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1. 发明申请

WO2023287663A1 MULTI-VARIATE MODEL FOR PREDICTING CYTOKINE RELEASE SYNDROME 审中-公开
公开(公告)号：WO2023287663A1
公开(公告)日：2023-01-19
申请号：PCT/US2022/036557
申请日：2022-07-08
申请人： GENENTECH, INC. , F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： GRIFFIN, Emily Piccione , MCCALL, Bruce , NIELSEN, Tina Geritz , BELOUSOV, Anton
IPC分类号： G16H20/17 , G16H50/30
摘要： Techniques are provided for predicting a risk of a subject experiencing a cytokine release syndrome of at least a threshold grade subsequent to receiving a treatment. The risk may be predicted based on (for example) a set of baseline characteristics, a risk-score generation model, an on-treatment cytokine level, and/or a treatment dosage. The risk may be used to generate an output corresponding to a recommendation as to whether to monitor the subject via in-patient monitoring.

2. 发明申请

WO2014083178A1 IDENTIFICATION OF PATIENTS IN NEED OF PD-L1 INHIBITOR COTHERAPY 审中-公开
标题翻译：鉴定需要PD-L1抑制剂COEPAPY的患者
公开(公告)号：WO2014083178A1
公开(公告)日：2014-06-05
申请号：PCT/EP2013/075162
申请日：2013-11-29
申请人： F. HOFFMANN-LA ROCHE AG , HOFFMANN-LA ROCHE INC.
发明人： BELOUSOV, Anton , BIANCHINI, Giampaolo , GIANNI, Luca , THOMAS, Marlene
IPC分类号： G01N33/74 , G01N33/68
CPC分类号： C12Q1/6886 , A61K31/337 , A61K39/39558 , A61K2039/505 , C12Q2600/106 , C12Q2600/158 , G01N33/57415 , G01N33/6866 , G01N33/6872 , G01N33/743 , G01N2333/57 , G01N2333/70532 , G01N2333/723 , G01N2800/7033
摘要： The present invention relates to means and methods for determining whether a patient is in need of a PD-L1 inhibitor cotherapy. A patient is determined to be in need of the PD-L1 inhibitor cotherapy if a low or absent ER expression level and an expression level of programmed death ligand 1 (PD-L1) that is increased in comparison to a control is measured in vitro in a sample from the patient. The patient is undergoing therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) or such a therapy is contemplated for the patient. Also provided herein are means and methods for treating a cancer in a cancer patient for whom therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) is contemplated, wherein the patient is to receive PD-L1 inhibitor cotherapy.
摘要翻译：本发明涉及用于确定患者是否需要PD-L1抑制剂治疗的方法和方法。如果在体外测量与对照相比增加的程序性死亡配体1（PD-L1）的低或不存在的ER表达水平和程序性死亡配体1（PD-L1）的表达水平，则确定患者需要PD-L1抑制剂治疗来自病人的样本。患者正在接受治疗，其包括HER2 / neu（ErbB2）信号传导途径的调节剂（如曲妥珠单抗）和化学治疗剂（如十四赛酚）），或者为患者预期这种治疗。本文还提供了用于治疗癌症患者中的癌症的方法和方法，所述癌症患者包括HER2 / neu（ErbB2）信号传导途径的调节剂（如曲妥珠单抗）和化学治疗剂（如十二赛酚）），其中患者是接受PD-L1抑制剂治疗。

