JP2017533201A - 疾患及び障害の治療のためにインターロイキン−10を使用する方法 - Google Patents
疾患及び障害の治療のためにインターロイキン−10を使用する方法 Download PDFInfo
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Abstract
Description
本出願は、2014年10月22日出願の米国特許仮出願第62/067,337号の優先権を主張し、その全体を参照により本明細書に組み込む。
本開示は、様々な疾患、障害及び状態ならびに/もしくはそれらの症状を治療するならび/または予防するための、本明細書に記載される薬剤ならびにその組成物の使用を想定する。本開示の特定の態様では、このような治療または予防は、特定の投薬パラメータを利用することによって行われる。いくつかの実施形態において、薬剤は、例えば炎症性及び免疫関連障害、線維性障害、癌及び癌関連の障害、または心血管障害(例えば、アテローム性動脈硬化症)の治療のために最適化される血清中トラフ濃度が達成されるように投与される。
特に指示のない限り、以下の用語は、下記に示す意味を有することを目的としている。他の用語は、明細書の全体を通して他の場所で定義される。
G グリシン Gly P プロリン Pro
A アラニン Ala V バリン Val
L ロイシン Leu I イソロイシン Ile
M メチオニン Met C システイン Cys
F フェニルアラニン Phe Y チロシン Tyr
W トリプトファン Trp H ヒスチジン His
K リジン Lys R アルギニン Arg
Q グルタミン Gln N アスパラギン Asn
E グルタミン酸 Glu D アスパラギン酸 Asp
S セリン Ser T トレオニン Thr
また、ヒトのサイトカイン合成阻害因子(CSIF)として知られている抗炎症性サイトカインIL−10は、IL−19、IL−20、IL−22、IL−24(Mda−7)、及びIL−26、インターフェロン(IFN−α、−β、−γ、−δ、−ε、−κ、−Ω、及び−τ)、及びインターフェロン様分子(リミチン、IL−28A、IL−28B、及びIL−29)を含む、2型(クラス)サイトカイン、1組のサイトカインとして分類されている。
ここに記載される方法におけるIL−10の血しょう濃度は、いくつかの方法で特徴づけることができ、それは、(1)ある特定のレベルを上回る、もしくはそのレベルの範囲にある平均IL−10血清中トラフ濃度、(2)ある期間にある特定のレベルを上回る平均IL−10血清中トラフ濃度、(3)ある特定のレベルを上回るもしくは下回る、もしくはそのレベルの範囲にある定常状態IL−10血清中濃度レベル、または(4)ある特定のレベルを上回るもしくは下回る、もしくはそのレベルの範囲にある濃度プロファイルのCmax、を含む。ここに記載されるように、平均血清中トラフIL−10濃度は、特定の指標における有効性において特に重要であることが判明した。
実験の項では、PDV6扁平上皮細胞癌及びCT−26結腸癌におけるmIL−10及びPEG−mIL−10の治療有効性の評価について記載し、そこでmIL−10及びmPEG−IL−10投薬パラメータ(投与の量及び頻度)は、1〜2ng/mLの平均IL−10血清中トラフ濃度を達成するに十分である。実験の項に記載のとおり、PEG−IL−10治療は完全寛解をもたらした一方で、IL−10治療は、抗腫瘍機能を実証したものの、完全寛解には至らなかった。
本開示のいくつか実施形態では、生成することができる血しょうレベルの濃度プロファイルは、約0.1ng/mLよりも大きい、約0.15ng/mLよりも大きい、約0.2ng/mLよりも大きい、約0.25ng/mLよりも大きい、約0.3ng/mLよりも大きい、約0.35ng/mLよりも大きい、約0.4ng/mLよりも大きい、約0.45ng/mLよりも大きい、約0.5ng/mLよりも大きい、約0.55ng/mLよりも大きい、約0.6ng/mLよりも大きい、約0.65ng/mLよりも大きい、約0.7ng/mLよりも大きい、約0.75ng/mLよりも大きい、約0.8ng/mLよりも大きい、約0.85