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Use of Anti-il-6 antibody, e.g., clazakizumab for desensitization of solid organ transplant recipients and/or for preventing, stabilizing or reducing antibody mediated rejection (ABMR)

An IL-6, recipient technology, applied in the direction of resistance to vector-borne diseases, anti-animal/human immunoglobulins, antibodies, etc.

Pending Publication Date: 2020-10-30
VITAERIS INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, there are no approved treatments for active ABMR including CABMR

Method used

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  • Use of Anti-il-6 antibody, e.g., clazakizumab for desensitization of solid organ transplant recipients and/or for preventing, stabilizing or reducing antibody mediated rejection (ABMR)
  • Use of Anti-il-6 antibody, e.g., clazakizumab for desensitization of solid organ transplant recipients and/or for preventing, stabilizing or reducing antibody mediated rejection (ABMR)
  • Use of Anti-il-6 antibody, e.g., clazakizumab for desensitization of solid organ transplant recipients and/or for preventing, stabilizing or reducing antibody mediated rejection (ABMR)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0249] Clarizumab as part of a desensitization regimen waiting for transplant and in allograft transplantation highly sensitized subjects after

[0250] Curative or prophylactic treatment to alleviate or eliminate or prevent renal transplantation in patients awaiting kidney transplantation who have previously become sensitized or are at risk of becoming sensitized to a donor organ (eg, due to history of blood transfusion, pregnancy, or previous transplantation) Sensitization to antigens (eg, HLA antigens and non-HLA antigens) present in donor organs. For example, the patient is treated by one or more of: plasmapheresis, plasma exchange, optionally with intravenous immunoglobulin and an anti-B cell agent such as rituximab or a plasma cell inhibitor such as boron Tezomib (proteosome inhibitor) combination. These procedures are repeated as necessary and are generally continued until, and may be continued after, organ transplantation.

[0251] In addition, to enhance the eff...

Embodiment 2

[0257] Example 2: Use of clarizumab in highly HLA-sensitized patients awaiting renal transplantation

[0258] Patients who have suffered previous allograft failure represent a major problem for transplant centers because they are highly human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. Eligible transplant patients in accordance with the present invention will typically receive up to 6 once-monthly doses of clarizumab at 25 mg prior to transplantation. If the patient received an HLAi transplant during treatment, participants could continue to receive 6 additional once-monthly doses of clarizumab at a dose of 25 mg, followed by a 6-month regimen of biopsies. If improvement is observed after the 6th dose of clarizumab, patients will receive 6 additional doses over 6 months. Patients showing signs of persistent allograft dysfunction may undergo causative off-protocol biopsy. Patients receiving 12 doses of c...

Embodiment 3

[0262] Example 3: Treatment of patients with advanced AMBR with clarizumab

[0263] Evaluation of the safety, tolerability, pharmacokinetics, pharmacokinetics, and Pharmacodynamics and efficacy (initial assessment). The study was designed as a phase 2 trial and had two follow-up subparts, a 12-week randomized placebo-controlled trial (Part A), in which recipients were assigned to receive the anti-IL-6 antibody clarizumab (n =10) or placebo (n=10), followed by an open-label prospective study in which all 20 study patients received clarizumab for a 40-week period. A study protocol biopsy was performed at the end of Part A and Part B.

[0264] Part A:

[0265] Patients who were positive for anti-HLA donor-specific antibodies (DSA) and had biopsy-proven advanced ABMR (acute / active or chronic / active according to Banff 2015 classification) were identified and recruited at the Kidney Transplant Outpatient Service at two central sites. sexual phenotype) patients. Participants w...

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Abstract

Novel therapeutic protocols are provided relating to the use of an anti-IL-6 antibody, e.g., Clazakizumab in order to prevent, stabilize, reduce or arrest antibody mediated rejection responses in patients receiving solid organ transplants, e.g., patients receiving transplanted kidney, heart, liver, lungs, pancreas, intestines or combinations of any of the foregoing. Also novel therapeutic protocols are provided pertaining to the use of an anti-IL-6 antibody, e.g., Clazakizumab as part of a desensitization protocol for treating highly sensitized subjects waiting for and / or after allograft transplants, e.g., patients who are to receive solid organ transplants, e.g., kidney, heart, liver, lungs, pancreas, intestines, skin or combinations of any of the foregoing. The foregoing treatments may be effected in combination with one or more other immunosuppressant regimens or other desensitization procedures.

Description

[0001] priority claim [0002] This invention claims U.S. Provisional Application No. 62 / 613,447, filed January 4, 2018; U.S. Provisional Application No. 62 / 684,870, filed June 14, 2018; U.S. Provisional Application No. 62 / 736,205, filed September 25, 2018 and the priority of U.S. Provisional Application No. 62 / 773,630, filed November 30, 2018. The contents of each of these provisional applications are incorporated herein by reference in their entirety. [0003] sequence listing [0004] The present invention contains a Sequence Listing containing the sequences of exemplary anti-IL-6 antibodies suitable for use in the claimed therapies. technical field [0005] The present invention relates to the use of anti-IL-6 antibodies such as clarizumab to prevent, stabilize or reduce antibody-mediated rejection in patients receiving solid organ transplants, such as transplanted kidneys, hearts, livers, etc. , lung, pancreas, intestine, skin, or any combination of the foregoing. [...

Claims

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Application Information

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IPC IPC(8): A61K39/395C07K16/24
CPCA61K2039/545A61K2039/505C07K16/248C07K2317/24A61P37/06C07K2317/76Y02A50/30A61P13/12A61P27/02A61P25/28C07K2317/565
Inventor K·周E·庄N·穆尼J·莱昂S·C·乔丹
Owner VITAERIS INC
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