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Find FDA Investigational New Drug (IND) Submissions for Infections and Infectious Diseases

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            Lead Product(s): MRT5500

            Therapeutic Area: Infections and Infectious Diseases Product Name: MRT5500

            Highest Development Status: IND Enabling Product Type: Vaccine

            Partner/Sponsor/Collaborator: Translate Bio

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 15, 2020

            Details:

            Preclinical evaluation of MRT5500, importantly, demonstrated a favorable immune response profile against SARS-CoV-2. These data support the selection of MRT5500 for clinical development.

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            Lead Product(s): IMS001

            Therapeutic Area: Infections and Infectious Diseases Product Name: IMS001

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: ImStem Biotechnology

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 28, 2020

            Details:

            ImStem has obtained from AgeX a non-exclusive, royalty-bearing sublicense to use AgeX’s clinical-grade ESC line ESI-053 to derive ImStem’s investigational MSC product candidate IMS001 for development in COVID-19 as well as acute respiratory distress syndrome from other causes.

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            Lead Product(s): Emricasan

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Histogen

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration October 27, 2020

            Details:

            Histogen will retain ownership and oversight over emricasan and responsibility for all regulatory filings and maintaining its existing caspase inhibitor patent portfolio. Amerimmune will lead development efforts of emricasan in a phase 1 study in mild-COVID-19 patients.

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            Lead Product(s): T Cell Therapy

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Thomas Jefferson University

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 14, 2020

            Details:

            Under normal circumstances, the body generates specific T cells to rid itself of viruses such as COVID-19. In the proposed trials, such T cells will be generated in the laboratory and administered to patients at the sicker end of the COVID-19 spectrum.

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            Lead Product(s): Hydroxychloroquine Sulphate

            Therapeutic Area: Infections and Infectious Diseases Product Name: TLC19

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

            Details:

            The Phase I randomized, vehicle-controlled, blinded study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of inhaled TLC19 in 30 healthy volunteers.

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            Lead Product(s): rNAPc2

            Therapeutic Area: Infections and Infectious Diseases Product Name: AB201

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

            Details:

            ARCA anticipates initiating a Phase 2b/3 sequential clinical trial, ASPEN-COVID-19, of AB201 in approximately 100 patients hospitalized with COVID-19 in the fourth quarter of this year, with Phase 2b followed by a contiguous Phase 3 study that is dependent on Phase 2 results.

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            Lead Product(s): Ischemic-tolerant mesenchymal stem cells

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 27, 2020

            Details:

            Prior to submission of an IND, fourteen critically ill COVID-19 patients were treated on Emergency Use and Expanded Use INDs. The stem cell treatment resulted in an improved clinical course for the patients within 24-48 hours of receiving the therapy.

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            Lead Product(s): Cannabidiol

            Therapeutic Area: Infections and Infectious Diseases Product Name: CardiolRx

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 25, 2020

            Details:

            Cardiol’s Phase II/III trial is designed to assess the efficacy, safety, & tolerability of CardiolRx™ in preventing cardiovascular complications in hospitalized patients, with a confirmed COVID-19 infection and who have pre-existing CVD or significant risk factors for CVD.

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            Lead Product(s): rNAPc2

            Therapeutic Area: Infections and Infectious Diseases Product Name: AB201

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            AB201 is a small recombinant protein and a potent, selective inhibitor of tissue factor, developed as a potential treatment for RNA virus- associated disease, initially focusing on COVID-19.