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Find Drugs for Infections and Infectious Diseases in Phase I/ Phase II Clinical Development in UNITED STATES

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            Lead Product(s): mRNA vaccine

            Therapeutic Area: Infections and Infectious Diseases Product Name: BNT162

            Highest Development Status: Phase I/ Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: U.K Governement

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 20, 2020

            Details:

            The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The BNT162 vaccine candidates are undergoing clinical studies.

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            Lead Product(s): BNT162

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 05, 2020

            Details:

            The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates, under BNT162 vaccine program, evaluated in a single, continuous study.

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            Lead Product(s): Lucinactant

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase I/ Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

            Details:

            FDA has accepted Windtree's Investigational New Drug (IND) application for a Phase 2 clinical trial studying lyo lucinactant, its KL4 surfactant drug, in COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS) patients.

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            Lead Product(s): Zofin

            Therapeutic Area: Infections and Infectious Diseases Product Name: Zofin

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

            Details:

            Aside from Convalescent Plasma, Zofin, is the first reported acellular therapy which can be accessed under FDA’s approved expanded access program.

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            Lead Product(s): Dexamethasone Sodium Phosphate

            Therapeutic Area: Infections and Infectious Diseases Product Name: AVM0703

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 16, 2020

            Details:

            This second study will evaluate AVM0703 in two different ARDS patient populations: one with COVID-19-mediated moderate to severe ARDS and the other with Influenza-mediated severe ARDS.

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            Lead Product(s): Rintatolimod,Interferon Alfa-2B

            Therapeutic Area: Infections and Infectious Diseases Product Name: Ampligen

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 16, 2020

            Details:

            Recruitment has begun in Roswell Park Comprehensive Cancer Center's Phase 1/2a clinical study of the effectiveness of rintatolimod (Ampligen) in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection.

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            Lead Product(s): GX-19

            Therapeutic Area: Infections and Infectious Diseases Product Name: GX-19

            Highest Development Status: Phase I/ Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Genexine

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership September 15, 2020

            Details:

            PharmaJet's Stratis® Needle-free Injection System will be used to deliver a novel DNA vaccine against COVID-19 (GX-19) which is being developed by an international consortium led by Genexine.

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            Lead Product(s): V591

            Therapeutic Area: Infections and Infectious Diseases Product Name: V591

            Highest Development Status: Phase I/ Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2020

            Details:

            In the case of V591, the antigen would help the patient develop antibodies against the novel coronavirus that causes COVID-19.

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            Lead Product(s): AG0302-COVID19

            Therapeutic Area: Infections and Infectious Diseases Product Name: AG0302-COVID19

            Highest Development Status: Phase I/ Phase II Product Type: Vaccine

            Partner/Sponsor/Collaborator: Brickell Biotech

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration September 08, 2020

            Details:

            AnGes is currently conducting Phase 1/2 clinical studies with its vaccine candidate in Japan, and the results from these studies will guide AnGes’ and Brickell’s global development efforts of this novel vaccine candidate.

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            Lead Product(s): CYNK-001

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

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            The trial will evaluate the safety and clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray.

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