Wednesday October 16, 2019 0 comments
FORT COLLINS and VIENNA, Austria -- Vivaldi Biosciences Inc., a clinical-stage company developing the deltaFLU universal influenza vaccine, announced it signed a technology co-ownership agreement with BlueSky Vaccines GmbH, a Vienna company developing immunotherapies against cancer.
The agreement covers U.S. and European patent applications relating to high-growth influenza virus strain technology. The jointly filed patent applications result from a successful collaboration between the two companies to genetically engineer influenza viruses for development of vaccines and immunotherapies.
The agreement grants Vivaldi the exclusive right to develop and commercialize the technology in the field of infectious diseases. Vivaldi is applying the technology to optimize production of its deltaFLU universal influenza vaccine in Vero cell culture.
Vivaldi has developed high-growth deltaFLU vaccine strains and an efficient Vero cell production system that, in combination, allow production of the finished deltaFLU vaccine product within just seven weeks.
Most licensed influenza vaccines are produced in eggs, which can take up to six months.
Vivaldi’s deltaFLU universal influenza vaccine is a self-adjuvanting vaccine administered by nasal spray. deltaFLU rapidly generates a robust immune response in the nasal passages, inducing interferon (a key component of the immune response to viral infection) and antibodies with neutralizing activity against a broad range of influenza virus subtypes.
deltaFLU also establishes broad and long-lasting protection through activation of T cells and systemic antibodies. With demonstrated potential for superior efficacy and broad protection, advanced cell-based manufacturing, and needle-free administration, deltaFLU satisfies key objectives of the recent Presidential Executive Order titled “Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health.”
Specifically, deltaFLU addresses urgent needs for: a broadly protective influenza vaccine that provides more effective and longer lasting immunity, reducing reliance on egg-based influenza vaccine production with a faster and more scalable manufacturing platform, and a delivery system that does not rely on needles and syringes, and enables rapid and large-scale administration of pandemic vaccines.
Vivaldi Biosciences is developing deltaFLU for intranasal administration, to provide broad protection and superior efficacy in the prophylaxis of seasonal and pandemic influenza.
deltaFLU is composed of influenza vaccine strains genetically modified by deletion of the gene for nonstructural protein 1 (NS1). Deletion of NS1 confers the unique and broadly protective mechanism of action of deltaFLU and ensures the vaccine is safely attenuated.
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. deltaFLU vaccines have been evaluated successfully in four Phase 1 and Phase 2 clinical trials involving a total of 245 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.
In a nonclinical study, Vivaldi said a single dose of deltaFLU protected against widely drifted influenza A and B strains and even protected against a shifted influenza A strain.