Posted: Jan. 16, 2025, 3:26 p.m. EST
AMENDMENT SIX
The purpose of Amendment Six is to:
- Update the Original Date Offers Due in the SAM.Gov system to February 21, 2025, 3:00pm EST for Research Area 001. Please note that the Date Offers Due for Research Area 002 remains unchanged at January 21, 2025, 3:00pm EST. In eCPS, the 2026 Omnibus BAA is separated into four (4) separate solicitations which correspond to each of the two (2) Research Areas, including each of the three (3) Topic numbers for Research Area 001. An Offeror shall ensure that its proposal is submitted to the Research Area and Topic number, if applicable, to which it is applying for in eCPS.
- Provide NIAID's response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.
______________________________________________________________________
AMENDMENT FIVE
The purpose of Amendment Five is to:
- Provide NIAID's response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.
______________________________________________________________________
AMENDMENT FOUR
The purpose of Amendment Four is to:
- Provide NIAID's response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.
______________________________________________________________________
AMENDMENT THREE
The purpose of Amendment Three is to:
- Provide NIAID's response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.
____________________________________________________________________________
AMENDMENT TWO
The purpose of Amendment Two is to:
- Provide NIAID's response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.
__________________________________________________________________________
AMENDMENT ONE
The purpose of Amendment One is to:
- Provide NIAID's response to questions received regarding the solicitation. The responses are offered for information only and do not modify or become part of this solicitation. Additional amendments may be provided as needed to address further questions and their related responses.
- Provide a cut-off date for questions for each Research Area.
_________________________________________________________________________
Introduction:
The National Institute of Allergy and Infectious Diseases (NIAID), one of 27 institutes of the National Institutes of Health (NIH), an agency within the Department of Health and Human Services (DHHS); conducts and supports research to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. Through a variety of research grants and contracts, NIAID's Division of Microbiology and Infectious Diseases (DMID) specifically supports extramural research to develop new medical countermeasures (MCMs) against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases. This Broad Agency Announcement (BAA) is soliciting proposals to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for biodefense and emerging infectious diseases.
The following two (2) distinct Research Areas are included in the attached NIAID DMID OMNIBUS BROAD AGENCY ANNOUNCEMENT No. HHS-NIH-NIAID-BAA2025-1:
Research Area 001 Development of Candidate Therapeutics, Vaccines, and In Vitro Diagnostics for Antimicrobial-Resistant (AMR) Bacterial or Fungal Pathogens
For Research Area 001, there are three (3) separate Topics A, B, and C. Offerors may submit a proposal in response to Topics A, B, and/or C. If proposing to multiple Topics, Offerors must submit separate technical and business proposals for each Topic.
Topic A: Therapeutics for AMR Bacterial or Fungal Pathogens
The objective of Topic A is to develop new therapeutic products against severe infections and/or drug-resistant strains of the following bacterial and fungal pathogens:
a. Pseudomonas aeruginosa, and/or Acinetobacter baumannii; OR
b. Candida auris, Cryptococcus spp., Aspergillus fumigatus, and/or Mucorales.
For the purpose of this Topic, therapeutic activity refers to the cure of disease, by elimination or substantial reduction of infective pathogens, by administration of a pharmaceutical agent after symptoms of disease are clinically observable. An antimicrobial therapeutic candidate refers to an advanced lead series, optimized leads, or product candidate, that is a new chemical entity and either a small molecule (e.g., natural products, nucleosides, or peptides of </= 40 amino acids), monoclonal antibody or a nanobody conjugate/fusion product, or a bacteriophage product. The following are not included: proteins, other biological entities, and conjugates of such entities (except monoclonal antibodies, nanobodies and bacteriophages).
This Topic will support lead optimization, pre-clinical Investigational New Drug (IND) enabling studies, and clinical Phase I trials of lead candidates with demonstrated therapeutic activities. For some pathogens, the development of a therapeutic product under the U.S. Food and Drug Administration's (FDA) Animal Rule will be supported.
Topic B: Vaccines for AMR Bacterial Pathogens
The objective of Topic B is to protect human health and well-being by advancing vaccine candidates for the following ESKAPE bacterial pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species.
