- MVA-BN® RSV vaccine candidate with competitive Phase 2 efficacy data in older adults
- Completed enrollment of 20,000 subjects in global Phase 3 study, data expected mid-2023
- Partnership in place for China and selected Asian markets
MVA-BN RSV is being developed for prevention of RSV in older adults. The vaccine candidate is based on our proprietary vaccine platform technology, MVA-BN, and incorporates five distinct RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B). In a clinical Phase 2 doubleblinded, placebo-controlled human challenge trial, a significant reduction in viral load was reported in vaccinated subjects versus placebo and MVA-BN RSV demonstrated a vaccine efficacy of up to 88.5% when active RSV infection was confirmed by cell culture1.
We have previously reported results from a Phase 2 trial of MVA-BN RSV in 421 subjects aged 55 years and older, 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 Phase 2 program in older adults 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 vaccination2.
Clinical trials to-date have furthermore shown MVA-BN RSV to have an acceptable safety profile as previously observed for MVA-BN or other recombinant MVA-BN based vaccines.
Based on the preliminary clinical evidence, indicating that the vaccine may demonstrate a substantial improvement over available therapy on a clinically significant endpoint, MVA-BN RSV received special designations from U.S. and EU regulatory authorities in 2022, intended to expedite the development and regulatory review of the product candidate. In February, the U.S. Food and Drug Administration (FDA) granted MVA-BN RSV Breakthrough Therapy Designation for the prevention of RSV in older adults, and in June, the European Medicines Agency (EMA) granted access to its priority medicines (PRIME) scheme for MVA-BN RSV in active immunization for the prevention of LRTD caused RSV in adults ≥60 years of age.
As part of the strategy to commercialize the vaccine globally, we entered into a regional license and supply agreement with Nuance Pharma in the first quarter of 2022 on the development and commercialization of MVA-BN RSV for adults in China and selected Asian markets. The milestone-based agreement has a total value of up to USD 225 million in addition to tiered, double-digit royalties. Nuance Pharma obtains rights to commercialize MVA-BN RSV in Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia and will be responsible for all material costs, including development and regulatory. Nuance Pharma is planning the initiation of a Phase 3 trial of MVA-BN RSV in 2023.
In April 2022, we initiated a global, randomized, double-blind Phase 3 clinical study of MVA-BN RSV in adults ≥60 years of age. The primary objective of the study will assess the efficacy of the vaccine candidate against lower-respiratory tract disease (LTRD) caused by RSV compared to placebo. In December 2022, we reached the planned enrollment of 20,000 subjects in the study. Topline results from the study are anticipated in mid-2023.
2. Jordan E. et al. 2010. J. Infect, Dis. 28:223(6). 1062-1072
RSV (respiratory syncytial virus) has been recognized as a significant cause of respiratory illness in all age groups. It is highly infectious and the most common cause of lower respiratory tract infection in infants and children worldwide, resulting in a high number of hospitalizations. RSV infections are also a serious health concern in the elderly and in adults with cardiopulmonary disease.
According to estimates from WHO, RSV infects more than 64 million people globally each year and causes a similar number of deaths as influenza, yet unlike influenza, there is no vaccine to prevent RSV.
There are only two subtypes of RSV, A and B, which are typically present either simultaneously or alternately during yearly epidemics.