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公开(公告)号：US09352001B2
公开(公告)日：2016-05-31
申请号：US14206785
申请日：2014-03-12
发明人： Michael Har-Noy
IPC分类号： A61K35/26 , A61K35/28 , A61K35/17 , C12N5/0783 , A61K39/00
CPC分类号： A61K39/0005 , A61K35/17 , A61K2039/5154 , A61K2039/57 , C12N5/0636 , C12N2501/51 , C12N2501/515 , C12N2531/00 , C12N2533/40
摘要： A method of manipulating allogeneic cells for use in allogeneic cell therapy protocols is described. The method provides a composition of highly activated allogeneic T-cells which are infused into immunocompetent cancer patients to elicit a novel anti-tumor immune mechanism called the “Mirror Effect”. In contrast to current allogeneic cell therapy protocols where T-cells in the graft mediate the beneficial graft vs. tumor (GVT) and detrimental graft vs. host (GVH) effects, the allogeneic cells of the present invention stimulate host T-cells to mediate the “mirror” of these effects. The mirror of the GVT effect is the host vs. tumor (HVT) effect. The “mirror” of the GVH effect is the host vs. graft (HVG) effect. The effectiveness and widespread application of the anti-tumor GVT effect is limited by the severe toxicity of the GVH effect. In the present invention, the anti-tumor HVT effect occurs in conjunction with a non-toxic HVG rejection effect. The highly activated allogeneic cells of the invention can be used in methods to stimulate host immunity. The method includes a complete HLA mis-matched setting in patients that have not had a prior bone marrow transplant or received chemotherapy and/or radiation conditioning regimens.
摘要翻译： 描述了用于同种异体细胞治疗方案中的同种异体细胞的操作方法。 该方法提供高度激活的同种异体T细胞的组合物，其被输注到免疫活性癌症患者中以引发称为“镜效应”的新型抗肿瘤免疫机制。 与当前的同种异体细胞治疗方案相反，其中移植物中的T细胞介导有益的移植物抗肿瘤（GVT）和有害的移植物抗宿主（GVH）效应，本发明的同种异体细胞刺激宿主T细胞介导 这些效果的“镜子”。 GVT效应的镜子是宿主与肿瘤（HVT）的作用。 GVH效应的“镜子”是宿主与移植物（HVG）的作用。 抗肿瘤GVT效应的有效性和广泛应用受到GVH效应的严重毒性的限制。 在本发明中，抗肿瘤HVT作用与无毒的HVG排斥反应有关。 本发明的高度激活的同种异体细胞可用于刺激宿主免疫的方法。 该方法包括在没有先前骨髓移植或接受化学疗法和/或放射治疗方案的患者中完整的HLA错配。
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公开(公告)号：US20160136270A1
公开(公告)日：2016-05-19
申请号：US15003437
申请日：2016-01-21
发明人： Michael Har-Noy
CPC分类号： A61K39/0011 , A61K9/0019 , A61K35/17 , A61K39/39 , A61K2039/5152 , A61K2039/5158 , A61K2039/54 , A61K2039/57 , A61P35/00
摘要： The invention disclosed herein relates generally to immunotherapy and, more specifically, to the use of immunotherapy for treating tumors and pathogen infected tissues by first priming patients with allogeneic cells designed to be rejected by a Th1 mediated mechanism, then inducing necrosis or apoptosis in a tumor or pathogen infected lesion by methods such as cryotherapy, irreversible electroporation, chemotherapy, radiation therapy, ultrasound therapy, ethanol chemoablation, microwave thermal ablation, radiofrequency energy or a combination thereof applied against at least a portion of the tumor or pathogen infected tissue, and then delivering one or more doses of allogeneic cells (e.g., Th1 cells) within or proximate to the tumor or pathogen-infected tissue in the primed patient. The present invention provides an immunotherapeutic strategy to develop de-novo systemic (adaptive) immunity to a tumor or pathogen.
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公开(公告)号：US20140294781A1
公开(公告)日：2014-10-02
申请号：US14301700
申请日：2014-06-11
发明人： Michael Har-Noy
IPC分类号： A61K35/14
CPC分类号： A61K39/0005 , A61K35/17 , A61K2039/5154 , A61K2039/57 , C12N5/0636 , C12N2501/51 , C12N2501/515 , C12N2531/00 , C12N2533/40
摘要： A method for formulating T-cells for use as a medicant comprises suspending T-cells with cross-linked surface moieties in a media suitable for infusion. The cross-linked T-cells are packaged in a container suitable for administration to a patient.
摘要翻译： 用于配制用作药物的T细胞的方法包括将具有交联表面部分的T细胞悬浮在适于输注的培养基中。 将交联的T细胞包装在适合给予患者的容器中。
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公开(公告)号：US11045541B2
公开(公告)日：2021-06-29
申请号：US14962728
申请日：2015-12-08
发明人： Michael Har-Noy
IPC分类号： A61K39/00 , A61K39/39 , A61K38/19 , A61K38/21 , A61K39/085 , A61K38/17 , A61K35/17 , A61K38/20 , C12N5/0783 , A61K39/385 , A61K39/44
摘要： The present invention relates to compositions and methods that promote the induction of IL-12 in a patient. The composition includes activated allogeneic cells that are administered to a patient with a disease such as cancer. Administration of the composition skews the patient's immune response to a Th1 environment and produces detectable levels of IL-12 in the patient's plasma, without any IL-12 related toxicity.
