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Author Topic: HIV gene therapy - AGT103-T  (Read 7479 times)

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Offline em

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HIV gene therapy - AGT103-T
« on: November 08, 2019, 07:00:17 am »

I do not know if this has already been posted ? but it is relatively new news from nov 6
I know cure hype  believe it when you see it  thought this info might be worth sharing

https://www.localdvm.com/news/i-270/american-gene-technologies-believes-they-have-the-cure-for-hiv-aids/

Offline Mindless

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Re: HIV gene therapy - AGT103-T
« Reply #1 on: November 08, 2019, 08:34:24 am »
Quote
AGT should hear from the FDA sometime before the end of the year. If it’s approved, they will have the green light to begin phase one of the clinical trial in January.

I guess this means that even if this is actually working (yet to be demonstrated) we’d be years maybe decades away from real world application (at what cost is another big question), is that correct?

Offline Jim Allen

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Re: HIV gene therapy - AGT103-T
« Reply #2 on: November 08, 2019, 08:38:58 am »
https://forums.poz.com/index.php?topic=73181.msg762655#msg762655

Someone mentioned it, it's just another nice idea like so many and throwing the word cure around for investment & buzz.

Anyhow it's going into a phase 1 study, I'll find you a better link thought later today then the one you have



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Offline geobee

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Re: HIV gene therapy - AGT103-T
« Reply #4 on: November 08, 2019, 05:22:08 pm »
I participated in something similar a while back.  A company, Sangamo, was going to use ZFN (Zinc Finger Nuclease) to edit T-Cells. The idea was to collect your T-Cells through apheresis, modify them, and put them back.  The resistant cells would survive and be immune to HIV. 

I was eventually DQ'd from the study.  Didn't have enough HIV in my blood apparently.  So they couldn't tell if it was CCR5 or not.

From what I read, this is similar.  Take your cells out, modify them to produce an AB, and put them back.  Pretty cool. 

This process is a lot less scaleable then a pill / vaccine of course.  Apheresis takes about two hours and, while not unpleasant, wasn't particularly comfortable.  Still, if this thing shows promise, sign me up! 

Offline ZachR

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Re: HIV gene therapy - AGT103-T
« Reply #5 on: November 08, 2019, 06:14:43 pm »
It is a nice one and has made it to human trials. There is some good likelyhood for it to reach phase II and III and hope it does, but one of the potentially serious obstacles would be:
a/ no measurable effect
b/ even if it happens to work, will take at least 5 years to be available if given priority.
c/ serious immunogenicity, which could lead to a pronounced inflammatory effect throughout the body with potential consequences like organ damage and failure.
Only speculating tho, lentiviral vector technology is promising for many diseases, let's hope it grants us a safe functional cure. Even if it doesn't though, it will answer many questions that will help get closer to the real 'cure'.
« Last Edit: November 08, 2019, 06:18:58 pm by ZachR »
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline Expat1

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Re: HIV gene therapy - AGT103-T
« Reply #6 on: November 09, 2019, 03:18:18 pm »
IF a treatment cured say 90% of people living with HIV, but killed the other 10 %, would you sign  up?

What if it cured 99% and killed only 1%?

What it the final cost/benefit level that is acceptable?  And compare that to current
practices with ART?

No answer from me?  Just a question.

(Maybe only  use with  multidrug resistant HIV after salvage therapy unable to reduce VL below a certain threshold?)

Offline ZachR

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Re: HIV gene therapy - AGT103-T
« Reply #7 on: November 09, 2019, 04:48:02 pm »
IF a treatment cured say 90% of people living with HIV, but killed the other 10 %, would you sign  up?

What if it cured 99% and killed only 1%?
 

If it killed 10% it wouldn't be approved for widespread use anyway. In case it killed 1% while successfully curing 99, it would be approved, because numerous interventions used in medicine already have a worse risk/benefit ratio than 99/1.

