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Tesidolumab for use in the treatment of transplant rejection

A transplant rejection and pre-transplant technology, applied in the direction of antibodies, specific peptides, antibody medical components, etc., can solve problems such as difficulties, increase the risk of infection with Neisseria meningitidis, and susceptibility to opportunistic infections.

Inactive Publication Date: 2019-02-05
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chronic administration of eculizumab can be problematic, especially in patients who are particularly susceptible to such infections, such as pediatric patients or patients who cannot be vaccinated, therefore, chronic administration of eculizumab in these patient groups Antibiotics May Increase Risk of Neisseria Meningitidis Infection
Transplant patients are often on immunosuppressive therapy throughout their lives and are therefore susceptible to and at risk of developing opportunistic infections
Treatment of these infections in transplant patients is also difficult and more complicated than in non-transplant patients

Method used

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  • Tesidolumab for use in the treatment of transplant rejection
  • Tesidolumab for use in the treatment of transplant rejection
  • Tesidolumab for use in the treatment of transplant rejection

Examples

Experimental program
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Effect test

example 1

[0137] The relationship between serum concentration of total testolumab and serum complement activity was determined. Analysis of these data indicated that total testolumab concentrations below 55 μg / mL resulted in less than complete inhibition of serum complement activity.

[0138] Using modeling, the relationship between testolumab dose and exposure suggests that a dose of 20 mg / kg every two weeks is sufficient to ensure inhibition of complement activity. According to this model, less than 0.5% of patients had exposure values ​​at trough levels below the limit of 55 μg / ml.

[0139] Based on the relationship between total serum concentrations of tesdolumab and serum complement activity, it has been found that total serum tesdolizumab concentrations <55 μg / mL result in less than complete inhibition of serum complement activity. Therefore, a minimum total serum concentration of tesidolumab of 55-100 μg / mL is sufficient to ensure inhibition of complement activity.

example 2

[0141] For the Phase 2 study of prevention of antibody-mediated rejection (AMR) after kidney transplantation, two cohorts of presensitized kidney transplant recipients (KTR) at high or intermediate risk of developing AMR will be recruited. Forty-eight KTRs will be enrolled according to immune risk as defined by their pre-existing donor-specific antibody concentration (DSA) and B-cell flow cytometry crossmatch (BFXM)-based functional assessment of immune risk. Both groups will receive the same treatment regimen with tesidolumab in addition to conventional immunosuppressive therapy and local pre- and post-transplant desensitization.

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Abstract

The present invention relates to the use of tesidolumab for the prevention or treatment of transplant rejection and in particular antibody mediated rejection of allografts.

Description

technical field [0001] The present invention relates to tesidolumab or an antigen-binding fragment thereof, particularly in presensitized patients, for use in the prevention or treatment of transplant rejection or its associated conditions such as antibody-mediated rejection (AMR) , and involves appropriate weight-based adjusted doses and dosing regimens. Background technique [0002] Every year, patients are barred from receiving potentially life-saving organ transplants because of pre-existing antibodies against human leukocyte antigens (HLA) on the surface of donor cells. These patients are considered "sensitized" or "presensitized" to their donor organs, which sensitization may be the result of previous transplantation, pregnancy and / or blood transfusion. The presence of certain donor-specific antibodies (DSAs), regardless of other factors that might indicate a donor match, causes limitations on transplantation. In the United States and Europe, approximately 20%–40% of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/18C07K16/40
CPCA61K39/395A61K39/39541A61K39/3955C07K16/40A61K2039/505A61K2039/54A61K2039/545C07K2317/76C07K16/18A61P37/06C07K2317/94
Inventor F·穆埃尔斯豪森M·迈耶A·斯莱德I·巴尔切娃M·密尔顿
Owner NOVARTIS AG
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