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公开(公告)号：US10548956B2
公开(公告)日：2020-02-04
申请号：US14500395
申请日：2014-09-29
发明人： Michael Har-Noy
IPC分类号： A61K39/00
摘要： A method for stimulating the immune system in immunocompromised patients in order to treat opportunistic infection. The method involves the infusion of intentionally mismatched allogeneic cells. In order to prevent graft vs. host disease complications, the allogeneic cells can be irradiated prior to infusion.
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公开(公告)号：US20190350976A1
公开(公告)日：2019-11-21
申请号：US16433659
申请日：2019-06-06
发明人： Michael Har-Noy
摘要： The present invention includes methods for handling live cell compositions in non-nutritive buffer. The cells in the compositions maintain their identity and functional characteristics after being stored in non-nutrititive media up to about 72 hours. The storage method enables the cells to be manufactured at a processing facility and shipped to a point of care site. The invention also includes compositions that have been stored in non-nutritive buffer at storage temperatures while maintaining the functional characteristics.
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公开(公告)号：US10318712B2
公开(公告)日：2019-06-11
申请号：US15077493
申请日：2016-03-22
发明人： Michael Har-Noy
摘要： An apparatus stores and dispenses biologic drug compositions. The apparatus is an automated device that stores a biologic drug under the desired conditions. When authorized, the automated device processes the stored biologic drug by performing the desired processing steps to prepare the biologic drug for administration to a patient. The automated device includes a computing system to transmit patient information to a remote location and receive authorization from a remote location.
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公开(公告)号：US09593308B2
公开(公告)日：2017-03-14
申请号：US14500381
申请日：2014-09-29
发明人： Michael Har-Noy
IPC分类号： C07K16/00 , C12N5/0783 , A61K39/00
CPC分类号： C12N5/0636 , A61K2039/5154 , A61K2039/57 , C12N2501/23 , C12N2501/40 , C12N2501/51 , C12N2501/515 , C12N2501/998 , C12N2531/00 , C12N2533/40
摘要： T-cells are generated with enhanced immunostimulatory capabilities for use in self therapy treatment protocols, by utilizing a biodegradable device with a biodegradable support that has one or more agents that are reactive to T-cell surface moieties. The biodegradable devices are mixed with the T-cells sufficiently so that the one or more agents cross-link with the T-cells' surface moieties and deliver a signal to the T-cells to enhance immunostimulatory capabilities.
摘要翻译： 通过利用具有一种或多种对T细胞表面部分具有反应性的生物可降解载体的可生物降解的装置，产生具有增强免疫刺激能力的T细胞用于自我治疗治疗方案。 将可生物降解的装置与T细胞充分混合，使得一种或多种试剂与T细胞的表面部分交联并向T细胞递送信号以增强免疫刺激能力。
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公开(公告)号：US20160206718A1
公开(公告)日：2016-07-21
申请号：US15084206
申请日：2016-03-29
发明人： Michael Har-Noy
IPC分类号： A61K39/00
CPC分类号： A61K39/0011 , A61B18/02 , A61B18/12 , A61B2018/00613 , A61K38/191 , A61K38/193 , A61K38/2013 , A61K38/208 , A61K38/217 , A61K39/00 , A61K2039/5154 , A61K2039/55516 , A61K2039/55522 , A61K2039/55533 , A61K2039/55538 , A61K2039/57
摘要： This invention relates to compositions and methods for immunotherapy of cancer. Specifically, a method of cancer immunotherapy is described which results in the systemic liquidation of both solid and metastatic tumors whereever they reside in the body. The compositions include activated allogeneic Th1 cells that when administered appropriately lead to liquidation of tumors. The method includes administering priming doses of the therapeutic composition, ablation of a selected tumor lesion along with intratumoral injection of the composition and then infusion of the therapeutic composition. These steps enable the systemic liquidation of tumors secondary to immune cell infiltration and leads to immune-mediated tumor eradication.
摘要翻译： 本发明涉及癌症免疫治疗的组合物和方法。 具体地，描述了一种癌症免疫治疗方法，其导致无论身体存在于固体和转移性肿瘤中的系统性清除。 组合物包括活化的同种异体Th1细胞，其当被适当地施用导致肿瘤的清除时。 该方法包括施用引发剂量的治疗组合物，消融所选择的肿瘤损伤以及肿瘤内注射组合物，然后输注治疗组合物。 这些步骤使得免疫细胞浸润继发的肿瘤的系统性清除并导致免疫介导的肿瘤根除。
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公开(公告)号：US20160203295A1
公开(公告)日：2016-07-14
申请号：US15077493
申请日：2016-03-22
发明人： Michael Har-Noy
CPC分类号： G06F19/3462 , G05B15/02 , G06F19/00 , G06Q50/22 , G07F9/105 , G07F17/0092
摘要： The present disclosure relates to an apparatus for dispensing biologic drug compositions. The apparatus includes an automated device that can store a biologic drug under the desired conditions. When authorized, the automated device can process the stored biologic drug by performing the desired processing steps to prepare the biologic drug for administration to a patient. The automated device may include a computing system to transmit patient information to a remote location and receive authorization from a remote location.
摘要翻译： 本公开涉及用于分配生物药物组合物的装置。 该装置包括可在所需条件下储存生物药物的自动装置。 当被授权时，自动化装置可以通过执行所需的处理步骤来处理储存的生物药物以制备用于给予患者的生物药物。 自动化设备可以包括将患者信息发送到远程位置并从远程位置接收授权的计算系统。
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