[{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Cell and Gene therapy","year":"2020","type":"Not Applicable","leadProduct":"Bone marrow-derived extracellular vesicle and exosome product","moa":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Bioclinica","pharmaFlowCategory":"D","therapeuticArea":"Pulmonary\/Respiratory Diseases","country":"","productType":"Cell and Gene therapy","year":"2020","type":"Partnership","leadProduct":"DB-001","moa":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Respiratory Diseases","amount2New":0,"dosageForm":"","sponsorNew":"Direct Biologics \/ Direct Biologics","highestDevelopmentStatusID":"8","companyTruncated":"Direct Biologics \/ Direct Biologics"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Cell and Gene therapy","year":"2020","type":"Not Applicable","leadProduct":"DB-001","moa":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Intravenous Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Cell and Gene therapy","year":"2020","type":"Not Applicable","leadProduct":"DB-001","moa":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"","productType":"Cell and Gene therapy","year":"2021","type":"Not Applicable","leadProduct":"DB-001","moa":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Pulmonary\/Respiratory Diseases","country":"","productType":"Cell and Gene therapy","year":"2022","type":"Not Applicable","leadProduct":"DB-001","moa":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Respiratory Diseases","amount2New":0,"dosageForm":"Intravenous Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Good Works II Acquisition Corp.","pharmaFlowCategory":"D","therapeuticArea":"Pulmonary\/Respiratory Diseases","country":"","productType":"Cell and Gene therapy","year":"2022","type":"Agreement","leadProduct":"ExoFlo","moa":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III","graph3":"Direct Biologics","amount2":0.080000000000000002,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Respiratory Diseases","amount2New":0.080000000000000002,"dosageForm":"Infusion","sponsorNew":"Direct Biologics \/ Good Works II Acquisition Corp.","highestDevelopmentStatusID":"10","companyTruncated":"Direct Biologics \/ Good Works II Acquisition Corp."},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Pulmonary\/Respiratory Diseases","country":"","productType":"Cell and Gene therapy","year":"2023","type":"Not Applicable","leadProduct":"ExoFlo","moa":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Respiratory Diseases","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Gastroenterology","country":"","productType":"Cell and Gene therapy","year":"2023","type":"Not Applicable","leadProduct":"ExoFlo","moa":"","graph1":"Gastroenterology","graph2":"Phase I","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Gastroenterology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Direct Biologics \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Direct Biologics \/ Not Applicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not 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Find Clinical Drug Pipeline Developments & Deals by Direct Biologics

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                          Therapeutic Area by Lead Product

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                          01

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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 medically refractory perianal fistulizing ...

                          Brand Name : DB-001

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          April 26, 2023

                          Lead Product(s) : ExoFlo

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Phase I

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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.

                          Brand Name : DB-001

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          April 19, 2023

                          Lead Product(s) : ExoFlo

                          Therapeutic Area : Pulmonary/Respiratory Diseases

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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.

                          Brand Name : DB-001

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          March 21, 2023

                          Lead Product(s) : ExoFlo

                          Therapeutic Area : Gastroenterology

                          Highest Development Status : Phase I

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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.

                          Brand Name : DB-001

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          March 14, 2023

                          Lead Product(s) : ExoFlo

                          Therapeutic Area : Pulmonary/Respiratory Diseases

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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”).

                          Brand Name : DB-001

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : $75.0 million

                          October 13, 2022

                          Lead Product(s) : ExoFlo

                          Therapeutic Area : Pulmonary/Respiratory Diseases

                          Highest Development Status : Phase III

                          Sponsor : Good Works II Acquisition Corp.

                          Deal Size : $75.0 million

                          Deal Type : Agreement

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                          06

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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.

                          Brand Name : ExoFlo

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          April 21, 2022

                          Lead Product(s) : DB-001

                          Therapeutic Area : Pulmonary/Respiratory Diseases

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          Details : ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.

                          Brand Name : ExoFlo

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          June 29, 2021

                          Lead Product(s) : DB-001

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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).

                          Brand Name : ExoFlo

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          December 30, 2020

                          Lead Product(s) : DB-001

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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 d...

                          Brand Name : ExoFlo

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Undisclosed

                          September 09, 2020

                          Lead Product(s) : DB-001

                          Therapeutic Area : Pulmonary/Respiratory Diseases

                          Highest Development Status : Phase II

                          Recipient : Bioclinica

                          Deal Size : Undisclosed

                          Deal Type : Partnership

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                          10

                          2024 ACI Convention
                          Not Confirmed
                          2024 ACI Convention
                          Not Confirmed

                          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.

                          Brand Name : ExoFlo

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          September 09, 2020

                          Lead Product(s) : DB-001

                          Therapeutic Area : Infections and Infectious Diseases

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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