Let me only remind you that we don't have a 100% guarantee that we'll make it till tomorrow, right?  So demanding 100% from those guys would be unnatural.
« Last Edit: November 09, 2019, 04:52:24 pm by ZachR »
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline Expat1

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Re: HIV gene therapy - AGT103-T
« Reply #8 on: November 09, 2019, 09:56:57 pm »
Zack, I asked: "Would you sign up?"   Not if it would be approved.  Me no.

IF my CD4 were 25 and I was symtomatic with OIs, maybe. 

Offline em

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Re: HIV gene therapy - AGT103-T
« Reply #9 on: November 09, 2019, 11:39:36 pm »
that was me over twenty years ago when my ID doc suggested I go on trial testing norvir.   My count was 7 viral load inconceivable large    that i gladly tried thinking even if I die at least I gave every option a try if it did not help me it might help others on the same path .    I would be willing to be selected to try this .  to help push things toward a cure .   I cannot see why anyone would not want to but that is your choice

I hope we live to see this turn out to be cure for everyone's sake 

em

Offline Expat1

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Re: HIV gene therapy - AGT103-T
« Reply #10 on: November 10, 2019, 04:36:45 am »
Good points em. 

Whenever I see cure in the headlines with HIV , first thing I think is that it is probably a pump and dump scheme or someone wanting to make a fortune with  an IPO.   

Call me skeptical.

Offline Jim Allen

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Re: HIV gene therapy - AGT103-T
« Reply #11 on: November 10, 2019, 05:06:34 am »
Good points em. 

Whenever I see cure in the headlines with HIV , first thing I think is that it is probably a pump and dump scheme or someone wanting to make a fortune with  an IPO.   

Call me skeptical.

I'm with you on that, every year the next big "cure" is announced and for decades nothing has panned out. If I had been a mouse, monkey or petri-dish I would have been cured a dozen times over mind you.  ;D

Scientifically it's fascinating stuff, take the "Research News & Studies" section if you like and you search for the keyword "cure" you will find decades of exciting announcements about cures some of them at human testing stages that simply did not work out. It's great we keep learning from this stuff though in the sense of scientific development

For me getting excited or hopeful every time would be an utter waste of energy & life. Worse is the odd cases of people not starting treatment or stopping as they believe there is or will be a cure soon or people taking risks because of cure headlines  😡
« Last Edit: November 10, 2019, 05:22:33 am by Jim Allen »
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Offline Almost2late

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Re: HIV gene therapy - AGT103-T
« Reply #12 on: August 15, 2020, 07:45:11 am »
The FDA has approved a possible HIV cure gene therapy trial.

Quote
"The FDA this week authorized a Phase I trial of the product known as AGT103-T. It is made from blood cells and initiates a process that increases the body’s T cells, which fight HIV, and uses a gene therapy to help those cells survive. In preclinical studies in cell models, it has demonstrated “the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells,” according to a press release from the company, based in Rockville, Md. American Gene Technologies researched the product in collaboration with the National Institute of Allergy and Infectious Disease, a federal government agency."..

https://www.hivplusmag.com/treatment/2020/8/14/trials-begin-potential-hiv-cure?amp
Diagnosed - Feb.2014 Cd4 13, at 2.8%
Recent - Sept 2021 Cd4 284 at 17.8%

Offline Jim Allen

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Re: HIV gene therapy - AGT103-T
« Reply #13 on: August 15, 2020, 08:20:39 am »
Does not seem like everyone likes their PR spin, anyhow, as with all claims and promises time will tell.

https://www.poz.com/article/gene-therapy-cure-claims-premature-advocates-say

Quote
“From its research, AGT believes a cure is attainable and is now taking the significant step of testing in humans,” the company announced in a press release. Added AGT founder and CEO Jeff Galvin, “I am confident AGT103-T will be an important step toward an eventual cure for HIV.”

But advocates say such claims are not only premature, they are also harmful in giving people with HIV the false impression that a cure is around the corner.

AGT’s public relations strategy “preys on the emotions of people living with HIV” and “has a deleterious effect on the understanding of the cure field overall,” Seattle advocate Michael Louella told POZ. “They make their outrageous comments, and these are then picked up and believed to be certain truth. Any attempt to promote a more nuanced and better-grounded understanding of gene therapy or the clinical process becomes impossible.

