JP6426706B2 - がん処置で使用するためのgla単剤療法 - Google Patents
がん処置で使用するためのgla単剤療法 Download PDFInfo
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- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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Description
(a)式:
(式中、R1、R3、R5およびR6は、C11〜C20アルキルであり、R2およびR4は、C12〜C20アルキルである)
のGLAと、
(b)薬学的に許容される担体または賦形剤と
を含み、抗原を含まない、処置方法を提供する。本明細書に記載される方法の一実施形態において、R1、R3、R5およびR6は、ウンデシルであり、R2およびR4は、トリデシルである。本明細書に記載される方法の別の実施形態において、哺乳動物は、ヒトである。さらなる追加の実施形態において、本組成物は、水性製剤であり、所定の実施形態において、本組成物は、水中油型エマルジョン、油中水型エマルジョン、リポソーム、ミセル製剤、または微粒子の形態である。
(式中、R1、R3、R5およびR6はC11〜C20アルキルであり;R2およびR4はC12〜C20アルキルである。)
のグルコピラノシルリピドA(GLA)化合物またはその薬学的に許容される塩;より具体的な実施形態では、GLAは、R1、R3、R5およびR6がC11〜C14アルキルであり;R2およびR4がC12〜C15アルキルである上記式(Ia)を有し;さらにより具体的な実施形態では、GLAは、R1、R3、R5およびR6がC11アルキルまたはウンデシルであり;R2およびR4がC13アルキルまたはトリデシルである上記式(Ia)を有し;
あるいは、式(Ib):
(式中、L1、L2、L3、L4、L5およびL6は、同一または異なり、独立して、O、NHおよび(CH2)から選択され;L7、L8、L9およびL10は、同一または異なり、任意の出現位置において存在しないか、またはC(=O)のいずれかであることができ;Y1は酸官能基であり;Y2およびY3は、同一または異なり、それぞれ独立して、OH、SHおよび酸官能基から選択され;Y4はOHまたはSHであり;R1、R3、R5およびR6は、同一または異なり、それぞれ独立して、C8〜C13アルキルの群から選択され;そして、R2およびR4は、同一または異なり、それぞれ独立して、C6〜Cl1アルキルの群から選択される。)
のグルコピラノシルリピドA(GLA)化合物またはその薬学的に許容される塩。
(式中、部分A1およびA2は、独立して、水素、ホスフェートおよびリン酸塩からなる群から選択される。)
で記載される。ナトリウムとカリウムは、リン酸塩の例示的な対イオンである。部分R1、R2、R3、R4、R5およびR6は、独立して、C3〜C23で表される3〜23個の炭素を有するヒドロカルビルの群から選択される。追加的に明確にするために、部分が複数のメンバーを有する特定された群「から、独立して、選択される」場合には、最初の部分のために選択されたメンバーは、第二の部分のために選択されるメンバーの選択に、いかなる方法においても、影響を与えまたは制限するものではないと理解すべきであることが、説明されるであろう。R1、R3、R5およびR6が結合する炭素原子は、非対称であり、したがって、RまたはS立体化学のいずれかで存在してもよい。一実施形態では、これらの炭素原子のすべてがR立体化学であり、別の実施形態では、これらの炭素原子のすべてが、S立体化学である。
E2:R1、R3、R5およびR6はC3〜C21アルキルであり、R2およびR4はC5〜C23ヒドロカルビルである。
E3:R1、R3、R5およびR6はC5〜C17アルキルであり、R2およびR4はC7〜C19ヒドロカルビルである。
E4:R1、R3、R5およびR6はC7〜C15アルキルであり、R2およびR4はC9〜C17ヒドロカルビルである。
E5:R1、R3、R5およびR6はC9〜C13アルキルであり、R2およびR4はC11〜C15ヒドロカルビルである。
E6:R1、R3、R5およびR6はC9〜C15アルキルであり、R2およびR4はC11〜C17ヒドロカルビルである。
E7:R1、R3、R5およびR6はC7〜C13アルキルであり、R2およびR4はC9〜C15ヒドロカルビルである。
