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

September 29, 2016 7:32 AM EDT

Get daily under-the-radar research with's Stealth Growth Insider Get your 2-Wk Free Trial here.

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.

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

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 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.

Serious News for Serious Traders! Try Premium Free!

You May Also Be Interested In

Related Categories

Corporate News, FDA, Hot Corp. News, Hot FDA News, Management Comments, Trader Talk, Trading Halts

Related Entities



Dr Erediawa Okoh on 2017-01-20 22:02:14
Mark as Spam | Reply to this comment

why waiting, stop dying in silence,come for both physical an some problems like Spiritual problems.Has your Doctor told you there is no cure to that you Illness or Disease, has it belong you have this problems have you been to Hospital or visit any Herbal home an you fine know cure or solution to that your problems, an you want to give up or you given up already, i said to you today that your problem or Disease has solution, why not try Roots an Herbs today an see the power in Roots an Herbs today, i tell you stop dying in silent that you problem have cure you don,t have to give up, i DR EREDIAWA is telling you there is a cure to that your problems an i am happy to see so many testimony about this my Roots an Herbs an i am happy, why you out there not also try an see the power in this my Roots an Herbs. Are you having Herpes,Diabetes,Fibroid, Hypertension, Stroke,Gonorrhea, Syphilis, Staphylococcus, Weak Erection,Rheumatism or Body Odor Etc, i tell you there is a cure. contract me on my email or my mobile whatsapp number +2348159412586. Don,t die in silent there is a solution to that your problem this Roots an Herbs was given to me to save lives an also build a broken Home due to inability to bear Child, if many can Testify you too can also Testify.

Doris melody on 2017-01-13 19:43:45
Mark as Spam | Reply to this comment

cure HIV-AIDS and herpes disease, my name is Doris, I head east
DR.Aluebor I ever could get my HIV-AIDS cured with healing spell, I have
tried almost everything, but I could 'not find any solution to my
disease, despite all this I happen to me, I always spend a lot for buy
an anti-HIV medicines hospital and taking some several medications,
but not relieved, until one day I was surfing the Internet when I come
across a great post! Smith! It is actually said that he has been
diagnosed with HIV and cured in the same week through the help of
these great powerful medical healing spell, sometime I wonder why
people called him DR Ugbo I never knew it was because of the great and
perfect work he has been doing that is causing all this. so quickly contact with him, and I wonder few questions
and told me something I will never forget that anyone who contacted
him always get your healing within 6 hours after doing everything you ask
them to do, so I was surprised all the time I had heard from him, so I
did everything just to see that on the same day in which he said will
be healed, whole force that has left me before rush back and becomes
very strong and healthy, the disease almost killed my life because of
me, so I went to the hospital to give the final test of the disease
and the doctor said that I am HIV negative, I am very surprised and
happy about the healing DR Aluebor gave me from the old part of Africa,
you can email now for your own healing well, and I promise to work
fast immediately as my own situation can email here .. again thank you DR Aluebor....

1. Love spells
2. Loss of love spells
3. Divorce Spells
4. spells marriage
5. spells union
6. spells Breakup
7. Banish a past lover.
8. You want to be promoted in his office.
9. fertility spells / spells Pregnancy

Add Your Comment