Codagenix Q&A: Diversifying vaccination options for patients

Digital Image of an RSV virus, colored blue and red with a light pink and yellow background.

Respiratory syncytial virus, or RSV, innovations are big news this year—and for good reason. The biotech industry has finally cracked the code for treating and helping prevent RSV in both elderly and pediatric patient populations, which will help reduce hospital burden and save thousands of lives.

Bio.News spoke with Jeffrey Fu, Ph.D., Chief Business Officer at Codagenix, about their intranasal CodaVax RSV vaccine in development and work during COVID-19. Currently in Phase 1 trials, Codagenix’s RSV vaccine aims to create a stronger, longer-term immune response in older pediatric patients.

Codagenix is a member of the Biotechnology Innovation Organization (BIO).

Bio.News: 2023 is becoming “The Year of RSV.” Talk about Codagenix’s development of CodaVax and how it is unique to the market, both in the adult and pediatric space.

Many RSV vaccines either approved or in development are proteins and focus immunity solely on a specific protein target called preF, meaning that they only render immunity against this specific RSV protein. And all are injectables. Our vaccine, CodaVax™-RSV, is different in that it is an intranasal, live-attenuated virus vaccine that enables a broad antibody and T-cell response, designed to induce immunity against a spectrum of RSV viral proteins and, as live virus vaccine, generally known to provide a durable immune response. This is a much more exhaustive immune response that may also protect against potential variants than antigen-delivery-based vaccines.

RSV poses a significant risk to children; the virus hospitalizes up to 80,000 and annually in the U.S. and >80% of RSV-associated lower respiratory infections and more than half of RSV deaths occur in children ages 6 months and older. The RSV vaccine for infants currently under U.S. Food and Drug Administration (FDA) review is designed to be received by the mother during pregnancy, with immunity waning after a few months. The recently approved passive monoclonal antibody against RSV is indicated for prevention of RSV for the first 5 months of life. There is an unmet need for the protection of older infants and toddlers in the 6-month to 5-year-old age group. We have recently initiated dosing in a Phase 1 study of CodaVax-RSV in this age group. As intranasally-delivered, our vaccine should be easy to integrate into the routine childhood vaccine schedule. At this time, we have not disclosed our plans for adults.

Bio.News: Talk about how science and technology have advanced in recent years to allow companies like Codagenix to start breaking long-standing barriers when it comes to the development of things like RSV vaccines, which have historically been a distinct challenge.

RSV vaccine development has been stalled for a long time after a terrible RSV vaccine tragedy in 1966 that resulted in the death of two children and hospitalization of many more. This was thought to be associated with inactivated RSV vaccines which induced enhancement of subsequent infection. Since that time, vaccine developers have proceeded with caution in testing inactivated and other vaccine platforms with the exception of live virus vaccines in which merely recapitulate natural RSV infection. Since then, we have come a long way in developing vaccines that are safe and efficacious as evidenced by the recent and pending approvals of RSV vaccines for adults and our understanding of the human immune system has improved, and we have better technology for packaging vaccines into a safe delivery system.

Bio.News: You’re also working on a COVID vaccine. What are challenges this vaccine can help solve when it comes to achieving manufacturing scale and access globally?

Next-generation COVID vaccines need to possess several factors to contribute to global public health beyond existing approved vaccines. They must induce broad immunity against SARS-CoV-2 variants, such as Omicron lineages, and be durable, easy to administer and store. Our COVID vaccine program, CoviLiv™, strives address these factors as a live-attenuated, intranasal vaccine that induces an antibody and cell-mediated immunity (CMI). Live virus vaccines are generally known to induce durable immunity and CoviLiv has been demonstrated to induce a broad CMI response and addition to an antibody response.

A significant barrier to COVID immunity in developing nations is the storage requirements for vaccines currently on the market, which must be stored at -80° C. These highly specialized laboratory freezers are not available in many parts of the world, preventing many nations from effectively immunizing their populations on a routine basis. Codagenix’s CoviLiv is expected to be stored in a regular freezer long term and in a refrigerator for a month, making it likely one of a few vaccine candidates able to achieve access needed to mount a global vaccination effort.

Furthermore, Codagenix’s established manufacturing process utilizes mammalian cells to manufacture vaccines with high yields and favorable cost of goods (COGs). This process can be effectively scaled to meet global manufacturing demands. Our COVID manufacturing partner, Serum Institute, is the world’s biggest vaccine manufacturer for COVID and already possesses the infrastructure required for a global vaccination effort.

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