Nano Bios Vaccine Demonstrates Efficacy...

[NorCal_Herpster]

http://www.prnewswire.com/news-releases/nanobios-genital-herpes-vaccine-demonstrates-efficacy-in-guinea-pigs-as-both-a-prophylactic-and-a-therapeutic-vaccine-300147057.html

[NorCal_Herpster]

ANN ARBOR, Mich., Sept. 22, 2015 /PRNewswire/ -- NanoBio Corporation today announced that its intranasal nanoemulsion (NE) adjuvanted genital herpes vaccine has demonstrated efficacy in studies conducted in both the prophylactic and the therapeutic guinea pig model. Guinea pigs represent the primary animal model used to study genital herpes vaccines. The data was recently presented at the 40^th Annual International Herpesvirus Workshop in Boise, ID. 

Under the National Institute of Allergy and Infectious Diseases' (NIAID) preclinical services program, researchers at the Cincinnati Children's Hospital Medical Center investigated the potential of NanoBio's intranasal NE glycoprotein vaccine in guinea pig challenge models. Using the prophylactic model, guinea pigs were administered an intranasal NE vaccine then subsequently challenged with the herpes simplex virus-2 (HSV2). In this study, the NE HSV2 vaccine prevented infection and viral latency in 92 percent of animals vaccinated, versus 8 percent in the no treatment arm. No adverse events were observed in any of the animals that received the NE vaccine.

In a separate therapeutic guinea pig study, animals were first infected with HSV2 then vaccinated with the intranasal NE vaccine. During the post-vaccination observation period, the NE HSV2 vaccine reduced recurrent lesions by 64 percent and viral shedding by more than 50 percent, as compared to animals that received no treatment. Of the animals receiving the NE vaccine, 53 percent did not shed any detectable virus. Again, no adverse events were observed in any of the animals that received the NE vaccine.      

"The results of these studies demonstrate the potential impact and benefits of intranasal NE vaccines to prevent and treat sexually transmitted diseases. Based on the consistently positive data observed in four guinea pig studies conducted to date, we are planning to raise additional capital in 2016 to advance our NE-HSV2 vaccine candidate into Phase 1 clinical studies," said David Peralta, Chief Executive Officer of NanoBio. "The use of intranasal NE vaccination elicits a mucosal immune response in addition to the systemic immunity generated by intramuscular vaccines, offering unique and significant advantages. A mucosal response is potentially critical to adequately protect against certain respiratory and sexually transmitted pathogens that enter the body across mucosal surfaces."

[lexyz22]

92% Percent is pretty dam impressive. 

But still, it would need to get through human safety trials, then phase 2/3 trials before even thinking about being considered by the regulatory bodies. Even Admedus if they get successful results in their current phase would be looking at 5-6 years before it goes global, or possibly just in Australia as other  countries outside of Aus are somehow behind in many respects.

Wish i could fast forward time explicitly for these vaccines! lol

[StayingUpbeat]

Why is joining one of the clinical trials not an option?

[Evaluate]

Really interesting - I always wondered why a nasal approach hadn't been tried. I wonder if this type of vaccine would have to undergo the exact same type of testing as a needle vaccine? I would assume so.

@StayingUpBeat what are your thoughts on the data and feasibility of a NanoBio's HSV2 vaccine candidate?

Edited September 23, 2015 by Evaluate

[NorCal_Herpster]

Why is joining one of the clinical trials not an option?

StayingUpbeat, how long before this goes to human trials in your opinion?  I'd be interested in clinical trials and willing to travel on my own dime.

[StayingUpbeat]

Genocea appears to be gearing up for their next round of clinical trials: https://clinicaltrials.gov/ct2/show/NCT02515175?term=gen-003&rank=3

Their last trial of this vaccine induced a ~55% reduction in shedding.

Immune design would probably be the next in line, though they haven't announced a trial yet.

 

[StayingUpbeat]

Really interesting - I always wondered why a nasal approach hadn't been tried. I wonder if this type of vaccine would have to undergo the exact same type of testing as a needle vaccine? I would assume so.

@StayingUpBeat what are your thoughts on the data and feasibility of a NanoBio's HSV2 vaccine candidate?

I recall reading about this concept years ago.  Its interesting that they imply it could be coupled with another immunotherapy.  As crazy as this sounds a 50% reduction in shedding is not actually all that impressive nowadays compared with the other pre-clinical vaccines being investigated. 

Their concept is novel and the idea that this could be administered without a needle has definite advantages in situations like sub-Saharan Africa where oral and nasal vaccines are very important but I question whether their efficacy is simply OBE for the developed world with things like HSV-529 already in clinical trials and GEN-003 showing better efficacy than that in humans.

