JPWO2021225961A5 - - Google Patents
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- JPWO2021225961A5 JPWO2021225961A5 JP2022567339A JP2022567339A JPWO2021225961A5 JP WO2021225961 A5 JPWO2021225961 A5 JP WO2021225961A5 JP 2022567339 A JP2022567339 A JP 2022567339A JP 2022567339 A JP2022567339 A JP 2022567339A JP WO2021225961 A5 JPWO2021225961 A5 JP WO2021225961A5
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- 229920001184 polypeptide Polymers 0.000 claims description 81
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 81
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 81
- 125000003275 alpha amino acid group Chemical group 0.000 claims description 54
- 241000282465 Canis Species 0.000 claims description 52
- 238000000034 method Methods 0.000 claims description 18
- 210000001744 T-lymphocyte Anatomy 0.000 claims description 10
- 206010028980 Neoplasm Diseases 0.000 claims description 9
- 201000011510 cancer Diseases 0.000 claims description 9
- 210000004027 cell Anatomy 0.000 claims description 6
- 238000000338 in vitro Methods 0.000 claims description 6
- 102000039446 nucleic acids Human genes 0.000 claims description 6
- 108020004707 nucleic acids Proteins 0.000 claims description 6
- 150000007523 nucleic acids Chemical class 0.000 claims description 6
- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims description 4
- 102000008096 B7-H1 Antigen Human genes 0.000 claims description 4
- 108010074708 B7-H1 Antigen Proteins 0.000 claims description 4
- 238000011319 anticancer therapy Methods 0.000 claims description 4
- 238000001727 in vivo Methods 0.000 claims description 4
- 239000008194 pharmaceutical composition Substances 0.000 claims description 4
- 201000003076 Angiosarcoma Diseases 0.000 claims description 2
- 206010006187 Breast cancer Diseases 0.000 claims description 2
- 208000026310 Breast neoplasm Diseases 0.000 claims description 2
- 201000009030 Carcinoma Diseases 0.000 claims description 2
- 208000001258 Hemangiosarcoma Diseases 0.000 claims description 2
- 206010025323 Lymphomas Diseases 0.000 claims description 2
- 208000006265 Renal cell carcinoma Diseases 0.000 claims description 2
- 230000003213 activating effect Effects 0.000 claims description 2
