JP2021518380A - プログラム細胞死リガンド1(pd−l1)に対する高親和性中和モノクローナル抗体、及びその使用 - Google Patents
プログラム細胞死リガンド1(pd−l1)に対する高親和性中和モノクローナル抗体、及びその使用 Download PDFInfo
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- 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
- C07K16/2803—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 immunoglobulin superfamily
- C07K16/2827—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 immunoglobulin superfamily against B7 molecules, e.g. CD80, CD86
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
Abstract
Description
充実性腫瘍を治療するために現在利用可能な治療法は、大部分が、腫瘍増殖及び湿潤領域における、治療に効果的なレベルの化学療法剤を達成することの困難さに依るものである。一般に、治療は手術及び/又は放射線治療及び/又は化学療法をベースにするが、これらの方法では、著しい割合の症例において、満足のいかない結果がもたらされる。したがって、充実性腫瘍を伴う癌治療のために、現在利用可能な治療法を改善すること、及び/又は、上記充実性腫瘍を標的にする新規の治療法を開発することが必要とされていることがはっきりとしている。
本明細書においては、一態様において、PD−L1が媒介する疾患及び障害の治療に使用するのに好適な、PD−L1に向けられる結合分子を開示する。
本化合物、組成物、物品、機器及び/又は方法が開示及び記述される前に、これらは、別段の明示がなければ、特定の合成方法若しくは特定の組み換えバイオテクノロジー法に、又は別段の明示がなければ、特定の試薬に限定されるものではなく、それ故、当然、変形し得ることを理解されたい。また、本明細書で使用される用語は、特定の実施形態のみを説明するためのものであり、限定することを意図するものではないことも理解されたい。
明細書及び添付の特許請求の範囲において使用される場合、単数形「a」、「an」及び「the」は、文脈からそうでないことが明確に示されていない限り、複数の指示対象を含む。このため、例えば、「薬学的担体(a pharmaceutical carrier)」という表記は、2つ以上のこのような担体の混合物などを含む。
開示された組成物を作製するために使用されるコンポーネントは、本明細書に開示された方法の中で使用される組成物自体と同様に開示されている。これら及び他の材料は、本明細書に開示されており、これらの材料の組み合わせ、サブセット、相互作用、群などが開示されているとき、これらの合成物の、それぞれの様々な、個別の及び集合的な、組み合わせ及び並べ替えへの具体的な言及は、明示的に開示されていないことがあるが、それぞれが本明細書において具体的に企図され、記載されていることが理解される。例えば、具体的な抗PD−L1抗体が開示されて論じられ、抗PD−L1抗体を含む多数の分子を作製可能な多くの変更が論じられる場合、特に反対の指摘がされない限り、抗PD−L1抗体のあらゆる全ての可能な組み合わせ及び並べ替え、並びに変形例が具体的に想到される。したがって、分子D、E及びFのクラスのみならず分子A、B及びCのクラスが開示され、かつ、組み合わせ分子、A−Dの例が開示されている場合、それぞれが個別に記載されていないときであっても、それぞれが個別に、かつ集合的に考慮される。つまり、組み合わせA−E、A−F、B−D、B−E、B−F、C−D、C−E及びC−Fが開示されているものとみなされる。同様に、これらのあらゆるサブセット又は組み合わせもまた開示されている。したがって、例えば、A−E、B−F及びC−Eのサブグループは、開示されているものとみなされる。この考え方は、開示された組成物を生産かつ使用する方法中の工程を含むがこれらに限定されない、本出願の全ての態様に適用される。したがって、実行可能な様々な追加の工程が存在する場合、これらの追加の工程のそれぞれは、開示された方法の任意の特定の実施形態又は実施形態の組み合わせによって実行されることができることが理解される。
本明細書で使用する場合、用語「結合分子」とは、モノクローナル抗体、ポリクローナル抗体、キメラ抗体、ヒト化又はヒト抗体を含むインタクトな免疫グロブリン、並びに、免疫グロブリンの結合パートナーに特異的に結合するためのインタクトな免疫グロブリンと競合する免疫グロブリンの断片を含む抗原結合及び/又は可変ドメインを含む抗体断片及び機能性多様体、例えばPD−L1を意味する。
一態様において、開示したPD−L1結合分子(例えば、中和抗PD−L1抗体などの、中和PD−L1結合分子が挙げられるがこれに限定されない)は、表1に示す可変ドメインCDRのうちの1つ以上を含む。
