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

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            Lead Product(s): K-NK-ID101

            Therapeutic Area: Infections and Infectious Diseases Product Name: K-NK-ID101

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

            Partner/Sponsor/Collaborator: Kiadis Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration November 12, 2020

            Details:

            Pluristyx will be supporting a collaboration between Kiadis Pharma and the Advanced Regenerative Manufacturing Institute’s BioFabUSA program working on Kiadis’ COVID-19 research and development program K-NK-ID101 as a universal countermeasure to fight COVID-19.

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            Lead Product(s): Vasculotide

            Therapeutic Area: Infections and Infectious Diseases Product Name: AV-001

            Highest Development Status: IND Enabling Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 12, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for AV-001, a Tie2 tyrosine kinase receptor agonist, as a potential treatment for hospitalized patients diagnosed with moderate-to-severe COVID-19 disease.

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            Lead Product(s): STI-2099

            Therapeutic Area: Infections and Infectious Diseases Product Name: Covi-drops

            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 November 11, 2020

            Details:

            A single intra-nasal administration of COVI-DROPS (STI-2099) 12 hours after infection prevented disease-associated weight loss in treated hamsters.

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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): 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.