Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : M-001
Molecule Type : Vaccine
Upfront Cash : Not Applicable
October 23, 2020
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 s...
Brand Name : M-001
Molecule Type : Vaccine
Upfront Cash : Not Applicable
July 01, 2020
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Vaccine
Upfront Cash : Not Applicable
June 10, 2020
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : $4.2 million
Deal Type : Funding
BiondVax Announces Receipt of $4.2 Million Through Exercise of Warrants
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 se...
Brand Name : Undisclosed
Molecule Type : Vaccine
Upfront Cash : Undisclosed
May 20, 2020
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : $4.2 million
Deal Type : Funding
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
NIAID-sponsored Trial of M-001 Validates Previous Clinical Trials
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.
Brand Name : Undisclosed
Molecule Type : Vaccine
Upfront Cash : Not Applicable
February 05, 2020
Lead Product(s) : Proglumide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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