Obviously apart from the fact they have results out... In terms of timeline (realistically) how far behind are we? We are awaiting 2A results and they are commencing 2B trials.
How quickly could we get into 2B (design, approval, recruitment, commence etc)
They've set a benchmark 58% reduction in shedding. What will be a statistically significant enough result for us to not be concerned that we probably won't have "first to market" advantage? Will 65% be enough? Do we need to be in the 80%+ range?.
Also, their share price is near 52 week lows, currently $4.30 with a $16 high and $2.60 low.
http://ir.genocea.com/releasedetail.cfm?ReleaseID=952378
Jan 29, 2016
Genocea Commences Dosing in Phase 2b Study for Genital Herpes Treatment, GEN-003
- Top-line viral shedding data expected in mid-2016 -
- Six month clinical efficacy data against potential Phase 3 endpoints expected in 2H 2016 -
CAMBRIDGE, Mass., Jan. 29, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced the commencement of the dosing phase in a Phase 2b clinical trial for GEN-003 for the treatment of genital herpes. Patient screening for the trial, which was initiated in December 2015, is complete. The Company expects to report top-line viral shedding data from the immediate post-dosing observation period in mid-2016 and clinical efficacy data against potential Phase 3 study endpoints at six months after dosing in the second half of 2016.
"This is the first study testing potential Phase 3 endpoints with an improved formulation of GEN-003 manufactured with commercially-scalable processes," said Seth Hetherington MD, chief medical officer of Genocea. "This placebo-controlled data, combined with the positive clinical and virologic efficacy and safety data from our first two clinical trials, will be the foundation for our end of Phase 2 meeting with the FDA, planned for the fourth quarter of 2016."
The Phase 2b study will enroll approximately 135 subjects from nine institutions in the United States. Subjects will be randomized to one of two dose levels of GEN-003 or placebo, and receive three injections at 21-day intervals. Viral shedding rate reductions will be measured to demonstrate the activity of the new formulation. The study will also compare GEN-003 efficacy to placebo for the clinical endpoints of: the proportion of patients who are lesion free at six and 12 months after dosing; the time to first lesion recurrence after dosing; and, the impact on percentage of days with genital herpes lesions at six and 12 months after dosing. All subjects will be followed for 12 months after the last dose.
Genocea is currently conducting a Phase 2 dose optimization study with an anticipated 12-month data read out later in the first quarter of 2016. In October, the Company announced positive results from a planned interim analysis of data collected six months after dosing. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p < 0.0001), the primary endpoint of the study. In a planned secondary analysis, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in clinical trials with oral antiviral therapies. In addition, the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. In a further secondary analysis measuring the impact on genital lesion rates, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent. The Phase 2 study continued to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.
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