Amendment 25: DRIVe EZ Broad Agency Announcement

EZBAA-22-100-SOL-00003

Amendment #025

Office of Biomedical Advanced Research and Development Authority Division of Research, Innovation & Ventures (DRIVe)
Easy Broad Agency Announcement EZBAA-22-100-SOL-00003

The purpose of Amendment #025 is the following:

1) Reopen the following Area of Interest (AOI):

AOI #24: RePAIR

2) Revise the following Area of Interest (AOI):

AOI #24: RePAIR

EZBAA-22-100-SOL-00003

Amendment #025

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

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

Reopening the following research Area of Interest (AOI):

AOI #24: RePAIR

2)

Revising the following research Area of Interest (AOI):

AOI #24: RePAIR

Repurposing and Advancing Innovations Against Rad/Nuc Threats (REPAIR)

Exposure to ionizing radiation can result in a spectrum of injuries known as Acute Radiation Syndrome (ARS). Due to multiple organ involvement, medical countermeasures (MCM) that treat the systemic nature of the injury or multi-organ pathologies are needed. These MCMs need to be effective when given 24 hours or later post-exposure to be consistent with current deployment expectations. Optimally, MCMs would be commercially available products that are familiar to end users, as well as be potentially available at multiple points of care such as pharmacies and hospitals. This availability ensures MCMs are immediately accessible when and where they are needed, while additional resources are being deployed from stockpiles.
BARDA’s goal for REPAIR is to repurpose existing FDA-approved and clinical-stage investigational therapeutics through label expansion (e.g. additional clinical indications after initial approval or if investigational, in addition to proposed commercial clinical indication(s)) as potential MCMs for radiological and nuclear events to expand treatment options as well as support the concept of predeployed MCMs. It is expected that the data collected to reach these stages of clinical development would aid development of the MCM indication under FDA’s Animal Rule and therefore, must include a well-defined mechanism of action (MOA) anticipated to be relevant for ARS, clinical safety data, and stage appropriate manufacturing.
BARDA is seeking abstracts that propose the repurposing, through label expansion, of therapeutics as MCMs to treat ARS. Candidate MCMs should either be FDA approved or in a Phase 2 clinical trial or later, having successfully completed their Phase 1 trial for their commercial indication(s), with a