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DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for medically refractory perianal fistulizing crohn’s disease.
Lead Product(s): ExoFlo
Therapeutic Area: Gastroenterology Product Name: DB-001
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2023
Details:
DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.
Lead Product(s): ExoFlo
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: DB-001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2023
Details:
DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.
Lead Product(s): ExoFlo
Therapeutic Area: Gastroenterology Product Name: DB-001
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2023
Details:
DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.
Lead Product(s): ExoFlo
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: DB-001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2023
Details:
ExoFlo received regenerative medicine advanced therapy (“RMAT”) designation for the treatment of severe or critical COVID-19 from the U.S. Food and Drug Administration (“FDA”).
Lead Product(s): ExoFlo
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: DB-001
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Good Works II Acquisition Corp.
Deal Size: $75.0 million Upfront Cash: $75.0 million
Deal Type: Agreement October 13, 2022
Details:
ExoFlo is an extracellular signal product isolated from human bone marrow MSCs that contains growth factors and extracellular vesicles including exosomes, to treat Acute Respiratory Distress Syndrome due to Covid-19.
Lead Product(s): DB-001
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ExoFlo
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2022
Details:
ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
Lead Product(s): DB-001
Therapeutic Area: Infections and Infectious Diseases Product Name: ExoFlo
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2021
Details:
ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs).
Lead Product(s): DB-001
Therapeutic Area: Infections and Infectious Diseases Product Name: ExoFlo
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
Under the terms of the agreement, Direct Biologics will leverage Bioclinica’s Interactive Response Technology (IRT) for their EXIT COVID-19 study, a multi-center FDA phase II clinical trial for the use of ExoFlo™ to treat COVID-19 acute respiratory distress syndrome (ARDS).
Lead Product(s): DB-001
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ExoFlo
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Recipient: Bioclinica
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 09, 2020
Details:
EXIT COVID-19 has initiated enrollment of 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery.
Lead Product(s): DB-001
Therapeutic Area: Infections and Infectious Diseases Product Name: ExoFlo
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
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