MVA-BN RSV(Bavarian Nordic)

Ending the RSV program means that the company will no longer be in line for 195 million Danish kroner in milestone payments from its Chinese partner Nuance Pharma. Bavarian Nordic has crashed out of the respiratory syncytial virus (RSV) vaccine race, with a phase 3 failure in older adults sending the company’s plans—and stock price—into a tailspin. The shot, dubbed MVA-BN RSV, failed to meet one of the two primary endpoints of the VANIR study, only demonstrating a 42.9% efficacy for preventing more severe lower respiratory tract disease (LRTD) based on at least 3 pre-defined symptoms. Despite hitting the other primary endpoint by showing 59% efficacy in preventing at least 2 pre-defined LRTD symptoms, the Danish drugmaker has decided to discontinue its RSV program completely. “We are disappointed that our RSV vaccine candidate was not successful in this pivotal trial,” Bavarian Nordic CEO Paul Chaplin said in the Saturday release. “While this outcome was unexpected and will impact our short-term growth expectations, we continue to have a unique commercial business and given the recent strong brand and market growth, this provides a solid foundation for profitable growth in the years to come.” Investors didn’t seem as easily convinced, sending the company’s stock plunging 21% to 148.80 Danish kroner in the opening hours of trading on the Copenhagen stock exchange Monday from a Friday close of 190 kroner. Ending the program means that the company will no longer be in line for 195 million kroner ($28.9 million) in milestone payments from its Chinese partner Nuance Pharma for a planned launch of the RSV vaccine into Asian markets. But the “continued strong growth” of its travel vaccine business—which now includes the typhoid fever vaccine Vivotif and cholera shot Vaxchora both acquired from Emergent BioSolutions earlier this year—is “expected to absorb” the loss of these payments, Bavarian Nordic claimed in the release. MVA-BN RSV uses five RSV antigens to try to stimulate a broad immune response against both subtypes of the virus that is equivalent to how the body responds to infection with the pathogen. The VANIR study was assessing MVA-BN RSV against placebo in 20,000 adults aged 60 years and older. Since the first participant was dosed in that trial back in April 2022, the RSV landscape has been transformed. In May of this year, GSK made history by securing the first-ever FDA approval for a RSV vaccine, with Pfizer following around a month later. Meanwhile, Moderna remains hot on the heels of both Big Pharmas, while Johnson & Johnson has thrown in the towel. In a note Monday morning, Jefferies analysts noted that at 42.9% and 59%, respectively, the efficacy endpoints reported for MVA-BN RSV over the weekend were “well below” those of the shots by GSK, Pfizer and Moderna “even though endpoint definitions may differ somewhat across studies.” Despite Saturday's setback, the analysts said that Bavarian Nordic was still “on track to become a leading pure-play fully integrated vaccines company.” They also suggested there could be “record deliveries” of the company’s mpox vaccine Jynneos this year, “driven by strong demand triggered by the recent mpox outbreak April-July last year.”

Bavarian Nordic said Saturday that its investigational respiratory syncytial virus (RSV) vaccine for older adults has failed to meet all primary endpoints in a Phase III trial, prompting the company to discontinue the programme.One of two co-primary endpoints missed Final study results showed the vaccine met one of the efficacy criteria by demonstrating 59% efficacy in preventing at least two predefined lower respiratory tract disease (LRTD) symptoms. However, the co-primary endpoint of more severe LRTD based in at least three predefined symptoms was missed because the vaccine demonstrated efficacy of just 42.9% efficacy against these criteria. Discontinuation of the programme extends to a partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets, Bavarian Nordic said.CEO Paul Chaplin said “while this outcome was unexpected and will impact our short-term growth expectations, we continue to have a unique commercial business and given recent strong brand and market growth, this provides a solid foundation for profitable growth in the years to come.”Major setback, say analysts  The company said that continued strong growth for its travel vaccine business should ensure that discontinuation of the RSV vaccine programme should have no impact on its financial guidance for 2023. However, analysts at Jefferies described the news as a “major setback” which removes hopes of entry into a blockbuster market.Earlier this year, RSV vaccines for older adults developed by GSK and Pfizer were approved for use in the US. GSK’s vaccine has also been approved in the EU and Pfizer’s has been recommended for approval in the EU.