及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号5、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号6、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号7、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号8、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号5、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号6、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号7、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号3、配列番号8、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号5、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号6、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号7、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号8、及び配列番号9に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号5、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号6、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;配列番号4、配列番号7、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDR;又は、配列番号4、配列番号8、及び配列番号10に記載の重鎖可変ドメインCDR、並びに、配列番号11;配列番号12;配列番号13;配列番号14;配列番号15;配列番号11、及び配列番号13;配列番号11、及び配列番号14;配列番号11、及び配列番号15;配列番号12、及び配列番号13;配列番号12、及び配列番号14;配列番号12、及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、
及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載の軽鎖可変ドメインCDRを含むことができる。一態様において、PD−L1結合分子(例えば、中和抗PD−L1抗体などの中和PD−L1結合分子を含むがこれに限定されない)は、配列番号1に記載の可変重鎖ドメイン、及び配列番号2に記載の可変軽鎖ドメインを含むことができる。
本明細書にて開示するとおり、結合分子、抗体、断片、及び多様体は、例えばPD−L1などの抗原標的に特異的に結合可能である。
モノクローナル抗体は、Kohler and Milstein,Nature,256:495(1975)or Harlow and Lane.Antibodies,A Laboratory Manual.Cold Spring Harbor Publications,New York,(1988)に記載されているものなどの、ハイブリドーマ法を使用して調製することができる。ハイブリドーマ法では、免疫化剤に特異的に結合する抗体を産生する、又は産生することができるリンパ球を誘発するために、通例、マウス又はその他の適切な宿主動物が免疫化剤で免疫化される。あるいは、リンパ球は、インビトロで免疫化され得る。免疫化剤はPD−L1を含むのが好ましい。従来、モノクローナル抗体の産生は、免疫原として使用するための精製タンパク質又はペプチドの入手可能性に左右されてきた。より近年では、DNAベースの免疫化が、強力な免疫応答を誘発し、モノクローナル抗体を産生するための方法として有望であることが示されている。このアプローチにおいて、ヒトIgG1との融合タンパク質として発現するPD−L1の一部をコードするDNAを、当該技術分野において既知の方法に従い、かつ実施例に記載のとおりに宿主動物に注入する、DNAベースの免疫化(例えば、Kilpatrick KE,et al.Gene gun delivered DNA−based immunizations mediate rapid production of murine monoclonal antibodies to the Flt−3 receptor.Hybridoma.1998 Dec;17(6):569−76;Kilpatrick KE et al.High−affinity monoclonal antibodies to PED/PEA−15 generated using 5 microg of DNA.Hybridoma.2000 Aug;19(4):297−302;抗体産生の方法については、全てが参照により本明細書に組み込まれている)を使用することができる。
