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1. 发明申请

WO2019105916A1 TARGET INTERFERENCE SUPPRESSED ANTI-DRUG ANTIBODY ASSAY 审中-公开
公开(公告)号：WO2019105916A1
公开(公告)日：2019-06-06
申请号：PCT/EP2018/082664
申请日：2018-11-27
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： DAHL, Uwe , JORDAN, Gregor , STAACK, Roland , MOHEYSEN-ZADEH, Miriam
IPC分类号： G01N33/68 , G01N33/543
摘要： Herein is reported an immunoassay for quantifying the amount of anti-drug antibody, which anti-drug antibody can specifically bind to a drug antibody, which drug antibody can specifically bind to a therapeutic target, in a serum or plasma sample comprising the steps of a) incubating the serum or plasma sample at a pH value that is about the pI value of the target, and optionally removing formed precipitate after the incubation, b) incubating the serum or plasma sample obtained in step a) at a pH value of about 2, and optionally centrifuging the incubated sample to remove formed precipitate, c) adjusting the pH value to about 7.4, adding capture antibody conjugated to a first member of a binding pair and tracer antibody conjugated to a detectable label to the serum or plasma sample obtained in step b) and incubating the mixture to form a capture antibody-anti-drug antibody-tracer antibody-complex, d) quantifying the complex formed in step c) and thereby quantifying the amount of anti-drug antibody in the serum or plasma sample.

2. 发明申请

WO2021122733A1 BISPECIFIC ANTI-CCL2 ANTIBODIES 审中-公开
公开(公告)号：WO2021122733A1
公开(公告)日：2021-06-24
申请号：PCT/EP2020/086403
申请日：2020-12-16
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： FENG, Shu , FISCHER, Jens , GAN, Siok Wan , GEORGES, Guy , GERTZ, Michael , HO, Wei Shiong Adrian , JOCHNER, Anton , JORDAN, Gregor , KETTENBERGER, Hubert , LAM, Runyi Adeline , MAJETY, Meher , MOELLEKEN, Joerg , RUNZA, Valeria , SCHAEFER, Martin , SCHLOTHAUER, Tilman , TIEFENTHALER, Georg , VIERT, Maria
IPC分类号： A61P35/00 , A61P37/06 , C07K16/24 , A61K2039/505 , C07K2317/31 , C07K2317/33 , C07K2317/52 , C07K2317/565 , C07K2317/76 , C07K2317/92 , C07K2317/94
摘要： The present invention relates to bispecific anti-CCL2 antibodies binding to two different epitopes on human CCL2, pharmaceutical compositions thereof, their manufacture, and use as medicaments for the treatment of cancers, inflammatory, autoimmune and ophthalmologic diseases.

3. 发明申请

WO2017102786A1 THREE-STEP ACID DISSOCIATION ENZYME LINKED IMMUNOSORBENT (TADELIS) ASSAY 审中-公开
标题翻译：三步酸离心酶联免疫吸附（TADELIS）测定法
公开(公告)号：WO2017102786A1
公开(公告)日：2017-06-22
申请号：PCT/EP2016/080887
申请日：2016-12-14
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： JORDAN, Gregor , STAACK, Roland
IPC分类号： G01N33/536 , G01N33/68 , G01N33/94
CPC分类号： G01N33/536 , G01N33/6854 , G01N33/94
摘要： Herein is reported a method for determining in a sample the (total, i.e. binding competent) amount of a ligand of a ligand-binding protein (therapeutic) comprising the following steps in the following order: subjecting the sample to an acid treatment, forming in solution a non-covalent complex comprising i) an anti-ligand antibody, ii) the ligand, and iii) labelled ligand-binding protein, by adding anti- ligand antibody and labelled ligand-binding protein to the sample, and determining the amount of the complex and thereby determining the amount of the ligand of the ligand-binding protein.
摘要翻译：本文报道了用于确定样品中配体结合蛋白（治疗性）的配体（总量，即结合活性）量的方法，其包括以下步骤的顺序：使样品进行酸处理，在溶液中形成包含i）抗配体抗体，ii）配体和iii）标记的配体结合蛋白的非共价复合物，通过将抗配体抗体和标记的配体结合蛋白加入样品，并确定复合物的量，从而确定配体结合蛋白的配体量。

