Bavarian Nordic has found a taker for the Chinese rights to its RSV vaccine candidate. Nuance Pharma has taken the other side of the deal, handing over $12.5 million and committing to $212.5 million more in milestones to license the drug in China, South Korea and some other markets in Southeast Asia.
The deal covers regional rights to MVA-BN RSV, a vaccine candidate that 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. Bavarian Nordic sees Shanghai-based Nuance as the right company to take the candidate through a phase 3 trial and onto the market in China.
“Their regional presence combined with a strong leadership and focus on respiratory diseases provides a unique first-to-market opportunity for MVA-BN RSV to fulfill the unmet need for a vaccine to prevent severe disease from RSV infections in the aging Chinese population,” Bavarian Nordic CEO Paul Chaplin said in a statement.
Nuance, a drug developer that has previously licensed candidates from companies including Antibe Therapeutics and Verona Pharma, is risking relatively little upfront for a shot at being first to market with a RSV vaccine for seniors. But the cost of the program could rise quickly as the company embarks on its late-phase program and starts paying out the milestones.
Bavarian Nordic is now nearing the start of its own, self-funded phase 3 trial of the vaccine, with a study in the U.S. and Germany set to get underway by the midpoint of the year. The development strategy has been complicated by responses to COVID-19 such as masks and social distancing, which kept RSV cases below normal levels some of the time and resulted in out-of-season surges as restrictions were lifted.
With the situation normalizing in many countries, Bavarian Nordic is now ready to run a phase 3 trial it hopes will generate the data to support a filing for FDA approval. The phase 3 study is set to enroll up to 20,000 subjects across multiple geographies and to run over the course of one year. Once follow-up work in 2023 and 2024 is factored in, Bavarian Nordic expects the study to cost around $250 million.
Bavarian Nordic is committing the cash despite trailing other RSV vaccine developers. GlaxoSmithKline, which has run into trouble in the maternal population, is closing in on the release of phase 3 data on its RSV vaccine in older adults. Johnson & Johnson and Pfizer are also in phase 3 in older adults.