Vivaldi Buys Flu Vaccine R&D Assets From Baxter

Vivaldi Biosciences said today it acquired from Baxter R&D assets-;including intellectual property, clinical data, knowhow, and materials-;for live attenuated influenza vaccines (LAIVs) in which the gene for influenza nonstructural protein 1 (NS1) has been fully deleted.

The price was not disclosed for the LAIV assets, which were previously were owned by Vienna-based AVIR Green Hills Biotechnology.

Vivaldi did say, however, that the acquisition complements and "substantially" broadens its LAIV platform, as well as product development opportunities in pandemic preparedness and seasonal influenza.

Vivaldi's platform uses its own reverse genetics and plasmid rescue technologies to engineer a specific truncation in the NS1 gene, generating LAIVs with partially deleted NS1. According to the company, the LAIVs are attenuated for safety and provide a potent, protective immune response including cross-protection against unmatched strains, without viral replication or the need for adjuvants, as demonstrated in preclinical studies.

The acquired assets-;LAIVs with fully deleted NS1, called delta-NS1 LAIVs-;were well tolerated and generated positive immunogenicity data in a dose-dependent manner in four earlier clinical trials with a total 160 patients conducted at the Medical University of Vienna by AVIR Green Hills. The four consisted of a Phase I clinical study of a delta-NS1 LAIV for highly pathogenic avian influenza A (H5N1 or "bird flu"), two Phase I studies of delta-NS1 LAIVs for seasonal H1N1 influenza strains, and a Phase I/II study of a trivalent delta-NS1 LAIV for seasonal influenza.

"Acquisition of these assets catapults Vivaldi into a very favorable position for further advancing in clinical trials multiple NS1-technology-based LAIVs to address the most pressing public health issues of influenza: the need for effective protection against emerging pandemic influenza strains, and the need for greater protection of the most vulnerable population groups-;seniors and the very young-;against seasonal influenza," Doug Given, M.D., Ph.D., Vivaldi's president and CEO, said in a statement.

The delta-NS1 programs received €20 million ($27 million) in nondilutive funding from the European Union and the Austrian government.

"The considerable achievements by AVIR Green Hills in the development, cell-based manufacture, and clinical evaluation of delta-NS1 LAIVs, combined with Vivaldi's technology platform and programs, give us a range of NS1-technology-based approaches for LAIVs for these significant unmet needs," Dr. Given said.

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