ng/mLよりも大きい、約0.9ng/mLよりも大きい、約0.95ng/mLよりも大きい、約1.0ng/mLよりも大きい、約1.1ng/mLよりも大きい、約1.2ng/mLよりも大きい、約1.3ng/mLよりも大きい、約1.4ng/mLよりも大きい、約1.5ng/mLよりも大きい、約1.6ng/mLよりも大きい、約1.7ng/mLよりも大きい、約1.8ng/mLよりも大きい、約1.9ng/mLよりも大きい、約2.0ng/mLよりも大きい、約2.1ng/mLよりも大きい、約2.2ng/mLよりも大きい、約2.3ng/mLよりも大きい、約2.4ng/mLよりも大きい、約2.5ng/mLよりも大きい、約2.75ng/mLよりも大きい、または約3.0ng/mLよりも大きい平均IL−10血清中トラフ濃度を含む。
CD8(分化抗原群8)は、T細胞受容体(TCR)の共受容体としての機能を果たす膜貫通型糖タンパク質である。CD8共受容体は主に細胞傷害性Tリンパ球(CTL)の表面上で発現するが、それは、ナチュラルキラー細胞(NK)を含む他の細胞型上でも見出される。TCRのように、CD8は主要組織適合遺伝子複合体(MHC)分子に結合するが、MHCクラスIタンパク質に特異的である。
本発明のポリペプチドは、非組み換え(例えば、化学合成)及び組み換え法を含む任意の適切な方法により産生することができる。
ポリペプチドが化学合成される場合、合成は液相または固相を介して進行できる。固相ペプチド合成(SPPS)は、非天然アミノ酸及び/またはペプチド/タンパク質骨格改変の組み込みを可能にする。9−フルオレニルメトキシカルボニル(Fmoc)及びt−ブチルオキシカルボニル(Boc)などのSPPSの様々な形態は、本開示のポリペプチドを合成するために利用可能である。化学合成の詳細は当該技術分野で周知である(例えば、Ganesan A.(2006)Mini Rev.Med.Chem.6:3−10;及びCamarero J.A.et al.,(2005)Protein Pept Lett.12:723−8)。
ヒト及びマウスIL−10の調製を説明する方法は、例えば米国特許第5,231,012号に見出すことができ、それは組み換え及び他の合成技術を含む、IL−10活性を有するタンパク質を産生するための方法を教示する。IL−10はウイルス起源であり得て、Epstain Barrウイルス(BCRF1タンパク質)からクローニング及びウイルス性IL−10の発現がMooreら(1990)Science248:1230に開示されている。IL−10は、本明細書に記載のものなど当該技術分野で周知の標準的技術を用いて多数の方法で得ることができる。組み換えヒトIL−10は、PeproTech,Inc.(Rocky Hill、N.J.)からも市販品として入手可能である。
いくつかの場合では、IL−10はペプチド結合以外の1つ以上の連結を含み、例えば少なくとも2つの隣接するアミノ酸はアミド結合以外の連結を介して結合される。例えば、望ましくないタンパク質分解もしくは分解の他の手段を低減もしくは排除するため、及び/または血清の安定性を増加させるために、及び/または骨格内の立体配座の柔軟性を制限もしくは増加させるために、IL−10の主鎖内の1つ以上のアミド結合を置換できる。
1つ以上のアミノ酸置換は、IL−10ポリペプチド内で行われる。下記は非限定的な例である。
システイン残基またはシステイン類似体は、ジスルフィド結合を介して別のペプチドに結合を提供するために、またはIL−10ポリペプチドの環化を提供するために、IL−10ポリペプチドに導入され得る。システインまたはシステイン類似体を導入する方法は、当該技術分野で周知である。例えば米国特許第8,067,532号を参照。
本明細書に開示された治療法(例えば、IL−10)及び/またはそれらを投与する方法における、1つ以上の物理的特性を向上させることは、しばしば有益であり、時には必須である。物理的特性の改善は、例えば免疫原性を調節すること、水溶解性、バイオアベイラビリティ、血清中半減期及び/もしくは治療用半減期、ならびに/または生物学的活性を上昇させる方法を含む。特定の改変は、例えば検出アッセイ(例えばエピトープタグ)で使用するための抗体を産生するために、及びタンパク質精製の容易性を提供するためにも有用であり得る。このような改変は一般的に、治療モダリティの生物活性に悪影響を与えることなく、及び/またはその免疫原性を増大させることなく付与される必要がある。
