FDAnews Drug Daily Bulletin

Vivaldi & NIAID to Collaborate on Live Attenuated H7N9 Vaccine

Jan. 22, 2014

Fort Collins, Colo.-based Vivaldi Biosciences has signed a cooperative research and development agreement with the NIH’s National Institute of Allergy and Infectious Diseases to generate and evaluate live attenuated H7N9 influenza vaccine candidates in preclinical studies.

The collaboration comes four months after Vivaldi acquired R&D assets, including clinical data, intellectual property and materials, on live attenuated influenza vaccines from Baxter in an effort to broaden its pandemic awareness portfolio.

The partners will use Vivaldi’s LAIV master strain, created by using reverse genetics and plasmid rescue technologies on the NS-1 virulence factor to produce a replication-deficient LAIV that can generate a safe immune response. The partners will then proceed with in vitro and in vivo studies evaluating safety, efficacy and immunogenicity in animals; these results will eventually contribute to an IND application, Vivaldi says.

Vivaldi CEO Douglass B. Givens told Drug Daily Bulletin that the agreement with NIAID supports Vivaldi’s efforts to develop next-generation LAIV technology for the H7N9 strain, adding that a Phase I study of an NS-1-based LAIV for the H5N1 strain has already shown promise. — Lena Freund

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