Bavarian Nordic gets FDA OK to start breast cancer vacc trial
Danish biopharmaceutical firm Bavarian Nordic AS says that its US subsidiary, BN ImmunoTherapeutics, has been granted Food and Drug Administration approval to initiate trials of the developmental breast cancer vaccine MVA-BR-HER-2. The firm added that it intends to begin patient enrollment in the US Phase I/II study as soon as possible, in addition to undertaking a similar program in Europe.
Bavarian Nordic explained that the trial will evaluate the safety and tolerability of the vaccine, in addition to assessing the level of immune response that it elicits. The agent will also be examined in combination with Roche's Herceptin (traztuzumab) and chemotherapy.
The company said that European studies will also examine the drug as a first-line treatment for metastatic breast cancer indications.
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