Genocea's latest test succeeds

[AychEsVee]

Chill

 

http://www.xconomy.com/boston/2015/10/07/genocea-climbs-on-follow-up-data-for-herpes-vaccine/

 

The primary goal of this test was to reduce patients’ viral shedding compared to their baseline levels, and Genocea said it’s succeeded here, with four out of the six doses that were tested achieving statistically significant reductions. The “best performing dose”—60 micrograms of GEN-003 combined with 75 ug of an accompanying adjuvant—led to a 58 percent decrease in viral shedding at the six month mark.

Genocea said that five of the six doses of its vaccine also led to “sustained and statistically significant reductions” in blisters and sores compared to baseline. These reductions ranged from 43 to 69 percent after six months, though it’s unclear which doses achieved these rates. GEN-003 led to a 48 percent reduction in viral shedding and a 52 percent reduction in lesions in its previous, Phase 1/2 trial. In regulatory filings, Genocea has said that its consultants believe repeating similar results in a late-stage would make GEN-003 a “commercially viable” product.

[lexyz22]

This is great news  

Vaccine + Daily Antivirals should eliminate the worry of transmission pretty well (and throw in condoms, well... thats basically a stupidly low chance of transmission). 

If Genocea has managed this, imagine how good Admedus' vaccine will be, im hoping for levels of 80+% reduction in their studies.

[ST]

I haven't been following this as I should...is this for hsv 1 or 2?

 

[Evaluate]

I haven't been following this as I should...is this for hsv 1 or 2?

 

GEN-003 is designed for HSV2. They plan on testing it on HSV1 to see what effect, if any, it has.

[StayingUpbeat]

  If Genocea has managed this, imagine how good Admedus' vaccine will be, im hoping for levels of 80+% reduction in their studies.

I simply don't understand why this would be expected.  Considering how nearly identical to Vical's failed vaccine the Admedus offering is, what about it would make it more effective than Genocea's? 

Edited October 9, 2015 by StayingUpbeat

[throwawayday345]

There really is an Admedus > Genocea mentality in this forum and I'm worried people will be upset come December. 

[AychEsVee]

Aren't they two different mechanisms...?

[lexyz22]

Perhaps guys, I'm just being optimistic. 

You know, instead of pessimistic. 

 

[oneday]

This is great news  

Vaccine + Daily Antivirals should eliminate the worry of transmission pretty well (and throw in condoms, well... thats basically a stupidly low chance of transmission). 

If Genocea has managed this, imagine how good Admedus' vaccine will be, im hoping for levels of 80+% reduction in their studies.

Totally believe Admedus will achieve levels of >80% reduction!!

[herpes-sucks]

Question for Chip Clark / Genocea

As many people seem excited over a 58% reduction, I am still not in that camp.  Sure it is better than nothing and maybe I'm looking at the glass 1/2 empty.... but that is based on my personal experience, suffering, and emotions with HSV-2.  So my question may seem simplistic or possibly ignorant, but why is a 100% reduction from Gen-003 not possible ? Or even 80-90% ? What components or elements are lacking to achieve these results ? Are there any adjustments or improvements that could be made to the current compound to raise and improve the results ?  It seems like other companies have higher goals or expectations, which seemingly would put Genocea at a competitive disadvantage.

Thank you in advance...

[StayingUpbeat]

There really is an Admedus > Genocea mentality in this forum and I'm worried people will be upset come December. 

I could not agree more

[Chip Clark]

Hi Herpes-Sucks,

Thanks for your questions.  Here's how we are thinking about GEN-003 and about our approach to fighting genital herpes.  We believe the GEN-003 profile, if it continues to perform as it has thus far, will be compelling to many people.  For that reason, it is worth continued development.  But that does not mean we are satisfied.  In parallel, we are conducting early stage research on a next-generation program.  n this research, we are investigating both additions to, and tweaks to, the existing GEN-003 formulation.  It is likely that such a program, if it were to succeed, is at least a couple of years from human studies.  Our goal in this "2.0" program would be to get even closer to a functional cure as possible.  So we do not know if we can improve on GEN-003, but we are definitely trying to do so in parallel to advancing GEN-003 as quickly as we can.

Hope this answers your questions.  Please let me know if not.

Thanks

Chip

[Herbfresh]

Haven't they canceled vaccines with similar drops? And correct me if I am wrong, the best case scenario is a reduction of 58%, as that article claims. 

Just seems like all we are wasting so much time shooting sparrows with canons instead of actually going for a genuinely effective cure. 

I don't think these guys want to cure anything. They just want to play this pass the hot potato game, to enrich themselves. We know what needs to be done to create an effective vaccine, but pharma elects to go after proven ineffective techniques. It's sick. They're playing games with our lives. 

I mean, their legal responsibility is to make money, so that means they are actually legally bound to not cure us. Until this changes, we are screwed. 

