HIV gene therapy - AGT103-T

[Da2020]

Link to the paper they have published

https://www.frontiersin.org/articles/10.3389/fmed.2022.1044713/full?utm_medium=email&_hsmi=239180469&_hsenc=p2ANqtz-9jiN8VOy5OIQXQCMAQ7LUBWJrhRNl-iSMa1FGKdiGHbyI7bF-oisORe4ONr60dXTG_uq6Lc-JXwIfzMuZyU0pXj7LsRdx-BctgYU_Q8dznw0vtC3k&utm_content=239180469&utm_source=hs_email

I think there was viral rebound in all the people. They are now trying to make changes to the trail protocol and start phase 2 where they start an ati quicker than they did in phase 1

[em]

just received an email on this today


AGT Newsletter Graphics vol 16-2
Clinical Trial Progress Update
American Gene Technologies® has recorded data that meets the primary and secondary endpoints of its AGT103-T Phase 1 trial. The Phase 1 trial demonstrated that AGT103-T — an autologous T cell product that has been modified with the AGT103 lentiviral vector for HIV resistance — was well-tolerated in humans and that these enhanced T cells persist in the body, ready to respond to HIV. Data from this first-in-human study of AGT103-T has been published in Frontiers.

 

Having collected data from the Phase 1 clinical trial, we expect to submit the final Phase 1 trial report to the U.S. Food and Drug Administration (FDA) in 2023. American Gene is currently writing the Phase 2 protocol for FDA consideration to continue the clinical development of this potential HIV cure.


Does not seem encouraging or optimistic data disclosure.
If this had been major success I would think there would be more information.
Potential cure meaning in need of money for research and lots of time to get real results toward a cure.  Rather disappointing

[Jim Allen]

Does not seem encouraging or optimistic data disclosure.
Potential cure meaning in need of money for research and lots of time to get real results toward a cure.  Rather disappointing

was well-tolerated in humans

With respect and not trying to sound harsh, but did you really expect much? You and I are not newbies to living with HIV, so we have heard the novel cure, new technology and approach speech a dozen times and more before during the Petri-dish stages and phase 1/2 human testing.

It's phase 1/2, making sure they don't kill the patients, and it sounds like it was well-tolerated, so they didn't kill anyone yet. As for the rest of the data, it's only a few weeks of interruption under a tiny sample of people. Even if AGT103-T gene therapy does nothing, you could have some people or all of them show no rebound under 4-5 months. 

If it gets into phase 2 and then phase 3 by then, data might be more interesting.

[em]

email about this had this statement .

  Phase 1 HIV clinical trial in which 100% of participants experienced no adverse effects. In addition, remarkable data from the antiretroviral withdrawal study showed that 100% of the participants completing the withdrawal protocol experienced an effective immune response against their HIV with significant viral suppression in the absence of antiretroviral therapy!

very long email ,   of course seems a bit vaqué . That it might have potential but not a cure yet ?  The cost might be expensive ?

website link :    https://www.americangene.com/milestones/hiv-cure-countdown/

today's email sent a link :    https://www.americangene.com/news-releases/american-gene-technologies-launches-new-spinoff-company-addimmune-to-focus-exclusively-on-development-of-hiv-cure/?utm_medium=email&_hsmi=262514304&_hsenc=p2ANqtz--4RlwoLD7-o7sqWsyscPdRMvgNmzGgfXg-21_v_9-L9jN54e5oZ_TnWN9Alb4odsbat6L2ViY5Oa-w6mVPtKGtH7jQ3g&utm_content=262514304&utm_source=hs_email

[Jim Allen]

Not much I can say; I mean, we haven't seen the data or any published scientific report 

Reading the email, if they get approval for, as claimed, phase two with hundreds of people, it will be more interesting to see results at, let's say, 48 weeks.

[geobee]

I got an 2 emails from Quest Labs in San Francisco last week.  They are beginning the recruitment process for the AGT-103 study.