“Saying ’AGT believes there is a high likelihood that participants in the upcoming trial will be cured’ is beyond outrageous and completely undermines informed consent because it’s an unethical inducement to participate [in trials],” Richard Jefferys of the Treatment Action Group told POZ.

“And it’s not based on a shred of evidence. To my knowledge, there’s no humanized mouse data, no macaque data—it’s all theory,” he continued. "I would hope that they pause to reconsider their PR strategy and broaden their consultation with stakeholders, including community-based advocates.
« Last Edit: August 15, 2020, 08:41:29 am by Jim Allen »
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Offline Almost2late

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Re: HIV gene therapy - AGT103-T
« Reply #14 on: August 15, 2020, 09:09:45 am »
Does not seem like everyone likes there PR spin, anyhow, as with all claims and promises time will tell.

Ofcourse, time will tell, but I see nothing wrong with scientist feeling confident in there research.. I mean what are they supposed to say, "I don't think it's going to work"🤨.

It sometimes seems like these "advocates" would prefer no research into a cure at all, like they have stock Gilead or something.

Diagnosed - Feb.2014 Cd4 13, at 2.8%
Recent - Sept 2021 Cd4 284 at 17.8%

Offline Jim Allen

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Re: HIV gene therapy - AGT103-T
« Reply #15 on: August 15, 2020, 11:31:42 am »
Well I don't know about what the advocates have or have not invested in, but personlly I would pefer a dose of commen sense and data to support claims about these things instead of throwing the "cure" word arround but that does not get investments, money and attention I suppose, Greed? Anyhow, I guess the hype for these things has a reason.
« Last Edit: August 15, 2020, 11:43:54 am by Jim Allen »
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Offline nethan1621

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Re: HIV gene therapy - AGT103-T
« Reply #16 on: May 30, 2021, 01:17:16 am »
“”the first participant of the Phase 1 clinical trial has been infused with the company’s cell and gene therapy product, AGT103-T. “”

“”The first infusion took place on May 19 at the Washington Health Institute in Northeast Washington.””

“It was about 15 minutes to infuse about 100 milliliters that contains 1 billion HIV-specific T-cells that are immune to HIV and then after that, because now the drug is in their body, essential their cells, those modified cells are the drug, they sit for four hours of observation,”

“”it could be done somewhere around $500,000 a patient.”””  :o :o :o

https://wjla.com/news/local/maryland-based-company-hits-huge-milestone-in-development-of-hiv-funtional-cure



Offline Almost2late

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Re: HIV gene therapy - AGT103-T
« Reply #17 on: May 30, 2021, 10:27:00 am »
Well that's good.. but real creep that they're already discussing the price tag when they don't know if it worls yet.
Diagnosed - Feb.2014 Cd4 13, at 2.8%
Recent - Sept 2021 Cd4 284 at 17.8%

Offline nethan1621

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Re: HIV gene therapy - AGT103-T
« Reply #18 on: May 30, 2021, 04:38:15 pm »
Could be a positive  signal giving by them …. In other hand they are saying gonna earn more profit from hiv patients than transitional pharma does at the moment means competition is also set in hiv market   ;D :D however it feels they gonna do something before Chinese market enter to  hiv business using gene tech ,

Offline Almost2late

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Re: HIV gene therapy - AGT103-T
« Reply #19 on: July 19, 2021, 01:03:55 am »
I don't know but the CEO of American Gene Technologies seems like an asshole. He called my meds "poison" in this video.. how can I trust this fool when he doesn't know what he's talking about.

https://youtu.be/PrKW0Sio5Q4

Diagnosed - Feb.2014 Cd4 13, at 2.8%
Recent - Sept 2021 Cd4 284 at 17.8%

Offline nethan1621

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Re: HIV gene therapy - AGT103-T
« Reply #20 on: July 19, 2021, 04:14:58 pm »
Its called marketing…it is a  hiv market , they have to fights each other manufacturers to increase sales, specially when they introduce new products . Victims they consider its a life saving thing, for the manufacture, its a business for $$$ .. so they will use any word to convince us “ come and buy my product once its ready”  For fun , In business and marketing we say “ Your coffin is my business “

Offline Almost2late

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Re: HIV gene therapy - AGT103-T
« Reply #21 on: July 19, 2021, 06:46:24 pm »
Victims they consider its a life saving thing, for the manufacture, its a business for $$$ .. so they will use any word to convince us.