[herpes-sucks]

Hi Herpes-Sucks,

Thanks for your questions.  Here's how we are thinking about GEN-003 and about our approach to fighting genital herpes.  We believe the GEN-003 profile, if it continues to perform as it has thus far, will be compelling to many people.  For that reason, it is worth continued development.  But that does not mean we are satisfied.  In parallel, we are conducting early stage research on a next-generation program.  n this research, we are investigating both additions to, and tweaks to, the existing GEN-003 formulation.  It is likely that such a program, if it were to succeed, is at least a couple of years from human studies.  Our goal in this "2.0" program would be to get even closer to a functional cure as possible.  So we do not know if we can improve on GEN-003, but we are definitely trying to do so in parallel to advancing GEN-003 as quickly as we can.

Hope this answers your questions.  Please let me know if not.

Thanks

Chip

Thank you Chip. I think that answers my question in so far as I am not alone in my thinking that a 58% reduction is just so-so... as you say about the current version, "But that does not mean we are satisfied".  That you realize and acknowledge a better "2.0 version" is needed and in development is helpful.

Question. If the 2.0 is being developed in parallel, why would there be such a long time duration (at least a couple of years) to human studies ?  

Thanks again....

[Chip Clark]

Thank you Chip. I think that answers my question in so far as I am not alone in my thinking that a 58% reduction is just so-so... as you say about the current version, "But that does not mean we are satisfied".  That you realize and acknowledge a better "2.0 version" is needed and in development is helpful.

Question. If the 2.0 is being developed in parallel, why would there be such a long time duration (at least a couple of years) to human studies ?  

Thanks again....

It's just that it takes a lot of time to do the animal studies that would need to convince us we have something better than GEN-003, and time to make the material for clinical trials, and time to do the safety studies to convince the FDA that we can do human studies, etc.  We're talking at least 2 years from now, even with best efforts and full resource commitment by us.

[Evaluate]

It's just that it takes a lot of time to do the animal studies that would need to convince us we have something better than GEN-003, and time to make the material for clinical trials, and time to do the safety studies to convince the FDA that we can do human studies, etc.  We're talking at least 2 years from now, even with best efforts and full resource commitment by us.

If GEN-003 passes phase II trials as expected (with the effects remaining strong at 12 months say), would Genocea put any further resources behind GEN-003?  And if so, would this help it get to market faster or just support the current time line?

Edited October 11, 2015 by Evaluate

[Chip Clark]

If GEN-003 passes phase II trials as expected (with the effects remaining strong at 12 months say), would Genocea put any further resources behind GEN-003?  And if so, would this help it get to market faster or just support the current time line?

Evaluate,

We are already spending millions every month on advancing GEN-003 as rapidly as possible.  I do not see a path to substantially faster approval even with more resources.  More positive data at 12 months, while obviously good news for all, would not change our path.

Chip

[Sanguine108]

So wild how much money goes into this.

[oneday]

@chip I have a question about the carcinogenicity of the drug and also if would it be tested to determine safety during pregnancy or just prior to falling pregnant. Could it cause any genetic changes to parent or fetus or is it just don't know at this point?

Edited October 13, 2015 by oneday

[Chip Clark]

@chip I have a question about the carcinogenicity of the drug and also if would it be tested to determine safety during pregnancy or just prior to falling pregnant. Could it cause any genetic changes to parent or fetus or is it just don't know at this point?

This seems really unlikely to be a problem.  After all, we are largely injecting HSV proteins, and HSV itself does not cause such problems.  But we cannot say for sure until we test for these things.  Customarily, the FDA requires companies to conduct such testing during Phase 3 (a slight generalization but largely true, I think.)  So that's when we'd likely do that work.

[bayern77]

Chip, I know you have mentioned before you  plan on testing this vaccine to see if it will work for Hsv1 as well. Assuming you do that study , when will it take place? and would you say Hsv1 is a more difficult virus than Hsv2?  What are the chances it can offer some cross protection if you could give a prediction. Thank you Chip , we appreciate everything you are doing for each one of us.

Edited October 16, 2015 by bayern77

[Lovelylady1996]

Hello! So if all goes according to plan with this Gen-003 vaccine, is there an estimated year that it will be available  to us? And will people with just hsv1 still be able to get it? 

[Paul1976]

I believe from reading some posts that if all goes well it should be 2020 and I think it will only be available to hsv 2 at the moment but I think they are researching the effects of hsv1

[Chip Clark]

I believe from reading some posts that if all goes well it should be 2020 and I think it will only be available to hsv 2 at the moment but I think they are researching the effects of hsv1

Half right Paul1976, and thanks.  We are researching HSV-1 with an eye toward having data on the efficacy of GEN-003 in the label for 2020 launch.  Today, we cannot say that HSV-1 is easier or harder than HSV-2., 

[tom343]

I have read that your antibiotic vaccine failed to function as required and thereby you will be initiating more resources into the genital herpes vaccine. Could this mean a faster production date for the vaccine? Say 2017 or 2018?

 

http://www.fiercebiotech.com/story/genocea-halts-its-antibiotic-vaccine-program-after-phase-ii-failure/2015-10-19