E8:R1、R3、R5およびR6はC11〜C20アルキルであり、R2およびR4はC12〜C20ヒドロカルビルである。
E9:R1、R3、R5およびR6はC11アルキルであり、R2およびR4はC13ヒドロカルビルである。
E10:R1、R3、R5およびR6はウンデシルであり、R2およびR4はトリデシルである。
実施形態の例では、本明細書に記載のGLA化合物は、0.1〜10μg/用量、もしくは0.1〜20μg/用量、0.1〜30μg/用量、0.1〜40μg/用量、もしくは0.1〜50μg/用量、もしくは1〜20μg/用量、1〜30μg/用量、もしくは1〜40μg/用量、もしくは1〜50μg/用量、もしくは0.2〜5μg/用量の量で、または0.5〜2.5μg/用量の量で、または0.5〜8μg/用量、もしくは0.5〜15μg/用量の量で、組成物中に存在している。用量は、例えば0.5μg/用量、0.6μg/用量、0.7μg/用量、0.8μg/用量、0.9μg/用量、1.0μg/用量、2.0μg/用量、3.0μg/用量、3.5μg/用量、4.0μg/用量、4.5μg/用量、5.0μg/用量、5.5μg/用量、6.0μg/用量、6.5μg/用量、7.0μg/用量、7.5μg/用量、8.0μg/用量、9.0μg/用量、10.0μg/用量、11.0μg/用量、12.0μg/用量、13.0μg/用量、14.0μg/用量、または15.0μg/用量でもよい。用量は、対象の体質量、体面積、重量、血液量、または送達経路に応じて調節し得る。一実施形態では、1ml中GLA2μg、3μg、4μg、5μg、6μg、7μg、8μg、9μg、10μg、11μg、または12μgが腫瘍内に投与される。これに関して、GLAの1ml用量は、腫瘍の複数のゾーン中に同量を注射してもよい。ある種の実施形態では、体重に対してGLAが約0.01μg/kgから約100mg/kg、通常は皮内、腫瘍内、皮下、筋肉内もしくは静脈内経路で、または他の経路により投与されよう。ある種の実施形態では、GLAの投与量は、約0.1μg/kgから約1mg/kgであり、ある種の実施形態では、約0.1μg/kg、0.2μg/kg、0.3μg/kg、0.4μg/kg、0.5μg/kg、0.6μg/kg、0.7μg/kg、0.8μg/kg、0.9μg/kg、1μg/kg、2μg/kg、3μg/kg、4μg/kg、5μg/kg、6μg/kg、7μg/kg、8μg/kg、9μg/kg、10μg/kgから約200μg/kgの範囲にある。投与の回数および頻度がホストの反応に依存することは、当業者には明白であろう。本明細書に記載するように、適正な用量は、患者(例えばヒト)の状態、すなわち病期、全体的健康状態、ならびに年齢、性別および重量、さらに医療当事者になじみの他の要因にも依存し得る。本明細書のどこかで触れたように、本明細書に記載のGLA組成物は抗原を含まない。
1.有効量のGLA含有組成物を投与することを含む、がんに罹っている哺乳動物の処置方法であって、前記組成物は、
(a)式:
(式中、
R1、R3、R5およびR6は、C11〜C20アルキルであり、
R2およびR4は、C12〜C20アルキルである)
のGLAと、
(b)薬学的に許容される担体または賦形剤と
を含み、抗原を含まない、処置方法。
(a)式:
(式中、
R1、R3、R5およびR6は、C11〜C20アルキルであり、
R2およびR4は、C12〜C20アルキルである)
のGLAと、
(b)薬学的に許容される担体または賦形剤と
を含み、抗原を含まない、組成物。
(a)式:
(式中、
R1、R3、R5およびR6は、C11〜C20アルキルであり、
R2およびR4は、C12〜C20アルキルである)
のGLAと、
(b)薬学的に許容される担体または賦形剤と
を含み、抗原を含まない、使用。
(a)式:
(式中、
R1、R3、R5およびR6は、ウンデシルであり、R2およびR4は、トリデシルである)
のGLAと、
(b)薬学的に許容される担体または賦形剤と
を含み、抗原を含まない、処置方法を含む。
本実施例は、マウスB16黒色腫腫瘍モデルにおいて、GLAが生理食塩水処置に比べて、腫瘍の大きさを縮小させ、生存率を高めることに有効であることを示す。
