- Study successfully achieved both primary endpoints
- Second positive Phase 3 demonstrating the safety and efficacy of IMVAMUNE and final study required for licensure, as agreed with FDA
- BLA filing expected in second half of 2018 with fast track designation
COPENHAGEN, Denmark, February 6, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced positive results from a Phase 3 pivotal study of its investigational, non-replicating smallpox vaccine, IMVAMUNE®. The study achieved both of its primary endpoints, demonstrating IMVAMUNE's efficacy in comparison to ACAM2000®, the current U.S. licensed replicating smallpox vaccine.
In this randomized, open-label study of 440 volunteers, the peak neutralizing antibodies induced by IMVAMUNE were shown to be 2-fold higher than those stimulated by ACAM2000. This met the co-primary endpoint of non-inferiority and was even shown to be a statistically superior immune response. A historical measure of efficacy against smallpox in people vaccinated for the first time was the induction of a vaccine take (pustule, scab and scar) following the skin vaccination (scarification) with replicating smallpox vaccines like ACAM2000. However, the prevention or attenuation of a take in subjects that are re-vaccinated was a historical measure that a subject had a protective immune response against smallpox. Importantly, this co-primary endpoint was also successful. Primary vaccination with IMVAMUNE resulted in a highly attenuated take (reduction in lesion size), and in fact prevented the vaccine take in the majority of subjects re-vaccinated with ACAM2000.
IMVAMUNE has been given to more than 7,800 subjects in 21 clinical studies, including two Phase 3 studies that have supported a favorable safety profile and efficacy in comparison to replicating smallpox vaccines. The company plans to file a Biological License Application in the second half of 2018. If approved, the Company would also be eligible to receive a Priority Review Voucher, which could be used to accelerate the review of a future BLA, and is also transferrable.
"The success of this study represents a hallmark achievement at Bavarian Nordic. These and earlier study results validate the promise of IMVAMUNE for the prevention of smallpox and support product registration with the U.S. FDA," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. "This program has only been possible through the consistent and strong support of numerous U.S. Government agencies and demonstrates what can be achieved through a successful public-private partnership to protect the public from the deliberate release of the smallpox virus."
The Phase 3 study enrolled 440 subjects at a U.S. military garrison in South Korea led by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in collaboration with the U.S. Defense Health Agency (DHA). Details of the study can be viewed at https://clinicaltrials.gov/ct2/show/NCT01913353.
Federal funding acknowledgments
The Phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200700034C.
About IMVAMUNE Smallpox Vaccine
IMVAMUNE is being developed as a smallpox vaccine for individuals for whom traditional replicating vaccines are contraindicated, such as people with atopic dermatitis (AD) and HIV. Studies comprising more than 7,800 subjects, including people diagnosed with AD or infected with HIV, demonstrate that IMVAMUNE has a favorable safety profile. The vaccine is approved in Canada under the trade name IMVAMUNE and in the European Union under the trade name IMVANEX® as the only non-replicating smallpox vaccine approved for use in the general population.
Bavarian Nordic has to-date delivered 28 million doses of liquid-frozen IMVAMUNE to the U.S. Strategic National Stockpile for emergency use. The Company has ongoing contracts the Biomedical Advanced Research and Development Authority (BARDA) to replenish the stockpile with a freeze-dried formulation of the vaccine, which offers improved shelf life.
About United States Army Medical Research Institute of Infectious Diseases (USAMRIID)
USAMRIID's mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Research conducted at USAMRIID leads to medical solutions-vaccines, drugs, diagnostics, and information-that benefit both military personnel and civilians. The Institute plays a key role as the lead military medical research laboratory for the Defense Threat Reduction Agency's Joint Science and Technology Office for Chemical and Biological Defense. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command. For more information, visit www.usamriid.army.mil.
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe 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 improve the health and quality of life for children and adults. We supply our IMVAMUNE® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Registration studies are currently underway in the U.S. In addition to our long-standing collaboration with the U.S. government on the development of IMVAMUNE® and other 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, e.g. checkpoint inhibitors.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Company Announcement no. 03 / 2018