They haven't proven their product saves lives yet, so why should I believe him?
Bcz he calls the medication that does save lives "poison"?

If this company really does cure HIV, there's no need to use such deceitful marketing tactics. A cure will sell itself.
No need for a snake oil salesman.

My guess is he's looking for investors so they can make money whether or not it works.. and most likely it won't.
Diagnosed - Feb.2014 Cd4 13, at 2.8%
Recent - Sept 2021 Cd4 284 at 17.8%

Offline nethan1621

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Re: HIV gene therapy - AGT103-T
« Reply #22 on: July 21, 2021, 08:56:30 am »
Its generalized statement and nothing focus on anyones product. We all are entitled to have our own opinion… nothing can be done about it. Its not about who you are gonna believe or not , it just a marketing strategy. Thats all. You clearly said” marketing tactics” so what else..

You are right they are looking for investors but they are not the only one looking for investors. Currently Who has already earned using HIV , companies are together controlling and sharing profits each other. And some of them even hide the newest chemical formula until current patent expired no matter what happened to human… nothing to be panic worry  anger or stress jst looking at the word cure , poison, or whatever.
Again people can say anything , its us who decide to listen to whom.. hiv infected person who are very good in experience from old days up to today might have so many disappointments on their life long journey, as well cocktails ARV was the only hope for them back in days up to today or for the future for anyone… but so many things gonna happen, it  might not able to see by their lifetime but for some it could be happen. “ hiv infection change from dead sentence to new life, so many toxic pills change to one pill 3 in 1 , less aide effect, invented few class of  back bone medicine for hiv, and now once month is almost approved, twice a year is in phase 3 , soo some of infected people didnt live a life to see whats in today. Same for some of us but not for all of us … i hope any educated person wont stop eating their daily tablet , as well as looking forward to see whats next..regardless whats the statement in the media
« Last Edit: July 21, 2021, 08:59:32 am by nethan1621 »

Offline Jim Allen

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Re: HIV gene therapy - AGT103-T
« Reply #23 on: July 21, 2021, 11:05:36 am »
Nathan.

It seems you have a gripe that companies are not charities and make a profit and about how they do it. I'm not denying it or saying they are saints but we discussed this before, give it a rest already or open a specific thread to express whatever gripe you have about how they make their money.

Quote
nothing to be panic worry  anger or stress jst looking at the word cure , poison, or whatever.

Quote
i hope any educated person wont stop eating their daily tablet , as well as looking forward to see whats next..regardless whats the statement in the media

Well, we will have to disagree, it is something to get pissed off about, at least I do because I care about people living with HIV.

I hope nobody regardless of their level of education stops taking their meds based on some nonsense (biased) publications by some company/CEO of an unproven treatment looking prehaps for investors, attention and funds.

However, the truth is it happens, it's happened before and will happen again, and you also have people delaying treatment and having preventable issues down the line because of these kinds of unsubstantiated claims about current HIV meds.

People sadly get swept away in such things.

They haven't proven their product saves lives yet, so why should I believe him?
Bcz he calls the medication that does save lives "poison"?

If this company really does cure HIV, there's no need to use such deceitful marketing tactics. A cure will sell itself.
No need for a snake oil salesman.

My guess is he's looking for investors so they can make money whether or not it works.. and most likely it won't.

Agreed. It's similar headline stuff used by others over the years.