Edited September 24, 2015 by StayingUpbeat

[throwawayday345]

Genocea appears to be gearing up for their next round of clinical trials: https://clinicaltrials.gov/ct2/show/NCT02515175?term=gen-003&rank=3

Their last trial of this vaccine induced a ~55% reduction in shedding.

Immune design would probably be the next in line, though they haven't announced a trial yet.

 

StayingUpbeat, any idea what the details are of this new formulation of GEN-003?  Looks like they're trying something different here.  

[Evaluate]

I recall reading about this concept years ago.  Its interesting that they imply it could be coupled with another immunotherapy.  As crazy as this sounds a 50% reduction in shedding is not actually all that impressive nowadays compared with the other pre-clinical vaccines being investigated. 

Their concept is novel and the idea that this could be administered without a needle has definite advantages in situations like sub-Saharan Africa where oral and nasal vaccines are very important but I question whether their efficacy is simply OBE for the developed world with things like HSV-529 already in clinical trials and GEN-003 showing better efficacy than that in humans.

It surprises me that you say a 50% reduction in shedding isn't that impressive - I think anything above 50% is awesome.  I also, speaking as a non-scientist type, think that diversifying the approach to a HSV vaccine (e.g. nasal instead of the gD-2 injection vaccine) has great advantages, as this can hopefully lead to further progress.  In other words, tackling the same problem from a different angle.

Reading the post regarding NanoBio's research, when they say "in this study, the NE HSV2 vaccine prevented infection and viral latency in 92 percent of animals vaccinated, versus 8 percent in the no treatment arm," what do they mean exactly?  If I'm understanding this right, do they claim that their vaccine stopped HSV-2 going into hiding when tested in animals?  And if so, does this mean the the virus was cleaved in the process?

Edited October 4, 2015 by Evaluate

[vzhe]

It surprises me that you say a 50% reduction in shedding isn't that impressive - I think anything above 50% is awesome.  I also, speaking as a non-scientist type, think that diversifying the approach to a HSV vaccine (e.g. nasal instead of the gD-2 injection vaccine) has great advantages, as this can hopefully lead to further progress.  In other words, tackling the same problem from a different angle.

Reading the post regarding NanoBio's research, when they say "in this study, the NE HSV2 vaccine prevented infection and viral latency in 92 percent of animals vaccinated, versus 8 percent in the no treatment arm," what do they mean exactly?  If I'm understanding this right, do they claim that their vaccine stopped HSV-2 going into hiding when tested in animals?  And if so, does this mean the the virus was cleaved in the process?

Paragraph 1: It's already been done with GEN-003 in humans, but the question is if that is actually sustainable past 6 months. I agree having similar results in animal models isn't very impressive. A 50% reduction in shedding isn't even close to a functional cure, especially when that's the only starting point in animal models.

Paragraph 2: No, that means that they think their vaccine has potential as a prophylactic (to protect uninfected animals).

No vaccine will ever cleave the virus. Occasionally someone irresponsible (or interested in pushing the stock) makes claims about some vaccine candidate cleaving the virus. That's not how vaccines work. They can't cleave the virus. All they do is prime your immune system, which works better for those uninfected, but has some benefits for those already infected too.

 

Edited October 6, 2015 by vzhe

[Evaluate]

Paragraph 1: It's already been done with GEN-003 in humans, but the question is if that is actually sustainable past 6 months. I agree having similar results in animal models isn't very impressive. A 50% reduction in shedding isn't even close to a functional cure, especially when that's the only starting point in animal models.

Paragraph 2: No, that means that they think their vaccine has potential as a prophylactic (to protect uninfected animals).

No vaccine will ever cleave the virus. Occasionally someone irresponsible (or interested in pushing the stock) makes claims about some vaccine candidate cleaving the virus. That's not how vaccines work. They can't cleave the virus. All they do is prime your immune system, which works better for those uninfected, but has some benefits for those already infected too.

 

Thanks for your insight.  It seems GEN-003 is a leading contender in the world of potential vaccines.

It also seems that NanoBio is ready to raise funds for Phase I clinical testing and I hope they can do it. At very least it will be nice to see another potential vaccine get into the clinical testing stream.

[tom343]

Why can't genital herpes vaccines just be injected to the groin? Or thigh? Antibiotics are injected to the lower half of the body. 

Edited November 18, 2015 by tom343

[mcmich]

Was wondering why Nanobio's NB-001 cream was never released by Nanobio and GSK. They had a cream that was like a super Abreva. It worked well in Phase 1 and 2 trials. Phase 3 was completed and all information disappear from their website after trial completion and from GSK (was a agreement to market it). At least we would have had something that rapidly cleared the cold sores if you broke out while waiting for better vaccines/cures.

Edited November 19, 2015 by mcmich