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htmlOn November 6, Danish vaccine company Bavarian Nordic officially announced that it will launch the Phase 3 clinical trial of the RSV vaccine MVA-BN RSV. BavarianNordic has hired a CRO company and is expected to start the critical phase 3 clinical trial in the first half of 2022, recruiting 20,000 subjects to be conducted in clinical centers in multiple regions. The total cost is estimated to be US$2.5, all from equity financing. The equity used for financing accounts for about 10% of Bavarian Nordic's total share capital.
Respiratory syncytial virus (RSV) belongs to the genus Pneumovirus of the family Paramyxoviridae. It is a common virus that usually causes mild cold symptoms, but in severe cases it can lead to severe lung infections, including bronchiolitis and pneumonia, which can eventually lead to death. High-risk populations usually include infants, elderly people and immunodeficient people.
It is estimated that in the United States, about 1775,251 cases of hospitalization in adults aged 65 and above caused by RSV, of which about 140,001 deaths were hospitalized. Therefore, preventing infection caused by RSV is an urgent priority for governments and medical professionals around the world. There is currently no RSV vaccine approved by regulators to be launched. Therefore, RSV constitutes a huge and critical unmet medical need, with the potential RS vaccine market of approximately billions of dollars per year.
Bavarian Nordic's RSV candidate vaccine MVA-BN RSV is the primary target population of the elderly, including five different RSV antigens, stimulating the human body to generate a wide range of immune responses to two RSV subtypes (A and B). The five antigens include different MVA-BN RSV from other candidate RSV vaccines currently under development.
In September this year, Bavarian Nordic reported positive results of a double-blind, placebo-controlled phase 2 clinical trial. The subjects were healthy adult volunteers aged 18-50 and were randomly assigned to receive MVA-BN RSV or placebo vaccination. 28 days after vaccination, volunteers received intranasal injection of RSV type A strain, and the vaccine protection of 61 subjects can be assessed.
Results showed that compared with the placebo group (n=31), subjects (n=30) in the MVA-BNRSV group significantly reduced their viral load, reaching the main endpoint. Meanwhile, vaccinated subjects showed a significant reduction in clinical symptoms associated with RSV infection. The MVA-BN RSV vaccine is as effective as 79% in preventing symptomatic RSV infection.
Previously, another Phase 2 clinical trial reported by Bavarian Nordic included 421 elderly subjects aged 55 and older. The results showed that MVA-BN RSV was well tolerated and induced extensive and long-lasting anti-RSV antibody and T cell responses, as well as mucosal immune responses, which may produce important protection for preventing RSV. The second phase of the elderly subjects included the subject being re-vaccinated after one year. After the second vaccination, the immune response increased rapidly and significantly, especially the subjects with the weakest immunity before vaccination significantly strengthened the immune response level after vaccination.
This vaccine is developed based on Bavarian Nordic's proprietary MVA-BN technology platform, which also developed smallpox and Ebola vaccines based on the MVA-BN technology platform.
