Bavarian Nordic Initiates Phase 3 Trial of Vaccine

Bavarian Nordic A/S recently announced the initiation of a pivotal Phase 3 trial of the freeze-dried formulation of MVA-BN smallpox vaccine in 1,110 healthy, vaccinia-naïve subjects.

The randomized, double-blind, multicenter trial will evaluate the immunogenicity and safety of three consecutive vaccine lots of the freeze-dried formulation of MVA-BN smallpox vaccine, similar to the prior completed Phase 3 study for the liquid-frozen MVA-BN formulation.

The Biologics License Application (BLA) for the liquid frozen formulation of MVA-BN is currently under review at the FDA, with anticipated completion and licensure in the second half of 2019. Upon completion of the current study, expectedly in 2021, the company intends to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN. The requirement for only one Phase 3 study of the freeze-dried formulation was confirmed at an End-of-Phase 2 meeting with the regulatory authorities, following a prior Phase 2 study showing bioequivalence between the freeze-dried and liquid-frozen formulations of MVA-BN. Based on the successful completion of the study and subsequent regulatory process, the company anticipates approval of the freeze-dried vaccine in 2022.

“We are excited to initiate this final study, which, along with the anticipated approval of the liquid-frozen MVA-BN smallpox vaccine and the completion of our new fill and finish facility later this year, will reinforce our position as the global leader in smallpox vaccines, and also enable us to expand our market opportunities in the US and the rest of the world,” said Paul Chaplin, President and CEO of Bavarian Nordic.

The Phase 3 study and regulatory activities toward licensure are funded through an option valued at $37 million, which was exercised in November 2017 as part of the ongoing $539-million contract with the Biomedical Advanced Research and Development Authority (BARDA) for development and supply of freeze-dried MVA-BN to the US Strategic National Stockpile.

 Since 2003, Bavarian Nordic has worked with the US government on the development and production of MVA-BN smallpox vaccine and has to-date supplied 28 million doses of the liquid-frozen version to the US Strategic National Stockpile (SNS) for emergency use. Concurrently, BARDA has supported the development of a freeze-dried version of the vaccine with longer shelf-life to replace the current stockpile that has expired. Manufacturing of bulk vaccine to support this transition was initiated in 2016 and by end of 2019, the company will have manufactured and invoiced bulk vaccine worth $333 million. The fill-finish of this bulk will trigger additional contract options valued at $299 million. The 10-year contract, awarded in 2017, also includes pricing for additional orders of vaccine bulk and vaccine doses of either liquid-frozen or freeze-dried MVA-BN.

This project has been funded in whole or in part with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN, we have created a diverse portfolio of proprietary and partnered product candidates intended to unlock the power of the immune system to improve public health with a focus on high unmet medical needs. We supply our MVA-BN non-replicating smallpox vaccine to the US. SNS and other government stockpiles. The vaccine is approved in the European Union and in Canada (under the trade names IMVANEX and IMVAMUNE, respectively). In addition to our long-standing collaboration with the US government on the development of medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, eg, checkpoint inhibitors. For more information, visit www.bavarian-nordic.com.