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ExcisionBio - delays Phase1 clinical trials


GotEm

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Really bummed to see that excision bio delayed all their phase 1 clinical trials especially the HSV1/2 - they had initially been set to start in 2021 now delayed til 2023. I figured with the amazing news surrounding their HIV research that it would have sped up the process, not delay it. Thoughts/opinions on why they may have done this? 

https://excisionbio.com/pipeline/

 

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31 minutes ago, GotEm said:

Really bummed to see that excision bio delayed all their phase 1 clinical trials especially the HSV1/2 - they had initially been set to start in 2021 now delayed til 2. Then they moved it to 2021 and now 2023023. I figured with the amazing news surrounding their HIV research that it would have sped up the process, not delay it. Thoughts/opinions on why they may have done this? 

https://excisionbio.com/pipeline/

 

They initially were scheduled for 2019. Then they moved it to 2021 and now to 2023.

The work at Fred Hutch labs is more promising. Keep your chin up.

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16 minutes ago, Cas9 said:

They initially were scheduled for 2019. Then they moved it to 2021 and now to 2023.

The work at Fred Hutch labs is more promising. Keep your chin up.

I have been keeping an eye on FH lab, I donate when I can even though it’s not much I hope the little I do, helps. I wish a cure would just miraculously happen already. But I will continue to keep my chin up and my faith high and that this will all end soon for all of us. 🙏🏻

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2 hours ago, Cas9 said:

They initially were scheduled for 2019. Then they moved it to 2021 and now to 2023.

The work at Fred Hutch labs is more promising. Keep your chin up.

To expand on this;

It was revealed in Dr Jerome's brief foray with Cas9 that the level of efficacy achieved was not even a tenth of the efficacy of what he had achieved with Endonuclease mediated editing. 

Just today an article was published regarding Cas9 use to help treat HIV, the research in discussion being from China. They found that when they had a patient with cancer and HIV discontinue their Anti Retroviral Therapy post Crispr treatment, only about 5% of the edited cells remained a year and half later. I thought those figures were interesting and somewhat similar to the figures that Dr Jerome saw in his smaller scale usage, just scaled up by comparison. 

The reason they did this experiment was because the patient suffered from both Cancer and HIV, thus allowing more experimental treatments being permitted for use on the patient. Cancer treatments are more on the forefront of research from China, from what I understand. It made sense for them to test both HIV and Cancer Crispr treatments in one go since they aren't always granted such an opportunity. 

HIV progress is more clear and there is a huge push towards combination therapy, this study helps prove that. Use of ART could theoretically cure a person with HIV. However the length of treatment required for the HIV to be tamped down enough in the blood to no longer be able to re-infect is estimated to be about the length of a Human life. (86 years I believe was the figure) So with this in mind, Researchers are looking to see if we can accelerate that process with Crispr while using ART to control it and keep the Crispr progressing rather than battling the infection. All the pieces are in place and the methodology has proven to work, despite the size of Cas9

As mentioned with Dr Jerome's research, the efficacy of Cas 9 is not the same. It can't reach the infected cells through the neuronal axons. Cas 9 is the most advanced 'hijacked virus' in terms of our ability to control it and vector it where we want it. 

Excision is going to have to take more time to work with other versions of 'hijackable virus' that are smaller and try to reach the latent herpes that way. That is what has been revealed to them. 

The HIV research did in fact speed up their progress, despite the estimate of their clinical trials being pushed back. It has shown them the limitations of their current techniques with a larger and more accessible virus (though the reservoir is more plentiful).

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Thanks for the detailed breakdown @iFdUp . I had remained most hopeful about ExcisionBio over all other efforts, but after seeing Jerome's latest research using their custom made guide proteins (hopefully that's an accurate description) and the release of the newer Cas3 being said to be more accurate; I was concerned that Excision's work was too preliminary. Technology has advanced since 2016 when Excision started on their product and I think they might need to start over if they want to compete and/or get FDA approval at some point.

