Bavarian Nordic's Ph II Imvamune results to trigger $25M milestone

Denmark's Bavarian Nordic has completed a clinical safety report from a large Phase II study with Imvamune in HIV infected subjects that confirms the excellent safety profile of the vaccine. Within the next few days the safety report of this study will be submitted to the US Food and Drug Administration and this will trigger a $25.0 million milestone payment under the RFP-3 contract. The clinical safety report constitutes a major part of the data package that will be used to potentially support the use of the product in a declared emergency.

In support of using Imvamune as a smallpox vaccine in individuals otherwise contraindicated to receive conventional vaccinia vaccines, Bavarian Nordic has performed a large Phase II study in HIV-infected subjects with CD4 counts between 200 cells/microl and 750 cells/microl to compare the safety to healthy subjects.

The safety report from this study, includes safety data from over 300 HIV-infected and 86 healthy subjects, all of whom had no history of prior smallpox vaccination. The low number of adverse events confirmed the favourable safety profile of the product in vaccinia-naive, HIV-infected subjects with varying degrees of immune suppression. Indeed, there was no difference in adverse events between the healthy and HIV infected subjects, even in the most immune-compromised patients (CD4 counts greater than or equal to 200-350 cells/microl).