- 150000001413 amino acids Chemical class 0.000 claims description 2
- 239000005557 antagonist Substances 0.000 claims description 2
- 239000002246 antineoplastic agent Substances 0.000 claims description 2
- 230000004071 biological effect Effects 0.000 claims description 2
- 239000000539 dimer Substances 0.000 claims description 2
- 210000003630 histaminocyte Anatomy 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 201000001441 melanoma Diseases 0.000 claims description 2
- 208000002154 non-small cell lung carcinoma Diseases 0.000 claims description 2
- 201000008968 osteosarcoma Diseases 0.000 claims description 2
- 230000004962 physiological condition Effects 0.000 claims description 2
- 238000001959 radiotherapy Methods 0.000 claims description 2
- 238000002271 resection Methods 0.000 claims description 2
- 238000006467 substitution reaction Methods 0.000 claims description 2
- 238000002560 therapeutic procedure Methods 0.000 claims description 2
- 239000004308 thiabendazole Substances 0.000 claims description 2
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims description 2
- 102100040678 Programmed cell death protein 1 Human genes 0.000 description 16
- 101710089372 Programmed cell death protein 1 Proteins 0.000 description 16
- 239000003937 drug carrier Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
Description
本明細書に示される実施形態は、イヌＰＤ－１の活性を調節するイヌＰＤ－１結合性ポリペプチド、及び癌を治療する様々な方法におけるそれらの使用に関する。
項１
イヌＰＤ－１に結合する少なくとも１つのイヌ化ＶＨＨドメインを含むポリペプチドであって、前記ポリペプチドは、イヌＦｃ領域を含み、かつイヌＰＤ－１に結合する少なくとも１つのＶＨＨドメインは、
ａ）配列番号６のアミノ酸配列を含むＣＤＲ１、配列番号７のアミノ酸配列を含むＣＤＲ２、配列番号８のアミノ酸配列を含むＣＤＲ３、
ｂ）配列番号２２のアミノ酸配列を含むＣＤＲ１、配列番号２３のアミノ酸配列を含むＣＤＲ２、配列番号２４のアミノ酸配列を含むＣＤＲ３、
ｃ）配列番号２５のアミノ酸配列を含むＣＤＲ１、配列番号２６のアミノ酸配列を含むＣＤＲ２、配列番号２７のアミノ酸配列を含むＣＤＲ３、又は、
ｄ）配列番号２８のアミノ酸配列を含むＣＤＲ１、配列番号２９のアミノ酸配列を含むＣＤＲ２、配列番号３０のアミノ酸配列を含むＣＤＲ３、
を含む、ポリペプチド。
項２
イヌＰＤ－１に結合する少なくとも１つのＶＨＨドメインを含むポリペプチドであって、前記ポリペプチドは、イヌＦｃ領域を含み、かつイヌＰＤ－１に結合する少なくとも１つのＶＨＨドメインは、配列番号２～配列番号５から選択されるアミノ酸配列を含む、ポリペプチド。
項３
１つのＶＨＨドメインを含む、項１又は２に記載のポリペプチド。
項４
２つのＶＨＨドメインを含み、前記２つのＶＨＨドメインは、同じ又は異なるものである、項１又は２に記載のポリペプチド。
項５
３つのＶＨＨドメインを含み、前記３つのＶＨＨドメインは、同じ又は異なるものである、項１又は２に記載のポリペプチド。
項６
各ＶＨＨドメインは、イヌＰＤ－１に結合する、項１～５のいずれか一項に記載のポリペプチド。
項７
前記イヌＦｃ領域は、イヌＩｇＧ Ｆｃ領域である、項１～６のいずれか一項に記載のポリペプチド。
項８
前記イヌＦｃ領域は、イヌＩｇＧＢ Ｆｃ領域である、項７に記載のポリペプチド。
項９