本開示は、疾患、障害及び/もしくは状態ならびに/またはその症状の広い範囲の治療または予防における本明細書に記載のIL−10ポリペプチド(例えばPEG−IL−10)の使用を想到する。実際、本開示の教示は、上記のIL−10平均血清中トラフ濃度パラメータを達成するまたは保持することが有益となり得る、あらゆる疾患、障害または状態に適用することになっている。特定の用途を以下に詳細に記載するが、本開示はそれに限定されないことを理解すべきである。更に、特定の疾患、障害及び状態の一般的なカテゴリーを以下に記載するが、疾患、障害及び状態のいくつかは、2つ以上のカテゴリーに属する(例えば、癌及び線維性関連障害)ことができ、他のものは開示されたカテゴリーのいずれにも属さない可能性がある。
血管中の血栓(凝血)の形成である血栓症は、循環系による血液の流れを妨害するものであり、凝固性亢進もしくは血液凝固の増大、内皮細胞の傷害、または血流妨害(うっ血、乱流)(ウィルヒョウの3主徴)のうちの1つ以上における、異常に起因し得る。
本開示のIL−10ポリペプチドは、対象に投与するのに適した組成物の形態であり得る。一般にそのような組成物は、IL−10及び1つ以上の薬学的に許容されるもしくは生理学的に許容される希釈剤、担体または賦形剤を含む「医薬組成物」である。特定の実施形態では、IL−10ポリペプチドは治療的に許容される量で存在する。医薬組成物は本開示の方法で使用されることができ、したがって例えば医薬組成物は、本明細書に記載される治療法及び予防法ならびに使用を実践するために、ex vivoまたはin vivoで対象に投与され得る。
投与経路
本開示は、1つ以上の活性治療剤(例えばサイトカイン)または他の予防または治療法(例えば放射線)と併用した、IL−10(例えばPEG−IL−10)の使用を想定する。そのような併用療法では、様々な活性剤は、往々にして、異なる作用機序を有する。そのような併用療法は、薬剤のうちの1つ以上の用量減少を可能にし、それによって、薬剤のうちの1つ以上に関連する有害な作用を減少させる、または排除することにより特に有益であり、更にそのような併用療法は、基礎疾患、障害もしくは状態に対して相乗治療または予防作用を有し得る。
本開示のIL−10ポリペプチドは、例えば投与の目標(例えば所望の消失の程度);製剤が投与される対象の年齢、体重、性別ならびに健康及び身体状態;投与経路;ならびに疾患、障害、状態またはその症状の性質に依存する量で対象に投与され得る。投薬レジメンは、投与される薬剤(複数可)に関連する任意の副作用の存在、性質、及び程度も考慮に入れることができる。有効投与量及び投与レジメンは、例えば安全性及び用量漸増試験、in vivo試験(例えば、動物モデル)、及び当業者に周知の他の方法により容易に決定することができる。
本開示は、IL−10及びその医薬組成物を含むキットも想定する。キットは一般的に、以下に記載される様々な成分を収容する物理的構造の形態であり、例えば、上述の方法を実践する(例えば、コレステロール恒常性の回復を必要とする対象へのIL−10ポリペプチドの投与)際に利用され得る。
以下の実施例は、当業者に本発明をどのように作製及び使用するかの完全な開示及び説明を提供するように提示され、本発明者が自身の発明と見なすものの範囲を限定するようには意図されておらず、以下の実験が実施された及びすべての実験が実施され得ることを示すようにも意図されていない。現在形で書かれた例示の記述は必ずしも実施されたものとは限らず、むしろ、説明は、本明細書に記述されたデータなどを生成するために実施できることと理解すべきであろう。使用される数字(例えば量、温度など)に関して正確さを保証するために努力がはらわれているが、いくつかの実験誤差及び偏差があることを考慮すべきであろう。
下記の一般的な材料及び方法を、以下の実施例で使用する。
