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    [{"orgOrder":0,"company":"Direct Biologics","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Infections and Infectious Diseases","country":"U.S.A","productType":"Cell & Gene Therapy","year":"2021","type":"Inapplicable","leadProduct":"Bone Marrow Mesenchymal Stem Cell","moa":"Progenitor cell","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II","graph3":"Direct Biologics","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Infectious Diseases","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Direct Biologics \/ Undisclosed","highestDevelopmentStatusID":"7","companyTruncated":"Direct Biologics \/ Undisclosed"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Undisclosed","pharmaFlowCategory":"DU","therapeuticArea":"Pulmonary\/Respiratory Diseases","country":"U.S.A","productType":"Cell & Gene Therapy","year":"2021","type":"Inapplicable","leadProduct":"Bone Marrow Mesenchymal Stem 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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) : DB-3Q

                            Therapeutic Area : Immunology

                            Study Phase : Phase II

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

                            Details : DB-3Q is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Perianal Fistula-associated with Crohn Disease.

                            Product Name : Undisclosed

                            Product Type : Undisclosed

                            Upfront Cash : Inapplicable

                            April 09, 2025

                            Lead Product(s) : DB-3Q

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase II

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            02

                            Direct Biologics

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                            Lead Product(s) : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Gastroenterology

                            Study Phase : Phase I/ Phase II

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Study of ExoFlo for the Treatment of Perianal Fistulas

                            Details : ExoFlo (Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles) is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Rectal Fistula.

                            Product Name : ExoFlo

                            Product Type : Cell & Gene Therapy

                            Upfront Cash : Inapplicable

                            May 01, 2023

                            Lead Product(s) : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Gastroenterology

                            Highest Development Status : Phase I/ Phase II

                            Sponsor : Undisclosed

                            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 : Undisclosed

                            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 : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            April 26, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase I

                            Sponsor : Undisclosed

                            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 : Undisclosed

                            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 : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            April 19, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            05

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Study Phase : Phase I

                            Sponsor : Undisclosed

                            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 : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            March 21, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Immunology

                            Highest Development Status : Phase I

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            06

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            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 : Undisclosed

                            Product Type : Miscellaneous

                            Upfront Cash : Inapplicable

                            March 14, 2023

                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            07

                            Direct Biologics

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                            FNCE
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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 : Undisclosed

                            Product Type : Miscellaneous

                            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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                            08

                            Direct Biologics

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                            Lead Product(s) : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)

                            Details : ExoFlo (Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles) is a Cell and Gene Therapy drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Respiratory Distress Syndrome.

                            Product Name : ExoFlo

                            Product Type : Cell & Gene Therapy

                            Upfront Cash : Inapplicable

                            April 29, 2022

                            Lead Product(s) : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            09

                            Direct Biologics

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                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : DB-001,Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            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 & Gene Therapy

                            Upfront Cash : Inapplicable

                            April 21, 2022

                            Lead Product(s) : DB-001,Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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                            10

                            Direct Biologics

                            U.S.A arrow
                            FNCE
                            Not Confirmed

                            Direct Biologics

                            U.S.A arrow
                            FNCE
                            Not Confirmed
                            • fda
                            • EDQM
                            • WHO-GMP
                            Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

                            Lead Product(s) : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Immunology

                            Study Phase : Undisclosed

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

                            DEALS_DEV arrow-down

                            Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients

                            Details : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles is a Cell and Gene Therapy drug candidate, which is currently being evaluated in clinical studies for the treatment of Graft Rejection.

                            Product Name : Undisclosed

                            Product Type : Cell & Gene Therapy

                            Upfront Cash : Inapplicable

                            January 31, 2022

                            Lead Product(s) : Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles

                            Therapeutic Area : Immunology

                            Highest Development Status : Undisclosed

                            Sponsor : Undisclosed

                            Deal Size : Inapplicable

                            Deal Type : Inapplicable

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