 QGPPMQGGLS
配列番号44 QGPPLMSLAV
配列番号45 QGPPLMSLTV
配列番号46 QGPLSGWAQV
配列番号47 QGPLSQSSQV
配列番号48 QGPLSSQSQV
配列番号49 QGPLGQQGQV
配列番号50 QGPPLQWFQV
配列番号51 QGPPLQWTQV
配列番号52 QGPPLMALSV
配列番号53 QGPPLMWSQV
配列番号54 QGPPGQWGQV
配列番号55 QGPPGSWSQV
配列番号56 QGPPLMSSQS
配列番号57 QGPPLMGLSV
配列番号58 QGPPLMTLQV
配列番号59 QGPPGQWYQS
配列番号60 QGPPLQWMQA
配列番号61 QGPPLQWMQV
配列番号62 QGPPLMSTQV
配列番号63 QGPPLMSLSV
配列番号64 QGPPLMSLQS
配列番号65 QGPPLMSLQA
配列番号66 QGPPLMSVQS
配列番号67 QGPPLMSAQS
配列番号68 QGPPLMSGQS
配列番号69 QGPPLMSGQV
[0081]本発明は、組成物、例えば本明細書に記載のようなCCR5阻害剤を含む医薬組成物を提供する。本明細書で使用する場合、用語「医薬組成物」及び「組成物」は、文脈上必要な場合、互換的に使用されてもよい。本明細書に開示の医薬組成物は、治療有効量で対象に投与されてもよい。本明細書で使用する場合、「治療有効量」は、対象に治療、予防又は診断効果を提供するのに有効な組成物又は治療薬の量を意味する。いくつかの実施形態では、治療有効量の組成物は、特定の疾患又は障害の治療において対象に臨床応答を誘導することができる量である。組成物の治療有効量の決定は、当業者の能力の範囲内で、特に本明細書に提供する開示に照らして十分である。治療有効量は、対象の状態、体重、性別及び年齢などの様々な因子によって変わってもよい。
[0095]本明細書に提供するCCR5阻害剤、医薬組成物及び剤形は、がんを治療又は予防するために対象に治療薬を投与することが望ましい任意の例での適用が見出されることがある。本明細書で使用する場合、「個人」又は「対象」は哺乳動物、例えばヒトである。哺乳動物は、限定はされないが、家畜動物、競技動物、ペット、霊長類及びウマを含む。
[00139]本発明の特定の実施形態としては、限定はしないが、以下が挙げられる:
1.対象にCCR5阻害剤を投与するステップを含む、がんを治療する方法であって、CCR5阻害剤がN末端部分及びC末端部分を含み、N末端部分がシグネチャー配列QGP[P又はL]を含み、C末端部分のアミノ酸配列が配列番号1と少なくとも70%同一である、方法。
2.CCR5阻害剤がHIVの細胞への侵入を阻害し、CCR1及びCCR3よりもCCR5に選択的である、実施形態1に記載の方法。
3.CCR5阻害剤がCCR5細胞内シグナル伝達経路のサブセットのみを阻害する、実施形態1又は2に記載の方法。
4.CCR5阻害剤がCCR5の炎症作用を阻害又は低減し、例えば、カルシウム流入シグナル伝達アッセイにおいて300nMの濃度で試験した場合、PSC−RANTESによって誘発される最大応答(Emax)の30%以下のシグナル伝達応答をもたらす、実施形態1〜3のいずれか1つに記載の方法。
5.CCR5阻害剤がGタンパク質共役型及び非共役型構造の両方でCCR5に結合する、実施形態1〜4のいずれか1つに記載の方法。
6.CCR5阻害剤がCCR5内部移行を誘導しない、実施形態1〜5のいずれか1つに記載の方法。
7.CCR5阻害剤がCCR5表面ダウンモジュレーションアッセイによって測定された場合、20%以下の受容体隔離活性をもたらす、実施形態6に記載の方法。
8.シグネチャー配列がQGP[P又はL][L又はG又はS又はM][M又はD又はS又はQ又はG]である、実施形態1に記載の方法。
9.シグネチャー配列がQGP[P又はL][L又はG][M又はD又はS]である、実施形態1に記載の方法。
