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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): 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.

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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): ALVR109

            Therapeutic Area: Infections and Infectious Diseases Product Name: ALVR109

            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 17, 2020

            Details:

            ALVR109 is an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2 for high-risk COVID-19 patients.

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            Lead Product(s): COVID-19 Vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 14, 2020

            Details:

            The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine.

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            Lead Product(s): Human monoclonal antiviral antibody

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Avid Bioservices

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 26, 2020

            Details:

            Mapp Biopharmaceutical has contracted Avid to provide process transfer, scale-up and clinical manufacturing services to support one of its development programs for a novel antiviral drug candidate. Avid and Mapp will immediately commence the initial phase of the project.

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            Lead Product(s): HFB30132A

            Therapeutic Area: Infections and Infectious Diseases Product Name: HFB30132A

            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 August 26, 2020

            Details:

            The highly differentiated antibody, HFB30132A, has been rapidly identified, engineered, and evaluated in multiple preclinical studies. A Phase I single-IV administration ascending dose study will assess the safety, tolerability, and pharmacokinetics of HFB30132A.

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            Lead Product(s): RV1730

            Therapeutic Area: Infections and Infectious Diseases Product Name: RV1730

            Highest Development Status: IND Enabling Product Type: Vaccine

            Partner/Sponsor/Collaborator: Terra Magnum Capital Partners

            Deal Size: $2.3 million Upfront Cash: Undisclosed

            Deal Type: Financing August 24, 2020

            Details:

            The Company will use the proceeds to advance its Covid-19 vaccine (RV1730) program and neoantigen-based cancer vaccine programs.

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            Lead Product(s): ELI-005

            Therapeutic Area: Infections and Infectious Diseases Product Name: ELI-005

            Highest Development Status: IND Enabling Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 19, 2020

            Details:

            ELI-005 is made of two components: ELI-004, an Amphiphile adjuvant with a hydrophobic albumin-binding lipid linked to a hydrophilic immune stimulating CpG DNA oligonucleotide (AMP-CpG), and a COVID-19 Spike protein receptor binding domain.

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            Lead Product(s): Mesenchymal Stem Cell- Derived Exosomes

            Therapeutic Area: Infections and Infectious Diseases Product Name: XoGlo

            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 August 18, 2020

            Details:

            Kimera® Labs has filed an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes.

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