Commercializing Understudied Proteins from the Illuminating the Druggable Genome Project
Receipt Dates: September 8, 2020; January 5, 2021; April 6, 2021
Expires on September 6, 2021
This Funding Opportunity Announcement aims to provide funding support for small businesses to initiate translational research of understudied proteins identified in the "Illuminating the Druggable Genome" project (IDG; https://commonfund.nih.gov/idg/index). The purpose of the IDG is to reveal the function of selected understudied proteins in the druggable genome. Organized as a consortium, the project consists of multiple Data and Resource Generation Centers (DRGCs), a Knowledge Management Center (KMC), a Resource Dissemination and Outreach Center (RDOC) and projects developing Cutting Edge Informatics Tools (CEITs). Small businesses are expected to complement the IDG Centers by proposing projects to commercially validate reagents, data or experimental approaches. Projects could range from early proof-of-concept demonstration and assay development/validation to the initiation of preclinical drug discovery projects.
Potential projects could include but are not limited to the following topic areas:
- Isolation and purification of understudied proteins and initial in vitro characterization in the context of a marketed product Development of accessory reagents (e.g., antibodies, peptide fragments, labeled versions of the protein, etc.) for use in downstream studies
- Assay development, optimization, and validation with the intent of using these assays for further advancement of selected protein(s) or as stand-alone marketed products
- Validation or placement of protein(s) in signaling cascades, including upstream signals and downstream activities with the intent of initiating a biomarker or drug discovery project
- Characterization of cell and tissue-specific protein expression, localization, and function in native environments
- Use of data mining and experimental validation to analyze IDG-generated data sets and other public data resources to identify and study protein-protein interaction networks or generate hypotheses about the function of IDG protein(s)
- Use of IDG-generated (or other) tools to validate preliminary disease or physiological associations with IDG proteins in animal models, biomimetic systems, or ex vivo human samples
- Studies to establish preliminary structure-activity-relationships (SAR) between functions of an understudied protein and its ligands (e.g., small molecules, macrocycles, synthetic peptides)
- Experimental validation of predictive protein models produced by the IDG
- Medicinal chemistry efforts leveraging existing SAR of a chemical scaffold to optimize a lead preclinical candidate including characterization of efficacy as well as absorption, distribution, metabolism, excretion, and toxicity (ADMET) properties
- Protein engineering to produce a lead clinical candidate molecule that modulates the activity of key regulators of tissue and organ regeneration
- Pharmacological testing of novel preclinical lead candidates in state of the art efficacy models as well as the evaluation of novel models to better predict the efficacy of compounds (e.g. next-generation animal models, microfluidic-based 3D human organoid systems, etc.)
- Generation of labeled ligands, proteins, or biologics for use as clinical biomarkers such as in PET-imaging studies
- Construction of ready-to-use reagent kits for the study of IDG proteins.
All relevant datasets, tools, and capabilities associated with understudied proteins collected by the IDG can be found in Pharos. Applicants are strongly encouraged to use available resources in Pharos when applying to this FOA as part of the justification for the approach selected and/or to assist in accomplishing the goals of the project. Applicants should also review DruggableGenome, the IDG Consortium website, to ensure proposed work does not overlap with ongoing studies being performed by the IDG Consortium.
The following will not be considered for support under this FOA:
- Projects where most of the proposed work focuses on proteins outside of those listed above
- Applications that propose purely clinical studies involving IDG-eligible protein(s) and that meet the definition of an NIH clinical trial
- Any approach that does not primarily focus on elucidating the function of IDG-eligible proteins or their potential use as a commercial product
- Projects that propose work identical to that currently being performed by the IDG Consortium (consult DruggableGenome for a list of current IDG Consortium projects)
For more information about this funding opportunity, please contact NCI SBIR Program Director Ashim Subedee (firstname.lastname@example.org).