Ｋａｂａｔナンバリングによって決定されるＦｃ領域のアミノ酸Ｅ２３３、Ｍ２３４、及びＬ２３５が欠失している、項７又は８に記載のポリペプチド。
項１０
前記Ｆｃ領域は、Ｋａｂａｔナンバリングによって決定されるＤ２６５Ａ及びＮ２９７Ａの置換を含む、項７～９のいずれか一項に記載のポリペプチド。
項１１
前記Ｆｃ領域は、配列番号１９のアミノ酸配列を含む、項１～８のいずれか一項に記載のポリペプチド。
項１２
前記イヌＦｃ領域は、配列番号２０のアミノ酸配列を含む、項１～１０のいずれか一項に記載のポリペプチド。
項１３
イヌＰＤ－１に結合する少なくとも１つのＶＨＨドメインは、配列番号６のアミノ酸配列を含むＣＤＲ１、配列番号７のアミノ酸配列を含むＣＤＲ２、配列番号８のアミノ酸配列を含むＣＤＲ３を含む、項１～１２のいずれか一項に記載のポリペプチド。
項１４
イヌＰＤ－１に結合する少なくとも１つのＶＨＨドメインは、配列番号３のアミノ酸配列を含む、項１～１３のいずれか一項に記載のポリペプチド。
項１５
前記ポリペプチドは、配列番号２１のアミノ酸配列を含む、項１～１０又は項１２～１４のいずれか一項に記載のポリペプチド。
項１６
イヌＰＤ－１に結合する少なくとも１つのＶＨＨドメインは、イヌ化されている、項１又は項３～１３のいずれか一項に記載のポリペプチド。
項１７
イヌＰＤ－１に結合する少なくとも１つのイヌ化ＶＨＨドメインは、配列番号６のアミノ酸配列を含むＣＤＲ１と、配列番号７のアミノ酸配列を含むＣＤＲ２と、配列番号８のアミノ酸配列を含むＣＤＲ３と、配列番号９～配列番号１３から選択されるアミノ酸配列に対して少なくとも９０％、９５％、９６％、９７％、９８％、９９％、又は１００％の同一性を有するアミノ酸配列とを含む、項１６に記載のポリペプチド。
項１８
イヌＰＤ－１に結合する少なくとも１つのイヌ化ＶＨＨドメインは、配列番号９～配列番号１３から選択されるアミノ酸配列を含む、項１６又は１７に記載のポリペプチド。
項１９
前記ポリペプチドは、配列番号１４～配列番号１８から選択されるアミノ酸配列を含む、項１６～１８のいずれか一項に記載のポリペプチド。
項２０
生理学的条件下で二量体を形成する、項１～１９のいずれか一項に記載のポリペプチド。
項２１
前記ポリペプチドは、ｉｎ ｖｉｔｒｏ及び／又はｉｎ ｖｉｖｏでイヌＰＤ－１のイヌＰＤ－Ｌ１への結合を減少させる、項１～２０のいずれか一項に記載のポリペプチド。
項２２
前記ポリペプチドは、イヌＰＤ－１のイヌＰＤ－Ｌ１への結合をｉｎ ｖｉｔｒｏで少なくとも５０％、６０％、７０％、８０％、又は少なくとも９０％減少させる、項２１に記載のポリペプチド。
項２３
イヌＰＤ－１の生物学的活性のアンタゴニストである、項１～２２のいずれか一項に記載のポリペプチド。
項２４
前記ポリペプチドは、１００ｎＭ未満、５０ｎＭ未満、２５ｎＭ未満、又は１０ｎＭ未満の親和性（Ｋ
Ｄ
）でイヌＰＤ－１に結合する、項１～２３のいずれか一項に記載のポリペプチド。
項２５
項１～２４のいずれか一項に記載のポリペプチドと、薬学的に許容可能な担体とを含む医薬組成物。
項２６
項１～２４のいずれか一項に記載のポリペプチドをコードする単離された核酸。
項２７
項２６に記載の核酸を含むベクター。
項２８
項２６に記載の核酸又は項２７に記載のベクターを含む宿主細胞。
項２９
項１～２４のいずれか一項に記載のポリペプチドを発現する宿主細胞。
項３０
項１～２４のいずれか一項に記載のポリペプチドを生産する方法であって、前記ポリペプチドの発現に適した条件下で項２８又は項２９に記載の宿主細胞をインキュベートすることを含む、方法。
項３１
前記ポリペプチドを単離することを更に含む、項３０に記載の方法。
項３２
イヌＣＤ４
＋
Ｔ細胞及び／又はイヌＣＤ８
＋
Ｔ細胞を活性化させる方法であって、前記Ｔ細胞を項１～２４のいずれか一項に記載のポリペプチドと接触させることを含む、方法。
項３３
前記Ｔ細胞はｉｎ ｖｉｔｒｏで存在する、項３２に記載の方法。
項３４
前記Ｔ細胞はｉｎ ｖｉｖｏで存在する、項３２に記載の方法。
項３５
イヌにおける癌を治療する方法であって、癌を伴うイヌに、項１～２４のいずれか一項に記載のポリペプチド又は項２５に記載の医薬組成物を薬学的有効量、投与することを含む、方法。
項３６
前記癌は、リンパ腫、血管肉腫、肥満細胞癌、黒色腫、骨肉腫、乳癌、腎細胞癌、及び非小細胞肺癌から選択される、項３５に記載の方法。
項３７
追加の抗癌療法を更に含む、項３５又は３６に記載の方法。
項３８
前記追加の抗癌療法は、癌切除、放射線療法、及び追加の抗癌剤の投与から選択される少なくとも１つの療法を含む、項３７に記載の方法。
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The embodiments presented herein relate to canine PD-1 binding polypeptides that modulate the activity of canine PD-1, and their use in various methods of treating cancer.
