Vivaldi Biosciences Announces Issuance of U.S. Patent Enabling Rapid Manufacture of its Universal Influenza Vaccine
Vivaldi Biosciences Inc., a clinical-stage biotechnology company developing nasal spray vaccines for viral respiratory diseases, announced today that the United States Patent and Trademark Office has issued U.S. Patent Number 12,350,325, “Recombinant High Growth Rate Influenza Virus Comprising Mutations in M1, NS2, and PB2.” The patent includes claims covering specific genetic mutations that greatly increase growth rates of Vivaldi’s live attenuated influenza vaccine strains in cell culture, enabling rapid, efficient production of the Company’s lead clinical-stage vaccine, DeltaFLU universal influenza vaccine.
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.