For the purpose of this Topic, the definition of a lead vaccine candidate is a candidate in which the antigen(s), adjuvant (if applicable), vaccine platform (e.g., mRNA, viral vector, subunit, etc.), and delivery route have been selected and are clinically relevant (i.e., intended for the final clinical product), for which proof-of-concept immunogenicity in relevant animal model(s) has already been demonstrated.
This Topic will support the advancement of a promising lead candidate from pre-clinical testing through IND submission to the FDA, as well as Phase I clinical trial conduct.
Topic C: In Vitro Diagnostics for AMR Fungal Pathogens
The objective of Topic C is to develop innovative platform technologies to speed the identification of infection from among a broad panel of fungi and to profile the phenotypic antifungal susceptibility. This emphasis aligns with NIAID's goal of addressing persistent challenges in adequate clinical management associated with mycological infections and alleviating the burden of antifungal resistance.
The diagnostic test system must detect analytes from at least one, and preferably several, of the following agents and markers:
Candida spp. and associated resistance markers
Aspergillus fumigatus and associated resistance markers
Coccidioides spp.
Mucorales
Research Area 002 Development of Direct Acting Antivirals (DAA) for Viral Families of Pandemic Potential
This Research Area aims to develop safe and effective antivirals to combat viruses of pandemic potential, as well as to build sustainable platforms for targeted drug discovery and the development of a robust pipeline of candidates. Proposals MUST focus on antivirals that:
- Directly modify viral target function (not through the modulation of the host responses); AND
- Act by reducing viral burden in early stages of disease; AND
- Act against viruses of pandemic potential (i.e., Bunyaviridae, Coronaviridae, Filoviridae, Flaviviridae, Orthopoxviridae, Paramyxoviridae, Picornaviridae, and Togaviridae); AND
- Are new chemical entities limited to small molecules (e.g., natural products, nucleosides, or peptides of </= 40 amino acids) and nanobody conjugates/fusion products that are directly acting on viral targets and functions (not through the modulation of the host responses); AND
- Have safety profiles and suitable routes of administration for broad outpatient use.
For the purpose of this Topic, therapeutic activity refers to the elimination or substantial reduction of infective pathogens by administration of a pharmaceutical agent after viral challenge. A therapeutic candidate refers to an advanced lead series, optimized leads, or product candidate, that is a new chemical entity and either a small molecule (e.g., natural products, nucleosides, or peptides of </= 40 amino acids) or nanobody conjugate/fusion product. The following are not included: proteins, monoclonal antibodies, other biological entities, and conjugates of such entities.
Research Area 002 will support lead optimization, pre-clinical (IND enabling) studies, and/or Phase I clinical trials. Proposed products are not required to be narrow-spectrum and may include other pathogens in their spectrum of activity, provided one of the listed pathogens is in the primary indication of the proposed Target Product Profile (TPP). Product development under the FDA's Animal Rule (21 CFR 314 subpart I) will be supported if appropriate to the proposed pathogen target.
An offeror should carefully review the content of the BAA for information regarding the technical objective of each Research Area of this omnibus BAA, instructions regarding the proposal submission, and a description of the evaluation and award process; and exercise its professional judgement in compiling its proposal.
Each of the two (2) distinct Research Areas has a specified closing date and time. The proposals due date of January 21, 2025, specified in this solicitation posting, is the due date for Research Area 002 only. An Amendment will be issued at a later date to update the proposal due date for responses to Research Area 001. The proposals due date for each Research Area are identified below:
Research Area 001 - Development of Candidate Therapeutics, Vaccines, and In Vitro Diagnostics for Antimicrobial-Resistant (AMR) Bacterial or Fungal Pathogens
Proposals Due Date and Time February 21, 2025, 3:00PM Eastern Time
Research Area 002 - Development of Direct Acting Antivirals (DAA) for Viral Families of Pandemic Potential
Proposals Due Date and Time January 21, 2025, 3:00PM Eastern Time
For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by any other method is not permitted.
For directions on using eCPS, go to the website: https://ecps.nih.gov and then click on "How to Submit."
