Bavarian Nordic Provides Update on Business and Development Activities - All Programmes On-track
IMVAMUNE™ - non-replicating safe smallpox vaccine IMVAMUNE™ a third-generation Modified Virus Ankara (MVA) vaccine is expected to be effective in three days after one vaccination compared to traditional replicating vaccines that only show protection after 10-14 days.
Completed two clinical studies:
Phase ll dose-finding study in 165 healthy volunteers
Phase l study in 86 healthy volunteers
Ongoing studies:
Phase ll study in HIV-infected patients
Phase I comparing IMVAMUNE™ to DryVax®
Phase I study in patients with atopic disorders
Upcoming studies:
Bavarian Nordic will begin this year three further Phase II studies in 2000 subjects.
HIV vaccine programmes Completed one clinical study: A Phase I/II study in MVA nef vaccine HIV-infected patients previously on HAART therapy showed the vaccine controlled HIV replication in seven out of 14 patients for 11 months and continued to control replication in five out of 14 patients for 34 months. For almost three years the five HIV-infected patients received no other treatment than 3 vaccinations of MVA nef.
Ongoing studies: Bavarian Nordic has started a Phase II study of the MVA nef vaccine in 75 patients.
Upcoming studies: Bavarian Nordic will begin a Phase I/II and a Phase I study of the MVA-BN® polytopevaccine.
Cancer Immunotherapy Bavarian Nordic has several MVA-BN®-based cancer vaccines in development in breast cancer, prostate and colon cancers.
Manufacturing: The Danish production plant is on-track and will be ready for manufacturing in the summer, well before the anticipated RFP-III contract later this year. GlaxoSmithKline is Bavarian Nordics global partner in the manufacture of IMVAMUNE™.
Peter Wulff, President and CEO of Bavarian Nordic A/S will present an update on the company’s business today at the BIO CEO & Investor Conference in New York City. For more detail on the Bavarian Nordic update, please see the stock exchange announcement released today.