Item 1
A polypeptide comprising at least one caninized VHH domain that binds to canine PD-1, said polypeptide comprising a canine Fc region, and wherein the at least one VHH domain that binds to canine PD-1 comprises:
a) CDR1 comprising the amino acid sequence of SEQ ID NO:6, CDR2 comprising the amino acid sequence of SEQ ID NO:7, CDR3 comprising the amino acid sequence of SEQ ID NO:8;
b) CDR1 comprising the amino acid sequence of SEQ ID NO: 22, CDR2 comprising the amino acid sequence of SEQ ID NO: 23, and CDR3 comprising the amino acid sequence of SEQ ID NO: 24;
c) a CDR1 comprising the amino acid sequence of SEQ ID NO: 25, a CDR2 comprising the amino acid sequence of SEQ ID NO: 26, and a CDR3 comprising the amino acid sequence of SEQ ID NO: 27; or
d) CDR1 comprising the amino acid sequence of SEQ ID NO: 28, CDR2 comprising the amino acid sequence of SEQ ID NO: 29, and CDR3 comprising the amino acid sequence of SEQ ID NO: 30;
A polypeptide comprising:
Item 2
A polypeptide comprising at least one VHH domain that binds to canine PD-1, said polypeptide comprising a canine Fc region, and wherein the at least one VHH domain that binds to canine PD-1 comprises an amino acid sequence selected from SEQ ID NO:2-SEQ ID NO:5.
Item 3
Item 3. The polypeptide according to item 1 or 2, comprising one VHH domain.
Item 4
Item 3. The polypeptide according to item 1 or 2, comprising two VHH domains, the two VHH domains being the same or different.
Item 5
Item 3. The polypeptide according to item 1 or 2, comprising three VHH domains, the three VHH domains being the same or different.
Item 6
6. The polypeptide of any one of claims 1 to 5, wherein each VHH domain binds to canine PD-1.
Item 7
Item 7. The polypeptide of any one of Items 1 to 6, wherein the canine Fc region is a canine IgG Fc region.
Item 8
8. The polypeptide of claim 7, wherein the canine Fc region is a canine IgG Fc region.
Item 9
Item 9. The polypeptide according to item 7 or 8, wherein the amino acids E233, M234, and L235 of the Fc region as determined by Kabat numbering are deleted.
Item 10
Item 10. The polypeptide of any one of Items 7 to 9, wherein the Fc region comprises a D265A and N297A substitution as determined by Kabat numbering.
Item 11
The polypeptide of any one of claims 1 to 8, wherein the Fc region comprises the amino acid sequence of SEQ ID NO:19.
Item 12
The polypeptide of any one of claims 1 to 10, wherein the canine Fc region comprises the amino acid sequence of SEQ ID NO:20.
Item 13
Item 13. The polypeptide of any one of Items 1 to 12, wherein at least one VHH domain that binds to canine PD-1 comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 6, a CDR2 comprising the amino acid sequence of SEQ ID NO: 7, and a CDR3 comprising the amino acid sequence of SEQ ID NO: 8.
Item 14
Item 14. The polypeptide of any one of Items 1 to 13, wherein at least one VHH domain that binds to canine PD-1 comprises the amino acid sequence of SEQ ID NO:3.
Item 15
The polypeptide of any one of paragraphs 1 to 10 or paragraphs 12 to 14, wherein the polypeptide comprises the amino acid sequence of SEQ ID NO:21.
Item 16
Item 14. The polypeptide of any one of Items 1 or 3 to 13, wherein at least one VHH domain that binds to canine PD-1 is caninized.
Item 17
The polypeptide of claim 16, wherein at least one caninized VHH domain that binds to canine PD-1 comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 6, a CDR2 comprising the amino acid sequence of SEQ ID NO: 7, a CDR3 comprising the amino acid sequence of SEQ ID NO: 8, and an amino acid sequence having at least 90%, 95%, 96%, 97%, 98%, 99%, or 100% identity to an amino acid sequence selected from SEQ ID NOs: 9 to 13.
