Pegylated IL-10 Combination Therapy for Stable Serum Levels

Solution Overview

Problem

Current treatments for cancer and immune-related disorders often face challenges due to the limitations of single-agent therapies, including severe adverse effects and inefficacies in maintaining stable serum concentrations of IL-10, which hampers optimal therapeutic outcomes.

Innovation Solution

Combining pegylated IL-10 (PEG-IL-10) with immune checkpoint inhibitors, such as ipilimumab, to create a combination therapy that minimizes adverse effects and enhances therapeutic efficacy by maintaining specific serum trough concentrations of IL-10, thereby offering additive or synergistic effects in treating cancers and immune disorders.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If single-agent therapy with IL-10 is used, then therapeutic effect is achieved, but severe adverse effects occur and serum concentration stability is poor

Engineering Contradiction:

Improvetherapeutic effectVSAvoidadverse effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines pegylated IL-10 with immune checkpoint inhibitors in a single therapeutic regimen, creating a combination therapy that achieves synergistic antitumor effects while allowing dose reduction of individual agents, thereby reducing adverse effects associated with single-agent high-dose therapy

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent modifies the pharmacokinetic parameters of IL-10 through pegylation, which increases molecular weight and extends serum half-life, enabling maintenance of stable therapeutic serum concentrations over time and reducing the frequency of administration

Inventive Principle:

Principle #35Parameter changes

2Reliability

If single-agent therapy with IL-10 is used, then therapeutic effect is achieved, but serum concentration stability is poor

Engineering Contradiction:

Improvetherapeutic effectVSAvoidserum concentration stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent modifies the pharmacokinetic parameters of IL-10 through pegylation, which increases molecular weight and extends serum half-life, enabling maintenance of stable therapeutic serum concentrations over time and reducing the frequency of administration

Inventive Principle:

Principle #35Parameter changes

3Reliability

If high dosage of immune checkpoint inhibitors is used, then therapeutic efficacy is improved, but adverse effects increase

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidadverse effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines pegylated IL-10 with immune checkpoint inhibitors in a single therapeutic regimen, creating a combination therapy that achieves synergistic antitumor effects while allowing dose reduction of individual agents, thereby reducing adverse effects associated with single-agent high-dose therapy

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS11413332B2Methods of using interleukin-10 for treating diseases and disorders

Publication Date: 2022.08.16 ELI LILLY & CO

AI summary

Methods of treating subjects having diseases, disorders, or conditions, including cancer and immune- and inflammatory-related disorders, via the administration of IL-10 in combination with one or more additional agents, and methods and models associated therewith, are provided.