The Chinese Center for Drug Evaluation (CDE) has granted clearance for Nuance Pharma’s Investigational New Drug (IND) application for a Phase III clinical trial of an MVA-BN RSV vaccine for use in adults with respiratory syncytial virus (RSV) infection in the country.
In April this year, Bavarian Nordic commenced an international, double-blind, randomised, Phase III VANIR trial of this vaccine.
The trial has been designed to enrol 20,000 adults aged 60 years and above by the end of this year.
It is being carried out at nearly 115 sites in Germany and the US, with topline data expected mid-next year.
The MVA-BN RSV vaccine is being developed for the prevention of RSV infection in older adults.
It comprises five separate RSV antigens to induce a wide-ranging immune response against both RSV subtypes (A and B).
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Based on the MVA-BN platform technology of Bavarian Nordic, the vaccine imitates the immune response seen after a natural response to an RSV infection.
Nuance Pharma and Bavarian Nordic signed an agreement last year for exclusive rights for the development and marketing of the vaccine in the Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea, and Southeast Asia.
Nuance Pharma CEO and co-founder Mark Lotter said: “This is a significant milestone for Nuance Pharma, and we are confident that we will achieve solid and inspiring progress for the development of [the] MVA-BN RSV vaccine in China.
“The MVA-BN RSV vaccine holds the potential to become the first to market adult RSV vaccine in China.
“MVA-BN RSV represents another example of Nuance’s capability to bring differentiated solutions to address unmet medical needs in the respiratory space in China and the Asian markets.”