当技術分野で認められたあらゆる腫瘍モデル、アッセイなどを用いて、様々な腫瘍に関するIL−10及びPEG−IL−10の効果を評価することができる。この後記載される腫瘍モデル及び腫瘍分析は、利用可能なものの代表であり、それらを用いて、表1〜表15に記載されたデータを生成し、評価する。
上記の腫瘍モデル及び癌分析法を利用して、以下に記載するデータを生成した。しかし、上述のように、これらと同じモデル及び手順を他の実験の設定に用いてもよい。
用量漸増の試験では、予想されるピーク及びトラフ投与量レベルに想到する時間で、各群の代表的なマウスから尾静脈の出血を収集した。電気化学発光検出とパターン化されたアレイとの組み合わせであるマルチアレイ技術に基づく、Meso Scale Discoveryプラットフォームを用いて、採取された血清をmIL−10濃度について分析した。両側不対スチューデントt検定を用いて、血清mIL−10濃度で分類したmIL−10−処理またはPEG−mIL−10−処理マウスの平均腫瘍容積を、それらに対応するビヒクル対照群の平均腫瘍容積と比較した。2つの群に不等分散(t検定からp<0.05)があったとき、ウェルチ補正を用いた。
4T1乳癌モデルにおける肺転移は、Current Protocols in Immunology(Section20.2.4)John Wiley and Sons,Inc.,New York;Harlow and Lane(1999)に記載されるように、肺切除の後肉眼で(表9)、または培養の後肺転移のコロニーを計数することによって(表10)定量化された。簡潔にいうと、担4T1腫瘍マウスから採取した肺を細かく刻み、コラゲナーゼ/エラスターゼカクテルで消化処理して、その後、6‐チオグアニンを含有する媒体中の限界希釈アッセイで培養した。4T1細胞のみが6−チオグアニン耐性を示し、培養の10〜14日後にコロニー数を計数することによって定量化が可能である。1日2回の処理は移植の後17日目に開始され、その際、平均腫瘍容積は84〜90mm3であった。トリス及びHepes緩衝液はmIL−10及びPEG mIL−10に対する対照であった。肺当たり培養された転移のコロニーの数として、肺転移は計測された。
CD4+及びCD8+T細胞は、抗体媒介性排除によって除去された。250μgのCD4またはCD8特異的抗体が、この目的のために週1回注入された。細胞除去は、FACS及びIHC分析を用いて確認された。
IL−10治療の薬物動態パラメータの理解を高めるため、及び、ヒト対象中の組み換え型ヒトIL−10(rhIL−10)に対する腫瘍治療レジメンを最適化するのに有用なマウスのデータを生成するため、マウス実験はデザインされ実施された。
ヒト対象中の血清IL−10濃度の測定。ヒトのボランティアに所望の量のrhIL−10をSCまたはIVで投与し、投与後所望の時間(複数可)に、全血液試料をヘパリン抗凝固剤入りの容器内に取った。標準サンドイッチ酵素結合免疫吸着アッセイ(ELISA)キットを用いて、血清rhIL−10またはPEG−rhIL−10濃度を測定した。通常ELISAアッセイは、0.1〜10ng/mLの濃度範囲で、選択的、線状及び再現可能であると判断して、その定量下限(LOO)は0.1ng/mLであった。血清試料は、hIL−10に結合する抗体の存在に関しても、ELISAで分析された。更に、マウス肥満細胞株MC9を含むバリデーション済みのバイオアッセイを用いて、選択された血清試料は分析されて、この細胞株はIL−10に反応して増殖する。バイオアッセイを用いて、GMP生成rHuIL−10及びPEG−rHuIL−10の生物活性を決定するとともに、患者血清中のIL−10の生物活性を決定する。通常、IL−10濃度及び活性のELISA及びバイオアッセイの測定は、対応する値を明らかにした。
投与量逐次漸増試験。固形腫瘍の特定の種類を有する患者に異なる量のPEG−hIL−10を投与する効果を、評価した。図3で説明したように、合計28人の患者は1、2.5、5、10または20μg/kgのPEG−hIL−10を毎日SCで投与して、その患者のうちの24人の腫瘍を、免疫関連反応評価基準(irRC)、免疫療法薬による反応パターンを決定するために一般的に用いられる手順で評価した(例えば、Wolchok et al.,Clin.Cancer Res.15(23):7412−20(December1 2009)参照のこと)。患者は、卵巣腫瘍、腎臓腫瘍、結腸腫瘍、膵臓腫瘍または黒色腫に罹患していた。
