GENOCEA

[optimisticcali]

So, I noticed that the Genocea thread on here got locked. I'm assuming that happened because the thread got hijacked with a conversation slamming the moderators, personal attacks, etc. 

 

I for one was very grateful that Chip Clark had registered on the forum and that the Genocea thread had given him a direct line, both to answer questions and keep us updated on the vaccine progress. 

 

I'm hoping we can start (this) new thread and not run into the same problems.

 

 

[Smart_1]

I don't think it had to do with people misbehaving caused the thread to disappear. It was for the revamping of the site.

[optimisticcali]

I don't think it had to do with people misbehaving caused the thread to disappear. It was for the revamping of the site.

Good to know. Thread seems to still be locked though and I want to make sure if Chip comes back he has a place to post. It seemed rare that someone was willing to communicate with us like that. 

[zzzqzzz]

someone should shoot him an email letting him know about the site change and asking  him to post updates here

[optimisticcali]

someone should shoot him an email letting him know about the site change and asking  him to post updates here

Does anyone here have Chip's email? I know some people had had direct correspondence with him. 

[l95]

Chip has twitter account, but hasn't appeared there from July

[dont quit!]

Just post his name and explain to him what happened. @Chip Clark. When you have a minute, please respond to this new Genocea thread. Last thread was unexpectedly locked. We know you are really busy so thank you for everything!

Edited September 10, 2015 by dont quit!

[l95]

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2^TM 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.

http://ir.genocea.com/releasedetail.cfm?ReleaseID=935492

[Chip Clark]

Hey all, 

Sorry to have disappeared - I couldn't get into the previous thread for some reason for awhile, so I laid low until our good news today.  It looks like you beat me to posting it.  I'd be happy to take your questions.

Chip

[epic8797]

Hi Chip, thanks for coming back...really enjoy the fact that you participate in this community. Great news today! For you and for us

I see that the Phase 2 closing meeting with the FDA is a year from now. Phase 3 still has to happen as well. Forgive me for being impatient, but why does it take so long to wrap Phase 2 up? Don't get me wrong I'm happy today, but it's just tough accepting it's still so far out.

Also, out of curiosity, how would this fit in the market with respect to Valtrex? Don't they have similar efficacy rates?

Edited October 7, 2015 by epic8797
Added content

[Chip Clark]

Epic, believe me - if we could go to Phase 3 today we would.  But before you go to Phase 3 the FDA needs to sign off on your program.  And for them to sign off on your program they need confidence in your drug/vaccine's profile.  What we can't give them today is the performance by the "final" manufacturing product.  What I mean is this:  to date we've been using vaccine materials manufactured at small scale.  But Phase 3 trials and post-approval vaccinations have to be with stuff made at large scale.  And in that transition from small- to large-scale manufacturing the product theoretically can change (mostly because the manufacturing "recipe" may need to change slightly as you scale up).  So, we are about to run a "bridging" Phase 2 study to show that the new version of GEN-003 (again:  the exact same components, just made at larger scale).  Once we have clinical data from that, we can go to the FDA to discuss P3 next year.

The bottom line:  this stuff is hard, risky, and costs a lot of money.  But again, I promise you we're moving as fast as we can.

Your other question is how we might fit into treatment paradigms.  I'll give you my view, based on conversations with people like you and with lots of docs who treat people infected with HSV.  But I'd welcome your view (and the views of others on the forum).

Here's how Genocea sees it.  Some people treat their infection only when they have outbreaks.  What GEN-003 could offer such patients is not just shorter outbreaks, but also fewer outbreaks and much lower risk of spreading the virus to others, which usually happens during asymptomatic viral shedding.  Others treat their infections with daily therapy.  To such people, GEN-003 offers efficacy at least as good as that of Valtrex, plus a couple of potential advantages.  One is the ability to get protection without being reminded daily of the infection (I've heard very emotional stories about this burden to many people).  Plus, we offer the chance to use oral antivirals as "rescue".  Today, when people on daily therapy still see outbreaks, what can they do?  Not much, as I understand it.  And this speaks to a 3rd potential benefit:  additive efficacy to further reduce outbreak frequency, duration, and infection transmission risk.

What are your thoughts?

[moonrae]

Hi Chip, 

I'm a newbie to this conversation, but have a question for you. Does GEN-003 have cross-reactivity for HSV-1? 

