Vivaldi Biosciences is a clinical-stage biotechnology company developing live attenuated influenza vaccines (LAIVs) to address the most pressing public health issues of influenza: the need for a rapid and effective response to emerging pandemics with vaccines that are easily administered, safe and protective, and the need for vaccines that protect the most vulnerable populations – seniors and young children – against seasonal influenza. These age groups suffer disproportionately from influenza and its serious complications, but are poorly served by conventional influenza vaccines.
Vivaldi’s LAIV technology platform uses the biology of the influenza NS1 protein to provide a new vaccine approach with the potential for superior efficacy and protection. When the influenza virus causes disease, it uses NS1 to fend off the body’s immune response mediated by interferon. Vivaldi’s LAIVs incorporate genetically modified influenza vaccine strains that elicit a potent immune response and but lack NS1 activity. Instead of blocking interferon, Vivaldi’s LAIVs promote interferon production and immunity. Administered as a nasal spray, Vivaldi’s LAIVs generate a robust immune response in the nasal passages as a first line of defense at the natural point of entry of circulating viruses, and systemic antibody- and T-cell immune responses. Stimulation of interferon generates a self-adjuvanting effect, enhancing immunity. This unique mode of action generates a more potent and complete immune response than that induced by conventional inactivated influenza vaccines (“flu shots”).
Vivaldi’s lead vaccine candidate, deltaFLU LAIV, has performed successfully in four clinical trials involving a total of 245 adult volunteers. Preliminary safety and immunogenicity have been demonstrated with five different influenza strains, including H5N1 (“bird flu”). Vivaldi plans to begin a Phase 2 clinical trial of a quadrivalent deltaFLU LAIV for seasonal influenza in children and adolescents.
Through a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), Vivaldi is developing a LAIV against H7N9, an avian-origin strain with pandemic potential. Vivaldi also is pursuing clinical development of a LAIV designed to provide superior efficacy and protection in older and elderly adults.