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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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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
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
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
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
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