UPenn Experimental Vaccine likely to get funds to do phase 1

[MikeHerp]

Hey Guys,

I've been in touch with Dr. Harvey Friedman.  I've been communicating with him about the status of his experimental vaccine, which I have had a lot of hope for. 

I recently got the following update from him about his vaccine, and he mentioned that I can share this info with our community.

 

Hi Mike,

Thanks for your comments. I am comfortable with you saying that my lab plans to continue our efforts on a prophylactic vaccine and that we are optimistic that corporate funding will be available for phase 1 human trials. 

Harvey M. Friedman, MD

______________________________

 

This would likely be some time late next year when phase 1 may begin.  Anyway, based on what he's told me, I think this is fairly likely, but not 100% until it's actually received.  Still, I really believe that this will proceed based on what Dr. Friemdman explained

Dr. Friedman was interviewed by Josh Bloom in 2017 (interview).

So this is good news. Everything I've read about this vaccine, including that it incorporates immune evasion domains, has made me think this has a solid shot of showing efficacy. 

I would imagine there will be announcement about this in the coming months.  If there isn't, I will follow up with Dr. Friedman.

Together with the Einstein College vaccine which recently got big funding, this would mean two pretty solid sounding vaccines in human trials by the end of next year.

Note, this is a prophylactic vaccine.  Dr. Friedman and his team, are also separately working on a therapeutic version of the vaccine, uisng a prime and pull approach together with Yale researcher Dr. Iwasaki, and that is also ongoing, though I understand that is not yet ready to go into clinical trials.  But it's something that continues to be looked at (Dr. Iwasaki recently publiched a paper on it -- https://www.nature.com/articles/s41541-019-0129-1).

It's nice that, since our community started collaborating on the herpes cure fund raiser with the Fred Hutch Center, I've felt that HSV researchers also take us a bit more seriously. 

But anyway, please don't bombard Dr. Friedman with questions (especially "when will you cure me???" questions).  These guys are very busy and it's best if they are focused on doing their work and advancing their solutoin into the clinic than on answering questions.  Even the couple simple questions I posed to Dr. Friedman kind of felt like an imposition on his time.

 

 

 

Edited September 2, 2019 by MikeHerp

[LightafterDarkness]

This is good news and thanks for the update- if this comes through as a phase I its another "shot on goal" and all thats needed is 1 goal.

As I have said earlier I continue to hope for the following:

• Within 12-24 months: Pritelivir trial is successful and becomes available end of 2020 / early 2021 providing a "functional cure"
• Within 5 years: a prophylactic vaccine comes onto the market, whether its XVac or Friedman's work or something else
• Within 7-10 years: a full cure whether through gene therapy or some molecule that flushes all HSV out of latency enabling the body to annihilate this virus 

[MiLoBeng]

Hope everything goes smoothly.

[dont quit!17]

12 hours ago, MikeHerp said:

But anyway, please don't bombard Dr. Friedman with questions (especially "when will you cure me???" questions).  

Aww man, I was about to ask him, how long until he cures me right now, lol

[MikeHerp]

On 9/3/2019 at 1:18 PM, dont quit!17 said:

Aww man, I was about to ask him, how long until he cures me right now, lol

lol

[MikeHerp]

On 9/3/2019 at 2:32 AM, LightafterDarkness said:

This is good news and thanks for the update- if this comes through as a phase I its another "shot on goal" and all thats needed is 1 goal.

As I have said earlier I continue to hope for the following:

• Within 12-24 months: Pritelivir trial is successful and becomes available end of 2020 / early 2021 providing a "functional cure"
• Within 5 years: a prophylactic vaccine comes onto the market, whether its XVac or Friedman's work or something else
• Within 7-10 years: a full cure whether through gene therapy or some molecule that flushes all HSV out of latency enabling the body to annihilate this virus 

I think pritelivir is a good bet and that timeline looks solid. I think by end of next year it may be approved. The problem will be availability.  How to get it if you aren't immune compromised.  It will probably be gettable somehow, maybe online.  Or from a sympathetic doctor if you are in the US.  But it's not clear.  Also, price.  It won't be a generic.  The Japanese similar is currently $500 for 2 weeks supply.  Anyway, an approval for pritelivir, would be a big success and major progress in the field.

A prophylactic probably won't be available in 5 years, unless it's the HSV529.  Prophylactic trials may take 7 to 9 years.  Only HSV529 has completed a phase 1.  Others haven't started.  I'm willing to bet that one of the candidates, either Einstein or UPEnn would be approved.  But it will take some time.  A therapeutic could be approved in 5 years, but there is currently no clear therapeutic vaccine in trials.

A cure will take 10+ years, but it could be in trials as early as within 5 years from now, earlier if ExcisionBio figures their stuff out.  

Those are my thoughts.  It's going to take time, but there are some promising things in the works.

 

[Hopeful heart]

8 hours ago, MikeHerp said:

pritelivir is a good bet and that timeline looks solid. I think by end of next year it may be approved. The problem will be availability.  How to get it if you aren't immune compromised

Not sure why you think there would be difficulty in getting pritelivir.