[Evaluate]

Hi Chip, 

I'm a newbie to this conversation, but have a question for you. Does GEN-003 have cross-reactivity for HSV-1? 

moonrae, take a look at the thread that was locked some weeks ago. It has the answer to your question inside.  It will help reduce questions that have already been answered. Here's what chip said:

Correct that the more variables the more risk. A general comment: I really enjoy and learn from these interactions. I also feel as though several people have asked the same question - could GEN-003 work against HSV-1 infections? All, please read this entire thread before asking questions! As I have said, we would like to study GEN-003 against HSV-1 because the GEN-003 antigens look similar in the 2 viruses. We have hope, therefore, that GEN-003 could work against both. But we have to test this to confirm it - and we intend to do so. How and when are a function of resources, risk tolerance, etc.

[epic8797]

Epic, believe me - if we could go to Phase 3 today we would.  But before you go to Phase 3 the FDA needs to sign off on your program.  And for them to sign off on your program they need confidence in your drug/vaccine's profile.  What we can't give them today is the performance by the "final" manufacturing product.  What I mean is this:  to date we've been using vaccine materials manufactured at small scale.  But Phase 3 trials and post-approval vaccinations have to be with stuff made at large scale.  And in that transition from small- to large-scale manufacturing the product theoretically can change (mostly because the manufacturing "recipe" may need to change slightly as you scale up).  So, we are about to run a "bridging" Phase 2 study to show that the new version of GEN-003 (again:  the exact same components, just made at larger scale).  Once we have clinical data from that, we can go to the FDA to discuss P3 next year.

The bottom line:  this stuff is hard, risky, and costs a lot of money.  But again, I promise you we're moving as fast as we can.

Your other question is how we might fit into treatment paradigms.  I'll give you my view, based on conversations with people like you and with lots of docs who treat people infected with HSV.  But I'd welcome your view (and the views of others on the forum).

Here's how Genocea sees it.  Some people treat their infection only when they have outbreaks.  What GEN-003 could offer such patients is not just shorter outbreaks, but also fewer outbreaks and much lower risk of spreading the virus to others, which usually happens during asymptomatic viral shedding.  Others treat their infections with daily therapy.  To such people, GEN-003 offers efficacy at least as good as that of Valtrex, plus a couple of potential advantages.  One is the ability to get protection without being reminded daily of the infection (I've heard very emotional stories about this burden to many people).  Plus, we offer the chance to use oral antivirals as "rescue".  Today, when people on daily therapy still see outbreaks, what can they do?  Not much, as I understand it.  And this speaks to a 3rd potential benefit:  additive efficacy to further reduce outbreak frequency, duration, and infection transmission risk.

What are your thoughts?

Thanks so much for your thorough reply. I think the fact that you don't have to take it daily (I'm not sure about how it's applied, but I think I read somewhere that it's an injection once or twice a year?) is enough to make this a big deal compared to Valtrex, and the other benefits are icing on the cake. I hope we one day get to the point where we don't have to disclose and potentially lose out on great relationships, and while this doesn't quite get us there it's a big step forward. Love you guys!

[Evaluate]

Hey Chip,

Congratulations on the good news. My question is in reference to a comment you said in the previous thread, about your "shots on goal" with respect to decreasing viral shedding even more.  Are the recent results more evidence that GEN-003 works better over time?  And while Phase III trials are still more than a year out, are you able to test any of your shots on goal while waiting for phase III trails to commence?  For example, can booster shots be administered to the Phase II group, or would this be done in Phase III trials?  Thanks!

Edited October 7, 2015 by Evaluate

[JustHanginginThere]

Chip,

Congrats on the good news.  I see above someone posted your responses to an HSV-1 question from awhile back. Has Genocea decided to invest in any additional exploration or testing of the impact of the vaccine on people with HSV-1? I read online the report "both HSV-2 and HSV-1 Neutralizing Antibody Tilters are Boosted......"  The vaccine has similar traits to HerpeVac which reported strong protection against HSV-1. This could provide significant hope to individuals with chronic HSV-1.

Also you report that the vaccine could be similar to taking Valtrex (but you obviously don't have to dose daily). What about the efficiency for the people who don't respond to Valtrex or never developed HSV antibodies and have chronic infections? Could your T cell Vaccine help them where Valtrex cannot?

Thank you and I appreciate your openess with our group.

 

 

 

Edited October 7, 2015 by JustHanginginThere

[Paul1976]

Hey can someone please explain the latest results for gen 003 idiot proof please  

[epic8797]

Hey can someone please explain the latest results for gen 003 idiot proof please  

The good results they saw 6 months ago were sustained. Still good results 6 months later.

