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

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            Lead Product(s): ALS-4

            Therapeutic Area: Infections and Infectious Diseases Product Name: ALS-4

            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 01, 2020

            Details:

            Two sets of positive data showing both significant in vivo activities of its lead compound ALS-4 against Methicillin-Resistant Staphylococcus aureus in wound infected and bacteraemia mouse models, respectively when compared to prevailing antibiotics.

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            Lead Product(s): Palmitoylethanolamide

            Therapeutic Area: Infections and Infectious Diseases Product Name: FSD201

            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 August 31, 2020

            Details:

            The FSD201 COVID-19 Trial will be a multicenter study that assesses the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care compared to SOC alone in hospitalized patients with COVID-19 disease.

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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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            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 August 14, 2020

            Details:

            TLC19 utilizes TLC’s existing proprietary liposome technology to encapsulate ~1/100 of the oral HCQ dose into an inhalable formulation for direct deposit into the airways and lungs.

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            Lead Product(s): MRX-8

            Therapeutic Area: Infections and Infectious Diseases Product Name: MRX-8

            Highest Development Status: IND Enabling Product Type: Peptide

            Partner/Sponsor/Collaborator: CARB-X

            Deal Size: $8.0 million Upfront Cash: Undisclosed

            Deal Type: Financing August 13, 2020

            Details:

            The nondilutive financing is intended for a Phase 1 clinical trial and related R&D activities of its new antimicrobial agent MRX-8. Previously, CARB-X has funded investigational new drug (IND) enabling studies for MRX-8 in the US.

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            Lead Product(s): Niclosamide

            Therapeutic Area: Infections and Infectious Diseases Product Name: UNI911

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Union Therapeutics

            Deal Size: $210.0 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement August 13, 2020

            Details:

            UNION therapeutics completed an agreement with TFF Pharmaceuticals to acquire an option to obtain a worldwide exclusive license for the use of their Thin Film Freezing technology in combination with niclosamide to focus on treatments for COVID-19.

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