SNAP Platform enters Phase I clinical studies for RSV 

EuBiologics co.,Ltd has started Phase 1 testing of EuRSV, a next-generation RSV vaccine. This is now the second vaccine (after EuCorVac-19) to enter human testing based on University at Buffalo and POP Biotechnologies’ SNAP vaccine adjuvant system.

 

 

EuBiologics has initiated a phase 1 clinical trial of its respiratory syncytial virus (RSV) vaccine, EuRSV, in Korea.

EuBiologics said Thursday that it has begun dosing the first three participants in its phase 1 clinical trial with EuRSV.

EuBiologics received phase 1 approval from the Ministry of Food and Drug Safety (MFDS) in January and passed the institutional review board (IRB) of Korea University Guro Hospital in March. EuBiologics plans to evaluate the safety and tolerability of the investigational drug EuRSV in 100 healthy adults aged 19 to 80 after two doses of the investigational drug.

EuRSV is a recombinant protein subunit vaccine that combines the virus’s F protein antigen with an immune booster. It is manufactured using EuBiologics’ immune modulation technology (EuIMT).

RSV causes acute respiratory infections that can lead to bronchitis and pneumonia, which can be fatal, especially in infants, the elderly, and those with underlying medical conditions. The U.S. National Institutes of Health (NIH) estimates that about 3 million people are hospitalized with severe cases each year worldwide, with about 160,000 deaths.

Until recently, there was no vaccine to prevent the disease. Last year, however, GSK and Pfizer received approval from the U.S. Food and Drug Administration (FDA) for the RSV vaccines Arexvy and Abrysvo, respectively. According to Research and Market, the annual market for RSV vaccines is estimated to reach $9.53 billion (12.7 trillion won) in 2028.

“To develop EuRSV into a premium vaccine for the global vaccine market, we are considering phase 2 and phase 3 clinical trials in Korea and overseas,” a EuBiologics official said. “We will focus our capabilities on a rapid and successful product launch.”

 

출처 : KBR EuBiologics begins P1 clinical trial for RSV vaccine in Korea < Bio < Article – KBR (koreabiomed.com)