We’re developing Delta-19 to address the double disease threat of Covid-19 and influenza, including shifted seasonal influenza strains and emerging strains with pandemic potential.
Scientists predict that SARS-CoV-2, the virus that causes Covid-19, is here to stay. Because SARS-CoV-2 is so widespread, it is unlikely to be eliminated globally. Instead, SARS-CoV-2 is expected to become endemic and adopt a seasonal pattern of annual epidemics, much like influenza. Simultaneous circulation of SARS-CoV-2 and influenza is a looming public health threat that could impose a huge burden on provision of health care, with severe socioeconomic consequences.
Delta-19 is a nasal spray vaccine designed to provide the unprecedented benefit of protection against both Covid-19 and influenza. The Delta-19 combination vaccine builds on our Delta NS1 vaccine vector technology platform for broadly protective, self-adjuvanting intranasal vaccines. Delta NS1 is a genetically modified, safely attenuated influenza virus strain that is unable to replicate. Based on this unique and clinically proven vaccine vector technology, Delta-19 expresses key immunogenic proteins of SARS-CoV-2 and influenza viruses.
Administered as a nasal spray, Delta-19 rapidly induces antibodies in the nasal passages to neutralize invading infectious SARS-CoV-2 and influenza viruses at their point of entry. Delta-19 also has the unique ability to rapidly induce interferon, a signaling protein in the body that acts as an early-warning system and triggers a broad-based immune response in the form of antibodies and T cells, for protection throughout the body.
SARS-CoV-2 and influenza viruses are readily transmitted between individuals, predominantly via respiratory droplets. The ability of Delta-19 to induce neutralizing antibodies in the nasal passages confers the important advantage of blocking proliferation of SARS-CoV-2 and influenza viruses in the nose to reduce viral load and transmission to other individuals.
We’re evaluating Delta-19 in challenge-protection studies in animal models susceptible to both COVID-19 and influenza. These studies will provide data required for an Investigational New Drug (IND) application and commencing clinical trials of Delta-19.
Our rapid and efficient Vero cell production system for GMP manufacture of DeltaFLU is readily applied to manufacture of Delta-19.
We’ve developed and implemented a proprietary high-yield, high-efficiency process for producing Delta NS1 vaccines using Vero cells as the production substrate. Our Vero cell system is fast, efficient and economical. Vero cells are an advantageous production platform − they are widely used for manufacture of licensed vaccines, have a solid regulatory track record, and eliminate the problem of antigenic mutations caused by production in eggs, the most widely used substrate for production of licensed influenza vaccines.