Vivaldi Biosciences Inc., a clinical-stage biotechnology company developing live attenuated influenza vaccines (LAIVs) against seasonal and pandemic influenza, today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to generate and evaluate in preclinical studies LAIV candidates against influenza A(H7N9). The H7N9 strain is of concern due to its pandemic potential. Human cases of this avian-origin influenza strain were first recognized in early 2013.
Vivaldi's LAIV technology platform uses the biology of the influenza nonstructural protein 1 (NS1) to provide a new vaccine approach with the potential for superior efficacy and protection. NS1 is a multifunctional virulence factor of the influenza virus. Vivaldi uses proprietary reverse genetics and plasmid rescue technologies to modify the NS1 gene, generating replication-deficient LAIVs attenuated for safety and able to produce a potent, protective immune response.
Research under the CRADA will use Vivaldi's LAIV master strain, which incorporates a specifically truncated NS1 gene and other attenuating genes. The Vivaldi and NIAID teams jointly will select, clone and manipulate H7N9 genes for insertion into Vivaldi's master strain to generate candidate LAIVs against influenza H7N9. Vivaldi and NIAID together will conduct in vitro and in vivo evaluations of the candidate LAIVs, including studies of safety, immunogenicity and protective efficacy in animal models, and will carry out Good Laboratory Practices (GLP) toxicology evaluations of the candidate LAIVs. Data generated in the program are expected to support the filing of an Investigational New Drug (IND) application for a Phase 1 clinical trial in volunteers.
"We are pleased that NIAID has taken an active interest in Vivaldi's NS1-based LAIV platform and reverse genetics technologies by collaborating with the company on this important program for pandemic preparedness. We look forward to working with Dr. Kanta Subbarao and her team at NIAID's Laboratory of Infectious Diseases," said Douglass B. Given, MD, PhD, President and CEO of Vivaldi. "Promising activity and a favorable safety profile have been demonstrated in a Phase 1 study of our NS1-based LAIV for H5N1 influenza, another strain with pandemic potential. This CRADA with NIAID supports our efforts to further develop the next generation of our LAIV technology with the H7N9 strain."