10.シグネチャー配列がQGP[P又はL][L又はG又はS又はM][M又はD又はS又はQ又はG]XX[Q又はG又はL又はA又はT又はS]Xであり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態1に記載の方法。
11.シグネチャー配列がQGP[P又はL][L又はG][M又はD又はS]XX[Q又はG又はL]Xであり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態1に記載の方法。
12.シグネチャー配列がQGP[P又はL]LM又はQGPPG[D又はS]である、実施形態1に記載の方法。
13.シグネチャー配列がQGPPLM又はQGPPGDである、実施形態1に記載の方法。
14.シグネチャー配列がQGP[P又はL][L又はM][M又はQ][A又はW又はG又はQ又はN]X[Q又はG又はL][S又はV又はT又はG]であり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態1に記載の方法。
15.シグネチャー配列がQGP[P又はL][L又はM][M又はQ][A又はW又はG又はQ又はN][L又はT又はM又はS又はG又はQ又はR又はY][Q又はG又はL][S又はV又はT又はG]である、実施形態1に記載の方法。
16.シグネチャー配列がQGP[P又はL]LM[A又はW][L又はT又はM][Q又はG][S又はV又はT又はG]である、実施形態1に記載の方法。
17.シグネチャー配列がQGPPLM[A又はW][L又はT又はM][Q又はG][S又はV又はT又はG]である、実施形態1に記載の方法。
18.シグネチャー配列がQGPP[G又はL][M又はQ]XX[Q又はS][S又はV]であり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態1に記載の方法。
19.シグネチャー配列がQGPP[G又はL][M又はQ][S又はG又はW又はA又はT][L又はF又はT又はS又はG又はY][Q又はS][S又はV]である、実施形態1に記載の方法。
20.シグネチャー配列が、群QGPPLMALQS(配列番号2)、QGPPLMWMQV(配列番号3)、QGPPLMWLQV(配列番号4)、QGPPLMWTQS(配列番号5)、QGPPLMWLQT(配列番号6)、QGPPLMWTQV(配列番号7)、QGPPLMWMQS(配列番号8)、QGPPLMATQS(配列番号9)、QGPPLMWLQS(配列番号10)、QGPPLMALQV(配列番号11)、QGPPLMWLGG(配列番号12)、QGPPLMWRGS(配列番号13)、QGPLLMWLQV(配列番号14)、QGPPLMQTTP(配列番号15)、QGPPLSWLQV(配列番号30)、QGPPLSWLQS(配列番号31)、QGPPGQWSQV(配列番号32)、QGPPMMAGLS(配列番号33)、QGPPLSWQQS(配列番号34)、QGPPGMWSQS(配列番号35)、QGPPLQWRQS(配列番号36)、QGPPLMGTQS(配列番号37)、QGPPLMQLQV(配列番号38)、QGPPLSWSQV(配列番号39)、QGPPMSWSQS(配列番号40)、QGPPLMNLQV(配列番号41)、QGPPMSAYQV(配列番号42)及びQGPPMQGGLS(配列番号43)から選択される、実施形態1に記載の方法。
21.シグネチャー配列が、群QGPPLMALQS(配列番号2)、QGPPLMWMQV(配列番号3)、QGPPLMWLQV(配列番号4)、QGPPLMWTQS(配列番号5)、QGPPLMWLQT(配列番号6)、QGPPLMWTQV(配列番号7)、QGPPLMWMQS(配列番号8)、QGPPLMATQS(配列番号9)、QGPPLMWLQS(配列番号10)、QGPPLMALQV(配列番号11)、QGPPLMWLGG(配列番号12)、QGPPLMWRGS(配列番号13)、QGPLLMWLQV(配列番号14)及びQGPPLMQTTP(配列番号15)から選択される、実施形態1に記載の方法。