本明細書にて開示した遺伝子及びタンパク質の、任意の既知の多様体及び誘導体、又は生じ得る多様体及び誘導体を定義する1つの方法は、特定の既知の配列に対する相同性の観点から、多様体及び誘導体を定義することによるものであると理解されている。例えば、表4は、PD−L1重鎖可変ドメインの具体的な配列について記載している。記載する配列に対して、少なくとも70、71、72、73、74、75、76、77、78、79、80、81、82、83、84、85、86、87、88、89、90、91、92、93、94、95、96、97、98、99%の相同性を有する、本明細書で開示したこれらの多様体、並びに他の遺伝子及びタンパク質を具体的に開示する。当業者は、2つのタンパク質又は核酸、例えば遺伝子の相同性の測定方法を速やかに理解する。例えば、相同性が最も高いレベルになるように2つの配列をアラインメントした後に、相同性を計算することができる。
a)タンパク質多様体
本明細書で論ずるとおり、既知であり、本明細書にて想到される、本明細書にて開示したPD−L1結合分子及びPD−L1結合CDR、並びに重鎖及び軽鎖可変領域の様々な多様体が存在する。加えて、既知の機能性株の多様体に対しては、開示した方法及び組成物にても機能する、PD−L1結合分子及びPD−L1結合CDR、並びに重鎖及び軽鎖可変領域の誘導体が存在する。タンパク質多様体及び誘導体は、当業者には十分に理解されており、アミノ酸配列修飾を伴うことができる。例えば、アミノ酸配列修飾は通常、3分類:置換多様体、挿入多様体、又は欠失多様体の1つ以上に分類される。本明細書で使用する場合、「挿入」とは、親(多くの場合、天然に存在する)分子と比較して、それぞれ、1つ以上のアミノ酸又はヌクレオチド残基の付加をもたらす、アミノ酸又はヌクレオチド配列における変化を意味する。挿入としては、アミノ及び/又はカルボキシル末端融合、並びに単一又は複数のアミノ酸残基の配列内挿入が挙げられる。挿入は通常、アミノ又はカルボキシル末端融合の挿入よりも小さく、例えば、1〜4個の残基のオーダーである。実施例に記載されるものなどの免疫原性融合タンパク質誘導体は、インビトロでの架橋により、又は、融合体をコードするDNAにより形質転換した組み換え細胞培養物により、標的配列に対して免疫原性を付与するのに十分大きなポリペプチドを融合することにより作製される。欠失は、タンパク質配列からの1つ以上のアミノ酸残基の除去を特徴とする。典型的には、約2〜6個以下の残基が、タンパク質分子内の任意の1つの部位にて欠失される。これらの多様体は通常、タンパク質をコードするDNA内のヌクレオチドの、部位特異的突然変異誘発により調製されることにより、多様体をコードするDNAが作製され、その後、組み換え細胞培養物内でDNAを発現する。既知の配列を有するDNAの所定の部位において、置換変異を作製する技術(例えばM13プライマー突然変異誘発及びPCR突然変異誘発)が周知である。アミノ酸置換基は典型的には単一の残基であるが、一度に多数の異なる位置で発生することができる。挿入は通常、約1〜10個のアミノ酸残基のオーダーであり、欠失は約1〜30個の残基の範囲である。欠失又は挿入は、好ましくは隣接する対で行われる、すなわち、2個の残基の欠失、又は2個の残基の挿入である。置換、欠失、挿入、又はこれらの任意の組み合わせにより、最終の構成物にたどり着くことができる。変異は、リーディングフレームの外の配列を置き換えてはならず、二次mRNA構造体を作製し得る相補領域を作製しないのが好ましい。置換多様体は、少なくとも1つの残基が除去され、その位置に異なる残基が挿入されている多様体である。このような置換は通常、以下の表5に従い行われ、保存的置換と称される。
rsGFP;S65A;S65C;S65L;S65T;Sapphire GFP;SBFI;Serotonin;Sevron Brilliant Red 2B;Sevron Brilliant Red 4G;Sevron I Brilliant Red B;Sevron Orange;Sevron Yellow L;sgBFPTM(超成長BFP);sgGFPTM(超成長GFP);SITS(プリムリン;スチルベンイソチオスルホン酸);SNAFLカルセリン;SNAFL−1;SNAFL−2;SNARF calcein;SNARF1;Sodium Green;SpectrumAqua;SpectrumGreen;SpectrumOrange;Spectrum Red;SPQ(6−メトキシ−N−(3スルホプロピル)キノリニウム);スチルベン;スルホローダミンB及びC;スルホローダミンエクストラ;SYTO 11;SYTO 12;SYTO 13;SYTO 14;SYTO 15;SYTO 16;SYTO 17;SYTO 18;SYTO 20;SYTO 21;SYTO 22;SYTO 23;SYTO 24;SYTO 25;SYTO 40;SYTO 41;SYTO 42;SYTO 43;SYTO 44;SYTO 45;SYTO 59;SYTO 60;SYTO 61;SYTO 62;SYTO 63;SYTO 64;SYTO 80;SYTO 81;SYTO 82;SYTO 83;SYTO 84;SYTO 85;SYTOX Blue;SYTOX Green;SYTOX Orange;テトラサイクリン;テトラメチルローダミン(TRITC);Texas