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Anti-IL-17RA monoclonal antibody and application thereof

A monoclonal antibody, expression vector technology, applied in the direction of antibodies, anti-receptors/cell surface antigens/cell surface determinants, immunoglobulins, anti-inflammatory agents, etc., to achieve the effect of preventing progression, alleviating symptoms, and strong affinity

Active Publication Date: 2020-10-30
BEIJING DONGFANG BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no drug with the same target on the market in China. In order to meet the needs of the domestic market, it is urgent to develop anti-IL-17RA monoclonal antibodies with higher affinity and better efficacy to fill the gap in the domestic market

Method used

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  • Anti-IL-17RA monoclonal antibody and application thereof
  • Anti-IL-17RA monoclonal antibody and application thereof
  • Anti-IL-17RA monoclonal antibody and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Example 1 of the present invention provides an anti-IL-17RA monoclonal antibody, wherein the monoclonal antibody includes a heavy chain variable region and a light chain variable region, and the amino acid sequence of the heavy chain variable region is selected from one of the following sequences Species: SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9 or SEQ ID NO:10; the amino acid sequence of the light chain variable region is selected from one of the following sequences: SEQ ID NO:11, SEQ ID NO:12 or SEQ ID NO:13.

[0045] The present invention utilizes a fully synthetic ScFv single-chain phage antibody library to screen and obtain a fully human monoclonal antibody specifically binding to IL-17RA. At present, fully human antibodies are the main direction for the development of therapeutic antibodies, and the emergence of antibody library technology provides a good technical platform for the preparat...

Embodiment 2

[0097] Embodiment 2 of the present invention also provides a polypeptide or protein comprising the anti-IL-17RA monoclonal antibody screened in Embodiment 1.

[0098] The present invention also provides a polynucleotide sequence or combination, the polynucleotide sequence or combination encodes the amino acid sequence of the anti-IL-17RA monoclonal antibody screened in Example 1.

[0099] The present invention also provides a recombinant DNA expression vector, which comprises the above polynucleotide sequence or combination.

[0100] The present invention also provides a host cell transfected with the recombinant DNA expression vector, the host cell includes prokaryotic cells, yeast cells, insect cells or mammalian cells;

[0101] Preferably, the host cell is a mammalian cell, and the mammalian cell is HEK293E cell, CHO cell or NSO cell.

[0102] The present invention also provides a medicine or a pharmaceutical composition, which comprises the anti-IL-17RA monoclonal antibod...

Embodiment 3

[0105] Example 3, Gradual dilution of phage Elisa to compare the affinity of anti-IL-17RA monoclonal antibodies

[0106] 3.1 Preparation of monoclonal antibody purified phage:

[0107] The 11 monoclonal antibodies (mAb-1, mAb-2, mAb-3, mAb-4, mAb-5, mAb-6, mAb-7, mAb-8, mAb-4, mAb-5, mAb-6, mAb-7, mAb-8, mAb -9, mAb-10, mAb-11) were transferred to 2YTAG liquid medium, shake cultured to the logarithmic growth phase, and then added M13K07 auxiliary phage infection, after centrifugation, the bacteria were resuspended in 2YTAKA, cultured at 28°C overnight and expanded The phages were amplified, and the phages were purified by sedimentation with PEG6000-NaCl the next day. The purified phage of the anti-IL-17RA monoclonal antibody (AMH14 / AML14) provided by the core patent US7833527B2 of the marketed product Brodalumab was used as a positive control.

[0108] 3.2 Affinity comparison at the phage level

[0109] IL-17RA-ECD-His was coated with 0.01M PBS buffer solution of pH 7.2, 10...

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Abstract

The invention relates to the technical field of antibody engineering, and particularly provides an anti-IL-17RA monoclonal antibody which comprises a heavy chain variable region and a light chain variable region. The anti-IL-17RA monoclonal antibody has relatively strong affinity and good biological activity, the specific binding with the IL-17RA antigen can be realized, the combination of the IL-17A and the IL-17RA is blocked, the IL-17 / IL-17R signal pathway is antagonized and blocked, the IL-17 / IL-17R signal pathway is the autoimmune disease treatment drug having the huge potential, the symptoms of the autoimmune disease are effectively relieved, the progression of the disease is prevented, and the autoimmune disease comprises but is not limited to psoriasis, rheumatoid arthritis, ankylosing spondylitis or scleroderma and the like.

Description

technical field [0001] The invention relates to the technical field of antibody engineering, in particular to an anti-IL-17RA monoclonal antibody and its application. Background technique [0002] Autoimmune diseases refer to diseases caused by the body's immune response to self-antigens, resulting in damage to its own tissues. Many diseases have been listed as autoimmune diseases, such as psoriasis, rheumatoid arthritis, ankylosing spondylitis, scleroderma, etc. Among them, psoriasis (Psoriasis), also known as psoriasis, is characterized by erythematous and scaly plaques of different sizes and clear borders on the skin, covered with a large number of dry silvery white scales. The histological features of psoriatic skin are excessive proliferation of epidermal keratinocytes, vascular proliferation, and infiltration of dendritic cells, macrophages, neutrophils, and T cells. The pathogenesis of psoriasis involves complex inflammatory responses and immune system. The prevale...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/28A61K39/395A61P37/02A61P17/06A61P19/02A61P29/00A61P19/08A61P17/00
CPCA61K2039/505A61P17/00A61P17/06A61P19/02A61P19/08A61P29/00A61P37/02C07K16/2866C07K2317/52C07K2317/56C07K2317/92
Inventor 白义李晓敏张稳
Owner BEIJING DONGFANG BIOTECH
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