Bavarian Nordic Has Positive Phase 2 Universal RSV Vaccine Study Data

• Broad antibody and T cell responses against RSV remained durable 1 year post a single vaccination with MVA-BN® RSV in the majority of subjects
• An annual booster of MVA-BN-RSV induced a broad and robust immune response, particularly in subjects with waning immunity one year after first vaccination, demonstrated by fast post-vaccination increases of neutralizing and total antibodies against both RSV subtypes (A & B); increases in mucosal RSV specific IgA and a broad, robust, and cellular immune response to all 5 RSV proteins encoded in the vaccine

Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced positive data from the extension study of its Phase 2 study investigating the safety and immune responses of its universal RSV vaccine, MVA-BN^®RSV in an older adult population.

In 2017, the Company reported data from a Phase 2 study that investigated various schedules and doses of the MVA-BN RSV vaccine in 421 subjects aged 55 and older. This study demonstrated that the vaccine induced robust antibody and T cell responses against RSV with only a single booster vaccination and these responses remained elevated for an entire RSV season (6 months post vaccination). The extension study re-enrolled 88 subjects one year later, after having received a single vaccination with either a low or high dose of the vaccine in the Phase 2 study and were further boosted with the same vaccine dose; mimicking an annual booster regime.

The extension study demonstrated that in at least 60% of the subjects the broad antibody responses against RSV were durable and remained elevated compared to baseline, one year after receiving a single booster vaccination. Similarly, the T cell responses against RSV also remained elevated one year post vaccination in half of the subjects re-enrolled, depending on which the RSV protein encoded in the vaccine was evaluated (ranging from 27% to 72% of the subjects). Following a further annual booster with MVA-BN RSV, there was a rapid and significant increase in serum antibody responses, including neutralizing antibodies against both RSV subtypes (A & B) and total IgG and IgA antibodies against RSV. This effect was most notable in subjects with the weakest immunity at the baseline (week 56) prior to the second vaccination. Compared to pre-vaccination levels 1 year before, the boost effect was in the range of a 1.5 to 3-fold increase depending the antibody parameter, however the increases were in the range of 1.3 to 2-fold when compared to the week 56 levels (baseline for the annual boost), as the antibody responses remained elevated one year post the first vaccination. These were also supported by a significant boost in the mucosal IgA responses measured from nasal swabs that has been reported to be an important correlate of protection against RSV. The T cell responses against all five RSV encoded proteins were also significantly boosted following the annual vaccination. Again, this effect was most prevalent in subjects with the weakest immunity prior to the second vaccination.

These positive clinical results will be key in discussing the design of the Phase 3 study with the FDA at a meeting planned for later this year.

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