癌胎児性抗原(CEA)とは、健康成人の血清では超低レベルでしか現れない、胎児発達期中に胃腸組織で生じる1組の細胞表面アンカード糖タンパク質を意味する。CEA血清レベルは癌の特定の種類(例えばCRC)で増加して、CEAは、臨床効果を予測する、臨床試験中の腫瘍マーカーとして使用することが可能である。
3つの種類の一次腫瘍(黒色腫、RCC及びCRC)のうちの1つを有する患者の転移性病変のサイズにおけるPEG−hIL−10の効果を、評価した。各患者について、転移の病変サイズ(容積)のパーセンテージ変化は、PEG−hIL−10治療(20μg/kgのPEG−hIL−10 SC QD)にわたって、コンピュータ断層撮影(CT)画像診断(図7A〜図7Cそれぞれの左のグラフ)を使用して、判定された。PEG−hIL−10血清中濃度は各患者について測定されて、上記で判定したEC50と比較した(図7A〜図7Cの右のグラフ)。
2種類の固形腫瘍(黒色腫または腎細胞癌)の1つを有する患者に異なる量のPEG−hIL−10を投与する効果を、評価した。黒色腫投薬コホートにおいて、PEG−hIL−10は、表19に示す週の数にわたって投与量(1、5、20及び40μg/kg)毎に、1人の患者に毎日SCで投与された。腎細胞癌投薬コホートにおいて、PEG−hIL−10は、表19に示す週の数にわたって、投与量毎に2.5μg/kgで2人の患者に及び投与量毎に5、10及び20μg/kgで1人の患者に、毎日SCで投与された。ほとんど患者において、投薬は示された週の数を越えて継続した。
Claims (76)
- 対象の疾患、障害もしくは状態を治療または予防する方法であって、前記方法が治療に有効な量のIL−10薬を対象に投与することを含み、前記量が、少なくとも6.0ng/mLの平均IL−10血清トラフ濃度を達成するのに十分である、前記方法。
- 前記量が、少なくとも8.0ng/mLの平均IL−10血清中トラフ濃度を達成するのに十分である、請求項1に記載の方法。
- 前記量が、少なくとも10.0ng/mLの平均IL−10血清中トラフ濃度を達成するのに十分である、請求項1に記載の方法。
- 前記量が、少なくとも12.0ng/mLの平均IL−10血清中トラフ濃度を達成するのに十分である、請求項1に記載の方法。
- 前記量が、少なくとも14.0ng/mLの平均IL−10血清中トラフ濃度を達成するに十分である、請求項1に記載の方法。
- 前記量が、少なくとも16.0ng/mLの平均IL−10血清中トラフ濃度を達成するのに十分である、請求項1に記載の方法。
- 前記量が、少なくとも18.0ng/mLの平均IL−10血清中トラフ濃度を達成するのに十分である、請求項1に記載の方法。
- 前記量が、少なくとも20.0ng/mLの平均IL−10血清中トラフ濃度を達成するのに十分である、請求項1に記載の方法。
- 対象の疾患、障害もしくは状態を治療または予防する方法であって、前記方法が治療に有効な量のIL−10薬を対象に投与することを含み、前記量がある期間にわたって平均IL−10血清中トラフ濃度を維持するのに十分であり、
前記平均IL−10血清中トラフ濃度が少なくとも6.0ng/mLであり、及び
前記平均IL−10血清中トラフ濃度が前記期間の少なくとも90%の間維持される、前記方法 - 前記平均IL−10血清中トラフ濃度が少なくとも8.0ng/mLである、請求項9に記載の方法。
- 前記平均IL−10血清中トラフ濃度が少なくとも10.0ng/mLである、請求項9に記載の方法。
- 前記平均IL−10血清中トラフ濃度が少なくとも12.0ng/mLである、請求項9に記載の方法。
- 前記平均IL−10血清中トラフ濃度が少なくとも14.0ng/mLである、請求項9に記載の方法。
- 前記平均IL−10血清中トラフ濃度が少なくとも16.0ng/mLである、請求項9に記載の方法。
- 前記平均IL−10血清中トラフ濃度が少なくとも18.0ng/mLである、請求項9に記載の方法。
- 前記平均IL−10血清中トラフ濃度が少なくとも20.0ng/mLである、請求項9に記載の方法。
