Opportunity
Simpler Grants.gov #FOR-FD-24-007
FDA Solicits Research on Diastereomers in LEQVIO (Inclisiran) siRNA Drug
Buyer
Food and Drug Administration
Posted
November 30, 2023
Identifier
FOR-FD-24-007
NAICS
541714, 541715
The Food and Drug Administration (FDA) is seeking research partners to investigate the diastereomeric composition and biological activity of LEQVIO (Inclisiran), an FDA-approved siRNA drug: - Government Buyer: - Food and Drug Administration (FDA) - OEMs and Vendors: - LEQVIO (Inclisiran) is manufactured by Novartis AG - Products/Services Requested: - Research services to: - Synthesize each diastereomer of LEQVIO (Inclisiran) in stereochemically pure form - Assess biological activity of each diastereomer in vitro and in transgenic mouse models - Develop analytical methods for stereochemical characterization - Evaluate each diastereomer's contribution to pharmacological activity - Unique or Notable Requirements: - No clinical trials are permitted - Research aims to support evaluation of generic siRNAs and quality control of oligonucleotide drugs - Eligible applicants include nonprofits, educational institutions, businesses, and government entities - No specific part numbers or purchase quantities are provided, as this is a research grant solicitation
Description
This research aims to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved siRNA drug, and understand the biological and pharmacological activity of each diastereomer. The work includes stereochemically controlled synthesis of each diastereomer, biological activity assessment using in vitro assays and a transgenic mouse model, development of analytical methods to characterize stereochemical structures, and assessment of each diastereomer's contribution to LEQVIO's overall pharmacological activity. The tools and knowledge developed will aid in evaluating generic siRNAs and quality control of oligonucleotide drugs.