[Paul1976]

Oh right I get that now as I was wondering what was different as I read the 6 months ago about the 58% reduction, so it's another year until phase 3 which I'm guessing is a larger amount of people to test the vaccine with the best dose?

[Evaluate]

Hey can someone please explain the latest results for gen 003 idiot proof please  

Disclaimer: I'm no scientist and I'm answering based upon my layman knowledge.

Previous studies showed a reduction in viral shedding (how easily herpes spreads to others) by 55%.  The newest research, 6 months in, shows an increased effect in those numbers by 3%, showing a statistically significant (extremely low probably the results occurred by chance) 58% reduction in viral shedding.  In other words, it appears to me that the vaccine got slightly more effective with time.  I'm still waiting on Chip's response to my question above, where he might shed light about the decrease in viral shedding from previous studies.

The second part is that the results lasted at least 6 months.  An important thing to know when testing a vaccine is how long the effects last.  According to the announcement, they plan on testing again 12 months after participants received the vaccine to see if these stats go up/down/stay the same.  They will test viral shedding and genital legion rates (how often someone has a breakout) and the hope is that these numbers will stay constant or even go up.

TL;DR = vaccine candidate reduces chances of passing herpes to others, having outbreaks and it's not by chance.  Effectiveness increased slightly after 6 months from the last dosage of GEN-003.

Edited October 7, 2015 by Evaluate

[Paul1976]

That's great thanks for the info - this seems really promising  

[profligate]

Since I am a Phase 2 Participant and complete the 1 year study next week. (Currently doing the last round of swabs to turn in next week and get my 1 year blood work done)   I'll throw in my updated opinion and observations.

Short story.  This stuff TOTALLY works for me.  As far as I'm concerned its an unqualified success.  Last year, prior to starting the study I was getting outbreaks every other month at least, if not monthly.   After getting the shots I had one outbreak about 10 days after the first shot, and another outbreak about 10 days after the third shot.  I kind of suspect those outbreaks were in part triggered by the shots themselves and those two outbreaks were odd in that they were fairly serious but cleared up very very quickly.

After that........  Nothing.  all clear, not a hint that I even had such a thing as Herpes from December of 2014 until now.  I really hope this lasts and it will be a bummer if and when it wears off, but 2015 has been an awesome year so far.  10 solid month outbreak free!!!

I also hope my outbreak after shot #3 didnt skew some viral shedding statistic somewhere.  I know I turned in a bunch of "dirty" swabs in the first set after the 3rd shot because I had an active outbreak.  I suppose that also kicked me out of the "outbreak free" statistic.  I just bring up those points because for me the stuff totally, unequivocally works, but I'm not sure the tests adequately capture the magnitude of the success because I personally feel the shots themselves triggered outbreaks that in the first round of swabs would appear a failure, but were perhaps more like the virus putting up a last stand fight as it was getting beat down by the immune system.  (or something, LOL)  Anyway, they got a vast amount of my blood to look at.  Hope they get some interesting info from that.

 

[dont quit!]

58% for the whole year isn't bad! Now if we can get our hands on the HPI-Amenavir from Japan and in combination with this, we may be able to put this shit virus into a nice steady remission! Thank you Chip Clark! God bless your whole staff!

[rvision]

@Chip Clark Is there anything we can do to support you?

We have a great community here and with our combined efforts and energy to improve the situation we can make big things happen.

Would you consider being involved in a specific Genocea funding campaign which we could setup with you and support your firm to the finish line? and potentially lobby the FDA to accelerate harder as we get closer.

p.s great news on the results to date, I've been watching and reading on the sidelines and you guys are awesome. Thank you

[Mellisuga]

Hi there, I have a few questions about the vaccination.

1) I was wondering - if someone developed natural immunity to HSV2 and displays little symptoms, how does the vaccine work to reduce their shedding? Is the vaccine targeting more white blood cells to recognize and attack the virus? (From what I'm reading here, it sounds like it does, but I'm curious about how it actually works - what is it doing different)

 

2) Would this vaccine be used for only people with HSV infections, or can it be used for folks who may not have HSV, but want to build up immunity against it to prevent infection?

 

3) HSV is said to increase the risk of catching HIV due to increased C4-T cells around areas of possible infection. I wanted to ask if this vaccine might affect this at all - if it reduces HIV risk, or if it stays the same (my guess is that it would stay the same, but it doesn't hurt to ask!)

 

Thanks!