- 前記期間が少なくとも12時間である、請求項9〜16のいずれか一項に記載の方法。
- 前記期間が少なくとも24時間である、請求項17に記載の方法。
- 前記期間が少なくとも48時間である、請求項18に記載の方法。
- 前記期間が少なくとも72時間である、請求項19に記載の方法。
- 前記期間が少なくとも1週間である、請求項20に記載の方法。
- 前記期間が少なくとも2週間である、請求項21に記載の方法。
- 前記期間が少なくとも1か月である、請求項22に記載の方法。
- 前記平均IL−10血清中トラフ濃度が前記期間の少なくとも95%の間維持される、請求項9〜23のいずれか一項に記載の方法。
- 前記平均IL−10血清中トラフ濃度が、前記期間の少なくとも98%の間保持される、請求項24に記載の方法。
- 前記平均IL−10血清中トラフ濃度が前記期間の100%の間維持される、請求項25に記載の方法。
- 対象の疾病、障害もしくは状態を治療または予防する方法であって、前記方法が治療に有効な量のIL−10薬を対象に投与することを含み、前記量が、前記IL−10薬の少なくともEC50の平均IL−10血清中トラフ濃度を達成するのに十分である、前記方法。
- 前記量が前記IL−10薬の少なくともEC60の平均IL−10血清中トラフ濃度を達成するのに十分である、請求項27に記載の方法。
- 前記量が前記IL−10薬の少なくともEC70の平均IL−10血清中トラフ濃度を達成するのに十分である、請求項27に記載の方法。
- 前記量が前記IL−10薬の少なくともEC80の平均IL−10血清中トラフ濃度を達成するのに十分である、請求項27に記載の方法。
- 前記量が前記IL−10薬の少なくともEC90の平均IL−10血清中トラフ濃度を達成するのに十分である、請求項27に記載の方法。
- 前記IL−10薬が成熟ヒトIL−10である、請求項1〜31のいずれか一項に記載の方法。
- 前記IL−10薬が成熟ヒトIL−10の変異体であり、及び前記変異体が前記成熟ヒトIL−10と同等の活性を示す、請求項1〜31のいずれか一項に記載の方法。
- 前記疾患、障害または状態が増殖性疾患である、請求項1〜33のいずれか一項に記載の方法。
- 前記増殖性疾患が癌である、請求項34に記載の方法。
- 前記癌が固形腫瘍または血液障害である、請求項35に記載の方法。
- 前記疾患、障害もしくは状態が免疫性または炎症性障害である、請求項1〜33のいずれか一項に記載の方法。
- 前記免疫性または炎症性障害が、炎症性腸疾患、乾癬、リウマチ性関節炎、多発性硬化症、及びアルツハイマー病からなる群から選択される、請求項37に記載の方法。
- 前記疾患、障害もしくは状態が血栓症または血栓状態である、請求項1〜33のいずれか一項に記載の方法。
- 前記疾患、障害または状態が線維性障害である、請求項1〜33のいずれか一項に記載の方法。
- 前記疾患、障害または状態がウイルス性障害である、請求項1〜33のいずれか一項に記載の方法。
- 前記ウイルス性障害が、ヒト免疫不全ウイルス、B型肝炎ウイルス、C型肝炎ウイルス、及びサイトメガロウイルスからなる群から選択される、請求項41に記載の方法。
- 前記疾患、障害または状態が心血管障害である、請求項1〜33のいずれかに記載の方法。
- 前記心血管障害がアテローム性動脈硬化症である、請求項43に記載の方法。
- 前記対象が高いコレステロール値を有する、請求項43または44に記載の方法。
- 前記IL−10薬が改変IL−10薬を形成するために少なくとも1つの改変を含み、前記改変が前記IL−10薬のアミノ酸配列を変更しない、請求項1〜45のいずれか一項に記載の方法。
- 前記改変IL−10薬がPEG−IL−10薬である、請求項46に記載の方法。
- 前記PEG−IL−10薬が、IL−10の少なくとも1つのサブユニットの少なくとも1つのアミノ酸残基に共有結合する、少なくとも1つのPEG分子を含む、請求項47に記載の方法。
- 前記PEG−IL−10薬がモノPEG化及びジPEG化IL−10の混合物を含む、請求項47または48に記載の方法。
- 前記PEG−IL−10薬のPEG成分が約5kDa〜約20kDaの分子量を有する、請求項47〜49のいずれか一項に記載の方法。