3. 发明申请

WO2012084828A1 CHROMATOGRAPHY EQUIPMENT CHARACTERIZATION 审中-公开
标题翻译：色谱设备表征
公开(公告)号：WO2012084828A1
公开(公告)日：2012-06-28
申请号：PCT/EP2011/073243
申请日：2011-12-19
申请人： F. HOFFMANN-LA ROCHE AG , BELOUSOV, Anton , DAMS, Thomas , GERWAT, Benjamin
发明人： BELOUSOV, Anton , DAMS, Thomas , GERWAT, Benjamin
IPC分类号： G01N30/86 , G01N30/88 , C07K1/16
CPC分类号： G06F19/70 , C07K1/22 , G01N30/50 , G01N30/86 , G01N30/8665 , G01N30/88
摘要： Herein is reported a method for determining whether a re-useable chromatography column packing, which is used at least for the second time in a purification step of a purification of a polypeptide, has reduced separation efficacy in said purification step of said purification of said polypeptide, comprising in particular the following steps: a) identifying and determining the experimental data of an inert change of at least one physicochemical parameter of a mobile phase passing through said re-useable chromatography column packing, b) determining the parameters of a function of formula (I) by fitting the experimental data of the inert change of the physicochemical parameter of the at least second use, c) determining the difference between the experimental data of the inert change of the physicochemical parameter of the at least second use and the function of formula (I) with the parameters determined in step b).
摘要翻译：本文报道了用于确定在纯化多肽的纯化步骤中至少第二次使用的可再利用色谱柱填充是否在所述纯化所述多肽的纯化步骤中具有降低的分离功效的方法特别地包括以下步骤：a）鉴定和确定通过所述可重复使用的色谱柱填充物的流动相的至少一个物理化学参数的惰性变化的实验数据，b）确定式（I）通过拟合至少第二次使用的物理化学参数的惰性变化的实验数据，c）确定至少第二次使用的物理化学参数的惰性变化的实验数据与其功能的差异式（I）与步骤b）中确定的参数。

4. 发明申请

WO2010149367A1 CHARACTERIZATION OF RE-USEABLE CHROMATOGRAPHY EQUIPMENT 审中-公开
标题翻译：可重复使用的色谱设备的表征
公开(公告)号：WO2010149367A1
公开(公告)日：2010-12-29
申请号：PCT/EP2010/003813
申请日：2010-06-22
申请人： F. HOFFMANN-LA ROCHE AG , BELOUSOV, Anton , DAMS.Thomas , GERWAT, Benjamin
发明人： BELOUSOV, Anton , DAMS.Thomas , GERWAT, Benjamin
IPC分类号： G01N30/50 , G01N30/86
CPC分类号： G01N30/86 , C07K1/16 , G01N30/50 , G01N30/88
摘要： Herein is reported a method for determining whether a re-useable chromatography column packing, which is used at least for the second time in a purification step of a purification of a polypeptide, has reduced separation efficacy in said purification step of said purification of said polypeptide. The method comprises the following steps: a) identifying and determining the experimental data of an inert change of at least one physicochemical parameter of a mobile phase passing through said re-useable chromatography column packing, b) determining the parameters of a function of formula I by fitting the experimental data of the inert change of the physicochemical parameter of the at least second use, c) determining the difference between the experimental data of the inert change of the physicochemical parameter of the at least second use and the function of formula I with the parameters determined in step b), d) calculating the difference between the maximum value and the minimum value of the difference determined in step c) and normalizing said difference, e) determining reduced separation efficacy of said re-useable chromatography column packing when the absolute value of the difference calculated in step d) is more than 0.1, wherein the function of formula I is with the amplitude P1, the starting value AO, the mean value m, the standard deviation s, and wherein erf is the error function.
摘要翻译：本文报道了用于确定在纯化多肽的纯化步骤中至少第二次使用的可再利用色谱柱填充是否在所述纯化所述多肽的纯化步骤中具有降低的分离功效的方法。该方法包括以下步骤：a）鉴定和确定通过所述可重复使用的色谱柱填充物的流动相的至少一个物理化学参数的惰性变化的实验数据，b）确定式I的函数的参数通过拟合至少第二次使用的物理化学参数的惰性变化的实验数据，c）确定至少第二次使用的物理化学参数的惰性变化与式I的功能的实验数据之间的差异，步骤b）中确定的参数，d）计算在步骤c）中确定的差异的最大值和最小值之间的差异，并且对所述差异进行归一化，e）确定当所述可再利用的色谱柱填充物的分离效率降低时在步骤d）中计算的差的绝对值大于0.1，其中式I的函数与幅度相关 e P1，起始值AO，平均值m，标准偏差s，其中erf是误差函数。

5. 发明公开

EP4371125A1 MULTI-VARIATE MODEL FOR PREDICTING CYTOKINE RELEASE SYNDROME 审中-实审
公开(公告)号：EP4371125A1
公开(公告)日：2024-05-22
申请号：EP22748660.2
申请日：2022-07-08
申请人： Genentech, Inc. , F. Hoffmann-La Roche AG
发明人： GRIFFIN, Emily Piccione , MCCALL, Bruce , NIELSEN, Tina Geritz , BELOUSOV, Anton
IPC分类号： G16H20/17 , G16H50/30
CPC分类号： G16H50/30 , G16H20/17

