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Methods of Treating Rheumatoid Arthritis

a technology for rheumatoid arthritis and treatment methods, applied in the field of treatment methods of rheumatoid arthritis, can solve the problems of a substantial number of patients that either fail to respond to treatment options or eventually become refractory to treatment, and achieve the effects of less frequent injections, less cost to patients, and increased patient complian

Pending Publication Date: 2021-12-09
SINOMAB BIOSCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides methods for treating autoimmune disorders by using B-cell specific anti-CD22 antibodies. The biweekly dosing regimens have advantages over the traditional weekly dosing, including lower number of injections, increased patient compliances, and decreased cost. The antibodies can disrupt a protein called cis-ligation, which helps to reduce inflammation and promote tissue regeneration. Additionally, the antibodies can facilitate trans-ligation of immune cells with autologous cells, which means they can help to promote healing and regeneration within the patient's own body.

Problems solved by technology

Although the introduction of anti-TNF and anti-IL1 combination therapy with traditional disease-modifying drugs (DMARDs) have improved treatments to autoimmune diseases, there remains substantial number of patients that either fail to respond to the treatment options or eventually become refractory to the treatment.

Method used

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  • Methods of Treating Rheumatoid Arthritis
  • Methods of Treating Rheumatoid Arthritis
  • Methods of Treating Rheumatoid Arthritis

Examples

Experimental program
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example 1

Kinetic Analysis of Binding of Anti-CD22 Antibodies to CD22 and Surrogate Antigens / Anti-Idiotype Antibodies

[0269]Affinity of anti-CD22 antibodies against human CD22 was performed using BIAcore (GE Healthcare Life Sciences, Piscataway, N.J.) according to standard procedures. Briefly, human recombinant CD22 (20 μg / ml, PeproTech, Rocky Hill, N.J.) was immobilized on carboxymethylated dextran-coated CM5 sensor chip. The chip surface was firstly activated with N-ethyl-N′-(3-diethylaminopropyl) carbodiimide hydrochloride (EDC) and N-hydroxysuccinimide (NHS). Different concentrations of anti-CD22 antibodies, and in this case, SM03 (1.0625-34 nmol / ml) in phosphate buffer saline (PBS) were injected at a flow rate of 20 μL / min for 3 min. The residual carboxyl groups were subsequently blocked by 1M ethanolamine (pH 8.5). The dissociation was studied by washing with running buffer for 3 min. The chip surface was then regenerated by injection with 50 mM glycine-CI for 60 s. Kinetic parameters in...

example 2

[0272]Functional Activities of Anti-CD22 Antibodies Against Surrogate Target Cell Lines Expressing on the Cell Surface with a Binding Moiety Specific for the Anti-CD22 Antibodies

[0273]FIG. 3 shows the murine myeloma SP2 / 0 cells transfected with expression vector encoding the Fab fragment of the anti-idiotype antibody against SM03 (LRID Fab) fused either to the transmembrane portion of Glycophorin A (Fab-GlycoA) or the glycophosphatidylinosito (GPI) signal sequence from decay accelerating factor (DAF) protein demonstrated high level of surface expression of LRID Fab (FIG. 3A) and these cells can be used as the surrogate target cells for the induction of CMC inhibition by the anti-CD22 antibodies SM03 and SM06. Exemplary SM03-induced CMC killing against the Fab-GlycoA and Fab-GPI surrogate target cell is shown (FIG. 3B). SP2 / 0 murine myeloma cells that express endogenous Igβ were transfected with vectors containing sequences encoding LRID Fab fused to either the transmembrane portion ...

example 3

Specific Binding Epitope Mapping for Anti-CD22 Antibodies

[0275]Preliminary epitope mapping was done by expressing different combinations of extracellular domains encompassing the human CD22 sequence in bacteria and the refolded recombinant proteins were tested for binding to SM03 in an ELISA assay. Only the refolded and purified human CD22 encompassing domain 2-4 (CD22d2-4) (SEQ ID 011) showed binding. The recombinant protein CD22d2-4 was analyzed by reducing SDS-PAGE (FIG. 5A), and ELISA plate coated with CD22d2-4 showed dose-response binding to the anti-CD22 antibody SM03 (FIG. 5B), indicating that the epitope resides within the domain 2-4 region of the human CD22 protein. There are 6 extracellular domains for human CD22 antigen that are expressed on the surface of matured B cells. Preliminary mapping studies by expressing different extracellular portions of human CD22 indicated that SM03 binds to the extracellular portion of human CD22 at regions encompassing domains 2-4 (CD22d2-...

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Abstract

A method of treating rheumatoid arthritis in a subject in need thereof is described. The method comprises administering to the subject a therapeutically effective amount of an anti-CD22 antibody, wherein the anti-CD22 antibody is administered in at least two cycles; each cycle comprises two or more doses; and each dose is administered biweekly. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also disclosed herein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Patent Application No. 62 / 747,581 filed Oct. 18, 2018 and U.S. Provisional Patent Application No. 62 / 775,631 filed Dec. 5, 2018. The entire contents of these preceding applications and publications are hereby incorporated by reference herein.BACKGROUND OF THE PRESENT INVENTION[0002]Autoimmune diseases are a result of abnormal immune responses to normal body parts. The causes leading to the conditions are generally unknown. Currently, treatments on a variety of autoimmune diseases are directed towards pro-inflammatory factors (e.g. anti-TNFα antibodies), or the control of the release of these cytokines (e.g. JAK inhibitors).[0003]Although the introduction of anti-TNF and anti-IL1 combination therapy with traditional disease-modifying drugs (DMARDs) have improved treatments to autoimmune diseases, there remains substantial number of patients that either fail to respond to the treatment...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07K16/28A61K39/395A61K45/06A61K9/00A61P19/02
CPCC07K16/2803A61K39/3955A61K45/06A61K2039/545A61P19/02C07K2317/34C07K2317/56A61K9/0019A61P37/06G01N2500/10G01N2500/02C07K2317/92C07K2317/73C07K2317/732C07K2317/77A61K2039/505A61P35/00C07K14/70503C07K2317/76C07K2319/00G01N33/68G01N2333/70503
Inventor LEUNG, SHUI-ON
Owner SINOMAB BIOSCI
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