Genocea Biosciences (GNCA) Announces GEN-003 Phase 2b Met Primary Endpoint as Genital Herpes Treatment

September 29, 2016 7:32 AM EDT

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Genocea Biosciences, Inc. (Nasdaq: GNCA) announced positive results from its ongoing Phase 2b trial evaluating a new Phase 3-ready formulation of GEN-003 for the treatment of genital herpes. The study achieved its primary endpoint, with GEN-003 demonstrating a statistically significant reduction of 40 percent in the rate of viral shedding in the 60 µg per protein / 50 µg of Matrix-M2 dose group compared to both baseline and placebo. The viral shedding rate reduction for this dose was consistent with its performance at the same time point in a prior Phase 2 trial.

“We are very encouraged by this positive data and have now selected a dose of 60 µg per protein / 50 µg of Matrix-M2 of GEN-003 for our planned Phase 3 trials. This is the third consecutive trial in which GEN-003 has demonstrated a statistically significant reduction in viral activity immediately post-dosing. In the previous Phase 2 trial, success in this measure translated into a significant impact on genital herpes clinical disease, durable to at least 12 months,” said Chip Clark, president and chief executive officer of Genocea. “This body of data supports our strong belief that GEN-003 could be a cornerstone treatment for genital herpes. We look forward to reporting six-month placebo-controlled clinical data from this trial in January 2017 and expect to commence our Phase 3 program in the second half of 2017.”

During the 28-day observation period immediately after completion of dosing, the 60 µg per protein / 50 µg of Matrix-M2 dose of GEN-003 demonstrated a statistically significant 40 percent reduction from baseline in the viral shedding rate versus a marginal increase of 6 percent for placebo. The 60 µg per protein / 75 µg of Matrix-M2 dose demonstrated a 27 percent reduction in the viral shedding rate. The top-line viral shedding rate reductions for all of the dose groups in the trial are summarized in the following table:

60 µg per protein /50 µg of Matrix-M260 µg per protein /75 µg of Matrix-M2Placebo
Viral shedding rate reduction -40% -27% +6%
p-value vs. baseline* 0.03 0.16 0.76
p-value vs. placebo* 0.05 0.20 NA

* Statistical analysis performed using a modified Poisson model (refined since Phase 2a trial with reference to advances in the field: Magaret, Amalia, "Models for HSV shedding must account for two levels of overdispersion" (January 2016). UW Biostatistics Working Paper Series. Working Paper 410. http://biostats.bepress.com/uwbiostat/paper410)

Safety in the trial was continuously reviewed by an independent Data Safety Monitoring Board. There was no grade 4 reactogenicity or related serious adverse events in this trial and discontinuations due to adverse events were low and similarly distributed across active dose groups and placebo.

“The established clinical profile of GEN-003 is one that could be highly beneficial to patients looking for an effective treatment which potentially offers greatly improved convenience over daily oral antivirals, the only current treatment option for the millions of people suffering from genital herpes,” said Lori A. Panther, M.D., MPH, Infectious Diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School. “I’m extremely encouraged by these results, once again demonstrating that GEN-003 reduces viral shedding. Control of viral shedding is fundamental to the control of genital herpes outbreaks and the epidemic spread of the disease.”

About the GEN-003 Phase 2b Clinical Trial This Phase 2b trial is the first study testing potential Phase 3 endpoints with an improved formulation of GEN-003 - manufactured with commercially-scalable processes - which will be used in future Phase 3 trials. The trial enrolled 131 subjects from 9 institutions in the United States. Subjects have been randomized to one of three dose groups - placebo, 60 µg per protein / 50 µg of Matrix-M2 and 60 µg per protein / 75 µg of Matrix M2 - and have received three injections at 21-day intervals. Viral shedding rate reductions were measured to demonstrate the efficacy 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.For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.

Conference Call Genocea management will host a conference call and webcast today at 9 a.m. ET to review this data. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 87103963). A live webcast of the conference call will be available online from the investor relations section of the Company's website at http://ir.genocea.com. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.



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