Universal Influenza Vaccine Company Vivaldi Biosciences Forms Agreement with BlueSky Vaccines for Virus Purification Technologies

FORT COLLINS, Colorado and VIENNA, Austria – July 18, 2019 − Vivaldi Biosciences Inc., a clinical-stage company developing the deltaFLU universal influenza vaccine, has executed an agreement with BlueSky Vaccines GmbH granting Vivaldi an exclusive option on patent rights to BlueSky’s virus purification technologies in the field of live attenuated influenza vaccines (LAIVs) generated by deletion of the gene for nonstructural protein 1 (NS1), a virulence factor of influenza. The two companies expect to execute a definitive license agreement on the purification technologies within a year.

Vivaldi’s deltaFLU universal influenza vaccine is a self-adjuvanting vaccine administered by nasal spray. deltaFLU is composed of influenza vaccine strains genetically modified by deletion of the gene for NS1 and optimized for high growth and efficient production in Vero cells. Deletion of NS1 confers the unique and broadly protective mechanism of action of deltaFLU and ensures the vaccine is safely attenuated.

NS1, produced by disease-causing (wild-type) influenza viruses, blocks the body’s production of interferon, a key component of the immune system’s response to viral infection. Lacking the ability to produce NS1, deltaFLU rapidly induces interferon and broadly neutralizing antibodies in the nasal passages, creating a first line of defense directly at the point of entry of circulating viruses. The self-adjuvanting effect of interferon also creates a second line of defense by stimulating the immune system’s T cells and antibody-producing B cells to achieve a broadly protective systemic immune response.

Vivaldi has developed a high-efficiency high-yield Vero cell process that enables production of deltaFLU in just seven weeks. The BlueSky virus purification technologies provide Vivaldi an improved method to produce deltaFLU with excellent purity and potency, using continuous cell line production at large scale. The technologies were transferred successfully from BlueSky to Vivaldi and used in pilot-scale GMP production of deltaFLU for forthcoming clinical trials, achieving an overall yield of 80%. Commercial-scale production of live virus vaccines grown in cell culture typically achieves yields of 15% to 30%. The high-yield process translates to a low per-dose cost and opportunity for favorable pricing of Vivaldi’s deltaFLU universal influenza vaccine and vaccines in development for pandemic influenza.

About Vivaldi Biosciences

Vivaldi Biosciences is developing deltaFLU influenza vaccines for intranasal administration, to provide broad protection and superior efficacy in the prophylaxis of seasonal and pandemic influenza. deltaFLU vaccines have been evaluated successfully in four Phase 1 and Phase 2 clinical trials involving a total of 245 adult volunteers. The clinical trials demonstrate the potential for superior efficacy and broad protection against influenza A and B strains with a single dose. These studies also confirm that deltaFLU vaccine strains are replication-deficient and are not shed by the recipient, providing significant safety advantages. A recent nonclinical study showed that a single dose of deltaFLU provides protection against distantly drifted influenza strains, and even provides protection against an antigenically shifted influenza strain. Vivaldi Biosciences is based at the Research Innovation Center at Colorado State University and in Vienna, Austria. NGN Capital LLC is the lead investor in Vivaldi Biosciences. Additional information can be found at www.vivaldibiosciences.com.

NewCarrie Wick