Targeting a patient population in the millions, Cambridge, MA-based Genocea ($GNCA) this week released results of its genital herpes vaccine that CEO Chip Clark says affirm the jab's potential to one day break the $1 billion sales mark.
A 6-month analysis of a 310-patient Phase II trial of GEN-003 showed that the candidate's best performing dose demonstrated a 58% reduction from baseline in viral shedding--or the rate at which the virus makes its way to the skin and physically sheds. That reduction, Clark said, in conjunction with GEN-003's durable efficacy and convenience, could position the jab to serve as a "cornerstone" for genital herpes treatment.
"In contrast to episodic therapy, GEN-003 appears to reduce the frequency of outbreaks and reduce asymptomatic viral shedding, the cause of most transmission," he said on a conference call Wednesday.
|Genocea CEO Chip Clark|
For patients who are currently being treated with chronic suppressive therapy on a daily basis, Clark said, the value is "clear and we believe compelling," because the vaccine could serve as a replacement for daily therapy while reserving oral antiviral treatment for breakthrough outbreaks.
Genocea estimates that about 4.5 million patients in the U.S. treat genital herpes with oral antivirals episodically while 2.5 million use chronic oral therapy. On the call, Genocea CMO Seth Hetherington said the results represent an "important advance" for the program, describing what he called are "greater reductions in viral shedding than we have seen before, or anybody has for that matter."
Next up, the company anticipates 12-month data from the study in the first quarter of next year to see if the vaccine's efficacy leads to a 12-month effect and to provide more information on secondary endpoints such as lesion rates, time to next recurrence and proportion of recurrence free patients at 6 and 12 months.
In the meantime, the company says it'll initiate a Phase IIb study before year's end, with data from that trial expected in the second quarter of next year. Clark said Wednesday that Genocea expects its end of Phase II meeting with the FDA toward the end of 2016, putting it on track to initiate Phase III in 2017.
Also working on a genital herpes jab is Agenus ($AGEN), which reported last July that its HerpV was able to reduce viral load in some patients by 75% in a Phase II study. Despite those results, GlobalData analyst Daian Cheng said in May that Genocea's vaccine was better positioned to enter the market due to cash flow problems at Agenus--an assertion Agenus CSO Bob Stein denied.
"We have $100 million in the bank and we have over a year's worth of runway," he said at the time, adding that the company is in discussions on further funding options.
- here's the release