JP2015527318A5 - - Google Patents
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- JP2015527318A5 JP2015527318A5 JP2015521674A JP2015521674A JP2015527318A5 JP 2015527318 A5 JP2015527318 A5 JP 2015527318A5 JP 2015521674 A JP2015521674 A JP 2015521674A JP 2015521674 A JP2015521674 A JP 2015521674A JP 2015527318 A5 JP2015527318 A5 JP 2015527318A5
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- 239000003814 drug Substances 0.000 claims description 15
- 108090001123 antibodies Proteins 0.000 claims description 11
- 102000004965 antibodies Human genes 0.000 claims description 11
- 229920002857 polybutadiene Polymers 0.000 claims description 6
- 108010047814 Antigen-Antibody Complex Proteins 0.000 claims 13
- 125000003275 alpha amino acid group Chemical group 0.000 claims 13
- 206010029592 Non-Hodgkin's lymphomas Diseases 0.000 claims 7
- 125000005843 halogen group Chemical group 0.000 claims 5
- 125000003118 aryl group Chemical group 0.000 claims 4
- 125000005647 linker group Chemical group 0.000 claims 4
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims 4
- 102100000189 CD22 Human genes 0.000 claims 3
- 101700020617 CD22 Proteins 0.000 claims 3
- 208000000429 Leukemia, Lymphocytic, Chronic, B-Cell Diseases 0.000 claims 3
- 125000000623 heterocyclic group Chemical group 0.000 claims 3
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 3
- 206010008958 Chronic lymphocytic leukaemia Diseases 0.000 claims 2
- 108010016626 Dipeptides Proteins 0.000 claims 2
- 108010027440 Immunoconjugates Proteins 0.000 claims 2
- 102000018748 Immunoconjugates Human genes 0.000 claims 2
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 2
- 201000005510 acute lymphocytic leukemia Diseases 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 238000010276 construction Methods 0.000 claims 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 2
- 125000002485 formyl group Chemical group [H]C(*)=O 0.000 claims 2
- 201000009277 hairy cell leukemia Diseases 0.000 claims 2
- 229910052757 nitrogen Inorganic materials 0.000 claims 2
- 229910052760 oxygen Inorganic materials 0.000 claims 2
- YUOCYTRGANSSRY-UHFFFAOYSA-N pyrrolo[2,3-i][1,2]benzodiazepine Chemical compound C1=CN=NC2=C3C=CN=C3C=CC2=C1 YUOCYTRGANSSRY-UHFFFAOYSA-N 0.000 claims 2
- 229910052717 sulfur Inorganic materials 0.000 claims 2
- 125000004400 (C1-C12) alkyl group Chemical group 0.000 claims 1
- 125000001963 4 membered heterocyclic group Chemical group 0.000 claims 1
- 125000001255 4-fluorophenyl group Chemical group [H]C1=C([H])C(*)=C([H])C([H])=C1F 0.000 claims 1
- 125000002373 5 membered heterocyclic group Chemical group 0.000 claims 1
- 125000004070 6 membered heterocyclic group Chemical group 0.000 claims 1
- 125000003341 7 membered heterocyclic group Chemical group 0.000 claims 1
