ForecastedResearch announcementOpportunity FOR-FD-24-007

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

Food and Drug Administration · Department of Health and Human Services

At a glance

Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed is a forecasted federal cooperative agreement opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Individual awards are listed as $300K, with about 1 award expected. The notice is unrestricted by applicant type, subject to any clarifications in the notice. Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted: Nov 24, 2023
Est. close date: Not listed
Award floor: $300,000
Award ceiling: $300,000
Est. total funding: Not specified
Expected awards: 1
Cost sharing: Not required
Funding instrument: Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2024

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public colleges & universities
Federally recognized tribal governments
Public & Indian housing authorities
Native American tribal organizations
501(c)(3) nonprofits
Nonprofits without 501(c)(3) status
Private colleges & universities
For-profit organizations (not small businesses)
Small businesses
Others (see notice)
Unrestricted (any entity type)

Additional information on eligibility (from the notice)

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).

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above; no cost sharing is required.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Watch for the full noticeSave this grant to track when it opens.
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyTerrin Brown Grantor · terrin.brown@fda.hhs.gov Open ↗
Submit before the deadlineSubmit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

Reported obligations under ALN 93.103

Historical data · not a prediction

FY18

$173M

FY19

$199M

FY20

$212M

FY21

$219M

FY22

$256M est.

FY23

$247M est.

Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Who was funded under ALN 93.103

Historical data · not a prediction

Since October 1, 2023, 991 grant awards had funding actions under Food and Drug Administration Research, with 430 sub-awards passed on to other organizations. These are program-wide awards, not awards from this specific notice.

THE CRITICAL PATH INSTITUTE$56.2M
NATIONAL ENVIRONMENTAL HEALTH ASSOCIATION$39.7M
ASSOCIATION OF FOOD & DRUG OFFICIALS$29.5M
DUKE UNIVERSITY$19.1M
THE MEDICAL DEVICE INNOVATION CONSORTIUM$15.6M

Recipients, states, recent awards and sub-awards →Source: USAspending.gov.

Agency contact (as published)

Terrin Brown Grantor
terrin.brown@fda.hhs.gov
(240) 402-7610

Quick answers

Is this opportunity open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for this opportunity?

The notice lists eligibility as unrestricted — open to any type of entity — subject to clarifications in the notice's additional eligibility information.

How much funding is available through this opportunity?

Per the notice, individual awards are listed as $300k and the agency expects to make about 1 awards.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity FOR-FD-24-007), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

OpenResearchALN 93.103