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Federal Forecasted GRANTS-GOV-351130

Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed

Food and Drug Administration (HHS) · Competitive grant · Science & Technology

At a glance

Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed is a federal competitive grant from Food and Drug Administration for the science & technology sector. Funding is up to $300K. Eligible applicants: Small businesses; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarificat. Applications are accepted on a rolling basis. Apply via the official listing at www.grants.gov.

Amount
Up to $300K
Deadline
Rolling
Type
Competitive
Status
Forecasted

About this program

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereo chemically pure form; 2) assessment of the biological activity of each stereo chemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs. 

Who can apply

Small businesses; For profit organizations other than small businesses; Public and State controlled institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); County governments; Special district governments; Native American tribal organizations (other than Federally recognized tribal governments); Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"; Independent school districts; Private institutions of higher education; Public housing authorities/Indian housing authorities; Native American tribal governments (Federally recognized); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; State governments; City or township governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

How to apply

Apply through Grants.gov using funding opportunity number FOR-FD-24-007. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source