1) it reduces shedding better than valtrex

2) fewer side effects

When valtrex came out, people were not denied it and it worked only slightly better than the other drugs.

I think it will be available to everyone (immune compromised and immune competent) because less shedding means less chance of transferring to an uninfected partner.

It might cost more, but that is a different issue.

[dont quit!17]

14 hours ago, Hopeful heart said:

Not sure why you think there would be difficulty in getting pritelivir.

1) it reduces shedding better than valtrex

2) fewer side effects

When valtrex came out, people were not denied it and it worked only slightly better than the other drugs.

I think it will be available to everyone (immune compromised and immune competent) because less shedding means less chance of transferring to an uninfected partner.

It might cost more, but that is a different issue.

yeah, he is referring to Pritelivir being in trials specifically for immunocompromised as well as the price of new brand medications. It will not be cheap and probably won't be approved by most insurances. Valtrex is still expensive, even south of the border, where I sometimes get supplements and medications. After Pritelivir gets approved, then I figure valtrex price will drop significantly. 

[iFdUp]

On 9/7/2019 at 6:52 PM, MikeHerp said:

I think pritelivir is a good bet and that timeline looks solid. I think by end of next year it may be approved. The problem will be availability.  How to get it if you aren't immune compromised.  It will probably be gettable somehow, maybe online.  Or from a sympathetic doctor if you are in the US.  But it's not clear.  Also, price.  It won't be a generic.  The Japanese similar is currently $500 for 2 weeks supply.  Anyway, an approval for pritelivir, would be a big success and major progress in the field.

A prophylactic probably won't be available in 5 years, unless it's the HSV529.  Prophylactic trials may take 7 to 9 years.  Only HSV529 has completed a phase 1.  Others haven't started.  I'm willing to bet that one of the candidates, either Einstein or UPEnn would be approved.  But it will take some time.  A therapeutic could be approved in 5 years, but there is currently no clear therapeutic vaccine in trials.

A cure will take 10+ years, but it could be in trials as early as within 5 years from now, earlier if ExcisionBio figures their stuff out.  

Those are my thoughts.  It's going to take time, but there are some promising things in the works.

 

Do you think that Dr Jeromes work might be in trials within 5 years? 

I feel like his achievements are very close to that of Dr Khalili's, just with a less news worthy virus. Both of these teams have made their respective headlines with mice testing. Khalili's new expectation is to be clinical by 2022, for HSV-1. 

Everything we have about 50-90% elimination suggests Dr Jerome is very close, or perhaps 'there' with multiple doses? I Wish that had been tested. Maybe it was and did not produce something favorable to report. 

Regardless, I really hope that Dr. Jeromes next big update will set our expectations a little bit more clearly for the path forward. I am crossing my fingers that it gives us at least similar figures for clinical as compared to Excision. 

[MikeHerp]

On 9/9/2019 at 2:31 PM, iFdUp said:

Do you think that Dr Jeromes work might be in trials within 5 years? 

I feel like his achievements are very close to that of Dr Khalili's, just with a less news worthy virus. Both of these teams have made their respective headlines with mice testing. Khalili's new expectation is to be clinical by 2022, for HSV-1. 

Everything we have about 50-90% elimination suggests Dr Jerome is very close, or perhaps 'there' with multiple doses? I Wish that had been tested. Maybe it was and did not produce something favorable to report. 

Regardless, I really hope that Dr. Jeromes next big update will set our expectations a little bit more clearly for the path forward. I am crossing my fingers that it gives us at least similar figures for clinical as compared to Excision. 

Yes, trials for the FHC meganucleases within 5 years, are a definite possibility.  Dr. Jerome has stated that it could happen within 5 years "if everything goes well".  I sometimes feel that he tries really hard to be pessimistic or conservative so as not to give false hopes (Khalil has already done that once), so I'm a little bit hopeful that it might be slightly less than 5 years, but we'll see. Science can be unpredictable.

Speaking of Khalil's ExcisionBio stuff, that stuff has a chance, but it's unclear what they are going to do.  CRISPR-Cas9 hasn't been shown to be able to touch latent HSV (maybe it can edit 0.3% of it or something like that). And it seems unlikely that the FDA would allow a treatment that endlessly edits DNA in your body to stop HSV replication, unless some really major advances are made that make off targets basically impossible (that could actually happen, but I'm not aware that's happened yet). Even the 2022 date might be optimistic.  THey had some success with the HIV treatment, but it seems they need more work on that, so that's their first target.

I believe that multiple doses would potentially wipe out more of the virus.  However, if you watch the end of the video presentation from January 2019, Dr. Jerome emphasizes that they are looking to develop a one shot one kill.  Partly to minimize safety issues.  I wonder whether they have tried to do multiple shots--maybe this is the kind of stuff that our fund raiser could help address and allow to try since it might be outside of the NIH funding scope.  It seems that, at the time that video was made, they had no seriously tested more than one shot.

The next big update will be the peer reviewed paper.  There may not be ton of new info, but there could be some, and there may be a lot of really interesting details to help us understand how this is going and the potential issues it faces.