Genocea’s Herpes Vaccine Heads For Critical Proving Ground

9/12/13Follow @benthefidler

(Page 2 of 2)

effort to test this theory enrolled 143 volunteers with a history of moderate-to-severe, recurrent HSV-2 infections—or, those who have between 3 and 9 outbreaks of genital lesions per year, according to Clark. Those patients, recruited at seven clinics in the U.S., were broken into groups and randomly given small (10 micrograms), medium (30 micrograms), or large (100 micrograms) dosed injections of GEN-003, or a placebo. Each patient in each vaccinated group was given three total injections—one every three weeks. Genocea then used samples that patients collected themselves twice a day to track both B cell and T cell response, and the rate of viral shedding.

“To be clear, you don’t have symptoms unless you have viral shedding. We powered the study for viral shedding because there are way more [of these] events, than outbreak events,” Clark says.

In those purely scientific measures, the study is on track. Genocea reported that patients who got the vaccine saw that viral shedding reduced by up to 51 percent at the highest dose, compared to no decline whatsoever among the placebo group. That number, which Genocea says was statistically significant, or unlikely to be due to chance, correlated with an increased response from T cells and B cells. Clark says Genocea will now track those patients over the course of a year, and see how durable the vaccine’s response is.

While these results are the first indication Genocea has that it may be on to something, regulators are going to want to see this translate into a clinical benefit. So Genocea’s first real big test will come next year, when it starts a second trial that will likely be judged both by viral shedding rates and a reduction in symptoms.

Clark says that while the current study doesn’t sink or swim on symptom reduction, Genocea is still tracking it. So far, Clark cites one encouraging data trend. In an “exploratory” analysis the company did after 119 days of follow-up, one of the groups that got GEN-003 is showing a “strong trend” in the delay between an injection and the next occurrence of symptoms, according to Clark. On average, he says, the placebo patients saw their first recurrence occur 45 days after starting a regimen. By comparison, more than half of the patients in one of the groups getting GEN-003 (Clark declined to identify which) haven’t yet experienced an outbreak, he says.

“It’s too early to tell that that’s significant—if it were significant it would be a very meaningful difference, of course, but that’s still to be seen,” he says.

Genocea will have all the data from this study in the second quarter of 2014, and then likely test the same type of patient population with the two highest doses it is currently administering to patients in its second trial.

While GEN-003’s first day of clinical reckoning is a ways away, the potential payoff, should it prove to provide a real benefit, is big. Clark says between the U.S., U.K., France, Germany, Italy, Canada, and Japan, there are about 12 million people who are both affected with HSV-2 and showing symptoms. If Genocea were to price GEN-003 against the typical vaccine, it would amount to between $100 to $300 per patient, per year, creating a market opportunity worth more than $3 billion at the high end of the range, he says.

Today, people with HSV-2 typically take oral antiviral drugs like valaciclivir (Valtrex) either only when they have outbreaks, or daily. Genocea envisions HSV 2 patients combining those antivirals with periodic shots of GEN-003—how often isn’t known as of yet given Genocea doesn’t know how long the immune response lasts.

“They work by complementary mechanisms of action and so the protection should be increased in combination,” Clark says. “We haven’t proven that yet, of course, but that’s a reasonable theory that we would expect to test at some point.”

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

Single Page Currently on Page: 1 2 previous page

By posting a comment, you agree to our terms and conditions.

  • Susan Moore

    Dr Okoh God will continue to bless you more abundantly, for the good
    works you are doing in peoples life, I will keep on writing good and
    posting testimonies about you on the Internet, I’m Susan moore from San
    Juan, Puerto Rico. I was tested HIV positive, I saw a blog on how Dr
    Okoh cured people, i did not believe but i just decided to give him a
    try, I contacted him and also got my healing, i am so happy. If you have
    any problem or you are also infected with any disease, contact him now
    with his Email: Dr.Okohspellhome@gmail.com or call him on
    +2348153089532

  • Shella Morris

    Hi Everyone here in this forum, I am here to share with you all about how Dr Molemen was able to cure me from Hiv with his Herbal Medicine, Been with Hiv is something someone is never comfortable with, I was tested and confirmed Hiv Positive few years ago and i was taking medical treatment from my Doctor, some time back now while i was on the Internet i saw different amazing testimonies concerning Dr Molemen on how he has healed people from various sickness, someone also testified about how he was cured from Diabetics with the Help of Dr Molemen Herbal Herbs Medicine, they gave his personal information and advice anyone to contact him if you need his help, i took the email address of Dr Molemen and i sent him a message regarding my Problem and how he could possibly help me out, He responded to me and told me to have the faith and believe in God, Dr Molemen told me that he was going to prepare some Herbs for me which i am to take for some time as my medication, he told me the procedures and i agreed to it, after some days of communicating with Dr Molemen he actually sent me a package and he gave me the tracking number to my package, he gave me prescription on how i am to use the Medicine,after taking Dr Molemen Herbal Medicine i went back to my Doctor for another test and to my greatest surprise my result turned out Negative, and i still did not believed it i went to other hospitals for another test and the result still remain Negative, today i am so happy and living with my family as my health is back again, you can reach Dr Molemen for any problem or sickness his Herbal Medicine has it all as your solution, reach him on ( (drmolemenspiritualtemple@gmail.com) or call him on +2347036013351 ) God Bless you Doc for your good Work in my Life.

  • Harbert Michelle

    Hi,
    My name is Harbert Michelle, six months ago I had sex with
    the third guy in my life whom i was about to marry and now I have
    herpes. I couldn’t believe it because he wasn’t a random guy, he’s the
    closet guy I’ve had as a boyfriend, but it has been a never ending
    nightmare since. I’ve always believed in GOD and have asked him for
    forgiveness which is ironic.
    I felt like killing myself with the
    taught of having a husband and family will be quite difficult and i felt
    like I’m not really in the room when people are talking. I didn’t know
    what to do and pretty much cry and pray every day to God for help and
    looking at my family with so much love and feeling that i have
    disappointed them even though they don’t know. Until God lead me to DR.
    HARRY online who promised to help me cure my disease through herbals. At
    first i didn’t believe him, but to my greatest surprise i was cured
    completely by herbals, which medical doctor also verified that i was
    cured. Special thanks to DR. HARRY.
    Don’t be discourage because he that did it for me will also do it for you and you can contact him through his email address dr.harryherpescentre@gmail.com or call him on his cellphone number +2348052850617……

  • Alice

    i want to thank Dr Odemi for the herbal HIV medicine he gave to me and my daughter, i was suffering from HIV when i gave birth to my daughter and that was how my daughter got the sickness indirect from me, but to God be the glory that i am heal with the herbal medicine that DR Makuta gave to me when i contacted him. i want to use this medium to tell everyone that the solution to our sickness has come, so i will like you to contact this great healer on his email address: odemisolutioncenter@gmail.com with him all your pains will be gone, i am really happy today that i and my daughter are cured of HIV, we are now negative after the use of his medicine,my doctor confirm it. once more i say a big thank to you Dr Makuta for healing hands upon my life and my daughter, i say may God continue to bless you abundantly and give you more power to keep helping those that want your help in their lives. email him now he is waiting to receive you. :odemisolutioncenter@gmail.com Or contact his number:+2348110035171