I am still shocked and disappointed to hear this news...I wonder if they will switch to a different guide protein or deviate from Cas9

Edited by floydmonk
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1 hour ago, floydmonk said:

Thanks for the detailed breakdown @iFdUp . I had remained most hopeful about ExcisionBio over all other efforts, but after seeing Jerome's latest research using their custom made guide proteins (hopefully that's an accurate description) and the release of the newer Cas3 being said to be more accurate; I was concerned that Excision's work was too preliminary. Technology has advanced since 2016 when Excision started on their product and I think they might need to start over if they want to compete and/or get FDA approval at some point.

I am still shocked and disappointed to hear this news...I wonder if they will switch to a different guide protein or deviate from Cas9

In terms of their effort for herpes, it will most certainly be CasY or Cas3 perhaps something smaller. 

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They are using Cas9 for hsv1 but CasY for hsv2.  Their goal has been to stop viral replication since they didn't have a strategy for eradicating the latent virus. However, Dr. Jerome does have a strategy to eradicate the latent virus and statistically is more than half way there.

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It's disheartening to see Excision Bio slide the hsv1 phase 1 clinical trial to 2022 (and the hsv2 trial to 2023). The goal posts keep moving but at least they're planning on clinical trials. 

Thankfully Dr. Jerome's Fred Hutch lab keeps us informed about their hsv research on animals. I wonder what will happen if/when they  eradicate 100% of the latent hsv1 and hsv2 virus in mice. Maybe they will transfer the technology to a private company as Dr. Kalili did with crispr, Betsy Herold did with the Einstein vaccine, and Harvey Friedman might be doing with the trivalent vaccine.

Let's hope all four succeed. 

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24 minutes ago, Atrapasueños2 said:

What a disappointment, once again companies only focus on HIV

I don't believe this is truly the case. I believe their expectation has become less enthusiastic based on the levels of success with their HIV approach. 

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On 9/12/2019 at 5:54 PM, GotEm said:

Really bummed to see that excision bio delayed all their phase 1 clinical trials especially the HSV1/2 - they had initially been set to start in 2021 now delayed til 2023. I figured with the amazing news surrounding their HIV research that it would have sped up the process, not delay it. Thoughts/opinions on why they may have done this? 

https://excisionbio.com/pipeline/

 

It seems like with drug development delays are FAR more common than speed-ups.

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  • 3 weeks later...

This news is something I expected and I'm not that disappointed with it.  The original timeline was too aggressive.  There are a number of questions with CRISPR that haven't been figured out yet, including that it can't seem to reach latent HSV (or barely reaches it) and a solution that makes CRISPR/Cas continuously edit newly emitted virus, seemed unlikely to be approved without further improvements in safety.  These issues may be figured out--CRISPR break throughs have been happening continuously, but it might need a bit more time.  Jerome's meganucleases seem further along.

One the bright side, the company recently released their primate HIV results, which seemed quite promising.  It seemed like they might have cured some of the primates, though that conclusion is preliminary.  So, overall, I think they are making good progress, but it just needs more time.  They might need more funding as well as I'm only aware of a $10 million funding they received. 

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1 hour ago, MikeHerp said:

This news is something I expected and I'm not that disappointed with it.  The original timeline was too aggressive.  There are a number of questions with CRISPR that haven't been figured out yet, including that it can't seem to reach latent HSV (or barely reaches it) and a solution that makes CRISPR/Cas continuously edit newly emitted virus, seemed unlikely to be approved without further improvements in safety.  These issues may be figured out--CRISPR break throughs have been happening continuously, but it might need a bit more time.  Jerome's meganucleases seem further along.

One the bright side, the company recently released their primate HIV results, which seemed quite promising.  It seemed like they might have cured some of the primates, though that conclusion is preliminary.  So, overall, I think they are making good progress, but it just needs more time.  They might need more funding as well as I'm only aware of a $10 million funding they received. 

Do you have the source on excisions primate studies? I'm particularly interested in the results of curing simians of HIV, I would consider that very good evidence of a cure. HIV did jump from monkey to man, didn't it? 

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On 9/30/2019 at 9:04 AM, iFdUp said:

Do you have the source on excisions primate studies? I'm particularly interested in the results of curing simians of HIV, I would consider that very good evidence of a cure. HIV did jump from monkey to man, didn't it? 

https://www.aidsmap.com/news/mar-2019/molecular-scissors-successfully-remove-hiv-genes-all-tissues-infected-monkeys

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