Bavarian Nordic Announces Initiation of Phase 1/2a Clinical Trial of Therapeutic HPV Vaccine Regimen in Collaboration with Janssen

• First commercial program under Bavarian Nordic and Janssen Vaccines & Prevention B.V. collaboration advancing into clinical trials
• A therapeutic vaccine may represent a novel approach for early treatment and interception of HPV-induced cancers

COPENHAGEN, Denmark, February 21, 2019 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the first patient has been dosed in a Phase 1/2a clinical study evaluating a prime-boost vaccine regimen based on Janssen's AdVac technology and Bavarian Nordic's MVA-BN technology in female subjects with chronic infections with high risk subtypes of the human papillomavirus (HPV) of the cervix. 

This is the first study to enter the human clinical trial stage, under the strategic partnership with Janssen on the development of novel vaccination approaches for HPV, HIV and Hepatitis B. The HPV program aims to develop a therapeutic vaccine for women with persistent HPV types 16 or 18 infection, with a focus on early disease interception. 

HPV is known to be the primary cause of cervical cancer and certain types of head and neck cancer, in addition to a number of more rare cancers. Although vaccines have become available to protect against various high-risk HPV subtypes that can cause cancer, there is an unmet need for a therapeutic vaccine approach to address chronic infections that may lead to precancerous cell changes. 

The randomized, double-blind, placebo-controlled, Phase 1/2a study will evaluate the safety, reactogenicity and immunogenicity of monovalent HPV16 and HPV18 Ad26-vectored vaccine components and an MVA-vectored HPV16/18 vaccine component (MVA-BN HPV) in 66 otherwise healthy women with persistent HPV16 or 18 infection of the cervix. 

Additional information on the study is available at: https://clinicaltrials.gov/ct2/show/NCT03610581. 

MVA-BN HPV is licensed to Janssen Vaccines & Prevention B.V., who is funding the clinical development of the vaccine regimen. Upon initiation of the Phase 2 portion of the study (vaccination of the fifth subject), Bavarian Nordic will receive a milestone payment of USD 12.5 million, which is expected to be recognized as revenue in the years 2019 to 2021. The Company is eligible to receive predefined milestone payments relating to further clinical development and commercialization, together totaling up to USD 162 million in addition to potential royalties on future sales.