Bavarian Nordic reports RSV PhI data, inks $100M smallpox deal with BARDA

Respiratory Syncytial Virus--Courtesy of NIAID
Respiratory Syncytial Virus--Courtesy of NIAID

It's been a good week for Bavarian Nordic: the Danish company announced Monday positive topline results from a Phase I trial of its RSV candidate, and just four days prior, revealed yet another contract to supply HHS’ BARDA with its smallpox vaccine.

The RSV trial involved 63 healthy adults, aged 18 to 65. The participants were divided into three groups: high dose/elderly (ages 50 to 65), high dose/adult and low dose/adult. Older adults are a major target for RSV vaccination. The broad-spectrum vaccine targets 5 different RSV proteins so vaccinated individuals can mount an immune response against both RSV subtypes, A and B, the company said in a statement.

The candidate, dubbed MVA-BN RSV, was well tolerated with no unexpected or serious adverse reactions, according to the statement. All groups experienced a “significant” boost in antibody production and T cell response following vaccination. Further data will be released as the study progresses.

“These data suggest the potential of MVA BN RSV to be the first broad spectrum vaccine for RSV, delivering higher rates of protection compared to approaches currently available or in development,” said CEO Paul Chaplin in the statement. The company plans to launch a Phase II trial in elderly subjects in the second half of this year, as well as a Phase I trial in children in 2017.

There is currently no vaccine for RSV, though it is a main focus for a number of companies. Among them are AstraZeneca’s ($AZN) MedImmune and Maryland-based Novavax ($NVAX), both of which got their candidates fast-tracked by the FDA.

Meanwhile, Bavarian Nordic also inked a $100 million contract to supply BARDA with its smallpox vaccine, Imvamune. The company will produce and store bulk vaccine material for this order and convert it later to freeze-dried Imvamune pending U.S. approval of the freeze-drying manufacturing process.

This follows a $133 million deal last July to do the same. Imvamune was Bavarian Nordic's bread and butter in fiscal 2014, comprising 84% of sales and helping the company reach its first full-year profit in 5 years. But the smallpox vaccine took a back seat in 2015, making up only 25% of sales, which were largely driven by the DKK762 million ($115 million) sale of its Ebola vaccine to J&J’s ($JNJ) Janssen.

Imvamune is licensed in Canada and the European Union, where it is marketed as Imvanex. While the U.S. government maintains a stockpile, Imvamune is not yet FDA-approved. The liquid-frozen vaccine is currently in Phase III trials in the U.S., while a freeze-dried version is in Phase II trials.

- here's the RSV statement
- and here's the Imvamune statement

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