Engineered Polypeptides with Albumin Binding Domain for Extended Half-Life

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Solution Overview

Problem

There is a need for polypeptides with extended half-lives to effectively treat metabolic diseases such as obesity, diabetes, and central nervous system disorders, as existing treatments do not provide sufficient duration of action or convenience in dosing regimens.

Innovation Solution

Engineered polypeptides are developed that incorporate an albumin binding domain (ABD) combined with a biologically active hormone domain (HD), such as exendin, which binds to albumin, leading to increased duration of action due to decreased renal clearance and degradation, and can be administered orally for convenient dosing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If existing polypeptide treatments are used, then therapeutic efficacy is achieved, but duration of action is insufficient and dosing frequency is high

Engineering Contradiction:
Improveduration of actionVSAvoiddosing frequency
Core Design Contradiction:
Duration of action of moving objectVSProductivity

Solution Approach 1:

The patent introduces albumin as an intermediary carrier molecule. The polypeptide is engineered to bind to albumin, which acts as a mediator to extend circulation time and reduce renal clearance. This intermediary approach allows the therapeutic polypeptide to be sequestered in circulation, thereby extending its duration of action without requiring frequent dosing.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a composite structure by fusing the therapeutic polypeptide with an albumin-binding domain (ABD). This composite construct combines the therapeutic function of the original polypeptide with the prolonged circulation properties of albumin, achieving extended duration of action while maintaining therapeutic efficacy.

Inventive Principle:
Principle #40Composite materials

2Duration of action of stationary object

If polypeptide half-life is extended through modification, then duration of action increases, but molecular structure complexity increases

Engineering Contradiction:
Improvehalf-lifeVSAvoidmolecular structure
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

Solution Approach 1:

The patent segments the polypeptide structure into distinct functional modules: the original therapeutic domain and the albumin-binding domain (ABD). This segmentation allows the ABD to be added as a separate, standardized module that specifically confers prolonged half-life without complicating the core therapeutic mechanism, making the overall structure more manageable and designable.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent modifies specific parameters of the polypeptide by introducing the ABD with defined amino acid sequences (such as those containing hydrophobic residues that bind to albumin's hydrophobic pockets). These parameter changes in the molecular structure directly result in extended half-life and duration of action without requiring complex overall structural redesign.

Inventive Principle:
Principle #35Parameter changes

3Duration of action of moving object

If renal clearance is decreased to extend duration of action, then polypeptide remains in circulation longer, but risk of accumulation and immunogenicity increases

Engineering Contradiction:
Improvecirculation timeVSAvoidimmunogenicity
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent uses human albumin, a naturally abundant and biocompatible protein, as the binding partner. By copying the natural albumin structure and utilizing its endogenous binding sites, the engineered polypeptide mimics a self-tolerated molecule, thereby reducing the risk of immunogenicity while achieving prolonged circulation through decreased renal clearance.

Inventive Principle:
Principle #26Copying

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The engineered polypeptides demonstrate a prolonged duration of action, with effects lasting up to several days, providing robust glycemic control, body weight reduction, and improved patient compliance through oral delivery, while maintaining therapeutic efficacy similar to exendin-4.

Implementation Method 1

engineered polypeptides which incorporate an albumin binding domain in combination with a biologically active peptide... because the engineered polypeptides described herein can bind albumin, the compounds can be sequestered (e.g., bound to albumin) while in the circulation

Methodology Applied
Scientific EffectProtein-protein binding:

Data Source

PatentEP2729481B1Engineered polypeptides having enhanced duration of action with reduced immunogenicity
Publication Date: 2018.10.17 AMYLIN PHARMACEUTICALS INC
  • EP2729481B1 patent drawingFigure 1
  • EP2729481B1 patent drawingFigure 1
  • EP2729481B1 patent drawingFigure 1

AI summary

Compounds are provided having inter alia good duration of action, high potency and/or convenient dosing regimens including oral administration, and reduced immunogenicity. The compounds are engineered polypeptides which incorporate an albumin binding domain in combination with one or more biologically active polypeptides. Also provided are pharmaceutical compositions and methods of treatment for diseases and disorders including obesity and overweight, diabetes, dyslipidemia, hyperlipidemia, Alzheimer's disease, fatty liver disease, Short Bowel Syndrome, Parkinson's disease, and cardiovascular disease.