DeltaFLU is designed to provide protection against all influenza type A and B virus strains, including all seasonal influenza strains, and emerging strains with pandemic potential such as avian H5N1. The patented high-growth strain technology has been used in GMP manufacture of DeltaFLU universal influenza vaccine for upcoming clinical trials, including a Phase 2 clinical study for human proof of concept for universal protection.
“Development of a consistent, reliable production process for GMP manufacture is essential in the clinical development, licensure and commercialization of a novel vaccine. The patented high-growth strain technology enables rapid, high-yield production of DeltaFLU universal influenza vaccine that can be scaled to meet commercial needs, with favorable economics,” commented Manfred Reiter, PhD, Senior Vice President, Manufacturing, Vivaldi Biosciences.
Administered as a nasal spray, DeltaFLU generates a comprehensive immune response including rapid induction of interferon and broadly cross-neutralizing IgA antibodies in the nasal passages, and a broad systemic immune response including IgG antibodies and T cells. Interferon acts as a natural adjuvant, enhancing the immune response. Immunity generated in the nasal passages creates a first line of defense at the point of entry of infectious viruses. Distinct from other live attenuated influenza vaccines, DeltaFLU vaccine strains do not replicate, providing an important safety advantage.
DeltaFLU component vaccine strains have been evaluated in four clinical trials. The vaccine strains induced a broad immune response and were well-tolerated, with no safety signals. Vivaldi recently demonstrated in preclinical studies that DeltaFLU blocks transmission of influenza type A and B virus strains. Universal protection against all influenza virus strains causing disease in humans and prevention of virus transmission would be a significant advance in preventing influenza and reducing the disease burden, especially in the event of a pandemic.
About Vivaldi Biosciences
Vivaldi is developing intranasal vaccines for superior protection against influenza and other respiratory diseases, based on its DelNS1 technology platform. The company’s clinical-stage vaccines are DeltaFLU universal influenza vaccine, for protection against all influenza A and B strains; and DelNS1 H5N1, a Phase 2-ready vaccine for protection against highly pathogenic influenza H5N1 strains with pandemic potential. Clinical development of DeltaFLU is funded by the European Union's Horizon Europe Research & Innovation program, under grant agreement No. 101080692. The company’s Delta-19 combination vaccine for Covid-19 and influenza is in preclinical development. Vivaldi’s Vero cell-based vaccine manufacturing system uses patented advances in production and purification for high yields and excellent purity. U.S. Patent Number 12,350,325 is co-owned by BlueSky Immunotherapies. Vivaldi has exclusive rights to develop and commercialize the technology in the field of infectious diseases. Vivaldi is a venture-backed company with operations at the Research Innovation Center at Colorado State University, Fort Collins, Colorado, and in Vienna, Austria. NGN Capital LLC is the company’s lead investor. Learn more at www.vivaldibiosciences.com. Connect with Vivaldi Biosciences on Linkedin and Twitter.