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    [{"orgOrder":0,"company":"Direct Biologics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Cell and Gene therapy","year":"2020","type":"Inapplicable","leadProduct":"DB-001","moa":"Undisclosed","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 \/ Inapplicable","highestDevelopmentStatusID":"8","companyTruncated":"Direct Biologics \/ Inapplicable"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Cell and Gene therapy","year":"2020","type":"Inapplicable","leadProduct":"DB-001","moa":"Undisclosed","graph1":"Infections and Infectious 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    Find Clinical Drug Pipeline Developments & Deals by Direct Biologics

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                            01

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Study Phase : Phase I

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Receives FDA Clearance to Initiate Phase 1b/2a Clinical Trial of ExoFlo™ in Patients with M...

                            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 ...

                            Product Name : DB-001

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            April 26, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase I

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            02

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patient...

                            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.

                            Product Name : DB-001

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            April 19, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            03

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Study Phase : Phase I

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Announces Initiation of Phase 1 Clinical Trial for Medically Refractory Crohn’s Disease

                            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.

                            Product Name : DB-001

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            March 21, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase I

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            04

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Reports Compelling Results From Phase 2 Trial With ExoFlo™ in Hospitalized Patients With Re...

                            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.

                            Product Name : DB-001

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            March 14, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Good Works II Acquisition Corp.

                            Deal Size : $75.0 million

                            Deal Type : Agreement

                            DEALS_DEV arrow-down

                            Good Works II Acquisition Corp. and Direct Biologics, LLC Announce a Definitive Agreement for a Business Combi...

                            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”).

                            Product Name : DB-001

                            Product 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

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Tr...

                            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.

                            Product Name : ExoFlo

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            April 21, 2022

                            Lead Product(s) : DB-001

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Granted FDA Approval of Third IND Application for the Use of ExoFlo in Mild-to-Moderate COVID...

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

                            Product Name : ExoFlo

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            June 29, 2021

                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Highest Development Status : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            08

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Announces First Patient Treated Under Phase II Expanded Access Protocol Using ExoFlo™ to Tr...

                            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).

                            Product Name : ExoFlo

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            December 30, 2020

                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Highest Development Status : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            09

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Initiates Patient Enrollment in the Phase II EXIT COVID-19 Clinical Trial

                            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.

                            Product Name : ExoFlo

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            September 09, 2020

                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Highest Development Status : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Direct Biologics Receives FDA Approval to Initiate 'EXIT-COVID-19,' a Phase II Investigational New Drug Trial

                            Details : Direct Biologics believes that this study is the first and only Phase II IND trial utilizing bone marrow-derived extracellular vesicles to treat SARS-CoV-2 (COVID-19) related ARDS.

                            Product Name : ExoFlo

                            Product Type : Cell and Gene therapy

                            Upfront Cash : Inapplicable

                            July 30, 2020

                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Highest Development Status : Phase II

                            Sponsor : Inapplicable

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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