22.シグネチャー配列がQGPPLMATQS(配列番号9)である、実施形態1に記載の方法。
23.シグネチャー配列が最N末端に位置する、実施形態1〜22のいずれか1つに記載の方法。
24.C末端部分が配列番号1と同一である、実施形態1〜23のいずれか1つに記載の方法。
25.がんが結腸直腸がん、乳がん、肺がん、前立腺がん、卵巣がん、膵臓がん、食道がん、胃がん、肝臓がん又は白血病である、実施形態1〜24のいずれか1つに記載の方法。
26.がんが結腸直腸がんである、実施形態1〜25のいずれか1つに記載の方法。
27.がんが乳がんである、実施形態1〜25のいずれか1つに記載の方法。
28.がんが肺がんである、実施形態1〜25のいずれか1つに記載の方法。
29.がんが前立腺がんである、実施形態1〜25のいずれか1つに記載の方法。
30.がんが卵巣がんである、実施形態1〜25のいずれか1つに記載の方法。
31.がんが膵臓がんである、実施形態1〜25のいずれか1つに記載の方法。
32.がんが食道がんである、実施形態1〜25のいずれか1つに記載の方法。
33.がんが胃がんである、実施形態1〜25のいずれか1つに記載の方法。
34.がんが肝臓がんである、実施形態1〜25のいずれか1つに記載の方法。
35.がんが白血病である、実施形態1〜25のいずれか1つに記載の方法。
36.がんが急性リンパ芽球性白血病(ALL)である、実施形態35に記載の方法。
37.がんが転移性である、実施形態1〜36のいずれか1つに記載の方法。
38.がんが化学療法又は放射線に難治性及び/又は耐性である、実施形態1〜36のいずれか1つに記載の方法。
39.がんが化学療法又は放射線に難治性及び耐性である、実施形態37に記載の方法。
40.CCR5阻害剤が第2の活性剤と一緒に投与される、実施形態1〜39のいずれか1つに記載の方法。
41.第2の活性剤ががんに対して治療有効性を有する、実施形態40に記載の方法。
42.CCR阻害剤ががんの症状の出現前に投与される、実施形態1〜41のいずれか1つに記載の方法。
43.CCR5阻害剤が、経口、舌下、頬側、局所、直腸、吸入により、経皮、皮下、静脈内、動脈内又は筋肉内、心臓内投与により、骨内、皮内、腹腔内、脳内、経粘膜、膣、硝子体内、皮膚上、関節内、膀胱内、クモ膜下腔内、関節周辺、又は局在的に投与される、実施形態1〜42のいずれか1つに記載の方法。
44.CCR5阻害剤が、静脈内、経口、又は吸入により投与される、実施形態1〜43のいずれか1つに記載の方法。
45.CCR5阻害剤が、例えば注射可能制御放出装置により、静脈内投与される、実施形態1〜44のいずれか1つに記載の方法。
46.CCR5阻害剤が医薬担体と一緒に投与される、実施形態1〜45のいずれか1つに記載の方法。
47.CCR5阻害剤が約0.1mg〜約400mgの量で投与される、実施形態1〜46のいずれか1つに記載の方法。
48.CCR5阻害剤が約1mgの量で投与される、実施形態47に記載の方法。
49.CCR5阻害剤が約2mgの量で投与される、実施形態47に記載の方法。
50.CCR5阻害剤が約3mgの量で投与される、実施形態47に記載の方法。
51.CCR5阻害剤が約5mgの量で投与される、実施形態47に記載の方法。
52.CCR5阻害剤が約10mgの量で投与される、実施形態47に記載の方法。
53.CCR5阻害剤が約20mgの量で投与される、実施形態47に記載の方法。
54.CCR5阻害剤が約40mgの量で投与される、実施形態47に記載の方法。
55.CCR5阻害剤が1日1回又は1日あたり2、3、4、5又は6回の等量の別々の投与で投与される、実施形態1〜54のいずれか1つに記載の方法。
