JP2021184721A5 - - Google Patents
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- JP2021184721A5 JP2021184721A5 JP2021126285A JP2021126285A JP2021184721A5 JP 2021184721 A5 JP2021184721 A5 JP 2021184721A5 JP 2021126285 A JP2021126285 A JP 2021126285A JP 2021126285 A JP2021126285 A JP 2021126285A JP 2021184721 A5 JP2021184721 A5 JP 2021184721A5
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- bispecific
- bcma
- binding fragment
- antibody
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- 239000012634 fragment Substances 0.000 claims 33
- BGFTWECWAICPDG-UHFFFAOYSA-N 2-[bis(4-chlorophenyl)methyl]-4-n-[3-[bis(4-chlorophenyl)methyl]-4-(dimethylamino)phenyl]-1-n,1-n-dimethylbenzene-1,4-diamine Chemical compound C1=C(C(C=2C=CC(Cl)=CC=2)C=2C=CC(Cl)=CC=2)C(N(C)C)=CC=C1NC(C=1)=CC=C(N(C)C)C=1C(C=1C=CC(Cl)=CC=1)C1=CC=C(Cl)C=C1 BGFTWECWAICPDG-UHFFFAOYSA-N 0.000 claims 32
- 102000006942 B-Cell Maturation Antigen Human genes 0.000 claims 32
- 108010008014 B-Cell Maturation Antigen Proteins 0.000 claims 32
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- 210000004027 cell Anatomy 0.000 claims 10
- 206010028980 Neoplasm Diseases 0.000 claims 9
- 201000011510 cancer Diseases 0.000 claims 9
- 238000000034 method Methods 0.000 claims 7
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 3
- 210000001744 T-lymphocyte Anatomy 0.000 claims 3
- 239000002246 antineoplastic agent Substances 0.000 claims 3
- 229940124597 therapeutic agent Drugs 0.000 claims 3
- 208000034578 Multiple myelomas Diseases 0.000 claims 2
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 210000003719 b-lymphocyte Anatomy 0.000 claims 2
- 229940127089 cytotoxic agent Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 201000005787 hematologic cancer Diseases 0.000 claims 2
- 208000024200 hematopoietic and lymphoid system neoplasm Diseases 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 102000040430 polynucleotide Human genes 0.000 claims 2
- 108091033319 polynucleotide Proteins 0.000 claims 2
- 239000002157 polynucleotide Substances 0.000 claims 2
- 230000035755 proliferation Effects 0.000 claims 2
- 230000001568 sexual effect Effects 0.000 claims 2
- UHDGCWIWMRVCDJ-CCXZUQQUSA-N Cytarabine Chemical group O=C1N=C(N)C=CN1[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O1 UHDGCWIWMRVCDJ-CCXZUQQUSA-N 0.000 claims 1
- 101000801255 Homo sapiens Tumor necrosis factor receptor superfamily member 17 Proteins 0.000 claims 1
- 102000000588 Interleukin-2 Human genes 0.000 claims 1
- 108010002350 Interleukin-2 Proteins 0.000 claims 1
- 230000006044 T cell activation Effects 0.000 claims 1
- 239000000556 agonist Substances 0.000 claims 1
- 229940045799 anthracyclines and related substance Drugs 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 229960000684 cytarabine Drugs 0.000 claims 1
