Amendment 010 - DRIVe EZ BAA.pdf

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

(DRIVe)

Amendment 010 Issuance for Easy Broad Agency Announcement

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

The purpose of this Amendment 010 is the following:

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

AOI #24: REPAIR

2) Update the closing date for the following Area of Interest (AOI):

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

Under this Amendment, DRIVe is doing the following:

1) Revising the following research Area of Interest (AOI):

We are seeking abstract submissions for the following AOI:

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.

Repurposing existing FDA-approved and clinical-stage therapeutics through label expansion as potential MCMs for radiological and nuclear events could expand treatment options as well as support the concept of pre-deployed MCMs. The data collected to reach these stages of clinical development could aid development of the MCM indication under FDA’s Animal Rule and must include a well -defined mechanism of action (MOA), clinical safety data, and stage appropriate manufacturing.

BARDA is seeking abstracts that describe repurposing through label expansion of therapeutics to be used as MCMs to treat ARS. Candidate MCMs should either be FDA approved or be currently in a Phase 2 clinical trial or further, having successfully completed their Phase 1 trial for their commercial indication with an acceptable risk: benefit assessment in the target or intended population, with a defined mechanism anticipated to have efficacy for ARS.

This Program is focused on repurposing therapeutics expansion of their label for the following:

Cell Death: Development of MCMs to counteract loss of tissue/organ cellularity resulting from exposure to ionizing radiation injury. These treatments should either aim to maintain cellular populations, replenish, or preserve stem/progenitor cell population. Candidates should have mechanism distinct from acting on myeloid lineage progenitors.

Vascular Injury: Development of MCMS that treat vascular injury by targeting the vascular endothelium and prevent injury or repair injury to blood vessels resulting from exposure to ionizing radiation.

Bleeding/Coagulation: Development of MCMs that can address blood loss (hemorrhage), restore hemostasis, and/or target the coagulation cascade. Candidates should have a mechanism of action distinct from increasing thrombopoietin or by binding the thrombopoietin receptor.

Ischemia: Development of MCMs to treat and/or prevent hypoxia and facilitate tissue oxygenation resulting from exposure to ionizing radiation injury.

The end goal of this Area of Interest (AOI) is to support the collection of proof-of-concept data for FDA-approved and clinical-stage therapeutics in relevant nonclinical models following ionizing radiation exposure.

To be considered responsive under this AOI, respondents should have the following:

• A drug that is a candidate for repurposing as a MCM by label expansion with a mechanism against cell death, vascular injury, bleeding or coagulating disorders, or ischemia associated with ARS

• Is FDA-approved or is currently in Phase 2 clinical trial(s) or further, with a mechanism anticipated to have efficacy for treating the above pathologies associated with ARS;

evidenced by a clinical study report(s)

• Established an initial safety profile from a Phase 1 Clinical Trial with acceptable risk:

benefit profile.

• A clear rationale as to why the candidate should be effective as a post-exposure therapy to treat ARS

• Outline of appropriate facilities (or description of subcontractor or other partner) demonstrating ability to execute radiation exposure experiments in appropriate models.

• Freedom to operate for other indications using your proposed drug.

Out of scope:

-Evaluation of MCMs which already have an indication for the hematopoietic sub-syndrome of ARS.

-Prophylactic administration of drug prior to exposure to ionizing radiation.

-MCMs that do not have a defined MOA and relevant Pharmacodyanmic markers.

-Evaluation of MCMs outside the context of injuries resulting from a nuclear detonation.

-Projects that propose drugs that will only be developed as MCMs (even for more than one threat)

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

B. Eligible Respondents & Scope Parameters:

This Amendment is open to all responsible sources as described in the EZ-BAA. Abstract submissions that do not conform to the requirements outlined in the EZ-BAA may be considered non-responsive and will not be reviewed. In particular, an entity must have an active registration with https://sam.gov at the time of submission to be reviewed. If not, the abstract submission will not be reviewed and will be rejected. Please do not attempt to submit an abstract if your registration is not active in https://sam.gov.

IMPORTANT NOTE: Interested vendors are strongly encouraged to request and schedule a pre-submission call before submitting an abstract. This request should include the project title, key project staff, and a brief description of the proposed project. Please submit the requests https://sam.gov/ https://sam.gov/ to the following:

AOI #24: REPAIR (repair@hhs.gov)

The closing date for abstract submissions for this AOI, unless otherwise extended will be:

Area of Interest Closing Date for Abstract Submissions #24 12:00pm ET on December 1, 2023

C. Number of Awards:

Multiple awards are anticipated and are dependent upon the program priorities, scientific/technical merit of abstract submissions, how well the abstract submissions fit within the goals of the AOI, and the availability of funding. The program funding is subject to change based on the Government’s discretion.

Funding is limited, so we encourage any interested vendors to reach out to the respective program as soon as possible before submitting an abstract.

D. Amendment Application Process:

This Amendment will follow the same submission process and review procedures as those established under this EZ-BAA, unless otherwise noted. For complete details, please read the EZ-BAA in its entirety along with all amendments.

IMPORTANT NOTE: Respondents who are awarded a contract under each of these AOIs will be required to share any collected, de-identified data in an effort to advance the field and knowledge. Interested Respondents are strongly encouraged to commercialize their technology and algorithms, however note that consistent with BARDA’s mission and federal standards, data collected through the use of government funding will be delivered to BARDA for government usage pursuant to applicable regulations and law.

mailto:repair@hhs.gov