• Genocea Biosciences Inc., of Cambridge, Mass., reported preclinical results demonstrating the ability of its vaccine candidate, GEN-003, to elicit strong and lasting B-cell and T-cell immune responses. GEN-003 is in development to combat herpes simplex virus-2 (HSV-2), and in vivo studies showed T-cell response specific to HSV-2 antigens in mice. Data were presented at the Immunology 2012 meeting in Boston. A second presentation highlighted insights supporting the hypothesis that a vaccine strategy targeting T cells may provide a significant therapeutic benefit to patients.

• Gentium SpA, of Villa Guardia, Italy, said it received the Day 180 list of outstanding issues from the European Committee for Medicinal Products for Human Use in connection with the marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. The company said it plans to submit its responses within 60 days and, if no other issues are raised, it anticipates a drug approval as early as the third quarter.