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Searching_Info

Phase 2 Trials of UB-621

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WilsoInAus
2 hours ago, Searching_Info said:

All to early to say. 

Within the body, it is believed that cell-to-cell forms the key mechanism for how the virus can spread and replicate through your nerves. It is pretty well established that an infected cell binds to a neighbouring infected cell through a glycoprotein that exists on the outer membrane. This drug binds to this glycoprotein which in theory means there are no free glycoprotein receptors for herpes. This would mean less shedding if the theory works.

The real issue is does it work better than acyclovir which takes some beating.

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StayingUpbeat2

It depends on your definition of promising.  It is certainly an interesting addition to the treatment landscape.  It does not appear to be curative, simply another therapeutic.  It has a unique mechanism of action relative to the existing antivirals.  It therefore should be useful in situations when resistance to existing antivirals has arisen and have a synergistic effect with them. 

The major rub is that this treatment is an injection not a pill so the practicality is a bit thin relative to acyclovir and it's analogs.  It's also not clear how often it would need to be injected.  Judging from other mAb's something on the order of every  month would be likely.

Secondarily the treatment is in clinical trials in Taiwan so unless you're located there it will likely be a long time before it's available outside that country.

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MikeHerp

I'm curious about this one.  Hope this trial proceeds.  

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Searching_Info

Thank you for your explanations.

One more thing, do you know why it's hard to find any mention of this therapeutic vaccine? Is it because it didn't go well in phase I clinical trials or pre clinical trials? It is not even mentioned in the wikipedia page but judging by some info I managed to find it seems like it's a big, well funded company.

Thanks in advance!

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The
Posted (edited)
On 5/31/2019 at 7:56 PM, Searching_Info said:

The trials have been moved to 2020 🤦‍♀️

https://clinicaltrials.gov/ct2/show/NCT01915212?term=NCT01915212&rank=1

Wrong link haha. Thats for the HSV529 vaccine.

 

√√

https://clinicaltrials.gov/ct2/show/NCT03595995

But yeah, UB-621 phase 2 trials start in 6 months. Make no mistake its not a vaccine, its a drug. That being said, I would easily take a monthly injection for suppressive therapy rather than chewing on daily antivirals. Curious to find out the efficacy results though...

Here's a chinese article that came out yesterday (translate button)

https://www.chinatimes.com/realtimenews/20190611001822-260410

 

Edited by The
Edit

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g480

Yes here is the English link: United BioPharma Receives US FDA Approval for UB-621 Phase 2 Trial in Recurrent Genital Herpes Patients

United BioPharma (UBP) announced the receipt of Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 2 clinical trial with UB-621 monoclonal antibody for recurrent genital infection caused by Herpes Simplex Virus, type II (HSV-2). UB-621 works to inhibit the infection through high-affinity binding to the same epitope on viral surface envelope gD protein on both type I (HSV-1) and type II (HSV-2) viruses.... Of interest to note as well, UB-621 binds to the same epitope on the gD envelope protein shared by both HSV-1 and HSV-2 viruses.  UB-621 has been shown in vitro to block HSV-1 infections of wild type and acyclovir-resistant viral strains with over hundreds-fold higher potency.  

http://www.unitedbiopharma.com/event_detail.php?id=367

 

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MiLoBeng
Posted (edited)

If they ever implement gene editing tech into vaccine. I'm pretty sure it'll produce better result than normal vaccine. 

Edited by MiLoBeng

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iFdUp
12 minutes ago, MiLoBeng said:

If they ever implement gene editing tech into vaccine. I'm pretty sure it'll produce better result than normal vaccine. 

Sounds like this could be HSV's equivalent to HIV's Laser ART. 

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LightafterDarkness

Just did a bit more reading here. This is another intriguing option that could work synergistically (1,2 punch)!

  • The Phase II study is currently slated to begin Jan 2020 AND it will be in the United States; I assume it will be done in the Seattle Area among other places
    • Note recruiting has not started but could be something to look into for folks on this board who are willing and able
  • Its going to be led by Anna Wald (which is a great sign since she is a heavy hitter in the field, presumably the phase I data had legs for her to sign up)
  • It looks like halflife of the treatment is 25 days
    • That is big because its been shown that treatments with longer half lives are needed (pritelivir shows a long half live as well; one weakness with valacyclovir is that very short)
  • This is not only for immunocompromised individuals
  • They will be measuring efficacy for suppression, shedding, etc. approx. 15 weeks post vaccination (so basically just shy of 4 months).
  • As others pointed above it works by binding (and thus blocking) to the same spot that a HSV virus would use to enter another cell
    • If I am understanding correctly this is a good thing as it basically means it can protect uninfected cells (pritelivir has a similar mechanism) which means it may be better than valacyclovir (since another weakness of the med is that it only kicks in on infected cells)

Assuming a start date of Jan 2020 I think realistically we dont hear anything in terms of results until end of 2020 / early 2021.

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Morty123

This is not a one shoot treatment, after few months monoclonal antibodies will disappear, you have to get every 3-4 months a shoot 

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LightafterDarkness

Yes- that is correct; it would be something you would need to take monthly or quarterly given the 25 day half life

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