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[{"orgOrder":0,"company":"Scinai Immunotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NIAID-sponsored Trial of M-001 Validates Previous Clinical Trials","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Vaccine","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Scinai Immunotherapeutics","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$4.2 million","upfrontCash":"Undisclosed","newsHeadline":"BiondVax Announces Receipt of $4.2 Million Through Exercise of Warrants","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Vaccine","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Scinai Immunotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NIH Report on Phase 2 Clinical Trial of BiondVax's M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Vaccine","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Scinai Immunotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Last of 12,400 Participants Completes Final Visit in BiondVax's M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Vaccine","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Scinai Immunotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BiondVax Announces Topline Results from Phase 3 Clinical Trial of the M-001 Universal Influenza Vaccine Candidate","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Vaccine","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"}]

Find Clinical Drug Pipeline Developments & Deals for DSSTox_CID_3516

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            Development Status

            Details:

            Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints.

            Lead Product(s): Proglumide

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

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 23, 2020

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            Details:

            The purpose of the study is to assess M-001's ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate and severity, as well as to assess M-001's safety.

            Lead Product(s): Proglumide

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

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 01, 2020

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            Details:

            The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID’s Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA.

            Lead Product(s): Proglumide

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 10, 2020

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            Details:

            BiondVax's pivotal, Phase 3 trial in Europe is ongoing. The trial, which is assessing M‑001's ability to provide clinical protection from any circulating influenza strain, is being conducted with volunteers aged 50+ (with half aged 65+) over two flu seasons in 7 countries.

            Lead Product(s): Proglumide

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $4.2 million Upfront Cash: Undisclosed

            Deal Type: Funding May 20, 2020

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            Details:

            The data, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020.

            Lead Product(s): Proglumide

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Vaccine

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 05, 2020

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