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COPENHAGEN, Denmark, January 24, 2019 – Bavarian Nordic A / S (OMX: BAVA, OTC: BVNRY) reports new advances in the development of a prophylactic vaccine against equine encephalitis virus – a rare but potentially life-threatening disease . The program, funded by the Joint Management Project Office (JPM-MCS) of the US Department of Defense (DoD) as part of a multi-year agreement of up to $ 36 million, aims to develop a vaccine against three strains of equine encephalitis virus, Eastern (EEEV), Venezuelan (VEEV) and Western (WEEV), for which there is currently no preventive vaccine. The vaccine is based on MVA-BN, a smallpox virus, patented by Bavarian Nordic.® platform, which because of its large genome is able to encode multiple antigens, thus offering the potential for protection against multiple diseases.
Since the award of the contract in March 2018, Bavarian Nordic has received additional funding to support preclinical development, manufacturing of BPF and, more recently, funding of a Phase 1 clinical trial for different doses. in 45 healthy volunteers. The start of the study is scheduled for the second half of 2019 and the results of the graduate studies will be available in 2020. A successful phase 1, based on the demonstration of a favorable safety and immunogenicity , could lead to additional financing, beyond the initial allocation of 36 USD. million, to support clinical and preclinical development and manufacturing to support obtaining a license in the United States.
"As a trusted partner and provider of medical countermeasures for the US government, we are excited about the rapid progression of another vaccine candidate to support emerging and potentially emerging disease preparedness." lethal, "said Paul Chaplin, President and Chief Executive Officer. Bavarian Nordic. "We are pleased to be working with DoD among many other government agencies to leverage our technology platform through research contracts such as this one, which are now an integral part of our business and our number." The availability of funds is crucial for the successful development of new countermeasures, A project of this type could cost more than $ 150 million in development costs for obtaining a license. As shown by the development of our smallpox vaccine MVA-BN, which was triggered by a small research contract with the NIH more than 15 years ago, when we reviewed the BLA with the FDA, we have paved the way for public-private partnerships to improve public health, now and in the future. "
About equine encephalitis viruses
Eastern, Venezuelan and Western equine encephalitis viruses belong to the alphavirus family and are transmitted by mosquitoes, as well as by birds and some mammals. Although infection rates and disease severity vary among viruses, all three pathogens are badociated with risks of flu-like symptoms, potential CNS disorders, and death. The three viruses are considered potential biological threats, having been studied as potential biological weapons at different times of the last century. Viruses are on the US list of priority pathogens among other agents, such as smallpox, anthrax and other life-threatening diseases, covered by the current vaccination policy for US military personnel deployed around the world . However, there is currently no approved vaccine against equine encephalitis viruses.
Recognition of federal funding
This project is funded in whole or in part by federal funds as part of an agreement with another transaction authority with the US Army Contracts Command in New Jersey through the Defense Consortium CBRN for Medical Services Contract MCDC-17-04-001 / 2018-315.
About Nordic Bavaria
Bavarian Nordic is a fully integrated biotechnology company focused on developing innovative and safer therapies for cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN®we have created a diversified portfolio of proprietary and partnered product candidates to unlock the power of the immune system to improve public health by focusing on high unmet medical needs. We supply our MVA-BN® smallpox vaccine not replicating in the US strategic national stock and other government stocks. The vaccine is approved in the European Union and Canada (under the trade names IMVANEX® and IMVAMUNE® respectively). In addition to our longstanding collaboration with the US government on the development of medical countermeasures, our infectious disease pipeline includes an exclusive RSV control program, as well as candidate vaccines against Ebola, HPV, HBV and HIV, which are developed as part of a strategic partnership with Janssen. In addition, in collaboration with the National Cancer Institute, we have developed a portfolio of active anti-cancer immunotherapies, designed to modify the course of the disease by eliciting a robust and extensive anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple collaborations with industries, we seek to explore the potential synergies of combining our immunotherapies with other immunomodulatory agents, e.g. checkpoint inhibitors. For more information, visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.
About medical countermeasures systems
JPM-MCS, a component of the United States Department of Defense Chemical, Biological, Radiological and Nuclear Defense Joint Program Office, aims to provide US military forces and the nation with safe, effective and efficient medical solutions. innovative ways to combat chemical, biological and biological substances. radiological and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of countermeasures and medical systems to enhance the country's biodefense response capability.
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Rolf Sbad Sørensen
Vice President Investor Relations
Tel: +45 61 77 47 43
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