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Vivaldi Biosciences Signs Cooperative Research and Development Agreement CRADA with National Institute of Allergy and Infectious Diseases NIAID to...

February 5, 2014



Vivaldi Biosciences Signs Cooperative Research and Development Agreement CRADA with National Institute of Allergy and Infectious Diseases NIAID to Develop Live Attenuated Influenza Vaccine Against Influenza H7N9

By a News Reporter-Staff News Editor at Vaccine Weekly -- Vivaldi Biosciences Inc., a clinical-stage biotechnology company developing live attenuated influenza vaccines (LAIVs) against seasonal and pandemic influenza, 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 (see also Vivaldi Biosciences Inc.).

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.

Keywords for this news article include: Chemicals, Chemistry, Pandemics, RNA Viruses, Epidemiology, Viral Vaccines, Orthomyxoviridae, Influenza Vaccines, Pre-Trial Research, Vertebrate Viruses, Biological Products, Vivaldi Biosciences Inc, Clinical Trials and Studies, Influenza A Virus Subtype H7N9, Marketing and Licensing Agreements.

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Source: Vaccine Weekly


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