Item 18
18. The polypeptide of claim 16 or 17, wherein at least one caninized VHH domain that binds to canine PD-1 comprises an amino acid sequence selected from SEQ ID NO: 9 to SEQ ID NO: 13.
Item 19
19. The polypeptide of any one of claims 16 to 18, wherein the polypeptide comprises an amino acid sequence selected from SEQ ID NO:14 to SEQ ID NO:18.
Item 20
20. The polypeptide according to any one of claims 1 to 19, which forms a dimer under physiological conditions.
Item 21
Item 21. The polypeptide according to any one of Items 1 to 20, wherein the polypeptide reduces binding of canine PD-1 to canine PD-L1 in vitro and/or in vivo.
Item 22
22. The polypeptide of claim 21, wherein the polypeptide reduces binding of canine PD-1 to canine PD-L1 in vitro by at least 50%, 60%, 70%, 80%, or at least 90%.
Item 23
23. The polypeptide of any one of paragraphs 1 to 22, which is an antagonist of the biological activity of canine PD-1.
Item 24
24. The polypeptide of any one of paragraphs 1 to 23, wherein the polypeptide binds to canine PD-1 with an affinity (K D ) of less than 100 nM, less than 50 nM, less than 25 nM, or less than 10 nM.
Item 25
25. A pharmaceutical composition comprising the polypeptide according to any one of items 1 to 24 and a pharma- ceutically acceptable carrier.
Item 26
25. An isolated nucleic acid encoding the polypeptide of any one of paragraphs 1 to 24.
Item 27
Item 27. A vector comprising the nucleic acid according to item 26.
Item 28
28. A host cell comprising the nucleic acid of paragraph 26 or the vector of paragraph 27.
Item 29
A host cell expressing the polypeptide according to any one of items 1 to 24.
Item 30
30. A method for producing a polypeptide according to any one of paragraphs 1 to 24, comprising incubating a host cell according to paragraph 28 or paragraph 29 under conditions suitable for expression of said polypeptide.
Item 31
31. The method of claim 30, further comprising isolating the polypeptide.
Item 32
25. A method of activating canine CD4 + T cells and/or canine CD8 + T cells, the method comprising contacting said T cells with a polypeptide according to any one of paragraphs 1 to 24.
Item 33
33. The method of claim 32, wherein the T cells are present in vitro.
Item 34
33. The method of claim 32, wherein the T cells are present in vivo.
Item 35
A method for treating cancer in a dog, comprising administering a pharma- ceutical effective amount of the polypeptide according to any one of paragraphs 1 to 24 or the pharmaceutical composition according to paragraph 25 to a dog with cancer.
Item 36
36. The method of claim 35, wherein the cancer is selected from lymphoma, hemangiosarcoma, mast cell carcinoma, melanoma, osteosarcoma, breast cancer, renal cell carcinoma, and non-small cell lung cancer.
Item 37
37. The method of claim 35 or 36, further comprising an additional anti-cancer therapy.
Item 38
38. The method of claim 37, wherein the additional anti-cancer therapy comprises at least one therapy selected from cancer resection, radiation therapy, and administration of an additional anti-cancer agent.
