In support of the goals articulated in the above strategies, NIAID intends to use this BAA to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for biodefense and emerging infectious diseases in each of two (2) Research Areas
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: Pseudomonas aeruginosa, and/or Acinetobacter baumannii; OR 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.
