Date: 2016-11-24
Type of information: Production agreement
Compound: two experimental vaccines
Company: Novasep (France) Vaccine Research Institute (France) ANRS (National Agency for Research on AIDS and viral hepatitis) (France)
Therapeutic area: Infectious diseases
Type agreement: production manufacturing
Action mechanism: vaccine
Disease: HIV infection
Details: * On November 24, 2016, VRI, ANRS and Novasep announce the signature of an agreement for the production of two candidate vaccines against HIV, developed by teams at VRI. Process development and production of a prophylactic and a therapeutic vaccine will be performed under current good manufacturing practice (cGMP) conditions by GTP Technology and Novasep respectively, the two contract development and manufacturing companies (CDMOs) selected for these important steps in the development of these vaccines. Results of several years of research and collaboration with international teams including those from the Baylor Institute for Immunology Research (BIIR) in Dallas, these two candidate vaccines are meant to target and activate dendritic cells through the use of monoclonal antibodies coupled with HIV antigens. Depending on the type of HIV antigen coupled with the monoclonal antibodies, the vaccine will induce a potent neutralizing and non-neutralizing antibody response as well as a T-cell response, that will, thus, provide a preventative or therapeutic impact. The objective of VRI is now to pursue the development of these candidate vaccines for future clinical trials in humans. VRI and ANRS have selected the CDMOs Novasep and GTP Technology that, through their alliance, offer considerable expertise and industrial know-how in producing and releasing cGMP batches that will be used in future phase I/II clinical trials.
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