« Last Edit: July 21, 2021, 11:21:11 am by Jim Allen »
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Offline Jim Allen

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Re: HIV gene therapy - AGT103-T
« Reply #24 on: July 21, 2021, 11:08:51 am »
P.S

I merged the threads.  Just as a reminder please use the search function before opening a new thread. https://forums.poz.com/index.php?topic=11292.msg

Quote
Please use the search function particularly in this in this section to check if we have a thread open that already. If you can't find a thread on the study or subject then do open a new thread however always include a brief description of why you think it might be of interest to readers. Duplicate threads will be merged or deleted without warning
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Offline Almost2late

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Re: HIV gene therapy - AGT103-T
« Reply #25 on: July 24, 2021, 01:22:52 pm »
It appears UCLA is also in the HIV cure research business via gene therapy.. https://spectrumnews1.com/ca/la-west/health/2021/06/28/ucla-researchers-studying-gene-therapy-as-possible-hiv-cure

Oh look at that, they don't think treatment is poison :o
Quote
Thanks to HIV research producing reliable treatments, Amore has managed to live a healthy life while taking his meds.
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Offline Almost2late

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FDA approves first gene therapy trials for HIV cure
« Reply #26 on: September 17, 2021, 06:40:01 am »
This is finally happening, the trials will begin..

Quote
FDA approves first trial investigating CRISPR gene editing as HIV cure

Excision BioTherapeutics to begin trials testing CRISPR gene editing as a HIV cure. Image credit: Shutterstock
The US Food and Drug Administration (FDA) has given the nod for Excision BioTherapeutics to begin trials testing CRISPR gene editing as a treatment for HIV.

EBT-101 will be a first-in-human, CRISPR-based one-time gene therapy to be evaluated in individuals with HIV.

On 15 September Excision announced that the FDA had accepted its Investigational New Drug (IND) application for EBT-101 as a potential functional cure for chronic HIV.

The IND clearance will allow the firm to start a first-in-human Phase I/II trial to evaluate the safety, tolerability and efficacy of EBT-101 in healthy individuals living with HIV.

“The clearance of our IND application for EBT-101 represents an important milestone for Excision and is the result of years of commitment to developing a functional cure for individuals living with HIV,” said Excision CEO Daniel Dornbusch.

“Although antiviral treatments can manage HIV infection, they require life-long treatment, cause side effects, and do not provide the possibility of a functional cure. We are grateful for the FDA’s engaged review and acceptance of the IND for EBT-101 and look forward to initiating the Phase I/II clinical trial later this year.”

EBT-101 uses CRISPR to cut out or excise HIV that has wrapped around the DNA in cells. It has been HIV’s ability to coil itself into DNA that has made it so difficult to treat and largely the reason that past curative efforts have fallen flat.

The therapy harnesses an adeno-associated virus (AAV) at a relatively low dose to deliver the one-time treatment.

Excision said that the investigational programme employs CRISPR-Cas9 and two guide RNAs that target three sites within the HIV genome, “thereby excising large portions of the HIV genome and minimizing potential viral escape”.

The upcoming trial will be one of the first attempts to directly extract the latent virus from DNA.

In preclinical studies, the therapy demonstrated the ability to excise HIV proviral DNA in human primary cells as well as multiple animal models including non-human primates.

In later studies, after evaluating the safety and tolerability of the therapy, Excision hopes to take patients off their regular antiviral meds to test EBT-101 as a cure.

“EBT-101 has demonstrated removal of proviral DNA in multiple animal models and offers an opportunity for individuals living with HIV to potentially cease life-long therapies,” said Excision’s CMO Lisa Danzig.

“The Excision team looks forward to this important collaboration with our principal investigators, scientific advisors and regulators, to conduct a safe and informative trial with this first-in-class approach to a viral disease target previously considered to be incurable.”

The news of the trial comes just weeks after it was announced that J&J’s recent efforts at an HIV vaccine had failed and news broke that Moderna is set to begin trials of its HIV vaccine based on mRNA technology.

HIV can now be well managed with antiretroviral medications, but these are a lifelong commitment and cause side effects. For the last few decades, an elusive HIV vaccine has been considered ‘the holy grail’ in stopping the spread of the highly stigmatised disease, but CRISPR-based gene editing would represent a brand-new therapeutic approach.

https://www.clinicaltrialsarena.com/news/crispr-gene-editing-hiv-cure/
Diagnosed - Feb.2014 Cd4 13, at 2.8%
Recent - Sept 2021 Cd4 284 at 17.8%

 


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