Denmark-based Bavarian Nordic A/S (CPH: BAVA) has revealed that its pipeline respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV, did not achieve all primary endpoints in a Phase III trial. Consequently, the company has decided to discontinue its RSV program, including a co-development partnership with China-based Nuance Pharma for Greater China and Asian markets.
Phase III Trial Results and Impact on Growth Expectations
The Phase III trial assessed the efficacy of MVA-BN RSV in adults aged 60 years and over, with the goal of preventing lower respiratory tract disease (LRTD) caused by RSV. The final results indicated that the vaccine candidate had a 59% efficacy in preventing at least two pre-defined LRTD symptoms, one of the key endpoints. However, it fell short in the co-endpoint of preventing more severe LRTD based on three pre-defined symptoms, showing only 42.9% efficacy. Bavarian Nordic noted that the failure of the vaccine candidate will impact the firm’s short-term growth expectations.
Pipeline and Future Developments
Despite the setback, Bavarian Nordic’s pipeline remains active with vaccines under development for chikungunya (Phase III), equine encephalitis (Phase I), and an immuno-oncology therapeutic vaccine (Phase I), indicating the company’s continued commitment to advancing new vaccines and therapies.
Nuance Pharma’s RSV Vaccine Rights and Financial Commitments
Nuance Pharma had acquired rights to develop Bavarian’s RSV vaccine in Greater China and several Asian territories in a deal signed in March 2022, with an upfront payment of USD 12.5 million and potential milestone commitments of up to USD 215.5 million. The discontinuation of the RSV program will likely affect Nuance Pharma’s plans for the vaccine in these markets.-Fineline Info & Tech
