Amendment 15: DRIVe EZ Broad Agency Announcement

Office of Biomedical Advanced Research and Development
Authority (BARDA) Division of Research, Innovation & Ventures

(DRIVe)

Amendment 015 Issuance for Easy Broad Agency Announcement

(EZ-BAA) BAA-22-100-SOL-00003

The purpose of this Amendment is the following:

1) Update the closing date for the following Area of
Interest (AOI):
AOI #22: ReBoot
2) Update the closing date for the following Area of
Interest (AOI):

AOI #25: FASTx

3) Revise the following Area of Interest (AOI):
AOI #22: ReBoot
4) Revise the following Area of Interest (AOI):

AOI #25: FASTx

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

Under this Amendment, DRIVe is doing the following:
1)

Updating the closing date for the following research Area of Interest (AOI): AOI #22: ReBoot

2)

Updating the closing date for the following research Area of Interest (AOI):

AOI #25: FASTx

3)

Revising the following research Area of Interest (AOI): AOI #22: ReBoot
We are seeking abstract submissions for the following AOI:

AOI #22: ReBooT
Antiviral therapeutics have the potential to impact multiple viruses that utilize conserved mechanisms of action for infection, require specific host proteins for infection, or share conserved viral proteins. Typically, antivirals are advanced for one indication, but they may have efficacy against other related pathogens. As the commercial market for products targeting filoviruses is small and evaluation of candidates requires access to BSL4 facilities, product developers have limited incentive to test candidate products against filoviruses. Under the ReBooT program, the Antivirals and Antitoxins (AVAT) branch aims to support the testing and evaluation of candidate therapeutics that have been developed past Phase 1 clinical trials for another indication, but which have a mechanism of action likely to be effective against filoviruses (including but not limited to Ebola virus, Sudan virus, and Marburg virus). Products could then be considered for additional funding through the EZ-BAA+ mechanism or under the BARDA Broad Area Announcement (BAA-22-100-SOL-00003).
The ReBooT program will primarily support preclinical efficacy studies (i.e. efficacy in animal models of filovirus disease). Proposals for preclinical studies should clearly delineate the proposed study design; laboratory partners, if required; outcome measures; and proposed threshold for study success, which could guide go/no go decisions for follow on funding. Proposals focusing on chemistry manufacturing