4. 发明申请

WO2014023655A1 IMMUNOASSAY-BASED DETERMINATION OF IN-SOLUTION BINDING KINETICS 审中-公开
标题翻译：基于免疫测定的解决方案的绑定动力学
公开(公告)号：WO2014023655A1
公开(公告)日：2014-02-13
申请号：PCT/EP2013/066265
申请日：2013-08-02
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： DAHL, Uwe , JORDAN, Gregor , STAACK, Roland
IPC分类号： G01N33/557
CPC分类号： G01N33/557 , G01N33/15
摘要： Herein is reported a method for the determination of the binding affinity of a binder and its ligand comprising the step of determining based on the result of an immunoassay the fraction of free binder in a sample comprising binder, ligand and binder-ligand -complexes for at least two different binder:ligand ratios in the sample, and if the determined fraction of free binder is not comparable for all used binder:ligand ratios then the binder:ligand ratio in the sample is lowered and the sample is re-analyzed by the same immunoassay, and calculating based on the fraction of free binder in the previous step the binding affinity for the binder to its ligand.
摘要翻译：本文报道了用于确定粘合剂及其配体的结合亲和力的方法，包括基于免疫测定结果确定包含粘合剂，配体和粘合剂 - 配体 - 复合物的样品中游离粘合剂部分的步骤的步骤样品中至少两种不同的粘合剂：配体比例，如果确定的游离粘合剂的分数与所有使用的粘合剂：配体比例不相称，则样品中的粘合剂：配体比例降低，并且样品重新分析免疫测定，并且基于前一步骤中游离粘合剂的分数来计算粘合剂对其配体的结合亲和力。

5. 发明申请

WO2021254926A1 METHOD FOR DETERMINING THE FREE ANTIGEN OF AN ANTIBODY IN A SAMPLE 审中-公开
公开(公告)号：WO2021254926A1
公开(公告)日：2021-12-23
申请号：PCT/EP2021/065880
申请日：2021-06-14
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： JORDAN, Gregor , SCHAEFER, Martin , VIERT, Maria
IPC分类号： G01N33/543 , G01N33/54353 , G01N33/54393
摘要： Herein is reported a method for determining free antigen of an antibody in an undiluted serum sample comprising the steps of a) applying the undiluted sample to a solid phase on which a capture antibody has been immobilized to form a capture antibody-antigen complex, wherein the capture antibody competes with the antibody for binding to a first epitope on the antigen,, b) applying to the solid phase a tracer antibody to form a capture antibody-antigen-tracer antibody complex, wherein the tracer antibody specifically binds to a second epitope on the antigen, wherein the epitope of the tracer antibody is not overlapping with the epitope of the capture antibody on the antigen, and c) determining the free antigen of the antibody by determining the tracer antibody in the capture antibody-antigen-tracer antibody complex.

6. 发明申请

WO2021224360A1 HIGH IONIC STRENGTH DISSOCIATION ASSAY FOR HIGH DRUG TOLERANT TESTING 审中-公开
公开(公告)号：WO2021224360A1
公开(公告)日：2021-11-11
申请号：PCT/EP2021/061929
申请日：2021-05-06
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： JORDAN, Gregor , STAACK, Roland
IPC分类号： G01N33/536 , G01N33/68
摘要： Herein is reported a method for the determination of the presence of anti-drug antibodies in a sample comprising the steps of incubating the sample with MgCl2 at a final concentration in the range of 1 N to 12 N; adding a tracer antibody and incubating the sample thereafter; incubating the isolated tracer antibody-anti-drug antibody-complexes with a detection antibody conjugated to a detectable label and determining the presence of anti-drug antibodies if a signal above a threshold level is obtained.

7. 发明申请

WO2021019036A1 DOSAGE AND ADMINISTRATION REGIMEN FOR THE TREATMENT OR PREVENTION OF C5-RELATED DISEASES BY THE USE OF THE ANTI-C5 ANTIBODY CROVALIMAB 审中-公开
公开(公告)号：WO2021019036A1
公开(公告)日：2021-02-04
申请号：PCT/EP2020/071555
申请日：2020-07-30
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： SOSTELLY, Alexandre Antoine Bernard , BUATOIS, Simon Bertrand Marie , SOUBRET, Antoine , JAMINION, Félix Grégoire Jason , JORDAN, Gregor , BUCHER, Christoph , CHAROIN, Jean-Eric
IPC分类号： A61K39/00 , A61K38/00 , A61P7/00 , A61P37/06
摘要： The present invention relates to a dosage and administration regimen of anti-C5 antibodies, particularly of the anti-C5 antibody Crovalimab, for use in a method of treating or preventing C5-related disease in a subject, including paroxysmal nocturnal hemoglobinuria (PNH). The dosage and treatment regimen of the present invention include the administration of an anti-C5 antibody, preferably of the anti-C5 antibody Crovalimab, with loading doses followed by the administration of (a) maintenance dose(s) of the anti-C5 antibody to the subject, wherein the initial administered loading dose is intravenously given to the subject and the remaining loading and maintenance doses are subcutaneously administered in a lower dosage as the intravenously administered loading dose.