RedTM;Texas Red−XTMコンジュゲート;チアジカルボシアニン(DiSC3);Thiazine Red R;Thiazole Orange;Thioflavin 5;Thioflavin S;Thioflavin TON;Thiolyte;Thiozole Orange;Tinopol CBS(Calcofluor White);TIER;TO−PRO−1;TO−PRO−3;TO−PRO−5;TOTO−1;TOTO−3;TriColor(PE−Cy5);TRITCテトラメチルローダミンイソチオシアネート;True Blue;Tru Red;Ultralite;Uranine B;Uvitex SFC;wtGFP;WW 781;X−ローダミン;XRITC;Xylene Orange;Y66F;Y66H;Y66W;YellowGFP;YFP;YO−PRO−1;YO−PRO3;YOYO−1;YOYO−3;Sybr Green;チアゾールオレンジ(インターキレート染料);量子ドットなどの半導体ナノ粒子;若しくはケージ状フルオロフォア(光若しくは他の電磁エネルギー源により活性化可能である)、又はこれらの組み合わせが挙げられるが、これらに限定されない。
上述のとおり、組成物を、薬学的に許容される担体(薬学的に許容される賦形剤とも、本明細書では呼ばれる)中で、インビボ投与することもできる。「薬学的に許容される」によって、生物学的に又はその他不活性な材料が意味され、すなわち、材料は、いかなる望ましくない生物学的作用も引き起こすことなく、又は材料がその中に含まれている薬学的組成物のいずれの他のコンポーネントとも有害な形で相互作用することなく、核酸又はベクターとともに、対象に投与され得る。担体は、当業者に周知であるとおり、当然、活性成分のいずれの分解をも最小化するように、及び対象中のいずれの有害な副作用をも最小化するように選択されるであろう。したがって、一態様では、本明細書にて開示したPD−L1結合分子のいずれかを含む薬学的組成物を、本明細書にて開示する。
抗体を含む組成物は、薬学的に許容される担体と組み合わせて治療的に使用することができる。
組成物を投与するための有効用量及びスケジュールは実験により決定され得、このような決定を行うことは本分野における技術の範疇である。組成物の投与のための用量範囲は、障害の症状がもたらされる所望の効果を生じるのに十分大きな投与量範囲である。用量は、例えば不必要な交差反応、アナフィラキシー型反応等の副作用を引き起こす程多いものであってはならない。一般的に、用量は、年齢、状態、性別、患者中の疾患の程度、投与経路、又は、他の薬物がそのレジメンに含まれているか否かと共に変化し、当業者により決定することができる。用量は、任意の禁忌(counterindicatons)の場合には、個別の医師により調整することができる。用量は変えることができ、1日又は数日間で毎日、1回以上の用量投与で投与されることができる。手引きは、所与の部類の医薬製品に対する適切な用量に関する文献に見出すことができる。例えば、抗体に対する適切な用量を選択する上での手引きは、抗体の治療的使用に関する文献、例えば、Handbook of Monoclonal Antibodies,,Ferrone et al.,eds.,Noges Publications,Park Ridge,N.J.,(1985)ch.22 and pp.303−357;Smith et al.,Antibodies in Human Diagnosis and Therapy,Haber et al.,eds.,Raven Press,New York(1977)pp.365−389中に見出すことができる。単独で使用される抗体の典型的な一日投与量は、上に挙げられている要素に応じて、1日当たり約1μg/kg〜最大100mg/kg体重又はそれを超える範囲であり得る。
本明細書で使用する場合、用語「治療」、「治療する」、又は「治療すること」とは、対象における疾患又は状態(例えば、炎症性の状態又は癌など)の1つ以上の影響を低減させる方法を意味する。したがって、開示した方法において、「治療」とは、確立された感染症、又は感染症の症状の重症度の、10%、20%、30%、40%、50%、60%、70%、80%、90%、又は100%の低減を意味することができる。例えば、炎症性の状態又は癌の治療方法は、対照と比較して、対象における状態又は癌の1つ以上の症状の10%の低減が存在する場合、治療であるとみなされる。したがって、低減とは、生来のレベル、又は対照レベルと比較して、10%、20%、30%、40%、50%、60%、70%、80%、90%、100%、又は10%〜100%の間の、任意の割合での低減であることができる。「治療」とは、必ずしも状態若しくは疾患、又は状態若しくは疾患の症状の、治癒又は完全な消失を意味しないと理解されている。本明細書で論じる「治療」は、予防的又は治療的であることができることが理解され、本明細書において想到される。したがって、一態様は、対象にPD−L1結合分子を投与することを含む、対象における炎症性の疾患又は状態の重症度の治療又は低減方法である。対象にPD−L1結合分子を投与することを含む、対象における炎症性の疾患又は状態の開始の予防又は低減方法もまた開示されている。