- 208000009899 Burkitt Lymphoma Diseases 0.000 claims 1
- 102000033147 ERVK-25 Human genes 0.000 claims 1
- 206010024324 Leukaemias Diseases 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 206010026798 Mantle cell lymphomas Diseases 0.000 claims 1
- 206010025310 Other lymphomas Diseases 0.000 claims 1
- 108091005771 Peptidases Proteins 0.000 claims 1
- FADYJNXDPBKVCA-UHFFFAOYSA-N Phenylalanyl-Lysine Chemical compound NCCCCC(C(O)=O)NC(=O)C(N)CC1=CC=CC=C1 FADYJNXDPBKVCA-UHFFFAOYSA-N 0.000 claims 1
- 239000004365 Protease Substances 0.000 claims 1
- 125000002947 alkylene group Chemical group 0.000 claims 1
- 125000000319 biphenyl-4-yl group Chemical group [H]C1=C([H])C([H])=C([H])C([H])=C1C1=C([H])C([H])=C([*])C([H])=C1[H] 0.000 claims 1
- 229910052799 carbon Inorganic materials 0.000 claims 1
- 125000004432 carbon atoms Chemical group C* 0.000 claims 1
- 150000001768 cations Chemical class 0.000 claims 1
- 125000004980 cyclopropylene group Chemical group 0.000 claims 1
- 239000002254 cytotoxic agent Substances 0.000 claims 1
- 231100000599 cytotoxic agent Toxicity 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 125000001153 fluoro group Chemical group F* 0.000 claims 1
- 125000002541 furyl group Chemical group 0.000 claims 1
- 125000005842 heteroatoms Chemical group 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002184 metal Substances 0.000 claims 1
- 125000004433 nitrogen atoms Chemical group N* 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 125000004076 pyridyl group Chemical group 0.000 claims 1
- 125000001544 thienyl group Chemical group 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 description 22
- 229940079593 drugs Drugs 0.000 description 14
- 229920002574 CR-39 Polymers 0.000 description 6
- 230000003247 decreasing Effects 0.000 description 6
- 230000001747 exhibiting Effects 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- DASWEROEPLKSEI-UIJRFTGLSA-N Monomethyl auristatin E Chemical compound CN[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H]([C@@H](C)CC)[C@H](OC)CC(=O)N1CCC[C@H]1[C@H](OC)[C@@H](C)C(=O)N[C@H](C)[C@@H](O)C1=CC=CC=C1 DASWEROEPLKSEI-UIJRFTGLSA-N 0.000 description 2
- 230000000259 anti-tumor Effects 0.000 description 2
- 108010044540 auristatin Proteins 0.000 description 2
- 125000000446 sulfanediyl group Chemical group *S* 0.000 description 2
- 0 CC(C)(CCC(C)(C)COc(c(OC)c1)cc(N=C[C@](C2)N3C=C2C=CC)c1C3=O)CCOc(cc(c1c2)N(*C(OCC(C)(*)SC3CCCCCC=CCCCCCC3)=O)*[C@](C)(CC(C=C*)=C3)N3C1=O)c2OC Chemical compound CC(C)(CCC(C)(C)COc(c(OC)c1)cc(N=C[C@](C2)N3C=C2C=CC)c1C3=O)CCOc(cc(c1c2)N(*C(OCC(C)(*)SC3CCCCCC=CCCCCCC3)=O)*[C@](C)(CC(C=C*)=C3)N3C1=O)c2OC 0.000 description 1
Description
その実験の結果を表2及び図5に示す。表2は、各処理群、試験終了時に観察可能な腫瘍を伴ったマウスの数(TI)、部分寛解を示すマウスの数(「PR」、投与後のある時間における腫瘍体積が0日目で測定された腫瘍体積の50%を下回った)、完全寛解を示すマウスの数(「CR」、投与後のある時間における腫瘍体積が0mm3に低下した)、各群の薬剤用量、各群の抗体用量、及び投与された各ADCの薬剤負荷を示す。
