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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): Transcrocetinate sodium

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 July 27, 2020

            Details:

            NAMMD has regulatory oversight over the Company’s first planned clinical trial, an open-label Phase 1b lead-in trial in 24 hospitalized COVID-19 patients at the Romanian National Institute of Infectious Diseases (NIID).

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            Lead Product(s): Rigosertib

            Therapeutic Area: Infections and Infectious Diseases Product Name: ON-01910

            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 July 27, 2020

            Details:

            Onconova Therapeutics has submitted an application with the National Institute of Allergy and Infectious Disease (NIAID), with the goal of obtaining funding from the National Institutes of Health (NIH) to conduct human studies with rigosertib in COVID-19 disease patients.

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            Lead Product(s): CD377

            Therapeutic Area: Infections and Infectious Diseases Product Name: CD377

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 27, 2020

            Details:

            The SAB will work closely with the Cidara management team to help guide the direction and design of the company’s development programs with an emphasis on the continued development and expansion of the company’s Cloudbreak Antiviral Conjugate (AVC) program.

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            Lead Product(s): CF-370

            Therapeutic Area: Infections and Infectious Diseases Product Name: CF-370

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: CARB-X

            Deal Size: $18.9 million Upfront Cash: Undisclosed

            Deal Type: Funding July 20, 2020

            Details:

            This CARB-X funding is aimed at progressing ContraFect's second product candidate, CF-370, an engineered lysin targeting Pseudomonas aeruginosa (P. aeruginosa), in IND-enabling activities toward future Phase 1 clinical trials.

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            Lead Product(s): Vadadustat

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 July 14, 2020

            Details:

            The randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients who have been hospitalized at Memorial Hermann-Texas Medical Center for hypoxemia due to COVID-19.

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            Lead Product(s): Transcrocetinate sodium

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            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 July 07, 2020

            Details:

            The new IND details three studies, comprised of an open-label Phase 1b lead-in trial which, if successful, will be followed by two randomized double-blinded Phase 2b trials.

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            Lead Product(s): AR-701

            Therapeutic Area: Infections and Infectious Diseases Product Name: AR-701

            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 June 18, 2020

            Details:

            The discussion is intended to provide a comprehensive profile of the Company's CRISPR based, new platform technology APEX™.

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            Lead Product(s): IBIO-201

            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 June 04, 2020

            Details:

            The new subunit vaccine (“IBIO-201”) combines antigens derived from the SARS-CoV-2 spike protein fused with the Company’s patented lichenase booster molecule (“LicKM”), which is designed to enhance immune response.

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            Lead Product(s): T-COVID

            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 June 01, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19.

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            Lead Product(s): NV-HHV-101

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Maxim Group LLC

            Deal Size: $10.2 million Upfront Cash: Undisclosed

            Deal Type: Public Offering May 26, 2020

            Details:

            Funds to be used to further advance company's first drug candidate for Shingles through initial human clinical trials, and advance additional HerpeCide™ program candidates against HSV-1 and HSV-2, towards clinical candidate selection.

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