Inotuzumab Ozogamicin,Interferon Alfa−2b,Recombinant,Interleukin−2(Aldesleukin),Intron A(Recombinant Interferon Alfa−2b),Iodine I 131 Tositumomab and Tositumomab,Ipilimumab,Iressa(Gefitinib),Irinotecan Hydrochloride,Irinotecan Hydrochloride Liposome,Istodax(Romidepsin),Ixabepilone,Ixazomib Citrate,Ixempra(Ixabepilone),Jakafi(Ruxolitinib Phosphate),JEB,Jevtana(Cabazitaxel),Kadcyla(Ado−Trastuzumab Emtansine),Keoxifene(Raloxifene Hydrochloride),Kepivance(Palifermin),Keytruda(Pembrolizumab),Kisqali(Ribociclib),Kymriah(Tisagenlecleucel),Kyprolis(Carfilzomib),Lanreotide Acetate,Lapatinib Ditosylate,Lartruvo(Olaratumab),Lenalidomide,Lenvatinib Mesylate,Lenvima(Lenvatinib Mesylate),Letrozole,Leucovorin Calcium,Leukeran(Chlorambucil),Leuprolide Acetate,Leustatin(Cladribine),Levulan(Aminolevulinic Acid),Linfolizin(Chlorambucil),LipoDox(Doxorubicin Hydrochloride Liposome),Lomustine,Lonsurf(Trifluridine and Tipiracil Hydrochloride),Lupron(Leuprolide Acetate),Lupron Depot(Leuprolide Acetate),Lupron Depot−Ped(Leuprolide Acetate),Lynparza(Olaparib),Marqibo(Vincristine Sulfate Liposome),Matulane(Procarbazine Hydrochloride),Mechlorethamine Hydrochloride,Megestrol Acetate,Mekinist(Trametinib),Melphalan,Melphalan Hydrochloride,Mercaptopurine,Mesna,Mesnex(Mesna),Methazolastone(Temozolomide),Methotrexate,Methotrexate LPF(Methotrexate),Methylnaltrexone Bromide,Mexate(Methotrexate),Mexate−AQ(Methotrexate),Midostaurin,Mitomycin C,Mitoxantrone Hydrochloride,Mitozytrex(Mitomycin C),MOPP,Mozobil(Plerixafor),Mustargen(Mechlorethamine Hydrochloride),Mutamycin(Mitomycin C),Myleran(Busulfan),Mylosar(Azacitidine),Mylotarg(Gemtuzumab Ozogamicin),Nanoparticle Paclitaxel(Paclitaxel Albumin−stabilized Nanoparticle Formulation),Navelbine(Vinorelbine Tartrate),Necitumumab,Nelarabine,Neosar(Cyclophosphamide),Neratinib Maleate,Nerlynx(Neratinib Maleate),Netupitant and Palonosetron Hydrochloride,Neulasta(Pegfilgrastim),Neupogen(Filgrastim),Nexavar(Sorafenib Tosylate),Nilandron(Nilutamide),Nilotinib,Nilutamide,Ninlaro(Ixazomib Citrate),Niraparib Tosylate Monohydrate,Nivolumab,Nolvadex(Tamoxifen Citrate),Nplate(Romiplostim),Obinutuzumab,Odomzo(Sonidegib),OEPA,Ofatumumab,OFF,Olaparib,Olaratumab,Omacetaxine Mepesuccinate,Oncaspar(Pegaspargase),Ondansetron Hydrochloride,Onivyde(Irinotecan Hydrochloride Liposome),Ontak(Denileukin