さらに、2mg/kgの10F4v3−PBDは、オーリスタチン薬剤MMAEと結合したヒト化抗CD22チオMab(「10F4v3−MMAE」)の8mg/kgと匹敵する抗腫瘍活性を示した。図5を参照のこと。表2に示すように、2mg/kgの10F4v3−PBDを与えられたマウスは9匹が完全寛解を有したが、8mg/kgの10F4v3−MMAEを与えられたマウスは6匹が部分寛解で3匹が完全寛解だった。
その実験の結果を表3及び図6に示す。表3は、各処理群、試験終了時に観察可能な腫瘍を伴ったマウスの数(TI)、部分寛解を示すマウスの数(「PR」、投与後のある時間における腫瘍体積が0日目で測定された腫瘍体積の50%を下回った)、完全寛解を示すマウスの数(「CR」、投与後のある時間における腫瘍体積が0mm3に低下した)、各群の薬剤用量、各群の抗体用量、及び投与された各ADCの薬剤負荷を示す。
10F4v3−PBDを与えられたマウスはすべて腫瘍の退行を示したが、10F4v3−MMAEで処理したマウスの大部分はそうではなかった。単回用量の10F4v3−PBDでは、部分寛解が1匹及び完全寛解が8匹だった。
その実験の結果を表4及び図7に示す。表4は、各処理群、試験終了時に観察可能な腫瘍を伴ったマウスの数(「TI」)、部分寛解を示すマウスの数(「PR」、投与後のある時間における腫瘍体積が0日目で測定された腫瘍体積の50%を下回った)、完全寛解を示すマウスの数(「CR」、投与後のある時間における腫瘍体積が0mm3に低下した)、各群の薬剤用量、各群の抗体用量、及び投与された各ADCの薬剤負荷を示す。
さらに、2mg/kgの10F4v3−PBDは、オーリスタチン薬剤MMAEと結合したヒト化抗CD22チオMab(「10F4v3−MMAE」)の8mg/kgと匹敵する抗腫瘍活性を示し;双方とも処理した動物すべてで完全寛解を示した。図7及び表4を参照のこと。
その実験の結果を表5及び図8に示す。表5は、各処理群、試験終了時に観察可能な腫瘍を伴ったマウスの数(「TI」)、部分寛解を示すマウスの数(「PR」、投与後のある時間における腫瘍体積が0日目で測定された腫瘍体積の50%を下回った)、完全寛解を示すマウスの数(「CR」、投与後のある時間における腫瘍体積が0mm3に低下した)、各群の薬剤用量、各群の抗体用量、及び投与された各ADCの薬剤負荷を示す。
その実験の結果を表6及び図9に示す。表6は、各処理群、試験終了時に観察可能な腫瘍を伴ったマウスの数(「TI」)、部分寛解を示すマウスの数(「PR」、投与後のある時間における腫瘍体積が0日目で測定された腫瘍体積の50%を下回った)、完全寛解を示すマウスの数(「CR」、投与後のある時間における腫瘍体積が0mm3に低下した)、各群の薬剤用量、各群の抗体用量、及び投与された各ADCの薬剤負荷を示す。
その実験の結果を表7及び図10に示す。表2は、各処理群、試験終了時に観察可能な腫瘍を伴ったマウスの数(TI)、部分寛解を示すマウスの数(「PR」、投与後のある時間における腫瘍体積が0日目で測定された腫瘍体積の50%を下回った)、完全寛解を示すマウスの数(「CR」、投与後のある時間における腫瘍体積が0mm3に低下した)、各群の薬剤用量、各群の抗体用量、及び投与された各ADCの薬剤負荷を示す。
Claims (15)
- 式Ab−(L−D)pで表される免疫複合体であって、
(a)AbがCD22に結合する抗体であり;
(b)Lがリンカーであり;
(c)Dが細胞傷害剤であり;かつ
(d)pが1〜8の範囲であり;
Dが式A:
のピロロベンゾジアゼピンであり、式中、
波線は前記リンカーに対する共有結合部位を示し;
点線はC1とC2の間又はC2とC3の間での二重結合の任意選択的な存在を示し;
R2はH、OH、=O、=CH2、CN、R、OR、=CH−RD、=C(RD)2、O-SO2-R、CO2R及びCORから独立して選択され、かつ任意選択的にさらにハロ又はジハロから選択され、RDは、R、CO2R、COR、CHO、CO2H、及びハロから独立して選択され;
R6及びR9は、H、R、OH、OR、SH、SR、NH2、NHR、NRR’、NO2、Me3Sn及びハロから独立して選択され;
R7は、H、R、OH、OR、SH、SR、NH2、NHR、NRR’、NO2、Me3Sn及びハロから独立して選択され;
Qは、O、S及びNHから独立して選択され;
R11はH又はRのいずれかであり、又は、QがOである場合、SO3Mであり、Mが金属カチオンであり;
R及びR’はそれぞれ独立して、任意選択的に置換されたC1−12アルキル基、C3-20ヘテロシクリル基及びC5−20アリール基から選択され、任意選択的にNRR’基に関連して、R及びR’はそれらが結合する窒素原子と一緒に任意選択的に置換された4、5、6又は7員環の複素環を形成し;
R12、R16、R19及びR17はそれぞれR2、R6、R9及びR7について定義されたとおりであり;
R”は、C3−12アルキレン基であり、1以上のヘテロ原子及び/又は任意選択的に置換される芳香族環によってその鎖が中断されてもよく;かつ
X及びX’は独立してO、S及びN(H)から選択され;
Abが、(i)配列番号9のアミノ酸配列を含むHVR−H1、(ii)配列番号10のアミノ酸配列を含むHVR−H2、(iii)配列番号11のアミノ酸配列を含むHVR−H3、(iv)配列番号12及び15〜22から選択されるアミノ酸配列を含むHVR−L1、(v)配列番号13のアミノ酸配列を含むHVR−L2、及び(vi)配列番号14のアミノ酸配列を含むHVR−L3を含む抗体である、免疫複合体。 - 抗体が、
a)配列番号7のアミノ酸配列に対して少なくとも95%の配列同一性を有するVH配列、又は
b)配列番号8のアミノ酸配列に対して少なくとも95%の配列同一性を有するVL配列、又は
c)配列番号7のアミノ酸配列を有するVH配列、又は
d)配列番号6のアミノ酸配列を有するVL配列、又は配列番号8のアミノ酸配列を有するVL配列、又は
e)(a)又は(c)に記載のVH配列、及び(b)又は(d)に記載のVL配列、又は
f)配列番号7のアミノ酸配列を有するVH配列、及び配列番号8のアミノ酸配列有するVL配列、を含む、請求項1に記載の免疫複合体。 - リンカーがプロテアーゼによって切断可能であり、val−citジペプチド又はPhe−Lysジペプチドを任意選択的に含む、請求項1〜4のいずれか1項に記載の免疫複合体。
