Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
ID: 351130Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$300K - $300K

Eligible Applicants

Unrestricted

Funding Category

Consumer Protection

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351130
Timeline
    Description

    The Food and Drug Administration (FDA) is forecasting a funding opportunity for a cooperative agreement aimed at the synthesis and biological activity assessment of different diastereomers in the siRNA drug LEQVIO (Inclisiran). The primary objective of this research is to systematically evaluate the diastereomeric composition of LEQVIO, focusing on the synthesis of each diastereomer in stereochemically pure form and assessing their biological activity in inhibiting PCSK9 using in vitro assays and transgenic mouse models. This research is significant as it will enhance the understanding of the pharmacological activity of LEQVIO and contribute to the quality control of oligonucleotide drugs, with potential applications to other similar siRNAs. The award ceiling and floor for this opportunity are both set at $300,000, with one expected award to be made. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at (240) 402-7610 for further information.

    Point(s) of Contact
    Terrin Brown Grantor
    (240) 402-7610
    terrin.brown@fda.hhs.gov
    Files
    No associated files provided.
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