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Nuance Pharma says China’s Center for Drug Evaluation (CDE) has approved its investigational new drug (IND) application supporting its pivotal phase III clinical trial of MVA-BN RSV vaccine against respiratory syncytial virus (RSV) in adults in China. MVA-BN RSV is being developed for the prevention of RSV in older adults. The vaccine incorporates five distinct RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection. The vaccine candidate is based on Bavarian Nordic's proven MVA-BN platform technology, which is employed in several approved vaccines. Results mid-2023 In April 2022, Bavarian Nordic initiated a global, randomized, double-blind phase III trial (VANIR) of MVA-BN RSV, planned to enroll 20,000 adults aged 60 years and older, before year end 2022. The trial is being conducted at approximately 115 sites across the U.S. and Germany and is designed to run through the 2022/2023 RSV season with topline results expected mid-2023 if the pre-defined number of lower-respiratory tract disease events has occurred. Under this MVA-BN RSV Chinese IND approval, conduction of a phase III study in China has been granted. Haijin Meng, CMO of Nuance Pharma, said the company is planning to conduct the pivotal phase III study in 2023. "We are thrilled to introduce this vaccine to China and give our Chinese investigators and subjects the opportunity to participate in the global clinical development of this novel differentiated vaccine and to evaluate how to apply it to address the unmet needs in RSV prevention," she said. In 2021, Nuance Pharma entered into an agreement with Bavarian Nordic, granting Nuance Pharma exclusive rights to develop and commercialize MVA-BN RSV in China, Hong Kong, Macau, Taiwan, South Korea, and Southeast Asia. Nuance Pharma is first-to-market "This is a significant milestone for Nuance Pharma, and we are confident that we will achieve solid and inspiring progress for the development of 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. This is an opportune moment for us to be developing and commercializing the asset, riding the wave of appreciably heightened awareness to the benefits of vaccination in the COVID-era," said Mark G. Lotter, CEO and co-founder of Nuance Pharma. "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." MVA-BN RSV has been granted breakthrough therapy designation by the U.S. Food and Drug Administration for active immunization for prevention of lower respiratory tract disease caused by RSV in adults aged 60 years or older. It has also been granted access by European Medicines Agency (EMA) to its priority medicines (PRIME) scheme for MVA-BN RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults 60 years of age and older.

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