Vivaldi Biosciences Inc. (Vivaldi), a biotechnology company focused on development of vaccines for influenza, today announced that the United States Patent and Trademark Office has issued US Patent 7,588,768 covering live attenuated influenza vaccines (LAIVs) with modifications to the viral NS1 gene, and methods for producing the vaccines in cell culture systems. This proprietary technology is applicable to rapid development and production of LAIVs against virtually all seasonal and pandemic influenza strains, including novel (swine-origin) H1N1. Vivaldi has exclusive rights to the patented technology and has LAIV candidates in development.
Live attenuated vaccines replicate safely in the recipient without causing disease, providing longer lasting immunity and greater protection than vaccines based on inactivated virus. Vivaldi’s LAIV candidates represent the first prospectively designed live virus vaccines. Distinct from live influenza vaccines developed by isolation of temperature-sensitive strains, Vivaldi uses advanced reverse genetics methods to delete a portion of the gene for nonstructural protein 1 (NS1), a virulence factor of the influenza virus. Each LAIV candidate has a single, defined modification that is genetically stable. Vivaldi’s LAIVs are expected to produce a potent, durable immune response, with potential for cross-protection against a range of circulating influenza strains.
Vivaldi’s LAIVs have a unique mode of action. They stimulate production of interferon, which acts as a natural adjuvant, boosting both antibody and cell-based immunity. Vivaldi’s LAIVs thus will be “self-adjuvanted”, eliminating the safety and regulatory risks of novel adjuvants, which are integral to many influenza vaccine technologies in development. Vivaldi’s LAIVs are being developed as a single-dose nasal spray. Nasal administration is convenient and pain-free, and well-suited for mass immunization. Moreover, LAIVs administered intranasally elicit production of antibodies in the nasal passages, creating a first line of defense at the natural point of entry of circulating influenza viruses.