8. 发明申请

WO2021019033A1 DOSAGE AND ADMINISTRATION REGIMEN FOR THE TREATMENT OR PREVENTION OF C5-RELATED DISEASES BY THE USE OF THE ANTI-C5 ANTIBODY CROVALIMAB 审中-公开
公开(公告)号：WO2021019033A1
公开(公告)日：2021-02-04
申请号：PCT/EP2020/071551
申请日：2020-07-30
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： SOSTELLY, Alexandre Antoine Bernard , BUATOIS, Simon Bertrand Marie , SOUBRET, Antoine , JAMINION, Félix Grégoire Jason , JORDAN, Gregor , BUCHER, Christoph , CHAROIN, Jean-Eric
IPC分类号： A61K39/00 , A61K38/00 , A61P7/00 , A61P37/06
摘要： The present invention relates to a dosage and administration regimen of anti-C5 antibodies, particularly of the anti-C5 antibody Crovalimab, for use in a method of treating or preventing C5-related disease in a subject, including paroxysmal nocturnal hemoglobinuria (PNH). The dosage and treatment regimen of the present invention include the administration of an anti-C5 antibody, preferably of the anti-C5 antibody Crovalimab, with loading doses followed by the administration of (a) maintenance dose(s) of the anti-C5 antibody to the subject, wherein the initial administered loading dose is intravenously given to the subject and the remaining loading and maintenance doses are subcutaneously administered in a lower dosage as the intravenously administered loading dose.

9. 发明申请

WO2013132000A1 MULTIPLEXED CHROMATOGRAPHY-IMMUNOASSAY METHOD FOR THE CHARACTERIZATION OF CIRCULATING IMMUNE COMPLEXES 审中-公开
标题翻译：用于表征循环免疫复合物的多重色谱 - 免疫测定方法
公开(公告)号：WO2013132000A1
公开(公告)日：2013-09-12
申请号：PCT/EP2013/054587
申请日：2013-03-07
申请人： F. HOFFMANN-LA ROCHE AG , DAHL, Uwe , JORDAN, Gregor , STAACK, Roland
发明人： DAHL, Uwe , JORDAN, Gregor , STAACK, Roland
IPC分类号： G01N33/564 , G01N33/68 , G01N33/94
CPC分类号： G01N33/564 , G01N33/686 , G01N33/94
摘要： Thus, herein is reported a method for analyzing/characterizing circulating immune complexes (CICs) formed in vivo comprising a size-exclusion chromatography of a sample obtained from a mammal to which the drug had been administered at least once for determining the weight/size of the immune complexes, optionally a second non-SEC chromatography, and at least one immunoassay, whereby the immune complex is characterized by the correlation of the immune complex size and the immunoassay result/read-out. Also reported herein is the use of a method as reported herein for determining a correlation to altered pharmacokinetics, for determining loss or reduction of efficacy, for determining neutralization of natural counterparts of the drug, for determining immune and hypersensitivity reactions, including serum sickness/type III hypersensitivity reaction/immune complexmediated disease.
摘要翻译：因此，本文报道了用于分析/表征体内形成的循环免疫复合物（CIC）的方法，其包括从哺乳动物获得的样品的尺寸排阻色谱，所述样品已经至少施用一次以评估药物的重量/体积免疫复合物，任选的第二非SEC色谱法和至少一种免疫测定法，其中免疫复合物的特征在于免疫复合物大小与免疫测定结果/读数的相关性。本文还报道了使用如本文报道的用于确定与改变的药代动力学相关性的方法，用于确定药物的天然对应物的中和，用于确定药物的天然对应物的中和，用于确定免疫和超敏反应，包括血清病/类型 III超敏反应/免疫复合物介导的疾病。

10. 发明公开

EP4085251A1 METHOD FOR DETERMINING THE AMOUNT OF A THERAPEUTIC ANTIBODY IN THE BRAIN 审中-实审
公开(公告)号：EP4085251A1
公开(公告)日：2022-11-09
申请号：EP20842239.4
申请日：2020-12-29
申请人： F. Hoffmann-La Roche AG
发明人： BRADY, Kevin , JORDAN, Gregor , ROTTACH, Sylvia , SCHAEFER, Martin , STAACK, Roland , STUBENRAUCH, Kay-Gunnar
IPC分类号： G01N33/50

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