Stable Liquid Formulation for Anti-PVRIG Antibody Combination Therapy
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Solution Overview
Problem
Current cancer treatments face challenges in effectively activating T-cells and NK cells due to immunological checkpoints like PVRIG, which hinder immune responses against tumors, and existing therapies have limitations in enhancing immune activation.
Innovation Solution
A stable liquid pharmaceutical formulation combining anti-TIGIT, anti-PD-1, and anti-PVRIG antibodies, specifically designed with heavy and light chain variable domains and formulations that include histidine, NaCl, L-Arginine, and polysorbate 80, to enhance T-cell and NK cell activation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If immunological checkpoints like PVRIG are targeted to enhance immune responses, then T-cell and NK cell activation is improved, but the complexity of the therapeutic regimen increases
Solution Approach 1:
The patent combines anti-PVRIG, anti-TIGIT, and anti-PD-1 antibodies into a single pharmaceutical formulation, merging multiple therapeutic agents into one administration unit. This approach maintains the enhanced immune response effectiveness of targeting multiple checkpoints while reducing the complexity of the therapeutic regimen by enabling simultaneous delivery of all three antibodies in one injection rather than requiring separate administrations.
2Reliability
If multiple costimulatory pathways are targeted simultaneously, then immune activation is enhanced, but the manufacturing complexity increases
Solution Approach 1:
The patent merges anti-PVRIG, anti-TIGIT, and anti-PD-1 antibodies into a single pharmaceutical formulation with optimized stability conditions (pH 5.5-7.0, presence of histidine, NaCl, L-arginine, and polysorbate 80). This combining approach enhances immune activation by targeting multiple costimulatory pathways simultaneously while managing manufacturing complexity through a unified formulation platform with defined stability parameters.
3Ease of operation
If a stable liquid formulation is used for anti-PVRIG antibodies, then ease of administration is improved, but formulation stability requirements become more stringent
Solution Approach 1:
The patent specifies precise formulation parameters including pH range (5.5-7.0), buffer composition (histidine), ionic strength (NaCl), amino acid content (L-arginine), and surfactant concentration (polysorbate 80) to maintain anti-PVRIG antibody stability in liquid form. These parameter changes enable the conversion from less convenient storage forms to stable liquid formulations that are easier to administer while meeting stringent stability requirements through carefully controlled chemical and physical conditions.
Data Source
AI summary
The present invention is directed to combination treatments with anti-PVRIG antibodies, anti-TIGIT antibodies, and anti-PD-1 antibodies, in particular nivolumab, using stable liquid pharmaceutical formulations thereof.