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Claudin-6 binding molecules and uses thereof

A domain and composition technology, applied in the field of antigen-binding molecules and antibodies, can solve the problems of inconvenience to patients and medical accidents, and achieve the effects of improved safety, superior specificity and long half-life

Pending Publication Date: 2022-01-18
CHUGAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method of administration is not only extremely inconvenient for patients, but also has potential risks of medical accidents due to equipment failure, etc.
Therefore, it cannot be said that this method of administration is desirable

Method used

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  • Claudin-6 binding molecules and uses thereof
  • Claudin-6 binding molecules and uses thereof
  • Claudin-6 binding molecules and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0571] Example 1. sc(Fv) 2 molecular stability

[0572] Regarding the stability of blinatumomab, blinatumomab was purified in-house at 3.8 mg / mL in 20 mM His, 150 mm NaCl, pH 6.0. The proportion of high molecular weight (HMW) species was determined to be 6.4% by SEC analysis. For the purpose of physicochemical testing, it was dialyzed against PBS, pH 7.4, and the concentration was adjusted to 1 mg / ml. After dialysis, the HMW ratio became 42.6%. Typically, the HMW ratio of IgG antibodies does not change during dialysis. Therefore, blinatumomab has a tendency to aggregate in solution and is believed to be less stable than IgG antibodies. SEC analysis was performed using a SWXL G2000 column (TOSOH) with 50 mM sodium phosphate, 300 mM NaCl, pH 7.0 as running buffer. Detection is done by UV detector (280nm). Chromatograms were analyzed using Empower3 software (Waters).

Embodiment 2

[0573] Example 2. Selection of T cell redirecting antibodies that bind claudin-6 (CLDN6)

Embodiment 2-1

[0574] Example 2-1. Production of anti-CLDN6 T cell redirection antibodies

[0575] To overcome sc(Fv) 2 Due to format constraints, we produced an IgG format T cell redirecting bispecific antibody targeting CLDN6 (anti-CLDN6 / CD3 bispecific antibody), which enables the antibody to obtain better stability and longer serum half life.

[0576] The variable regions of three anti-CLDN6 antibodies (AE3-20, AHO5, CDA0013), the CLDN6-binding variable region of 6PHU3 and the variable region of one anti-CD3 antibody (TR01) were used to generate anti-CLDN6 / CD3 bispecific antibodies. CDA0013 was obtained from B cells of rabbits immunized with CLDN6 expression vector.

[0577] The variable regions described above were used to generate anti-CLDN6 / CD3 bispecific antibodies using the Fab arm exchange technique reported by Igawa et al. (WO2016159213). The variable regions included in the anti-CLDN6 / CD3 antibody arm are shown in Table 1, and the resulting bispecific antibody contained a sil...

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Abstract

The present disclosure provides antigen binding molecules that show binding activity towards Claudin-6 (CLDN6), methods for producing the antigen binding molecules, use of the antigen-binding molecules and immunoconjugates comprising the same in treating and / or preventing cancers, use of the antigen binding molecules in detecting the presence of CLDN6 in biological samples, and use of the antigen binding molecules in diagnosis of various cancers.

Description

technical field [0001] The present disclosure relates to (Claudin) claudin 6 binding molecules, including antigen binding molecules and antibodies, uses thereof, and the like. Background technique [0002] Antibodies have attracted attention as pharmaceuticals because they have high stability in plasma and few side effects. Among the many types of therapeutic antibodies, some types require effector cells to mount an antitumor response. Antibody-dependent cell-mediated cytotoxicity (ADCC) is the cytotoxicity exhibited by effector cells to antibody-bound cells through the binding of the Fc region of the antibody to the Fc receptors present on NK cells and macrophages. To date, various therapeutic antibodies that induce ADCC to exert antitumor effects have been developed as drugs for the treatment of cancer (NPL 1). [0003] In addition to antibodies that employ ADCC by recruiting NK cells or macrophages as effector cells, T cell recruiting antibodies that employ cytotoxicity...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/28C12N15/13C12N5/10C12N15/85A61K39/395A61K47/68A61P35/00
CPCC07K16/28C07K16/2809C12N5/0686C12N15/85A61K39/3955A61K47/6849A61P35/00C07K2317/71C07K2317/73C07K2317/31C07K2317/90C07K2317/94C07K2317/33C07K2317/24C07K2317/56C07K2317/64C12N2510/00C12N2800/107A61K2039/507C07K2317/622C07K2317/565A61K2039/505A61K2039/545A61K2039/572C07K2317/522C07K2317/567
Inventor 木村直纪儿玉达史石井慎也村冈优上川雄之
Owner CHUGAI PHARMA CO LTD
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