Date: 2015-06-17
Type of information: Initiation of preclinical development
phase: 2
Announcement: clinical trial authorization
Company: BiondVax Pharmaceutical (Israel)
Product: multimeric-001 vaccine (M-001)
Action
mechanism: vaccine. The multimeric-001 vaccine (M-001) is an universal influenza vaccine based on a proprietary combination of conserved non-changing epitopes, common to practically all existing and future flu virus strains, including both seasonal and pandemic flu strains such as the avian and swine flu, regardless of their antigenic drift and shifts. It comprises a proprietary combination of 9 conserved linear epitopes from influenza virus proteins, combined in triplicate into a single recombinant protein and produced by fermentation in E.coli. TheT- and B-cell epitopes were selected from Hemagglutinin (HA), Nucleoprotein (NP) and Matrix (M) proteins, therefore ensuring activation of both humoral and cellular immunity. The universal influenza vaccine has been the focus of multiple pre-clinical studies and 4 human clinical trials, two Phase 1/2 and three Phase 2, encompassing 480 adults and elderly (aged 65+).
BVX002 (NCT00877448): Phase 1/2 trial, in 63 participants 18-49 years old, successfully concluded in December 2009
BVX003 (NCT01010737): Phase 1/2 trial, in 60 participants 55-75 years old, successfully concluded in April 2010
BVX004 (NCT01146119): Phase 2 trial, in 200 participants 18-49 years old, successfully concluded in June 2011
BVX005 (NCT01419925): Phase 2 trial in 120 participants 65+ years old, successfully concluded in February 2012
BVX006 (NCT02293317): Phase 2 trial in 36 participants 60-64 years old. Final results to be published in Q4, 2015
The vaccine has a positive safety profile and induces both humoral (antibody) and cellular influenza-specific immune responses. The clinical grade universal vaccine is produced at the Company’s facility that successfully passed a European (EU) Qualified Person (QP) Good Manufacturing Practices (GMP) audit in 2012.
Disease: influenza
Therapeutic area: Infectious diseases
Country: USA
Trial details:
Latest
news: * On June 17, 2015, BiondVax Pharmaceuticals, a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, announced that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the FDA, and the Company was notified by its regulatory advisors that the \'study may proceed\'. FDA acceptance of an IND provides authorization for the distribution and administration in the U.S. of medical products that have not yet been approved for commercial use for purposes of conducting clinical trials. This IND continues BiondVax\'s clinical program, and will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax\'s product candidate.
