Direct Biologics
Developer of investigational secretome-based biologics derived from adult bone marrow mesenchymal stem cells (MSC). The company focuses on cGMP manufacturing of extracellular vesicle (EV)-enriched secretome products, clinical trial execution across phases, and multi-omics characterization using AI-enabled analytics to support mechanism-of-action and potency assay development. Programs target conditions with unmet needs including ARDS and inflammatory bowel disease.
Industries
Nr. of Employees
small (1-50)
Direct Biologics
Patents
Methods and compositions for treating inflammatory conditions associated with infectious disease
US-12590310-B2
View DetailsMethods and compositions for treating inflammatory conditions associated with infectious disease
US-12570980-B2
View DetailsTreatment of fistula with bone marrow mesenchymal stem cell derived extracellular vesicles
US-12502407-B2
View DetailsMesenchymal stem cell (MSC) growth factor and extracellular vesicle preparation in frozen or powdered form and methods of use
US-12453743-B2
View DetailsPreparations comprising mesenchymal stem cells and cannabinoids and methods of their use
US-12213995-B2
View Details
Methods and compositions for treating inflammatory conditions associated with infectious disease
US-12590310-B2
View DetailsMethods and compositions for treating inflammatory conditions associated with infectious disease
US-12570980-B2
View DetailsTreatment of fistula with bone marrow mesenchymal stem cell derived extracellular vesicles
US-12502407-B2
View DetailsMesenchymal stem cell (MSC) growth factor and extracellular vesicle preparation in frozen or powdered form and methods of use
US-12453743-B2
View DetailsPreparations comprising mesenchymal stem cells and cannabinoids and methods of their use
US-12213995-B2
View DetailsProducts
DB-2Q — Acute Respiratory Distress Syndrome (ARDS)
Investigational extracellular vesicle–enriched secretome product candidate under clinical evaluation for ARDS; development program includes Phase III clinical activity.
DB-3Q — Perianal Fistulizing Crohn's Disease
Investigational secretome-based product candidate being evaluated in clinical trials for perianal fistula due to Crohn's disease (Phase II noted).
DB-3Q — Medically Refractory Crohn's Disease
Investigational secretome-based product candidate under clinical evaluation for medically refractory Crohn's disease.
DB-3Y — Medically Refractory Ulcerative Colitis
Investigational secretome-based product candidate under clinical evaluation for medically refractory ulcerative colitis.
Natural Intelligence
An investigational extracellular vesicle (EV)-enriched secretome derived from adult bone marrow mesenchymal stem cells, developed for therapeutic research.
DB-3Q
An investigational secretome-based product being evaluated in clinical trials for Perianal Fistulizing Crohn’s Disease and Medically Refractory Crohn’s Disease.
DB-2Q — Acute Respiratory Distress Syndrome (ARDS)
Investigational extracellular vesicle–enriched secretome product candidate under clinical evaluation for ARDS; development program includes Phase III clinical activity.
DB-3Q — Perianal Fistulizing Crohn's Disease
Investigational secretome-based product candidate being evaluated in clinical trials for perianal fistula due to Crohn's disease (Phase II noted).
DB-3Q — Medically Refractory Crohn's Disease
Investigational secretome-based product candidate under clinical evaluation for medically refractory Crohn's disease.
DB-3Y — Medically Refractory Ulcerative Colitis
Investigational secretome-based product candidate under clinical evaluation for medically refractory ulcerative colitis.
Natural Intelligence
An investigational extracellular vesicle (EV)-enriched secretome derived from adult bone marrow mesenchymal stem cells, developed for therapeutic research.
DB-3Q
An investigational secretome-based product being evaluated in clinical trials for Perianal Fistulizing Crohn’s Disease and Medically Refractory Crohn’s Disease.
Expertise Areas
- Clinical trial management
- Biologics manufacturing (cGMP)
- Secretome and extracellular vesicle therapeutics
- Multi-omics bioanalysis
Key Technologies
- Extracellular vesicle (EV) isolation and characterization
- Proteomics
- Transcriptomics
- AI-enabled bioinformatics for multi-omics
News & Updates
Company founded.
Commercialized a product under tissue-regulation (HCT/P 361) framework.
Initiated clinical programs in response to COVID-19 including a Phase II ARDS trial and participation in Operation Warp Speed.
Completed a Phase II clinical trial for moderate-severe ARDS associated with COVID-19.
Received RMAT designation from the U.S. Food and Drug Administration for COVID-19 associated ARDS.
Received FDA agreement to expand the Phase III trial to include Classic ARDS.
Company founded.
Commercialized a product under tissue-regulation (HCT/P 361) framework.
Initiated clinical programs in response to COVID-19 including a Phase II ARDS trial and participation in Operation Warp Speed.
Completed a Phase II clinical trial for moderate-severe ARDS associated with COVID-19.
Received RMAT designation from the U.S. Food and Drug Administration for COVID-19 associated ARDS.
Received FDA agreement to expand the Phase III trial to include Classic ARDS.