6. 发明公开

EP3511718A1 PD-L1 INHIBITOR 审中-公开
公开(公告)号：EP3511718A1
公开(公告)日：2019-07-17
申请号：EP18204426.3
申请日：2013-11-29
申请人： F. Hoffmann-La Roche AG
发明人： BELOUSOV, Anton , BIANCHINI, Giampaolo , GIANNI, Luca , THOMAS, Marlene
IPC分类号： G01N33/74 , G01N33/68
摘要： The present invention relates to means and methods for determining whether a patient is in need of a PD-L1 inhibitor cotherapy. A patient is determined to be in need of the PD-L1 inhibitor cotherapy if a low or absent ER expression level and an expression level of programmed death ligand 1 (PD-L1) that is increased in comparison to a control is measured in vitro in a sample from the patient. The patient is undergoing therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) or such a therapy is contemplated for the patient. Also provided herein are means and methods for treating a cancer in a cancer patient for whom therapy comprising a modulator of the HER2/neu (ErbB2) signaling pathway (like Trastuzumab) and a chemotherapeutic agent (like dodetaxel) is contemplated, wherein the patient is to receive PD-L1 inhibitor cotherapy.

7. 发明公开

EP3141603A1 GPC3-TARGETED THERAPEUTIC AGENT FOR ADMINISTRATION TO PATIENTS FOR WHOM GPC3-TARGETED THERAPEUTIC AGENT THERAPY IS EFFECTIVE 审中-实审
标题翻译： GPC3 ANZIELENDES治疗剂与GPC3的靶向治疗的患者治疗手段的行政管理
公开(公告)号：EP3141603A1
公开(公告)日：2017-03-15
申请号：EP15789676.2
申请日：2015-05-08
申请人： Chugai Seiyaku Kabushiki Kaisha , F. Hoffmann-La Roche AG
发明人： OHTOMO, Toshihiko , TANAKA, Takayoshi , SUGITANI, Yasuo , PUIG, Oscar , CHEN, Gong , LEE, Ruey-min , BELOUSOV, Anton , CHEN, Ya-Chi , REIS, Bernhard
IPC分类号： C12N15/09 , A61K39/395 , A61P35/00 , C07K16/28 , C12Q1/02 , G01N33/53
CPC分类号： C07K16/303 , A61K47/486 , A61K2039/505 , A61K2039/55 , C07K2317/24 , C07K2317/732 , C07K2317/92 , C12Q1/6886 , C12Q2600/106 , C12Q2600/156 , C12Q2600/158 , G01N33/5011 , G01N33/56972 , G01N33/57438 , G01N2800/52 , G01N2800/7028
摘要： The present invention discloses a method for determining the efficacy of GPC3-targeting drug therapy for cancer in a patient before the start of GPC3-targeting drug therapy or a patient or determining the continuation of GPC3-targeting drug therapy for a patient, including measuring the number of an immunocyte or an expression level of a molecule expressed on the immunocyte in a biological sample isolated from the patient before the start of GPC3-targeting drug therapy and/or the patient treated with the GPC3-targeting drug therapy, wherein when the number of an immunocyte or an expression level of a molecule expressed on the immunocyte is a predetermined value, the efficacy of the GPC3-targeting drug therapy is determined or the continuation of the GPC3-targeting drug therapy is determined. The present invention also discloses a GPC3-targeting drug or a preparation which is to be administered to a patient for which the efficacy of the GPC3-targeting drug therapy has been determined or the continuation of the GPC3-targeting drug therapy has been determined.
摘要翻译：本发明光盘GPC3靶向药物治疗或患者或确定性采矿GPC3靶向药物治疗的患者中的延续，包括测量开始前失去了一种用于确定性采矿GPC3靶向药物治疗癌症的功效在患者中免疫细胞的或在GPC3靶向药物治疗和/或患者与GPC3靶向药物疗法治疗开始前从所述患者中分离的生物样品中过表达的免疫细胞的分子的表达水平数，worin当数免疫细胞的或过表达的在对免疫细胞的分子的表达水平是一个预定值时，GPC3靶向药物治疗的疗效是确定性的开采或GPC3靶向药物治疗的延续是确定性的开采。因此，本发明光盘松GPC3靶向药物或制剂的所有要被给予的量，GPC3靶向药物治疗的功效已经结束的患者，开采或者GPC3靶向药物治疗的延续已经结束开采。

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