Diftitox),Opdivo(Nivolumab),OPPA,Osimertinib,Oxaliplatin,Paclitaxel,Paclitaxel Albumin−stabilized Nanoparticle Formulation,PAD,Palbociclib,Palifermin,Palonosetron Hydrochloride,Palonosetron Hydrochloride and Netupitant,Pamidronate Disodium,Panitumumab,Panobinostat,Paraplat(Carboplatin),Paraplatin(Carboplatin),Pazopanib Hydrochloride,PCV,PEB,Pegaspargase,Pegfilgrastim,Peginterferon Alfa−2b,PEG−Intron(Peginterferon Alfa−2b),Pembrolizumab,Pemetrexed Disodium,Perjeta(Pertuzumab),Pertuzumab,Platinol(Cisplatin),Platinol−AQ(Cisplatin),Plerixafor,Pomalidomide,Pomalyst(Pomalidomide),Ponatinib Hydrochloride,Portrazza(Necitumumab),Pralatrexate,Prednisone,Procarbazine Hydrochloride,Proleukin(Aldesleukin),Prolia(Denosumab),Promacta(Eltrombopag Olamine),Propranolol Hydrochloride,Provenge(Sipuleucel−T),Purinethol(Mercaptopurine),Purixan(Mercaptopurine),Radium 223 Dichloride,Raloxifene Hydrochloride,Ramucirumab,Rasburicase,R−CHOP,R−CVP,Recombinant Human Papillomavirus(HPV)Bivalent Vaccine,Recombinant Human Papillomavirus(HPV)Nonavalent Vaccine,Recombinant Human Papillomavirus(HPV)Quadrivalent Vaccine,Recombinant Interferon Alfa−2b,Regorafenib,Relistor(Methylnaltrexone Bromide),R−EPOCH,Revlimid(Lenalidomide),Rheumatrex(Methotrexate),Ribociclib,R−ICE,Rituxan(Rituximab),Rituxan Hycela(Rituximab and Hyaluronidase Human),Rituximab,Rituximab and,Hyaluronidase Human,,ロラピタント塩酸塩,Romidepsin,Romiplostim,Rubidomycin(Daunorubicin Hydrochloride),Rubraca(Rucaparib Camsylate),Rucaparib Camsylate,Ruxolitinib Phosphate,Rydapt(Midostaurin),Sclerosol Intrapleural Aerosol(Talc),Siltuximab,Sipuleucel−T,Somatuline Depot(Lanreotide Acetate),Sonidegib,Sorafenib Tosylate,Sprycel(Dasatinib),STANFORD V,Sterile Talc Powder(Talc),Steritalc(Talc),Stivarga(Regorafenib),Sunitinib Malate,Sutent(Sunitinib Malate),Sylatron(Peginterferon Alfa−2b),Sylvant(Siltuximab),Synribo(Omacetaxine Mepesuccinate),Tabloid(Thioguanine),TAC,Tafinlar(Dabrafenib),Tagrisso(Osimertinib),Talc,Talimogene Laherparepvec,Tamoxifen Citrate,Tarabine PFS(Cytarabine),Tarceva(Erlotinib Hydrochloride),Targretin(Bexarotene),Tasigna(Nilotinib),Taxol(Paclitaxel),Taxotere(Docetaxel),Tecentriq,(Atezolizumab),Temodar(Temozolomide),Temozolomide,Temsirolimus,Thalidomide,Thalomid(Thalidomide),Thioguanine,Thiotepa,Tisagenlecleucel,Tolak(Fluorouracil−−Topical),Topotecan