56.CCR5阻害剤が慢性的に投与される、実施形態1〜55のいずれか1つに記載の方法。
57.CCR5阻害剤が、1、2、3、4、5、6又は7日間;1、2、3又は4週間;約1、2、3、4、5、6、7、8、9、10、11、12ヵ月間又はそれ以上投与される、実施形態56に記載の方法。
58.CCR5阻害剤が24週間以上投与される、実施形態57に記載の方法。
59.CCR5阻害剤が28週間以上投与される、実施形態58に記載の方法。
60.CCR5阻害剤が、毎日、週に6回、週に5回、週に4回、週に3回、週に2回、週に1回、2週間ごとに1回、3週間ごとに1回、4週間ごとに1回、5週間ごとに1回、6週間ごとに1回、7週間ごとに1回、8週間ごとに1回、9週間ごとに1回、10週間ごとに1回、月に2回、月に1回、2ヵ月ごとに1回、又は3ヵ月ごとに1回の頻度で投与される、実施形態56〜59のいずれか1つに記載の方法。
61.CCR5阻害剤が毎日投与される、実施形態60に記載の方法。
62.CCR5阻害剤が週に1回投与される、実施形態61に記載の方法。
63.CCR5阻害剤が、さらなる薬理学的に活性な化合物と組み合わせて、別々に、順に又は同時に投与するために投与又は提供される、実施形態1〜61のいずれか1つに記載の方法。
64.CCR5阻害剤がN末端部分及びC末端部分を含み、N末端部分がシグネチャー配列QGP[P又はL]を含み、C末端部分のアミノ酸配列が配列番号1と少なくとも70%同一である、がんを治療するためのCCR5阻害剤の使用。
65.CCR5阻害剤がHIVの細胞への侵入を阻害し、CCR1及びCCR3よりもCCR5に選択的である、実施形態64に記載の使用。
66.CCR5阻害剤がCCR5細胞内シグナル伝達経路のサブセットのみを阻害する、実施形態64又は65に記載の使用。
67.CCR5阻害剤がCCR5の炎症作用を阻害又は低減し、例えば、カルシウム流入シグナル伝達アッセイにおいて300nMの濃度で試験した場合、PSC−RANTESによって誘発される最大応答(Emax)の30%以下のシグナル伝達応答をもたらす、実施形態64〜66のいずれか1つに記載の使用。
68.CCR5阻害剤がGタンパク質共役型及び非共役型構造の両方でCCR5に結合する、実施形態64〜67のいずれか1つに記載の使用。
69.CCR5阻害剤がCCR5内部移行を誘導しない、実施形態64〜68のいずれか1つに記載の使用。
70.CCR5阻害剤がCCR5表面ダウンモジュレーションアッセイによって測定された場合、20%以下の受容体隔離活性をもたらす、実施形態69に記載の使用。
71.シグネチャー配列がQGP[P又はL][L又はG又はS又はM][M又はD又はS又はQ又はG]である、実施形態64に記載の使用。
72.シグネチャー配列がQGP[P又はL][L又はG][M又はD又はS]である、実施形態64に記載の使用。
73.シグネチャー配列がQGP[P又はL][L又はG又はS又はM][M又はD又はS又はQ又はG]XX[Q又はG又はL又はA又はT又はS]Xであり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態64に記載の使用。
74.シグネチャー配列がQGP[P又はL][L又はG][M又はD又はS]XX[Q又はG又はL]Xであり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態64に記載の使用。
75.シグネチャー配列がQGP[P又はL]LM又はQGPPG[D又はS]である、実施形態64に記載の使用。
76.シグネチャー配列がQGPPLM又はQGPPGDである、実施形態64に記載の使用。
77.シグネチャー配列がQGP[P又はL][L又はM][M又はQ][A又はW又はG又はQ又はN]X[Q又はG又はL][S又はV又はT又はG]であり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態64に記載の使用。