GLA−SE投与がC57BL/6マウスにおけるB16F10腫瘍の増殖を減弱させるかどうかをさらに確認するために、以下に詳細を述べるようなB16モデルを用いて確証実験が行われる。B16足蹠黒色腫モデルは、この分野において定着している。B16黒色腫細胞は黒色であるため、足蹠における腫瘍の増殖が容易に観察される。このモデルは図3に示されているように確立された。簡単に言えば、高用量(1E6)または低用量(1E5)のB16F10細胞が、以下にさらに詳しく述べるようにして、8週齢のC57BL/6J雌マウスの足蹠に注入される。(腫瘍面積が100mm2に達して)マウスが屠殺されるまで、GLA−SE(5μg/2%oil)が3日毎に様々な経路で注射される。
(第−4日):B16F10細胞を培養する;37℃のウォーターバス中で凍結保存された細胞を解凍する;B16F10ストック、1バイアル:B16−F10 ATCC Lot #59123188;細胞を計数し、T225フラスコあたり2〜3E6個の細胞を播種する→37℃、5%CO2でインキュベートする。
マウスB16黒色腫モデルにおけるGLAの制がん作用を確認し、さらに特徴付けるために追加の実験が実施された。
本実施例は、特定のマウス腫瘍モデルにおいて、GLAが溶媒処置に比べ、腫瘍増殖を遅延させることに有効であることを示す。試験された腫瘍モデルは、B16黒色腫、CT26直腸がん、4T1乳がん、およびP815肥満細胞腫であった。
本実施例は、GLAの存在下における特定の免疫チェックポイント阻害剤(CPI)の添加が、溶媒処置に比べて、腫瘍の増殖をさらに遅延させることを示す。
本実施例は、GLAの存在下における抗CD40の添加が、溶媒処置に比べて、腫瘍の増殖をさらに遅延させることを示す。
この実施例は、腫瘍内GLA−SEを投薬した最初のヒト患者からの予備的な所見を記述している。
この実施例は、がんの治療のための抗CTLA4およびリツキシマブ抗体と組み合わせたGLAの効果の調査について記述する。
Claims (19)
- 哺乳動物におけるがんの処置で使用するための有効量のGLA含有組成物であって、
(a)式:
(式中、
R1、R3、R5およびR6は、C11〜C20アルキルであり、
R2およびR4は、C12〜C20アルキルである)
のGLAと、
(b)薬学的に許容される担体または賦形剤と
を含み、抗原を含まない、組成物(ただし、抗原とともに投与するためのものを除く。)。 - R1、R3、R5およびR6が、ウンデシルであり、R2およびR4が、トリデシルである、請求項1に記載の組成物。
- 哺乳動物が、ヒトである、請求項1または2のいずれかに記載の組成物。
- 水性製剤である、請求項1から3のいずれかに記載の組成物。
- 水中油型エマルジョン、油中水型エマルジョン、リポソーム、ミセル製剤、または微粒子の形態である、請求項1から3のいずれかに記載の組成物。
- がんが、固形腫瘍を含む、請求項1から5のいずれかに記載の組成物。
- 固形腫瘍が、癌腫、肉腫またはリンパ腫である、請求項6に記載の組成物。
- 固形腫瘍が、原発性固形腫瘍である、請求項6に記載の組成物。
- 固形腫瘍が、二次性固形腫瘍である、請求項6に記載の組成物。
- がんが、黒色腫、メルケル細胞癌、肺がん、子宮頸がん、卵巣がん、子宮がん、乳がん、肝臓がん、胃がん、前立腺がん、結腸がん、腎臓がん、膀胱がん、脳がん、および膵臓がんからなる群より選択される、請求項1から5のいずれかに記載の組成物。
- 皮下、皮内、筋肉内、腫瘍内、または静脈注射によって投与される、請求項1から10のいずれかに記載の組成物。
- 鼻腔内または肺内に投与される、請求項1から10のいずれかに記載の組成物。
- 1種または複数の追加の治療剤または治療的処置と併用して投与される、請求項1から12のいずれかに記載の組成物。
- 治療剤が、免疫チェックポイント阻害剤である、請求項13に記載の組成物。
- 治療剤が、共刺激経路を活性化する抗体である、請求項13に記載の組成物。
- 抗体が、抗CD40抗体である、請求項15に記載の組成物。
- 治療剤が、がん治療剤である、請求項13に記載の組成物。
- がん治療剤が、タキソテール、カルボプラチン、トラスツズマブ、エピルビシン、シクロホスファミド、シスプラチン、ドセタキセル、ドキソルビシン、エトポシド、5−FU、ゲムシタビン、メトトレキセート、およびパクリタキセル、ミトキサントロン、エポチロンB、上皮成長因子受容体(EGFR)を標的とするモノクローナル抗体7A7.27、ボリノスタット、ロミデプシン、ドコサヘキサエン酸、ボルテゾミブ、シコニンおよび腫瘍溶解性ウイルスからなる群より選択される、請求項17に記載の組成物。
- 1種または複数の追加の治療的処置が、放射線療法である、請求項13に記載の組成物。
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