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

SHANGHAI,Nov. 14,2022 -- Nuance Pharma ("the Company") announces the Center for Drug Evaluation ("CDE") has approved its Investigational New Drug ("IND") application supporting its pivotal phase III clinical trial of MVA-BNRSV 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."

About MVA-BN RSV

Bavarian Nordic's vaccine candidate,MVA-BN RSV,which is employed in several approved vaccines.

In 2021,Bavarian Nordic reported results from a clinical Phase II double-blinded,placebo-controlled human challenge trial (n=61),which enrolled healthy adult volunteers,who were randomized to receive either a single vaccination of MVA-BN RSV or placebo. Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31),thus meeting the primary endpoint. In the vaccinated subjects,clinical symptoms typically associated with RSV infections were significantly reduced. Further,the vaccine demonstrated an efficacy of up to 79% in preventing symptomatic RSV infections [1].

Bavarian Nordic has also previously reported strong results from a Phase II trial of MVA-BN RSV in 421 older adults,demonstrating that the vaccine was well-tolerated and induced both broad and durable antibody and T-cell responses against RSV,as well as mucosal immune responses that may be important for protection against RSV. The trial included a revaccination of subjects after one year,following which the immune responses were rapidly and significantly increased,notably in subjects with the weakest immunity prior to the booster vaccination [2].

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.

About Nuance Pharma

Nuance Pharma is an innovation focused biopharmaceutical company,with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care,Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory,pain management,emergency care and iron deficiency anemia.

In addition to the Company's commercial base and innovative pipeline in mainland China,Nuance seeks to expand its presence into Asia as a region where it will focus on building its commercial presence for current and pipeline-based portfolio.

With the mission to address critical unmet medical needs in Asia Pacific,Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline,while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information,visit www.nuancepharma.com.

About Bavarian Nordic

Bavarian Nordic is a fully integrated vaccines company focused on the development,manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine,which has been approved by the FDA,also for the protection against monkeypox. The vaccine is also approved in Europe and Canada. Our commercial product portfolio furthermore contains market-leading vaccines against rabies and tick-borne encephalitis. Using our live virus vaccine platform technology,MVA-BN®,we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system,including an Ebola vaccine,which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine. For more information visit www.bavarian-nordic.com.

Forward-looking statements

This announcement includes forward-looking statements that involve risks,uncertainties and other factors,many of which are outside of our control,that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans,objectives,goals,future events,performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made,except as required by law.

References

https://www.resvinet.org/uploads/2/2/2/7/22271200/abstract_booklet_rsvvw21.pdf

Jordan E. et al. 2010. J. Infect,Dis. 28:223(6). 1062-1072

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