Anti-PD-1 Monoclonal Antibody Affinity Maturation via CDR Mutation

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Solution Overview

Problem

Current treatments for various diseases, including cancer and immune system disorders, are limited by the inability to effectively inhibit the PD-1/PD-L1 signaling pathway, which hampers the immune response and tumor cell killing.

Innovation Solution

Development of human anti-PD-1 monoclonal antibodies, such as DFPD1-1, through a method involving biopanning of synthetic ScFv phage libraries, affinity maturation of light and heavy chain CDRs, and cloning into eukaryotic expression vectors, to block the PD-1/PD-L1 interaction and enhance immune response against tumors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional treatments are used, then current therapy options are available, but the PD-1/PD-L1 signaling pathway cannot be effectively inhibited, resulting in limited immune response and tumor cell killing capability

Engineering Contradiction:
Improveinhibition of PD-1/PD-L1 signaling pathwayVSAvoidimmune response and tumor cell killing
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent uses monoclonal antibodies as intermediary substances that specifically bind to PD-1 or PD-L1, blocking their interaction and preventing the inhibitory signaling pathway. This intermediary approach restores T cell function and enhances tumor cell killing without directly attacking the tumor, thereby resolving the contradiction between pathway inhibition and immune response activation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces conventional chemical therapies or surgery with a biological mechanism-based approach using monoclonal antibodies. The antibodies utilize their binding capability to disrupt the PD-1/PD-L1 interaction, substituting mechanical/chemical treatment with a targeted biological mechanism that restores immune function and enhances tumor killing efficiency.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If monoclonal antibodies are developed through synthetic ScFv phage library biopanning, then high affinity anti-PD-1 antibodies can be obtained, but the process requires complex steps including affinity maturation of CDRs and cloning into eukaryotic expression vectors

Engineering Contradiction:
Improveaffinity of anti-PD-1 monoclonal antibodiesVSAvoidbiopanning process and antibody development methodology
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the antibody development process into distinct stages: initial biopanning of synthetic ScFv phage libraries to obtain candidate antibodies, affinity maturation through CDR mutation to enhance binding affinity, and cloning into eukaryotic expression vectors for production. This segmentation allows systematic optimization at each stage, achieving high affinity while managing process complexity through modular approach.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs parameter changes by introducing mutations in the CDR (complementary determining region) segments of the antibody to optimize binding affinity. By systematically altering amino acid sequences in key regions and selecting variants with improved PD-1 binding characteristics, the patent achieves high affinity antibodies through controlled parameter modification rather than random screening.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3770177A1Anti-PD-1 monoclonal antibodies and obtaining method thereof
Publication Date: 2021.01.27 BEIJING DONGFANG BIOTECH CO LTD
  • EP3770177A1 patent drawingFigure 1~2
  • EP3770177A1 patent drawingFigure 3~5
  • EP3770177A1 patent drawingFigure 6~8

AI summary

The present invention relates to the technical field of antibody engineering. Provided are a full human anti-PD-1 monoclonal antibody, a preparation method therefor, and uses thereof. Anti-PD-1 monoclonal antibodies are obtained from a fully synthetic antibody library by means of screening, and then light-chain CDR1-3-region and heavy-chain CDR1-3-region mutation construction libraries of the obtained antibody are screened in sequence by means of an affinity maturation technology to obtain a high-affinity anti-PD-1 antibody. The antibody can be used for treating tumors, inflammations, and autoimmune diseases.