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Modifying binding molecules to minimize pre-existing interactions

A domain-sequence technology, applied in the field of modifying binding molecules to minimize pre-existing interactions, can solve the problems of weakened ADA determination, high background, confounding ADA detection, etc.

Pending Publication Date: 2021-03-23
REGENERON PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In some subjects, there was already high background (noise) even without administration of any biologics, confounding detection of true treatment-emergent ADA due to background signal and impairing valid ADA determination

Method used

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  • Modifying binding molecules to minimize pre-existing interactions
  • Modifying binding molecules to minimize pre-existing interactions
  • Modifying binding molecules to minimize pre-existing interactions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0144] Example 1: IgG4C H Substitution of the 3 constant region reduced pre-existing immunoreactivity in some patient samples.

[0145] Competitive inhibition studies were performed to characterize the high pre-existing reaction signal observed in some samples. Commercially available antibody reagents or monoclonal antibodies specially constructed for this purpose were used in these studies. Table 2 provides a list of antibody constructs or reagents useful in elucidating the specificity of this pre-existing reactivity.

[0146] Table 2

[0147]

[0148] These antibody constructs were used at 200 μg / mL as competitive inhibitors in an anti-drug antibody (ADA) confirmation assay format. Figure 4 shows the format of the assay, and figure 1 The results of the measurements are shown ( figure 1 with Figure 4 ). A high percent inhibition in the assay indicates that a given competition is able to suppress the pre-existing reactivity signal in these samples, thereby indica...

example 2

[0158] Example 2: Development of an Improved Anti-Drug Antibody (ADA) Assay to Reduce Background Immunoreactivity in Patient Samples

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PUM

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Abstract

The present disclosure is directed towards modifying binding molecules in order to minimize pre-existing binding interactions, including binding molecules engineered to minimize or mitigate backgroundreactivity in a sample matrix caused by drug non-specific binding interactions.

Description

[0001] related application [0002] This application claims priority and benefit to U.S. Provisional Application No. 62 / 695,988, filed July 10, 2018, the contents of which are hereby incorporated by reference in their entirety. [0003] sequence listing [0004] This application contains a Sequence Listing that has been submitted via EFS-Web in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on July 8, 2019, is named "REGE-004_SeqList.txt" and is 32,813 bytes in size. technical field [0005] The present disclosure relates to modifying binding molecules to minimize pre-existing binding interactions, including engineering binding molecules to minimize or alleviate background reactivity in a sample matrix caused by non-specific binding interactions of drugs. Background technique [0006] Biological therapies are valuable tools for eliminating, supplementing or replacing elements of a subject's immune system to treat disease. ...

Claims

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Application Information

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IPC IPC(8): C07K16/00C07K16/28G01N33/53G01N33/68
CPCC07K16/00C07K2317/526C07K16/2866G01N33/6854G01N33/54393C07K16/42C07K2317/51C07K2317/515C07K2317/53G01N33/5306G01N33/577G01N2800/24G01N2800/52C07K2317/565
Inventor G·萨姆纳陈继华M·帕特里奇A·托里M·拉加亚克沙
Owner REGENERON PHARM INC