Natural Intelligence™
Advancing research in secretome-based investigational products
Natural Intelligence™ refers to Direct Biologics’ approach to leveraging naturally derived biological systems and processes in therapeutic development.
Advancing Clinical Research in Secretome-Based Investigational Products
Mesenchymal stem cell (MSC)-derived secretome science combined with cGMP manufacturing to support clinical research. Extracellular vesicle (EV)-enriched secretome derived from adult bone marrow MSCs is an area of active scientific research. Direct Biologics utilizes components derived from bone marrow–sourced MSCs to develop investigational products being evaluated in clinical research. MSCs interact with their surrounding environment through complex signaling processes.
cGMP Manufacturing Built for Consistency
All investigational products are manufactured under current Good Manufacturing Practice (cGMP) standards to support consistency, reproducibility, and quality for clinical research programs.
AI-Enabled Multi-Omics Analyses Supporting Mechanistic Characterization of Complex Biologics
Leveraging advanced artificial intelligence (AI)-enabled bioanalytic tools for proteomic and transcriptomic characterization supports the evaluation of potential mechanism-of-action pathways and may inform therapeutic development and intellectual property strategy. These data are being evaluated to support mechanistic hypotheses relevant to ARDS, IBD, and additional disease indications. The EV enriched secretome under investigation is a complex product with a large number of potential molecular targets. Potential pathways under investigation are being explored to inform the development of indication-specific potency assays and identity matrix profiling.
The MSC secretome is being studied to better understand its potential interactions with multiple biological pathways.
This illustration depicts proposed mechanisms of action based on preclinical and emerging scientific data. These effects have not been established in clinical studies and are not intended to represent clinical outcomes.
Reference:Saadh, M.J., Mikhailova, M.V., Rasoolzadegan, S. et al. Therapeutic potential of mesenchymal stem/stromal cells (MSCs)-based cell therapy for inflammatory bowel diseases (IBD) therapy. Eur J Med Res 28, 47 (2023). https://doi.org/10.1186/s40001-023-01008-7
All candidate therapies listed on this website are investigational and have not been approved by the U.S. Food and Drug Administration.