Bavarian Nordic Announces Initiation of NIH Sponsored Phase 1 Trial of MVA-BN-based Yellow Fever Vaccine

COPENHAGEN, Denmark, July 27, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the initiation of a Phase 1 clinical trial of MVA-BN YF, a new vaccine candidate based on the Company's proprietary MVA-BN platform, designed to protect against yellow fever virus. The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

"We are very pleased to see the advancement of this novel vaccine into human studies. Clearly there remains an unmet medical need in the protection of populations who are at risk from potential outbreaks like yellow fever. Now more than ever it is clear that proactive vaccine development is required for both existing and emerging threats to public health. We are excited to expand the scope of our MVA-BN technology and look forward to exploring its potential further. We remain a dedicated partner to the NIH and the U.S. government, and look forward to assisting as needed," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

A preclinical study conducted by Bavarian Nordic demonstrated that the vaccine candidate provided complete protection against infection with the virus in hamsters. Furthermore, preclinical studies suggest that combining MVA-BN with ISA 720, an adjuvant that has been used in prior clinical trials, induces a strong immune response after a single dose of vaccine. The preclinical challenge study was funded by the NIH.

The placebo-controlled, double-blinded clinical trial will evaluate whether the vaccine is safe, tolerable and induces a human immune response indicating a potential for preventing yellow fever virus infection. The study will enroll 90 healthy men and women ages 18 to 45. Participants will be divided into six groups: one that will receive the currently licensed yellow fever vaccine (15 participants) and five groups (15 participants each) will receive MVA-BN YF, either with or without ISA 720 adjuvant. Additional details about the trial can be found at ClinicalTrials.gov using the identifier NCT02743455. The study is being conducted under the supervision of NIAID, contract number HHSN272200800003C.