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Treatment paradigm for an Anti-cd19 antibody and venetoclax combination treatment

An antibody and BCL-2 technology, applied in the direction of antibody medical components, antibodies, drug combinations, etc., can solve the problem of increased risk of TLS

Pending Publication Date: 2020-01-10
MORFOZIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, a combination based therapy of MOR00208 and venetoclax offers a promising therapy for the treatment of CLL, NHL and / or ALL, but based on the additive / overlapping cytotoxicity of MOR00208 and venetoclax, its potential to bear the increased risk of TLS

Method used

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  • Treatment paradigm for an Anti-cd19 antibody and venetoclax combination treatment
  • Treatment paradigm for an Anti-cd19 antibody and venetoclax combination treatment
  • Treatment paradigm for an Anti-cd19 antibody and venetoclax combination treatment

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Embodiment approach

[0079] Because of the similar mechanism of action of venetoclax and other BCL-2 inhibitors, it is believed that combinations of exemplary anti-CD19 antibodies and BCL-2 inhibitors other than venetoclax may be useful in patients with non-Hodgkin Lymphoma, chronic lymphocytic leukemia and / or small lymphocytic lymphoma, the mode of administration disclosed herein should also be effective and mitigate the risk of TLS.

[0080] Because the exemplary anti-CD19 antibody and other anti-CD19 antibodies bind to CD19, it is believed that any combination of anti-CD19 antibody and B-cell lymphoma 2 (Bcl-2) protein inhibitor in the treatment of patients with non-Hodgkin lymphoma The mode of administration disclosed herein should also be effective and mitigate the risk of TLS in patients with chronic lymphocytic leukemia, chronic lymphocytic leukemia and / or small lymphocytic lymphoma, where anti-CD19 antibodies are described, for example, in U.S. Patent Application Serial No. 12 / 377,251(Xen...

Embodiment

[0122] Research

[0123] This is a multicenter, open-label Phase II study of MOR00208 in combination with venetoclax in relapsed / refractory (R / R) CLL or Adult patients with R / R SLL. A total of 120 patients were enrolled in Europe and the United States. The primary objective of the study is to determine the safety and efficacy of the combination of MOR00208 and venetoclax.

[0124] The study will include a safety run-in phase with 10-12 patients enrolled for each combination treatment. MOR00208 will be administered as an intravenous (IV) infusion at a dose of 12.0 mg / kg and the daily dose of venetoclax is a 400 mg oral tablet.

[0125] To mitigate the risk of TLS, after initial treatment with MOR00208, start venetoclax at 20 mg for 7 days starting on cycle 1 day 8 (C1D8), followed by a weekly dosing schedule up to the recommended The daily dose is 400mg.

[0126] Once 10 patients have completed at least 5 weeks of combination therapy, the safety run-in period ends with the...

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Abstract

The present disclosure provides anti-CD19 antibodies and venetoclax for use in the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia and / or small lymphocytic lymphoma. The anti-CD19 antibodies, in particular MOR00208, and venetoclax are administered to patients suffering non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and / or small lymphocytic lymphoma (SLL) according to a specific treatment paradigm to mitigate therapy associated tumor lysis syndrome.

Description

[0001] field of invention [0002] The present disclosure provides a treatment paradigm comprising an anti-CD19 antibody and venetoclax for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and / or small lymphocytic lymphoma. Anti-CD19 antibodies, especially MOR00208 and Venetoclax to mitigate treatment-associated tumor lysis syndrome. Background technique [0003] B cells are lymphocytes that play an important role in the humoral immune response. They are produced in the bone marrow of most mammals and comprise 5-15% of the circulating lymphoid pool. The main function of B cells is to make antibodies against various antigens and is an important part of the adaptive immune system. Due to their critical role in regulating the immune system, dysregulation of B cells is associated with a variety of diseases such as lymphomas and leukemias. These diseases include non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K31/00C07K16/28A61P35/00
CPCA61K39/395C07K16/2803A61K45/06A61K31/635A61K31/496A61P35/00A61K2300/00A61K39/3955A61K2039/505A61K2039/545
Inventor P·凯莱曼M·施瓦尔茨M·温德尔里奇S·黑格D·韦内特
Owner MORFOZIS AG
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