- 230000003013 cytotoxicity Effects 0.000 claims 1
- 231100000135 cytotoxicity Toxicity 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 229960004931 histamine dihydrochloride Drugs 0.000 claims 1
- PPZMYIBUHIPZOS-UHFFFAOYSA-N histamine dihydrochloride Chemical compound Cl.Cl.NCCC1=CN=CN1 PPZMYIBUHIPZOS-UHFFFAOYSA-N 0.000 claims 1
- 102000046935 human TNFRSF17 Human genes 0.000 claims 1
- 210000004408 hybridoma Anatomy 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 201000000050 myeloid neoplasm Diseases 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 230000034190 positive regulation of NF-kappaB transcription factor activity Effects 0.000 claims 1
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 1
Claims (26)
- 組換えBCMA×CD3二重特異性抗体又はそのBCMA×CD3二重特異性結合フラグメントであって、
a)第1の重鎖(HC1)と、
b)第2の重鎖(HC2)と、
c)第1の軽鎖(LC1)と、
d)第2の軽鎖(LC2)と、を含み、
HC1はLC1と結合され、HC2はLC2と結合され、CD3に免疫特異的に結合する第1の抗原結合部位を形成するために、HC1は配列番号59、配列番号60、及び配列番号61を含み、LC1は配列番号62、配列番号63、及び配列番号64を含み、またBCMAに免疫特異的に結合する第2の抗原結合部位を形成するために、HC2は配列番号4、配列番号5、及び配列番号6を含み、LC2は配列番号24、配列番号25、及び配列番号26を含む、組換えBCMA×CD3二重特異性抗体又はそのBCMA×CD3二重特異性結合フラグメント。 - 配列番号55を含むHC1と、配列番号56を含むLC1と、配列番号65を含むHC2と、配列番号76を含むLC2と、を含む、請求項1に記載の組換えBCMA×CD3二重特異性抗体又はそのフラグメント。
- 前記抗体又は二重特異性結合フラグメントはIgGである、請求項2に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又は二重特異性結合フラグメントはIgG4アイソタイプである、請求項1~3のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又は二重特異性結合フラグメントは、表面プラズモン共鳴により測定するとき、少なくとも0.22nMの親和性でヒトBCMAに免疫特異的に結合する、請求項1~4のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又はその二重特異性結合フラグメントは、ヒト骨髄腫細胞の表面上のBCMAに結合する、請求項1~5のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又はその二重特異性結合フラグメントは、ヒト多発性骨髄腫細胞の表面上のBCMAに結合する、請求項1~6のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又は二重特異性結合フラグメントは、約0.37nM未満のEC 50 でインビトロでヒトT細胞活性化を誘発する、請求項1~7のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又は二重特異性結合フラグメントは、約0.45nM未満のEC 50 でインビトロでBCMA発現細胞のT細胞依存性細胞傷害を誘発する、請求項1~8のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又は二重特異性結合フラグメントは、BCMAアゴニストではない、請求項1~9のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 前記抗体又は二重特異性結合フラグメントは、10nM未満の濃度でNF-κB活性化を変化させない、請求項1~10のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント。
- 請求項1~11のいずれか一項に記載の抗体又は二重特異性結合フラグメントを発現している、組換え細胞。
- 前記細胞はハイブリドーマである、請求項12に記載の細胞。
- がんを有する対象を処置するための方法で用いるための医薬組成物であって、請求項1~11のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメントを含み、前記方法は、前記BCMA×CD3二重特異性抗体又は二重特異性結合フラグメントの治療的に有効な量を、それを必要とする対象に、がんを処置するのに十分な時間投与することを含む、医薬組成物。
- がん細胞の成長又は増殖を阻害するための方法で用いるための医薬組成物であって、請求項1~11のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメントを含み、前記方法は、前記BCMA×CD3二重特異性抗体又は二重特異性結合フラグメントの治療的に有効な量を投与し、がん細胞の成長又は増殖を阻害することを含む、医薬組成物。
- T細胞をBCMA発現がん細胞にリダイレクトする方法で用いるための医薬組成物であって、請求項1~11のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメントを含み、前記方法は、前記BCMA×CD3二重特異性抗体又は二重特異性結合フラグメントの治療的に有効な量を投与し、T細胞をがんにリダイレクトすることを含む、医薬組成物。