Hydrochloride,Toremifene,Torisel(Temsirolimus),Tositumomab and Iodine I 131 Tositumomab,Totect(Dexrazoxane Hydrochloride),TPF,Trabectedin,Trametinib,Trastuzumab,Treanda(Bendamustine Hydrochloride),Trifluridine and Tipiracil Hydrochloride,Trisenox(Arsenic Trioxide),Tykerb(Lapatinib Ditosylate),Unituxin(Dinutuximab),Uridine Triacetate,VAC,Vandetanib,VAMP,Varubi(Rolapitant Hydrochloride),Vectibix(Panitumumab),VeIP,Velban(Vinblastine Sulfate),Velcade(Bortezomib),
Velsar(Vinblastine Sulfate),Vemurafenib,
Venclexta(Venetoclax),Venetoclax,Verzenio(Abemaciclib),Viadur(Leuprolide Acetate),Vidaza(Azacitidine),Vinblastine Sulfate,Vincasar PFS(Vincristine Sulfate),Vincristine Sulfate,Vincristine Sulfate Liposome,Vinorelbine Tartrate,VIP,Vismodegib,Vistogard(Uridine Triacetate),Voraxaze(Glucarpidase),Vorinostat,Votrient(Pazopanib Hydrochloride),Vyxeos(Daunorubicin Hydrochloride and Cytarabine Liposome),Wellcovorin(Leucovorin Calcium),Xalkori(Crizotinib),Xeloda(Capecitabine),XELIRI,XELOX,Xgeva(Denosumab),Xofigo(Radium 223 Dichloride),Xtandi(Enzalutamide),Yervoy(Ipilimumab),Yondelis(Trabectedin),Zaltrap(Ziv−Aflibercept),Zarxio(Filgrastim),Zejula(Niraparib Tosylate Monohydrate),Zelboraf(Vemurafenib),Zevalin(Ibritumomab Tiuxetan),Zinecard(Dexrazoxane Hydrochloride),Ziv−Aflibercept,Zofran(Ondansetron Hydrochloride),Zoladex(Goserelin Acetate),Zoledronic Acid,Zolinza(Vorinostat),Zometa(Zoledronic Acid),Zydelig(Idelalisib),Zykadia(Ceritinib),及び/又はZytiga(Abiraterone Acetate)を含むがこれらに限定されない、当該技術分野において公知の任意の抗癌剤を含むことができる。
以下の実施例は、本明細書の特許請求の範囲に記載された化合物、組成物、物品、装置及び/又は方法がどのように作製され及び評価されるかの完全な開示及び記述を当業者に提供するために提示されており、純粋に例示的であることが意図されており、本開示を限定することは意図されていない。数字(例えば、量、温度など)に関して正確性を確保するための努力がなされてきたが、いくつかの誤差及び偏差が考慮されるべきである。特に明記しない限り、部は、重量部であり、温度は、℃単位又は周囲温度であり、圧力は、大気圧又は大気圧に近い。
マウスIg−α、マウスIg−β、及びヒトインターロイキン6を過剰発現するトランスジェニックマウスに、組み換えヒトPD−L1(R&D Systems)を2週間の間隔で腹腔内投与した。血清ELISAにより測定した、大きな免疫応答をマウントした後で、リンパ節、脾臓、及び骨髄細胞を回収し、B細胞表面を発現するIgMアイソタイプ抗体を磁気ビーズで取り出し、残った細胞を、MoFlo Fluorescence−Activated Cell Sorterを使用して、PD−L1への結合能でソートした。
配列番号1:ABM101.11重鎖
QVQLVQSGpEVKKPGASVKVSCKaSGYTFTENSMHWVrQSHGKsLEWmGGINPNNGGTSYNQKFKGkvTmTTDKSTSTAYMELRSLTSDDTAVYYCARPYYYGYREDYFDYWGQGTTLTVSS
配列番号2:ABM101.11軽鎖
EIVMTQSPGTLSLSPGERATLSCRASSSVSYMYWYQQKPGQAPRPLIYLTSNLASGIPDRFSGSGSGTDYTLTISRLEPEDFAVYYCQQWSSYPPTFGQGTKVEIKR
II.
