Application of TACI-Fc fusion protein to preparation of medicines for treating neuromyelitis opticaspectrum disorders and multiple sclerosis

A technology for neuromyelitis optica and multiple sclerosis, applied in the preparation of drugs for the treatment of neuromyelitis optica spectrum diseases and multiple sclerosis, in the field of TACI-Fc fusion protein, which can solve the problem that TACI fusion protein cannot be used to treat NMOSD and TACI fusion protein Cannot be used to treat MS, MS recurrence rate and other problems, to achieve the effect of drug side effects, reduce drug cost, and small dosage

Inactive Publication Date: 2019-12-03
REMEGEN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, the latest data show that the clinical trials of Atacicept (Ataixipu) against optic neuritis (a type of neuromyelitis optica spectrum disease NMOSD) (February 17, 2016) failed, indicating that TACI fusion protein may not be used for the treatment of NMOSD
Two years ago, the randomized, double-blind, placebo-controlled phase II clinical trial of Atacicept (Artecept) in the treatment of MS also failed (MAR 20, 2014), and the results showed that atacicept treatment would lead to an increase in the recurrence rate of MS. Therefore, in Prior to the present invention, data in the prior art indicated that TACI fusion proteins may not be useful in the treatment of MS

Method used

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  • Application of TACI-Fc fusion protein to preparation of medicines for treating neuromyelitis opticaspectrum disorders and multiple sclerosis
  • Application of TACI-Fc fusion protein to preparation of medicines for treating neuromyelitis opticaspectrum disorders and multiple sclerosis
  • Application of TACI-Fc fusion protein to preparation of medicines for treating neuromyelitis opticaspectrum disorders and multiple sclerosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1: Effect of TACI-Fc fusion protein on lymphocyte proliferation and apoptosis

[0057] Separation of normal mouse spleen T and B cells by magnetic beads

[0058] Spleen of C57 / BL6 mice aged 6-8 weeks was aseptically isolated, placed on a 70 μm filter in pre-cooled PBS, and the spleen was carefully ground clockwise; the filtrate was placed in a 15ml centrifuge tube and processed by breaking red; ml of rat serum to block; transfer to a 5ml round bottom separation tube; add 50μl / ml Isolation Cocktail, incubate at room temperature for 10min; vortex for 30s; add 75μl / ml microspheres, incubate at room temperature for 2.5min; dilute to 2.5ml, Put it in a magnet and let it stand at room temperature for 3 minutes; pour out the liquid to obtain the isolated T cell or B cell suspension.

[0059] The finished product of RCT-18 dry powder (Rongchang Biopharmaceutical (Yantai) Co., Ltd.) was prepared with water for injection to 0.04mg / ml, 0.4mg / ml, and 0.8mg / ml concentration...

Embodiment 2

[0062] Embodiment 2: establish EAE mouse model

[0063] C57BL / 6J female mice at 8-10 weeks were subcutaneously injected with 200 μl of complete Freund’s adjuvant containing 100 μg MOG35-55 (GL Biochem) (containing heat-killed Mycobacterium tuberculosis (MTB)) subcutaneously in each mouse’s buttocks at three points (H37Ra strain; Difco). Specific methods: (1) Dissolve MOG33-35 in PBS, and prepare liquid A with an initial concentration of 1 mg / ml; (2) Weigh a certain mass of MTB in a mortar, and mix IFA (Incomplete Freund's adjuvant; Sigma-Aldrich) was slowly added dropwise into the mortar and ground while adding to prepare 5 mg / ml liquid B; (3) draw liquid A and liquid B with two glass syringes respectively, connect the three-way pipe, and Push back and forth on the ice until it is obviously difficult to push, then take a drop of the suspension in water, and if it does not spread, you can inject the model. The final concentration of MOG was 0.5mg / ml, and the final concentrati...

Embodiment 3

[0066] EAE mouse treatment protocol

[0067] Animals were divided into negative control group, positive control group and experimental group. The experimental group was given doses of 0.350, 1.105, 3.333, 10 and 30 mg / kg. The positive control group was given FTY-720 at a dose of 5 mg / kg. The period is the intraperitoneal injection on the next day on the 16th day after immunization, and the treatment is continued until the inflammation subsides, that is, the 35th day. The negative control group was intraperitoneally injected with normal saline at the same time point. The scores and body weights of the mice were recorded every day, and the scores were evaluated blindly by an independent second person. according to image 3 The experimental results shown showed that after TACI-Ig treatment, the clinical symptoms of EAE mice were significantly improved, and the clinical scores were statistically different from those of the negative control group, but not significantly different ...

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Abstract

The invention relates to the field of application of B lymphocyte stimulating factor acceptor-antibody fusion protein to treatment of autoimmunity diseases, in particular to an application of TACI-Fcfusion protein to preparation of medicines for treating neuromyelitis opticaspectrum disorders (NOOSD) and multiple sclerosis (MS).

Description

technical field [0001] The present invention relates to the field of applying B lymphocyte stimulating factor receptor-antibody fusion protein to treat autoimmune diseases, more specifically, relates to the preparation of TACI-Fc fusion protein for treating neuromyelitis optica spectrum disease (NMOSD) and multiple sclerosis ( MS) drug application. Background technique [0002] Neuromyelitis optica (NMO) is an acute or subacute demyelinating disease involving the optic nerve and spinal cord simultaneously or sequentially. The disease was first described by Devic (1894), and its clinical features are acute or subacute onset blindness in one or both eyes, accompanied by transverse or ascending myelitis in the days or weeks before or after it, research data show NMO accounts for up to 22% of all demyelinating diseases, with a low proportion in Western countries and a high proportion in non-Caucasians. The disease is mainly characterized by B-cell immune disorders, and is char...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61K38/17A61P25/00A61P37/02
CPCA61K38/177A61K39/395A61P25/00A61P37/02A61K2300/00A61K9/0019A61K38/1793A61K38/17A61P29/00A61P37/00C07K14/70578C07K2319/30A61K9/0053
Inventor 房健民姜静李慎军黄敏
Owner REMEGEN CO LTD
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