78.シグネチャー配列がQGP[P又はL][L又はM][M又はQ][A又はW又はG又はQ又はN][L又はT又はM又はS又はG又はQ又はR又はY][Q又はG又はL][S又はV又はT又はG]である、実施形態64に記載の使用。
79.シグネチャー配列がQGP[P又はL]LM[A又はW][L又はT又はM][Q又はG][S又はV又はT又はG]である、実施形態64に記載の使用。
80.シグネチャー配列がQGPPLM[A又はW][L又はT又はM][Q又はG][S又はV又はT又はG]である、実施形態64に記載の使用。
81.シグネチャー配列がQGPP[G又はL][M又はQ]XX[Q又はS][S又はV]であり、ここでXは任意の天然又は改変アミノ酸を示す、実施形態64に記載の使用。
82.シグネチャー配列がQGPP[G又はL][M又はQ][S又はG又はW又はA又はT][L又はF又はT又はS又はG又はY][Q又はS][S又はV]である、実施形態64に記載の使用。
83.シグネチャー配列が、群QGPPLMALQS(配列番号2)、QGPPLMWMQV(配列番号3)、QGPPLMWLQV(配列番号4)、QGPPLMWTQS(配列番号5)、QGPPLMWLQT(配列番号6)、QGPPLMWTQV(配列番号7)、QGPPLMWMQS(配列番号8)、QGPPLMATQS(配列番号9)、QGPPLMWLQS(配列番号10)、QGPPLMALQV(配列番号11)、QGPPLMWLGG(配列番号12)、QGPPLMWRGS(配列番号13)、QGPLLMWLQV(配列番号14)、QGPPLMQTTP(配列番号15)、QGPPLSWLQV(配列番号30)、QGPPLSWLQS(配列番号31)、QGPPGQWSQV(配列番号32)、QGPPMMAGLS(配列番号33)、QGPPLSWQQS(配列番号34)、QGPPGMWSQS(配列番号35)、QGPPLQWRQS(配列番号36)、QGPPLMGTQS(配列番号37)、QGPPLMQLQV(配列番号38)、QGPPLSWSQV(配列番号39)、QGPPMSWSQS(配列番号40)、QGPPLMNLQV(配列番号41)、QGPPMSAYQV(配列番号42)及びQGPPMQGGLS(配列番号43)から選択される、実施形態64に記載の使用。
84.シグネチャー配列が、群QGPPLMALQS(配列番号2)、QGPPLMWMQV(配列番号3)、QGPPLMWLQV(配列番号4)、QGPPLMWTQS(配列番号5)、QGPPLMWLQT(配列番号6)、QGPPLMWTQV(配列番号7)、QGPPLMWMQS(配列番号8)、QGPPLMATQS(配列番号9)、QGPPLMWLQS(配列番号10)、QGPPLMALQV(配列番号11)、QGPPLMWLGG(配列番号12)、QGPPLMWRGS(配列番号13)、QGPLLMWLQV(配列番号14)及びQGPPLMQTTP(配列番号15)から選択される、実施形態64に記載の使用。
85.シグネチャー配列がQGPPLMATQS(配列番号9)である、実施形態64に記載の使用。
86.シグネチャー配列が最N末端に位置する、実施形態64〜85のいずれか1つに記載の使用。
87.C末端部分が配列番号1と同一である、実施形態64〜86のいずれか1つに記載の使用。
88.がんが結腸直腸がん、乳がん、肺がん、前立腺がん、卵巣がん、膵臓がん、食道がん、胃がん、肝臓がん又は白血病である、実施形態64〜87のいずれか1つに記載の使用。
89.がんが結腸直腸がんである、実施形態64〜88のいずれか1つに記載の使用。
90.がんが乳がんである、実施形態64〜88のいずれか1つに記載の使用。
91.がんが肺がんである、実施形態64〜88のいずれか1つに記載の使用。
92.がんが前立腺がんである、実施形態64〜88のいずれか1つに記載の使用。
93.がんが卵巣がんである、実施形態64〜88のいずれか1つに記載の使用。
