Anti-LAG-3 Antibody Composition Stability via Merging
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Solution Overview
Problem
Current treatments for metastatic or refractory solid tumors have limited effectiveness in improving overall survival, highlighting the need for improved therapeutic methods.
Innovation Solution
The development of pharmaceutical compositions comprising anti-LAG-3 antibodies or their antigen binding fragments, either alone or in combination with anti-PD-1 or anti-PD-L1 antibodies, along with buffering agents, stabilizing agents, bulking agents, and surfactants, to enhance therapeutic efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current treatments for metastatic or refractory solid tumors are used, then treatment simplicity is maintained, but therapeutic effectiveness is limited
Solution Approach 1:
The patent combines multiple therapeutic antibodies (anti-LAG-3 antibody with anti-PD-1 or anti-PD-L1 antibody) into a single pharmaceutical composition, allowing simultaneous delivery of multiple therapeutic agents. This merging approach enhances therapeutic effectiveness against refractory solid tumors while simplifying administration compared to separate infusions of each antibody
Solution Approach 2:
The invention creates a composite pharmaceutical formulation containing multiple antibodies and excipients (buffering agents, stabilizing agents, surfactants) work together synergistically. The composite nature of the composition allows the antibodies to work in concert to overcome multiple immune checkpoint pathways simultaneously, improving therapeutic reliability
2Reliability
If pharmaceutical compositions with multiple components are developed, then therapeutic efficacy is enhanced, but formulation complexity increases
Solution Approach 1:
The pharmaceutical composition serves multiple functions simultaneously: the anti-LAG-3 antibody blocks the LAG-3 checkpoint, the anti-PD-1 or anti-PD-L1 antibody blocks the PD-1 pathway, buffering agents maintain pH stability, stabilizing agents preserve antibody integrity, and surfactants prevent aggregation. This multi-functionality within a single composition enhances therapeutic efficacy while managing formulation complexity through integrated design
Solution Approach 2:
The invention optimizes specific formulation parameters including pH (maintained by buffering agents), antibody concentration ratios, stabilizer concentrations, and surfactant levels to ensure stability and efficacy. By carefully controlling these parameters, the composition achieves enhanced therapeutic effect while maintaining manageable formulation complexity through standardized manufacturing parameters
Data Source
AI summary
This provides pharmaceutical compositions that comprise (i) an anti-LAG-3 antibody or antigen binding fragment thereof or (ii) an anti-LAG-3 antibody or antigen binding fragment thereof and an anti-PD-1 antibody, anti-PD-L1 antibody, or antigen binding fragment thereof. Also provided are pharmaceutical compositions that comprise a buffering agent, stabilizing or bulking agent, and a surfactant. The disclosure also provides a vial, syringe, intravenous bag, or kit that comprises the compositions, and methods for using the compositions.