- Ar1及びAr2がそれぞれ独立して、任意選択的に置換されたフェニル、フラニル、チオフェニル及びピリジルから選択される請求項9に記載の免疫複合体。
- RV1及びRV2がそれぞれ独立してH、フェニル及び4−フルオロフェニルから選択される請求項9に記載の免疫複合体。
- 抗体が、配列番号26の重鎖と配列番号23の軽鎖を含む請求項6に記載の免疫複合体。
- 請求項1〜12のいずれか1項に記載の免疫複合体と薬学上許容可能なキャリアとを含む医薬製剤。
- CD22陽性のがんを有する個体を治療するための医薬の製造のための、請求項1〜12のいずれか1項に記載の免疫複合体又は請求項13に記載の医薬製剤の、使用。
- CD22陽性のがんが、リンパ腫、非ホジキンリンパ腫(NHL)、侵攻性NHL、再発した侵攻性NHL、再発した緩慢型NHL、難治性NHL、難治性緩慢型NHL、慢性リンパ性白血病(CLL)、小リンパ性リンパ腫、白血病、ヘアリー細胞白血病(HCL)、急性リンパ性白血病(ALL)、バーキットリンパ腫及びマントル細胞リンパ腫から選択される請求項14に記載の使用。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261669272P | 2012-07-09 | 2012-07-09 | |
US61/669,272 | 2012-07-09 | ||
US201361777113P | 2013-03-12 | 2013-03-12 | |
US61/777,113 | 2013-03-12 | ||
PCT/US2013/049515 WO2014011518A1 (en) | 2012-07-09 | 2013-07-08 | Immunoconjugates comprising anti-cd22 antibodies |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2015527318A JP2015527318A (ja) | 2015-09-17 |
JP2015527318A5 true JP2015527318A5 (ja) | 2018-01-25 |
Family
ID=48803621
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015521674A Pending JP2015527318A (ja) | 2012-07-09 | 2013-07-08 | 抗cd22を含む免疫複合体 |
Country Status (21)
Country | Link |
---|---|
US (2) | US20140030279A1 (ja) |
EP (1) | EP2869849A1 (ja) |
JP (1) | JP2015527318A (ja) |
KR (1) | KR20150027829A (ja) |
CN (1) | CN104540524A (ja) |
AR (1) | AR091703A1 (ja) |
AU (1) | AU2013288929A1 (ja) |
BR (1) | BR112015000441A2 (ja) |
CA (1) | CA2873889A1 (ja) |
CL (1) | CL2015000027A1 (ja) |
CR (1) | CR20150048A (ja) |
EA (1) | EA201590174A1 (ja) |
HK (1) | HK1209043A1 (ja) |
IL (1) | IL235985A0 (ja) |
IN (1) | IN2014DN10510A (ja) |
MX (1) | MX2015000357A (ja) |
PE (1) | PE20150615A1 (ja) |
PH (1) | PH12014502797A1 (ja) |
SG (1) | SG11201500087VA (ja) |
TW (1) | TW201406785A (ja) |
WO (1) | WO2014011518A1 (ja) |
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- 2013-07-08 EA EA201590174A patent/EA201590174A1/ru unknown
- 2013-07-08 EP EP13739331.0A patent/EP2869849A1/en not_active Withdrawn
- 2013-07-08 US US13/936,279 patent/US20140030279A1/en not_active Abandoned
- 2013-07-08 CA CA2873889A patent/CA2873889A1/en not_active Abandoned
- 2013-07-08 AR ARP130102425 patent/AR091703A1/es unknown
- 2013-07-08 SG SG11201500087VA patent/SG11201500087VA/en unknown
- 2013-07-08 WO PCT/US2013/049515 patent/WO2014011518A1/en active Application Filing
-
2014
- 2014-11-30 IL IL235985A patent/IL235985A0/en unknown
- 2014-12-15 PH PH12014502797A patent/PH12014502797A1/en unknown
-
2015
- 2015-01-07 CL CL2015000027A patent/CL2015000027A1/es unknown
- 2015-02-04 CR CR20150048A patent/CR20150048A/es not_active Application Discontinuation
- 2015-10-06 HK HK15109754.0A patent/HK1209043A1/xx unknown
-
2017
- 2017-04-26 US US15/497,656 patent/US20170290920A1/en not_active Abandoned
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