Study to help determine if MVA-BN RSV will be administered as a seasonal vaccine or if a single shot is effective for multiple seasons
COPENHAGEN, Denmark I November 9, 2017 I Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that dosing has commenced in the Phase 2 extension study of MVA-BN® RSV, a universal vaccine candidate designed to elicit a broad antibody and T-cell response against multiple respiratory syncytial virus (RSV) antigens. This study is designed to help determine whether a single shot administration of vaccine is required annually, or if it remains effective over multiple seasons. The vaccine has previously shown to induce an immune response against RSV for a single season.
The initial Phase 2 study enrolled 421 volunteers to determine dose and response to MVA-BN RSV. This added booster portion of the study will enroll 86 of these subjects to receive a single shot of either low (1×108) or high (5×108) dose of the vaccine. The study will determine what, if any, boosting effect is seen from the additional shot when compared to the balance of subjects in the Phase 2 study, helping to determine whether MVA-BN RSV should be administered annually, or if the durability of the vaccine could extend across multiple seasons.
“The development of an RSV vaccine continues to be a significant healthcare need in our world today. Our plan of development is not only to establish the duration of response from our vaccine, which has already shown activity out to 6 months, but also to implement a human challenge study next year, which will give us an early indication of what level of efficacy we can anticipate with this vaccine,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.
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. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.
SOURCE: Bavarian Nordic
Post Views: 21
Study to help determine if MVA-BN RSV will be administered as a seasonal vaccine or if a single shot is effective for multiple seasons
COPENHAGEN, Denmark I November 9, 2017 I Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that dosing has commenced in the Phase 2 extension study of MVA-BN® RSV, a universal vaccine candidate designed to elicit a broad antibody and T-cell response against multiple respiratory syncytial virus (RSV) antigens. This study is designed to help determine whether a single shot administration of vaccine is required annually, or if it remains effective over multiple seasons. The vaccine has previously shown to induce an immune response against RSV for a single season.
The initial Phase 2 study enrolled 421 volunteers to determine dose and response to MVA-BN RSV. This added booster portion of the study will enroll 86 of these subjects to receive a single shot of either low (1×108) or high (5×108) dose of the vaccine. The study will determine what, if any, boosting effect is seen from the additional shot when compared to the balance of subjects in the Phase 2 study, helping to determine whether MVA-BN RSV should be administered annually, or if the durability of the vaccine could extend across multiple seasons.
“The development of an RSV vaccine continues to be a significant healthcare need in our world today. Our plan of development is not only to establish the duration of response from our vaccine, which has already shown activity out to 6 months, but also to implement a human challenge study next year, which will give us an early indication of what level of efficacy we can anticipate with this vaccine,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.
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. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.
SOURCE: Bavarian Nordic
Post Views: 21
