Bavarian Nordic Enters Trials With HIV Multiantigen Vaccine

Bavarian Nordic has initiated a Phase I/II clinical study with its HIV vaccine candidate: MVA-BN HIV multiantigen.

Enrolment in a Phase I/II safety and immunogenicity study in 15 HIV-infected patients (CD4 counts >350 ul/ml) has begun in the United States. The first safety data is expected by the end of 2008 and immunogenicity data will be available during first half of 2009.

The MVA-BN HIV multiantigen vaccine encodes eight genes from HIV, including Nef and thus represents a more advanced vaccine candidate compared to Bavarian Nordic's previous MVA-based HIV vaccine candidates, MVA HIV nef and MVA-BN HIV polytope. In previous clinical studies with MVA HIV nef, Bavarian Nordic has demonstrated proof-of-concept for the MVA technology's ability to control HIV replication.

Furthermore the vaccine was shown to be immunogenic and to induce a broad T-cell response to Nef. The MVA-BN HIV multiantigen builds on these positive results and thus represents an excellent opportunity to stimulate a broad immune response to the majority of the HIV proteins that will likely have important implications in a prophylactic and therapeutic setting for HIV.

Anders Hedegaard, President & CEO of Bavarian Nordic, commented: "Our strong expertise in HIV vaccine development has expedited the development of the multiantigen vaccine. It is exciting that we now again are in clinical development with an HIV vaccine candidate. The HIV multiantigen program indeed benefits from the data generated in our previous HIV studies, demonstrating a unique safety profile of MVA in this high-risk population, as well as the potential to control HIV replication."