Claims (16)
- 配列番号3、配列番号4、配列番号5、配列番号6、配列番号7、配列番号8、配列番号9、又は配列番号10に記載の少なくとも1つのCDRを含む重鎖可変ドメインを含む、単離されたPD−L1結合分子。
- 前記重鎖可変ドメインを含む結合分子が、配列番号3及び配列番号5;配列番号3及び配列番号6;配列番号3及び配列番号7;配列番号3及び配列番号8;配列番号3及び配列番号9;配列番号3及び配列番号10;配列番号4及び配列番号5;配列番号4及び配列番号6;配列番号4及び配列番号7;配列番号4及び配列番号8;配列番号4及び配列番号9;配列番号4及び配列番号10;配列番号3、配列番号5、及び配列番号9;配列番号3、配列番号6、及び配列番号9;配列番号3、配列番号7、及び配列番号9;配列番号3、配列番号8、及び配列番号9;配列番号3、配列番号5、及び配列番号10;配列番号3、配列番号6、及び配列番号10;配列番号3、配列番号7、及び配列番号10;配列番号3、配列番号8、及び配列番号10;配列番号4、配列番号5、及び配列番号9;配列番号4、配列番号6、及び配列番号9;配列番号4、配列番号7、及び配列番号9;配列番号4、配列番号8、及び配列番号9;配列番号4、配列番号5、及び配列番号10;配列番号4、配列番号6、及び配列番号10;配列番号4、配列番号7、及び配列番号10;又は配列番号4、配列番号8、及び配列番号10に記載のCDRを含む、請求項1に記載の単離されたPD−L1結合分子。
- 配列番号1に記載の可変重ドメインを含む、請求項2に記載の単離されたPD−L1結合分子。
- 配列番号11、配列番号12、配列番号13、配列番号14、又は配列番号15に記載の少なくとも1つのCDRを含む軽鎖可変ドメインを更に含む、請求項1に記載の単離されたPD−L1結合分子。
- 前記軽鎖可変ドメインを含む結合分子が、配列番号11及び配列番号13;配列番号11及び配列番号14;配列番号11及び配列番号15;配列番号12及び配列番号13;配列番号12及び配列番号14;配列番号12及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載のCDRを含む、請求項4に記載の単離されたPD−L1結合分子。
- 配列番号2に記載の可変軽ドメインを含む、請求項5に記載の単離されたPD−L1結合分子。
- 前記結合分子が、配列番号1に記載の可変重ドメインを含む、請求項6に記載の単離されたPD−L1結合分子。
- 配列番号11、配列番号12、配列番号13、配列番号14、又は配列番号15に記載の少なくとも1つのCDRを含む軽鎖可変ドメインを含む、単離されたPD−L1結合分子。
- 前記重鎖可変ドメインを含む結合分子が、配列番号11及び配列番号13;配列番号11及び配列番号14;配列番号11及び配列番号15;配列番号12及び配列番号13;配列番号12及び配列番号14;配列番号12及び配列番号15;配列番号11、配列番号13、及び配列番号14;配列番号11、配列番号13、及び配列番号15;配列番号12、配列番号13、及び配列番号14;又は配列番号12、配列番号13、及び配列番号15に記載のCDRを含む、請求項8に記載の単離されたPD−L1結合分子。
- 前記結合分子が抗体である、請求項1〜9のいずれか一項に記載の単離されたPD−L1結合分子。
- 前記結合分子が免疫毒素である、請求項1〜9のいずれか一項に記載の単離されたPD−L1結合分子。
- 配列番号1に記載の重鎖可変領域を含有する、又は含む、抗体。
- 配列番号2に記載の軽鎖可変領域を含有する、又は含む、抗体。
- 配列番号1に記載の重鎖可変領域及び配列番号2に記載の軽鎖可変領域の両方を含有する、又は含む、抗体。
- 前記抗体が中和抗体である、請求項10に記載の単離されたPD−L1結合分子、又は請求項12〜14のいずれか一項に記載の抗体。
- ある量の、請求項1〜11若しくは15に記載のPD−L1結合分子又は請求項12〜15に記載の抗体のいずれかを投与することによる、癌、又は細胞増殖の癌関連病の治療方法又は予防方法。
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