Claims (38)
ａ）配列番号６のアミノ酸配列を含むＣＤＲ１、配列番号７又は２６のアミノ酸配列を含むＣＤＲ２、配列番号８のアミノ酸配列を含むＣＤＲ３、
ｂ）配列番号２２のアミノ酸配列を含むＣＤＲ１、配列番号２３のアミノ酸配列を含むＣＤＲ２、配列番号２４のアミノ酸配列を含むＣＤＲ３、
ｃ）配列番号２５のアミノ酸配列を含むＣＤＲ１、配列番号２６のアミノ酸配列を含むＣＤＲ２、配列番号２７のアミノ酸配列を含むＣＤＲ３、又は、
ｄ）配列番号２８のアミノ酸配列を含むＣＤＲ１、配列番号２９のアミノ酸配列を含むＣＤＲ２、配列番号３０のアミノ酸配列を含むＣＤＲ３、
を含む、ポリペプチド。 A polypeptide comprising at least one caninized VHH domain that binds to canine PD-1, said polypeptide comprising a canine Fc region, and wherein the at least one VHH domain that binds to canine PD-1 comprises:
a) CDR1 comprising the amino acid sequence of SEQ ID NO: 6, CDR2 comprising the amino acid sequence of SEQ ID NO: 7 or 26 , and CDR3 comprising the amino acid sequence of SEQ ID NO: 8;
b) CDR1 comprising the amino acid sequence of SEQ ID NO: 22, CDR2 comprising the amino acid sequence of SEQ ID NO: 23, and CDR3 comprising the amino acid sequence of SEQ ID NO: 24;
c) a CDR1 comprising the amino acid sequence of SEQ ID NO: 25, a CDR2 comprising the amino acid sequence of SEQ ID NO: 26, and a CDR3 comprising the amino acid sequence of SEQ ID NO: 27; or
d) CDR1 comprising the amino acid sequence of SEQ ID NO: 28, CDR2 comprising the amino acid sequence of SEQ ID NO: 29, and CDR3 comprising the amino acid sequence of SEQ ID NO: 30;
A polypeptide comprising:
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063019817P | 2020-05-04 | 2020-05-04 | |
| US63/019,817 | 2020-05-04 | ||
| PCT/US2021/030476 WO2021225961A1 (en) | 2020-05-04 | 2021-05-03 | Canine pd-1-binding polypeptides and uses thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023524995A JP2023524995A (en) | 2023-06-14 |
| JPWO2021225961A5 true JPWO2021225961A5 (en) | 2024-05-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022567339A Pending JP2023524995A (en) | 2020-05-04 | 2021-05-03 | Canine PD-1 binding polypeptide and use thereof |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20230331846A1 (en) |
| EP (1) | EP4146696A1 (en) |
| JP (1) | JP2023524995A (en) |
| KR (1) | KR20230005955A (en) |
| CN (1) | CN115776990A (en) |
| AU (1) | AU2021266688A1 (en) |
| BR (1) | BR112022022352A2 (en) |
| CA (1) | CA3177921A1 (en) |
| MX (1) | MX2022013840A (en) |
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| CN110982824B (en) * | 2019-10-09 | 2022-04-15 | 天津大学 | PD-1 antagonistic antibody analogue BP gene, protein and application |
| CN117343185B (en) * | 2023-12-06 | 2024-03-01 | 北京伟杰信生物科技有限公司 | Anti-canine PD-1 antibody and application thereof |
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| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US7217797B2 (en) | 2002-10-15 | 2007-05-15 | Pdl Biopharma, Inc. | Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis |
| CN1871359B (en) | 2003-10-22 | 2010-11-17 | 凯克研究生院 | Methods of synthesizing heteromultimeric polypeptides in yeast using a haploid mating strategy |
| EP2771694A4 (en) * | 2011-10-26 | 2015-08-05 | Novartis Tiergesundheit Ag | Monoclonal antibodies and methods of use |
| JP6279733B2 (en) * | 2014-07-09 | 2018-02-14 | 日本全薬工業株式会社 | Anti-canine PD-1 antibody or anti-canine PD-L1 antibody |
| ES2847311T3 (en) * | 2014-08-05 | 2021-08-02 | MabQuest SA | Immunological reagents that bind to PD-1 |
| WO2020077257A1 (en) * | 2018-10-11 | 2020-04-16 | Inhibrx, Inc. | Pd-1 single domain antibodies and therapeutic compositions thereof |
| CN112920276B (en) * | 2019-06-03 | 2021-11-12 | 北京希诺谷生物科技有限公司 | Anti-canine PD-1 antibody and preparation method thereof |
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