Pharma Focus Asia

Nuance Pharma Announces Clearance of IND Application for Respiratory Syncytial Virus (RSV) Vaccine in China

Monday, November 14, 2022

Nuance Pharma announces the 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 mainland China.

MVA-BN RSV, is being developed for the prevention of respiratory syncytial virus (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.

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 RSV season 2022/2023 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 Phase III study in China is granted. According to Dr. Haijin Meng, CMO of Nuance Pharma, the company is planning to conduct the pivotal Phase III study as an extension of the global MRCT 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 Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia.

"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." commented 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."

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