94.がんが膵臓がんである、実施形態64〜88のいずれか1つに記載の使用。
95.がんが食道がんである、実施形態64〜88のいずれか1つに記載の使用。
96.がんが胃がんである、実施形態64〜88のいずれか1つに記載の使用。
97.がんが肝臓がんである、実施形態64〜88のいずれか1つに記載の使用。
98.がんが白血病である、実施形態64〜88のいずれか1つに記載の使用。
99.がんが急性リンパ芽球性白血病(ALL)である、実施形態98に記載の使用。
100.がんが転移性である、実施形態64〜99のいずれか1つに記載の使用。
101.がんが化学療法又は放射線に難治性及び/又は耐性である、実施形態64〜100のいずれか1つに記載の使用。
102.がんが化学療法又は放射線に難治性及び耐性である、実施形態101に記載の使用。
103.CCR5阻害剤が第2の活性剤と一緒に投与用である、実施形態64〜102のいずれか1つに記載の使用。
104.第2の活性剤ががんに対して治療有効性を有する、実施形態103に記載の使用。
105.CCR阻害剤ががんの症状の出現前の投与用である、実施形態64〜104のいずれか1つに記載の使用。
106.CCR5阻害剤が、経口、舌下、頬側、局所、直腸、吸入による、経皮、皮下、静脈内、動脈内又は筋肉内、心臓内投与による、骨内、皮内、腹腔内、脳内、経粘膜、膣、硝子体内、皮膚上、関節内、膀胱内、クモ膜下腔内、関節周辺、又は局在投与用である、実施形態64〜105のいずれか1つに記載の使用。
107.CCR5阻害剤が、静脈内、経口、又は吸入による投与用である、実施形態64〜106のいずれか1つに記載の使用。
108.CCR5阻害剤が、例えば注射可能制御放出装置による、静脈内投与用である、実施形態64〜107のいずれか1つに記載の使用。
109.CCR5阻害剤が医薬担体と一緒での投与用である、実施形態64〜108のいずれか1つに記載の使用。
110.CCR5阻害剤が約0.1mg〜約400mgの量での投与用である、実施形態64〜109のいずれか1つに記載の使用。
111.CCR5阻害剤が約1mgの量での投与用である、実施形態110に記載の使用。
112.CCR5阻害剤が約2mgの量での投与用である、実施形態110に記載の使用。
113.CCR5阻害剤が約3mgの量での投与用である、実施形態110に記載の使用。
114.CCR5阻害剤が約5mgの量での投与用である、実施形態110に記載の使用。
115.CCR5阻害剤が約10mgの量での投与用である、実施形態110に記載の使用。
116.CCR5阻害剤が約20mgの量での投与用である、実施形態110に記載の使用。
117.CCR5阻害剤が約40mgの量での投与用である、実施形態110に記載の使用。
118.CCR5阻害剤が1日1回又は1日あたり2、3、4、5又は6回の等量の別々の投与での投与用である、実施形態64〜117のいずれか1つに記載の使用。
119.CCR5阻害剤が慢性投与用である、実施形態64〜118のいずれか1つに記載の使用。
120.CCR5阻害剤が、1、2、3、4、5、6又は7日間;1、2、3又は4週間;約1、2、3、4、5、6、7、8、9、10、11、12ヵ月間又はそれ以上の投与用である、実施形態119に記載の使用。
121.CCR5阻害剤が24週間以上の投与用である、実施形態120に記載の使用。
122.CCR5阻害剤が28週間以上の投与用である、実施形態121に記載の使用。
123.CCR5阻害剤が、毎日、週に6回、週に5回、週に4回、週に3回、週に2回、週に1回、2週間ごとに1回、3週間ごとに1回、4週間ごとに1回、5週間ごとに1回、6週間ごとに1回、7週間ごとに1回、8週間ごとに1回、9週間ごとに1回、10週間ごとに1回、月に2回、月に1回、2ヵ月ごとに1回、又は3ヵ月ごとに1回の頻度での投与用である、実施形態119〜122のいずれか1つに記載の使用。
