Antibody-Drug Conjugate Dosing With Hyaluronidase for Fewer Injections
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Solution Overview
Problem
Current antibody-drug conjugates require frequent intravenous administration, leading to injection site reactions and altered pharmacokinetic profiles when combined with other drug products, and there is a need for a long-acting injectable regimen that minimizes these issues while maintaining stability and safety.
Innovation Solution
A combination dosing regimen involving soluble hyaluronidase, such as rHuPH20, administered with an antibody-drug conjugate to allow for less frequent dosing, reducing injection site reactions and improving safety profiles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If antibody-drug conjugate is administered via intravenous injection, then drug delivery is effective, but dosing frequency is high and patient compliance is poor
Solution Approach 1:
The patent applies preliminary action by pre-formulating the antibody-drug conjugate in a suspension suitable for subcutaneous injection, and pre-combining it with hyaluronidase to enable extended-release delivery. This preliminary preparation allows the drug to be administered less frequently (every 3-4 weeks instead of weekly), improving patient compliance without compromising therapeutic effectiveness.
2Duration of action of moving object
If antibody-drug conjugate concentration is increased to dose less frequently, then dosing interval is extended, but injection site reactions increase
Solution Approach 1:
The patent uses hyaluronidase as an intermediary enzyme that degrades hyaluronic acid in the subcutaneous tissue, creating a more favorable environment for drug absorption and distribution. This intermediary action reduces the formation of large blebs and injection site reactions, allowing higher drug concentrations to be administered safely with extended dosing intervals.
Solution Approach 2:
The patent changes the physical state parameter of the antibody-drug conjugate from intravenous solution to subcutaneous suspension, and adjusts the concentration to enable less frequent dosing. By combining this with hyaluronidase co-administration, the patent modifies the tissue environment parameters to reduce injection site reactions while maintaining the extended dosing interval.
3Reliability
If antibody-drug conjugate is combined with other drug products, then treatment efficacy is improved, but pharmacokinetic profile is altered and safety is reduced
Solution Approach 1:
The patent merges the antibody-drug conjugate with hyaluronidase in a single subcutaneous injection formulation. This combination allows the hyaluronidase to facilitate better tissue penetration and distribution of the antibody-drug conjugate, improving treatment efficacy while the synergistic interaction between the two agents reduces adverse events compared to separate administrations.
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 regimen enables less frequent administration of antibody-drug conjugates, reducing injection site reactions and adverse events, while maintaining effective drug delivery and stability.
Implementation Method 1
soluble hyaluronidase, such as rHuPH20, administered with an antibody-drug conjugate
Data Source
AI summary
Provided are combination dosing regimens comprising administering an antibody-drug conjugate and hyaluronidase. Combinations and compositions containing the antibody-drug conjugate and hyaluronidase are provided. The dosing regimens and combinations are for treating or preventing cancer.