- 前記がんは血液がんである、請求項14~16のいずれか一項に記載の医薬組成物。
- 前記血液がんはBCMA発現B細胞がんである、請求項17に記載の医薬組成物。
- 前記BCMA発現B細胞がんは多発性骨髄腫である、請求項18に記載の医薬組成物。
- 前記方法は第2の治療剤を投与することを更に含む、請求項14に記載の医薬組成物。
- 前記第2の治療剤は、化学療法剤又は標的化抗がん治療剤である、請求項20に記載の医薬組成物。
- 前記化学療法剤は、シタラビン、アントラサイクリン、ヒスタミン二塩酸塩、又はインターロイキン2である、請求項21に記載の医薬組成物。
- 請求項1~11のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメントと、医薬的に許容され得る担体と、を含む、医薬組成物。
- 請求項12または13に記載の細胞を培養することにより、請求項1~11のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメントを生成するための方法。
- 請求項1~11のいずれか一項に記載のBCMA×CD3二重特異性抗体又は二重特異性結合フラグメントのHC1、HC2、LC1、およびLC2をコードする、単離された合成ポリヌクレオチド。
- 請求項1~11のいずれか一項に定義されるようなBCMA×CD3二重特異性抗体又は二重特異性結合フラグメント、及び/又は請求項25に定義されるようなポリヌクレオチド、及びこれらのための包装、を含む、キット。
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JP2022196582A JP2023027228A (ja) | 2015-08-17 | 2022-12-08 | 抗bcma抗体、bcma及びcd3に結合する二重特異性抗原結合分子、並びにそれらの使用 |
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US201562206246P | 2015-08-17 | 2015-08-17 | |
US62/206,246 | 2015-08-17 | ||
JP2018508695A JP2018525005A (ja) | 2015-08-17 | 2016-08-16 | 抗bcma抗体、bcma及びcd3に結合する二重特異性抗原結合分子、並びにそれらの使用 |
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JP2021184721A JP2021184721A (ja) | 2021-12-09 |
JP2021184721A5 true JP2021184721A5 (ja) | 2022-07-12 |
JP7194240B2 JP7194240B2 (ja) | 2022-12-21 |
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JP2021126285A Active JP7194240B2 (ja) | 2015-08-17 | 2021-07-30 | 抗bcma抗体、bcma及びcd3に結合する二重特異性抗原結合分子、並びにそれらの使用 |
JP2022196582A Pending JP2023027228A (ja) | 2015-08-17 | 2022-12-08 | 抗bcma抗体、bcma及びcd3に結合する二重特異性抗原結合分子、並びにそれらの使用 |
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Country Status (40)
Country | Link |
---|---|
US (1) | US10072088B2 (ja) |
EP (2) | EP3337824B1 (ja) |
JP (3) | JP2018525005A (ja) |
KR (1) | KR20180040671A (ja) |
CN (1) | CN108350076B (ja) |
AR (1) | AR105724A1 (ja) |
AU (1) | AU2016308567B2 (ja) |
BR (1) | BR112018003017A2 (ja) |
CA (1) | CA2995754A1 (ja) |
CL (1) | CL2018000431A1 (ja) |
CO (1) | CO2018001524A2 (ja) |
CY (1) | CY1123297T1 (ja) |
DK (1) | DK3337824T3 (ja) |
EA (1) | EA201890513A1 (ja) |
EC (1) | ECSP18019568A (ja) |
ES (1) | ES2814550T3 (ja) |
FI (1) | FIC20230012I1 (ja) |
FR (2) | FR23C1011I1 (ja) |
HR (1) | HRP20201375T1 (ja) |
HU (2) | HUE050556T2 (ja) |
IL (2) | IL298041A (ja) |
JO (1) | JO3799B1 (ja) |
LT (2) | LT3337824T (ja) |
MA (1) | MA53750A (ja) |
MX (2) | MX2018002043A (ja) |
MY (1) | MY191325A (ja) |
NI (1) | NI201800027A (ja) |
NL (1) | NL301219I2 (ja) |
PE (1) | PE20180795A1 (ja) |
PH (1) | PH12018500361A1 (ja) |
PL (1) | PL3337824T3 (ja) |
PT (1) | PT3337824T (ja) |
RS (1) | RS60755B1 (ja) |
SI (1) | SI3337824T1 (ja) |
SV (1) | SV2018005634A (ja) |
TW (3) | TWI811023B (ja) |
UA (1) | UA127515C2 (ja) |
UY (1) | UY36859A (ja) |
WO (1) | WO2017031104A1 (ja) |
ZA (1) | ZA201801789B (ja) |
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