Genocea Bio's GEN-003 achieves primary endpoint in mid-stage genital herpes trial; shares up 21% premarket

• An interim analysis of six-month data from a Phase 2 clinical trial evaluating Genocea Biosciences' (NASDAQ:GNCA) lead product candidate GEN-003 for the treatment of genital herpes showed a 58% reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint. The results were generated by the best performing dose of 60 ug per protein/75 ug of Matrix-M2 adjuvant. The data will be presented this Friday at IDWeek 2015 in San Diego, CA.
• In a secondary analysis based on patient-reported lesion rates, GEN-003 demonstrated statistically significant reductions from baseline in five of six dose groups ranging from 43% to 69%. The proportion of patients who received GEN-003 who were lesion-free at six months post dosing ranged from 30% to 50%, which was comparable to trial results observed with other oral antivirals. Time-to-first recurrence ranged from 152 days to more than 180 days. GEN-003 was well tolerated with no serious adverse effects seen.
• 12-month efficacy data is expected in Q1. An end-of-Phase 2 meeting with the FDA should happen in late 2016 followed by the initiation of a Phase 3 study.
• GEN-003 is a T cell-directed immunotherapy (therapeutic vaccine) designed to elicit both a T cell and B cell (antibody) response to HSV-2. It licensed the Matrix-M2 adjuvant from Novavax (NASDAQ:NVAX). Genital herpes affects ~400M people worldwide.
• The company will host a conference call this morning at 9:00 am ET to discuss the data.
• Shares are up 21% premarket on light volume.