124.CCR5阻害剤が毎日の投与用である、実施形態123に記載の使用。
125.CCR5阻害剤が週に1回の投与用である、実施形態123に記載の使用。
126.CCR5阻害剤が、さらなる薬理学的に活性な化合物と組み合わせて、別々に、順に又は同時に投与するための投与又は提供用である、実施形態64〜125のいずれか1つに記載の使用。
127.さらなる薬理学的に活性な化合物がチェックポイント阻害剤である、実施形態63に記載の方法。
128.さらなる薬理学的に活性な化合物が抗PD−1抗体である、実施形態127に記載の方法。
129.さらなる薬理学的に活性な化合物が抗CTLA−4抗体である、実施形態127に記載の方法。
130.さらなる薬理学的に活性な化合物がチェックポイント阻害剤である、実施形態126に記載の使用。
131.さらなる薬理学的に活性な化合物が抗PD−1抗体である、実施形態130に記載の使用。
132.さらなる薬理学的に活性な化合物が抗CTLA−4抗体である、実施形態130に記載の使用。
[00141]HIV−1BaLに対する5P12−RANTESの抗レトロウイルス効力(logIC50)を、コーカサス人、黒人、アジア人及びラテン民族を代表するUSドナーのパネルからの末梢血単核細胞を使用する複製アッセイで、参照化合物AZT及びマラビロク(MVC)の抗レトロウイルス効力と比較した(図2)。各ドナーに関して、各化合物を3回反復で9つの濃度で評価した。各点は個々のドナーのlogIC50を表す。BD:アッセイ検出限界以下(すなわち、より強力である)。これらのデータは、HIV−1複製の阻害において5P12−RANTESがMVCより10〜30倍強力であることを示している。
[00142]5P12−RANTESは、GTPγ35S機能アッセイを使用して、用量応答及び2回反復で、組換えヒトCCR1(FAST−058G)及びCCR3(FAST−061G)受容体への阻害活性を試験した。
[00150]一実験では、BALB/cマウスにCT−26結腸直腸がん細胞株を皮下に接種した。接種3日後、5P12−RANTES、マウス抗PD−1抗体、5P12−RANTES+抗PD−1、又は生理食塩水プラセボによる腹腔内治療を開始した。治療は、毎日又は3日ごとに与えられた。図4Aに示すように、5P12−RANTES単独による治療は、複数の時点で腫瘍増殖の統計的に有意な遅延をもたらし、動物が5P12−RANTESと抗PD−1抗体の両方を受けた組合せコホートで平均腫瘍体積の減少へのさらにより甚大な効果が観察された(p>0.05)。一連の治療の間に顕著な有害事象は観察されなかった。
[0001]本出願は、2018年5月28日に出願した米国特許仮出願第62/677,114号及び2019年1月15日に出願した米国特許仮出願第62/792,600号に基づく利益及び優先権を主張するものであり、それらの全体が参照により本明細書に組み込まれる。
Claims (20)
- 対象にCCR5阻害剤を投与するステップを含む、がんを治療する方法であって、CCR5阻害剤がN末端部分及びC末端部分を含み、前記N末端部分がシグネチャー配列QGP[P又はL]を含み、前記C末端部分のアミノ酸配列が配列番号1と少なくとも70%同一である、方法。
- 前記CCR5阻害剤がHIVの細胞への侵入を阻害し、CCR1及びCCR3よりもCCR5に選択的である、請求項1に記載の方法。
- 前記CCR5阻害剤がCCR5細胞内シグナル伝達経路のサブセットのみを阻害する、請求項2に記載の方法。
- 前記CCR5阻害剤が、CCR5の炎症作用を阻害又は低減し、例えば、カルシウム流入シグナル伝達アッセイにおいて300nMの濃度で試験した場合、PSC−RANTESによって誘発される最大応答(Emax)の30%以下のシグナル伝達応答をもたらす、請求項3に記載の方法。
