Fc-Effector-Null Anti-CD137 Antibodies for Anti-PD-1 Efficacy

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Solution Overview

Problem

Current agonistic antibodies targeting human CD137 have not demonstrated sufficient responses as a monotherapy or combination therapy in human patients, and existing combinations with anti-PD-1 antibodies are limited by adverse events and sub-optimal efficacy, necessitating the development of improved antibodies with enhanced pharmacological attributes.

Innovation Solution

Development of engineered human Fcγ-receptor-mediated effector null antibodies that agonize the human CD137 receptor, promoting T cell activation, enhancing NF-kappa B activity, and inhibiting tumor growth, while being designed to combine effectively with anti-PD-1 antibodies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If agonistic antibodies targeting human CD137 are used as monotherapy or combination therapy, then T cell activation and anti-tumor immune response are enhanced, but sufficient therapeutic response is not achieved in human patients

Engineering Contradiction:
Improvetherapeutic responseVSAvoidefficacy
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent combines agonistic anti-CD137 antibodies with anti-PD-1 antibodies to create a combination therapy that synergistically enhances T cell activation and anti-tumor immune response, overcoming the limitations of monotherapy approaches

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent modifies antibody parameters including isotype selection (IgG1, IgG2, IgG4), Fc region engineering, and dosing regimens to optimize the balance between activating anti-tumor immunity and managing toxicity, thereby improving therapeutic response

Inventive Principle:
Principle #35Parameter changes

2Productivity

If agonistic antibodies targeting human CD137 are combined with anti-PD-1 antibodies, then anti-tumor immune response is enhanced, but adverse events occur

Engineering Contradiction:
ImproveefficacyVSAvoidadverse events
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent engineers antibodies with modified Fc regions and selects specific isotypes to modulate effector function and cytokine release, thereby enhancing anti-tumor efficacy while reducing immune-related adverse events through controlled immunomodulation

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses Fc region engineering as an intermediary mechanism to fine-tune the interaction between antibodies and immune cells, allowing optimization of therapeutic effect while minimizing harmful immune activation

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If existing combinations with anti-PD-1 antibodies are used, then some therapeutic effect is achieved, but sub-optimal efficacy limits clinical success

Engineering Contradiction:
Improvetherapeutic effectVSAvoidefficacy
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent optimizes multiple parameters including antibody affinity, isotype, Fc engineering, and dosing schedules to maximize the therapeutic index, transforming existing sub-optimal combinations into highly effective treatments with improved clinical outcomes

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20250333525A1Anti-CD137 antibodies for combination with Anti-PD-1 antibodies
Publication Date: 2025.10.30 ELI LILLY & CO

AI summary

The present invention relates to antibodies that bind to human CD137 and display agonist activity, and may be useful for treating solid and hematological tumors alone and in combination with anti-human PD-1 antibodies, chemotherapy, and ionizing radiation.