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    [{"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 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                            01

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Gastroenterology

                            Study Phase : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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 ...

                            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

                            Direct Biologics

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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.

                            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

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Gastroenterology

                            Study Phase : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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.

                            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

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                            Lead Product(s) : ExoFlo

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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.

                            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

                            Direct Biologics

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                            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”).

                            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

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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.

                            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

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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.

                            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

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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).

                            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

                            Direct Biologics

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                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Pulmonary/Respiratory Diseases

                            Study Phase : Phase II

                            Recipient : Bioclinica

                            Deal Size : Undisclosed

                            Deal Type : Partnership

                            DEALS_DEV arrow-down

                            Bioclinica Partners with Direct Biologics to Provide Interactive Response Technology (IRT) Solution for COVID-...

                            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

                            Direct Biologics

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                            Lead Product(s) : DB-001

                            Therapeutic Area : Infections and Infectious Diseases

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            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.

                            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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