- 前記シグネチャー配列がQGP[P又はL][L又はG又はS又はM][M又はD又はS又はQ又はG]である、請求項1に記載の方法。
- 前記シグネチャー配列がQGP[P又はL][L又はG又はS又はM][M又はD又はS又はQ又はG]XX[Q又はG又はL又はA又はT又はS]Xであり、ここでXは任意の天然又は改変アミノ酸を示す、請求項1に記載の方法。
- 前記シグネチャー配列がQGP[P又はL]LM又はQGPPG[D又はS]である、請求項1に記載の方法。
- 前記シグネチャー配列がQGPPLM又はQGPPGDである、請求項1に記載の方法。
- 前記シグネチャー配列がQGP[P又はL][L又はM][M又はQ][A又はW又はG又はQ又はN]X[Q又はG又はL][S又はV又はT又はG]であり、ここでXは任意の天然又は改変アミノ酸を示す、請求項1に記載の方法。
- 前記シグネチャー配列がQGPPLM[A又はW][L又はT又はM][Q又はG][S又はV又はT又はG]である、請求項1に記載の方法。
- 前記シグネチャー配列がQGPP[G又はL][M又はQ]XX[Q又はS][S又はV]であり、ここでXは任意の天然又は改変アミノ酸を示す、請求項1に記載の方法。
- 前記シグネチャー配列が、群QGPPLMALQS(配列番号2)、QGPPLMWMQV(配列番号3)、QGPPLMWLQV(配列番号4)、QGPPLMWTQS(配列番号5)、QGPPLMWLQT(配列番号6)、QGPPLMWTQV(配列番号7)、QGPPLMWMQS(配列番号8)、QGPPLMATQS(配列番号9)、QGPPLMWLQS(配列番号10)、QGPPLMALQV(配列番号11)、QGPPLMWLGG(配列番号12)、QGPPLMWRGS(配列番号13)、QGPLLMWLQV(配列番号14)、QGPPLMQTTP(配列番号15)、QGPPLSWLQV(配列番号30)、QGPPLSWLQS(配列番号31)、QGPPGQWSQV(配列番号32)、QGPPMMAGLS(配列番号33)、QGPPLSWQQS(配列番号34)、QGPPGMWSQS(配列番号35)、QGPPLQWRQS(配列番号36)、QGPPLMGTQS(配列番号37)、QGPPLMQLQV(配列番号38)、QGPPLSWSQV(配列番号39)、QGPPMSWSQS(配列番号40)、QGPPLMNLQV(配列番号41)、QGPPMSAYQV(配列番号42)及びQGPPMQGGLS(配列番号43)から選択される、請求項1に記載の方法。
- 前記シグネチャー配列が、群QGPPLMALQS(配列番号2)、QGPPLMWMQV(配列番号3)、QGPPLMWLQV(配列番号4)、QGPPLMWTQS(配列番号5)、QGPPLMWLQT(配列番号6)、QGPPLMWTQV(配列番号7)、QGPPLMWMQS(配列番号8)、QGPPLMATQS(配列番号9)、QGPPLMWLQS(配列番号10)、QGPPLMALQV(配列番号11)、QGPPLMWLGG(配列番号12)、QGPPLMWRGS(配列番号13)、QGPLLMWLQV(配列番号14)及びQGPPLMQTTP(配列番号15)から選択される、請求項1に記載の方法。
- 前記シグネチャー配列がQGPPLMATQS(配列番号9)である、請求項1に記載の方法。
- 前記シグネチャー配列が最N末端に位置する、請求項14に記載の方法。
- 前記C末端部分が配列番号1と同一である、請求項15に記載の方法。
- 前記CCR5阻害剤が配列番号70のアミノ酸配列を含む、請求項1に記載の方法。
- 前記がんが結腸直腸がん、乳がん、肺がん、前立腺がん、卵巣がん、膵臓がん、食道がん、胃がん、肝臓がん又は白血病である、請求項1に記載の方法。
- 前記がんが転移性である、請求項18に記載の方法。
- 前記がんが化学療法又は放射線に難治性及び/又は耐性である、請求項18に記載の方法。
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