Anti-ILT4 Antibody Dosing Regimens for Cancer Treatment

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Solution Overview

Problem

There is an unmet need for a safe and effective dosing regimen for anti-ILT4 antibodies, either alone or in combination with PD-1 antagonists like anti-PD-1 or anti-PD-L1 antibodies, in treating cancer, due to factors such as serum turnover rates, immunogenicity, and potential immune stimulation and cytokine release.

Innovation Solution

Administering specific dosages of anti-ILT4 antibodies, ranging from 3 to 1600 mg, either alone or in combination with PD-1 antagonists, such as pembrolizumab or nivolumab, via intravenous infusion on specific schedules, to treat various types of cancer, including melanoma, non-small cell lung cancer, and lymphomas.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If higher dosages of anti-ILT4 antibody are administered to improve cancer treatment efficacy, then anti-tumor response is enhanced, but risk of immune stimulation and cytokine release increases

Engineering Contradiction:
Improvecancer treatment efficacyVSAvoidimmune stimulation and cytokine release
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent establishes specific dosage parameters (3-1600 mg) and administration schedules for anti-ILT4 antibody that optimize therapeutic efficacy while controlling immune-related adverse effects. By defining precise dosage ranges and monitoring parameters, the invention transforms the dosage from a variable parameter into a controlled parameter that balances benefit and risk.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If combination therapy with anti-PD-1 or anti-PD-L1 antibody is used to enhance anti-tumor response, then cancer treatment efficacy is improved, but complexity of treatment regimen increases

Engineering Contradiction:
Improveanti-tumor responseVSAvoidtreatment regimen complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines anti-ILT4 antibody with anti-PD-1 or anti-PD-L1 antibody in a coordinated treatment regimen. By merging these therapies with defined dosage relationships and administration schedules, the invention creates a unified treatment approach that achieves synergistic anti-tumor effects while managing the complexity through structured protocols.

Inventive Principle:
Principle #5Merging (Combining)

3Productivity

If dosing regimen is optimized for rapid tumor response, then treatment speed is improved, but safety margin is reduced due to potential toxicities

Engineering Contradiction:
Improvetreatment speedVSAvoidsafety margin
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent employs periodic administration schedules for anti-ILT4 antibody that allow therapeutic accumulation while providing intervals for immune system recovery and toxicity management. The defined dosing intervals create a rhythmic treatment pattern that balances rapid response with safety monitoring.

Inventive Principle:
Principle #19Periodic action

4Quantity of substance

If higher dosage is administered to overcome serum turnover rate limitations, then drug exposure is improved, but formation of anti-drug antibodies increases

Engineering Contradiction:
Improvedrug exposureVSAvoidanti-drug antibody formation
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The patent defines flexible dosage ranges (3-1600 mg) that can be dynamically adjusted based on individual patient factors including serum turnover rate, immunogenicity profile, and treatment response. This dynamic approach allows optimization of drug exposure while monitoring for and adjusting against anti-drug antibody formation.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20230365678A1Dosing regimens of Anti-ILT4 antibody or its combination with Anti-PD-1 antibody for treating cancer
Publication Date: 2023.11.16 MERCK SHARP & DOHME LLC
  • US20230365678A1 patent drawing
  • US20230365678A1 patent drawing
  • US20230365678A1 patent drawing

AI summary

Provided herein are dosing regimens of an anti-immunoglobulin-like transcript 4 (anti-ILT4) antibody for treating cancer. Further provided are dosing regimens for treating cancer using a combination of an anti-ILT4 antibody and another agent (e.g., a PD-1 antagonist, such as an anti-PD-1 antibody or an anti-PD-L 1 antibody).