Type of information:
Product name: VAC-3S immunotherapy
Compound: VAC-3S immunotherapy
Action mechanism: The VAC-3S vaccine is intented to induce sustainable levels of anti-3S peptide antibodies in patients, therefore blocking the 3S peptide-mediated pathway of CD4+ T lymphocyte depletion. 3S is a short and conserved peptide from the gp41 envelope protein of the HIV-1 and was shown to be responsible for the loss of CD4+ T lymphocytes in HIV infected patients. The VAC-3S vaccine will not have a direct effect on the virus replication and propagation itself. It will protect the CD4+ T lymphocytes from being depleted and also reduce immune activation. Basically it will protect the immune against deleterious effects of the virus. These effects will be synergistic to that of antiretroviral therapies. This therapy will be used in poor and non immune responders patients under antiretroviral therapy, allowing their CD4+ T lymphocyte count to get to a value above 500/mm3. The poor and non immune responder patients represent a significant proportion of patients under antiretroviral therapies. This immunotherapy will also be used in asymptomatic patients delaying/preventing the patients to be subjected to a decrease of CD4+ T lymphocytes, therefore keeping such patients in the asymptomatic phase, for which there is no associated morbidity.
Company: Innavirvax (France)
Patents: * On June 18, 2012, InnaVirVax, a biopharmaceutical company specialized in the research and development of therapeutic and diagnostic innovations focused on immune dysregulation, has filed a new European patent application on VAC-3S, a « first-in-class » immunotherapy for the treatment of HIV infections.
This patent application claims the use of new immunogenic compositions that are optimized to induce a strong immune response in humans. It also relates to use of such immune compositions with enhanced properties compared to references. This industrial property consolidation is based on the research undertaken by the Company since its inception, more than 3 years ago. It deals with an essential stake showing InnaVirVax’s ability to create value through innovation and patents.
InnaVirVax is developing VAC-3S from a patent family covering Europe, the United States, Canada and China whose property belongs to Inserm and the AP-HP. InnaVirVax has been granted an exclusive worldwide license since May 2009.
This immunotherapy is currently under phase I/IIa clinical development since February 2012 in two major clinical reference centers in Paris: the Pitié-Salpêtrière and Cochin Hospitals.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
Pediatric exclusivity UE: