Gen-003 new article

[Jesus Chuy]

Genocea Awarded World Vaccine Congress 2017 Industry Excellence Award for Best Therapeutic Vaccine for GEN-003 for Genital Herpes

Company highlights its T cell-Directed Genital Herpes and Neoantigen Cancer Vaccine Candidates in two oral presentations

April 11, 2017 08:26 ET | Source: Genocea Biosciences

 

 

CAMBRIDGE, Mass., April 11, 2017 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced that it has been awarded the World Vaccine Congress 2017 Industry Excellence award for best therapeutic vaccine for GEN-003, an immunotherapy to treat genital herpes, which is expected to be Phase 3 ready by the end of 2017.

In addition, the company is giving two oral presentations and participating on a panel at the congress, which is taking place from April 10-12 in Washington DC. The two presentations highlight the success to date of Genocea’s ATLAS™ technology, a proprietary T cell immune response screening platform designed to identify clinically relevant T cell antigens. Using ATLAS, Genocea is building a pipeline of candidates that includes GEN-003 and GEN-009, a neoantigen cancer vaccine, for which the company expects to file an Investigational New Drug (IND) application by the end of 2017.

• “Developing an HSV vaccine to control clinical recurrences and viral shedding”
  Tuesday, April 11 at 12:10 pm ET
  Thomas Heineman, M.D., Ph.D., Genocea’s Vice President of Clinical Development
  In his presentation, Dr. Heineman will provide a comprehensive overview of GEN-003: its rational design and positive clinical results to date.
   
• “Comprehensive profiling of T cell responses to putative neoantigens reveals smarter targets for cancer immunotherapy”
  Wednesday, April 12 at 12:00 pm ET
  Jessica Baker Flechtner, Ph.D., Genocea’s Chief Scientific Officer 
  In her presentation, Dr. Flechtner will provide an overview of the company’s ATLAS technology: its advantages over predictive methods of antigen identification, and how Genocea is using ATLAS to develop neoantigen cancer vaccines and to help identify patients most likely to benefit from checkpoint blockade therapies.

In addition, Dr. Flechtner will be participating on the following panel:

• “For vaccines that are being paired with adjuvant or checkpoint blockade therapies, are we working with the right antigenic targets?”
  Tuesday, April 11 at 5:40 pm ET

About GEN-003
GEN-003 is an investigational T cell-directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response in patients with genital herpes. In multiple Phase 2 randomized, placebo-controlled clinical trials, GEN-003 has demonstrated the ability to statistically significantly reduce the clinical signs of genital herpes and the rate of viral shedding. The immunotherapy was designed using Genocea's ATLAS™ platform, which profiled the comprehensive spectrum of actual T cell responses mounted by humans in response to HSV-2 to identify antigen targets that drive protective T cell responses to the virus. If successfully developed and marketed, GEN-003 would be the first new therapy in more than 20 years to treat the large and unsatisfied global genital herpes patient population

[Jesus Chuy]

I'm confused does this mean the vaccine works? 

[Jesus Chuy]

Can anyone answer this question: Did Gen-003 worked on the phase 2 trial? 

[Cas9]

@Jesus Chey
Phase II had two sub-phases; a and b. They completed phase IIb. That concludes phase II.  I think the shedding was reduced by 40%. The lesions probably by a bit more. Those numbers are considered significant. They are now gearing up for phase III, the final phase. That is scheduled to begin in the final quarter of this year.

[Mackie82]

Ok if the phase 3 start at Q4 this year when we could expect the vax availability, 2020 or before this isnif it gets success and FDA approved. Thanks 

[Cas9]

34 minutes ago, Mackie82 said:

Ok if the phase 3 start at Q4 this year when we could expect the vax availability, 2020 or before this isnif it gets success and FDA approved. Thanks 

2020

[PurpleandGray]

I blew this vaccine off because  many were saying it didn't work & some even said it caused worsening but hearing this gives me hope. I believe the next trail will be this along with Valtrex so let's hope for the best here!  

[Mackie82]

1 hour ago, Cas9 said:

2020

I need a time machine to sleep till then 

[Atrapasueños]

Mejor usar esa máquina del tiempo para no infectarse

 

Better to use this time machine to avoid becoming infected. @Mackie82

[SnowAngel]

So is this a vaccine we'll be able to get at our local doctors office? Do you expect it to be covered by insurance? 

[Whyyyyy]

39 minutes ago, SnowAngel said:

So is this a vaccine we'll be able to get at our local doctors office? Do you expect it to be covered by insurance? 

I'm wondering the same thing.

And could we get this one then theravax later? 

[Whyyyyy]

And could we get this one then theravax later? 

[valleynovascotia]

So it's good there coming out with this but was wondering if it only reduces shedding by 40% will it still be marketed?

[Cas9]

1 hour ago, SnowAngel said:

So is this a vaccine we'll be able to get at our local doctors office? Do you expect it to be covered by insurance? 

I think you're confusing it with Theravax. Theravax is different because it is not FDA approved, which is why of course it will be made available outside the U.S.
Gen-003 will be like any other approved drug in the U.S.  That means it should be administered through your doctor like any other vaccination. How the insurance handles it is unknown. But personally, I don't see why they wouldn't cover the cost since it's used to alleviate a known medical issue.

[Cas9]

2 minutes ago, valleynovascotia said:

So it's good there coming out with this but was wondering if it only reduces shedding by 40% will it still be marketed?

Of course.

[SnowAngel]

1 minute ago, Cas9 said:

I think you're confusing it with Theravax. Theravax is different because it is not FDA approved, which is why of course it will be made available outside the U.S.
Gen-003 will be like any other approved drug in the U.S.  That means it should be administered through your doctor like any other vaccination. How the insurance handles it is unknown. But personally, I don't see why they wouldn't cover the cost since it's used to alleviate a known medical issue.

Great thank you!! You seem to be pretty knowledgeable about HSV, are you a fan of this vaccine? 

[valleynovascotia]

1 minute ago, Cas9 said:

Of course.

Do u know if you can get other vaccines if better ones come out/

[Cas9]

Just now, valleynovascotia said:

Do u know if you can get other vaccines if better ones come out/

Of course

[Cas9]

1 hour ago, SnowAngel said:

Great thank you!! You seem to be pretty knowledgeable about HSV, are you a fan of this vaccine? 

Not particularly. Assuming it does in phase III what it did in phase II, I consider it a moderate success in the overall scheme of things. Certainly, reducing shedding and OBs by half is a good thing. Plus, adding Valtrex to the mix could bring everything down by 3/4 perhaps; we will see. I think that other vaccines may have greater potential. Again, we will see.

[SnowAngel]

Thanks for the reply. Which upcoming vaccines do you feel will have more potential?