- 前記PEG−IL−10薬のPEG成分が約20kDaより大きい分子量を有する、請求項47〜49のいずれか一項に記載の方法。
- 前記PEG−IL−10薬のPEG成分が少なくとも約30kDの分子量を有する、請求項47〜49のいずれか一項に記載の方法。
- 前記改変IL−10薬がFc融合分子である、請求項46に記載の方法。
- 前記改変IL−10薬が血清アルブミンを含む、請求項46に記載の方法。
- 前記改変IL−10薬がグリコシル化されている、請求項46に記載の方法。
- 前記改変が部位特異的である、請求項46〜55のいずれか一項に記載の方法。
- 前記改変がリンカーを含む、請求項46に記載の方法。
- 前記IL−10薬が少なくとも1日2回対象に投与される、請求項1〜57のいずれか一項に記載の方法。
- 前記IL−10薬が少なくとも1日1回対象に投与される、請求項1〜57のいずれか一項に記載の方法。
- 前記IL−10薬が少なくとも72時間毎に対象に投与される、請求項1〜57のいずれか一項に記載の方法。
- 前記IL−10薬が少なくとも1週間に1回対象に投与される、請求項1〜57のいずれか一項に記載の方法。
- 前記IL−10薬が少なくとも2週間毎に対象に投与される、請求項1〜57のいずれか一項に記載の方法。
- 前記IL−10薬が少なくとも毎月1回対象に投与される、請求項1〜57のいずれか一項に記載の方法。
- 少なくとも1つの追加の予防または治療薬を投与することを更に含む、請求項1〜63のいずれか一項に記載の方法。
- 前記対象がヒトである、請求項1〜64のいずれか一項に記載の方法。
- 前記投与することが非経口注射を含む、請求項1〜65のいずれか一項に記載の方法。
- 前記非経口注射が皮下で行われる、請求項66に記載の方法。
- 前記治療または予防することがCD8+T細胞により媒介される、請求項1〜67のいずれか一項に記載の方法。
- 請求項1〜56のいずれか一項に記載のある量のIL−10薬と、薬学的に許容される希釈剤、担体または賦形剤とを含む、医薬組成物。
- 前記賦形剤が等張性の注射液である、請求項69に記載の医薬組成物。
- 前記組成物がヒトへの投与に好適である、請求項69に記載の医薬組成物。
- 少なくとも1つの追加の予防剤または治療薬を更に含む、請求項69〜71のいずれか一項に記載の医薬組成物。
- 請求項69〜72のいずれか一項に記載の前記医薬組成物を含む、滅菌容器。
- 前記滅菌容器が注射器である、請求項73に記載の減菌容器。
- 請求項73または請求項74に記載の前記滅菌容器を含むキット。
- 少なくとも1つの追加の予防剤または治療剤を含む第2の減菌容器を更に含む、請求項75に記載のキット。
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CN107106655A (zh) | 2017-08-29 |
JP6675394B2 (ja) | 2020-04-01 |
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EP3209320A4 (en) | 2018-07-18 |
US10143726B2 (en) | 2018-12-04 |
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US10653751B2 (en) | 2020-05-19 |
EP3209320B1 (en) | 2023-03-08 |
KR20170084033A (ko) | 2017-07-19 |
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CA2963995A1 (en) | 2016-04-28 |
MX2017004983A (es) | 2017-11-13 |
AU2015336101A1 (en) | 2017-04-20 |
US20170246252A1 (en) | 2017-08-31 |
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