Neoleukin Therapeutics Receives Clinical Hold Letter from U.S. FDA Related to CMC Assay Development for NL-201


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Message 100393 - Posted: 11 Jan 2021, 19:08:31 UTC
Last modified: 11 Jan 2021, 19:08:54 UTC

I thought it would be intersting to have a thread on Neoleukin Therapeutics, since it is a spin-off from the IPD and Rosetta crunchers have helped in designing de novo proteins.

Unfortunately, this topic starts with bad news: Neoleukin Therapeutics Receives Clinical Hold Letter from U.S. FDA Related to CMC Assay Development for NL-201. This means their phase I trial for the anticancer protein will be delayed at best, canceled at worst. Let's hope it will be the former.

http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-receives-clinical-hold-letter-us-fda
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Jim1348

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Message 100394 - Posted: 11 Jan 2021, 19:18:06 UTC - in response to Message 100393.  

Thanks. It seems to be a measurement problem more than anything.
We need feedback on what is going in in any case.
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Message 100395 - Posted: 11 Jan 2021, 22:57:53 UTC - in response to Message 100394.  

Thanks. It seems to be a measurement problem more than anything.
We need feedback on what is going in in any case.


Let's hope all issues are resolved soon. I'd love to see all that crunching (and folding) lead to actual therapies!
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Message 100526 - Posted: 2 Feb 2021, 6:08:16 UTC

https://interestingengineering.com/scientists-may-have-figured-out-why-cancer-cells-waste-so-much-energy?utm_source=Facebook&utm_medium=Article&utm_campaign=organic&utm_content=Feb01&fbclid=IwAR3bv1DRZ3GDz5VKDdRiCh2I4JtTHv5lk3FGh1BsmXsiUaNHWkmC9RT1tg0
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Message 100533 - Posted: 4 Feb 2021, 0:55:48 UTC
Last modified: 4 Feb 2021, 0:57:02 UTC

https://interestingengineering.com/scientists-may-have-figured-out-why-cancer-cells-waste-so-much-energy?utm_source=Facebook&utm_medium=Article&utm_campaign=organic&utm_content=Feb01&fbclid=IwAR3bv1DRZ3GDz5VKDdRiCh2I4JtTHv5lk3FGh1BsmXsiUaNHWkmC9RT1tg0


Interesting!
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Message 101521 - Posted: 26 Apr 2021, 14:01:43 UTC

Neoleukin Therapeutics Announces Clearance to Proceed with NL-201 Phase 1 Clinical Trial in the United States
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Message 101523 - Posted: 26 Apr 2021, 15:30:18 UTC - in response to Message 101521.  

Neoleukin Therapeutics Announces Clearance to Proceed with NL-201 Phase 1 Clinical Trial in the United States


Great news!
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Message 101740 - Posted: 5 May 2021, 15:35:05 UTC

NL-201 has been admnistered to the first patient as part of a Phase 1 clinical trial.

http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-initiation-phase-1-nl-201-trial
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Message 101769 - Posted: 8 May 2021, 17:53:37 UTC - in response to Message 101740.  

NL-201 has been admnistered to the first patient as part of a Phase 1 clinical trial.

http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-initiation-phase-1-nl-201-trial


Excellent news, let's hope the drug works!
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Message 103536 - Posted: 26 Nov 2021, 12:53:48 UTC

Does anyone know if they are still working on their COVID antiviral?
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Message 103537 - Posted: 26 Nov 2021, 13:48:05 UTC - in response to Message 103536.  

Does anyone know if they are still working on their COVID antiviral?



I don't see anything on their Research Page about a COVID Antiviral.
https://www.neoleukin.com/programs/#research
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Message 103543 - Posted: 26 Nov 2021, 16:57:46 UTC - in response to Message 103537.  

NL-CVX1

NL-CVX1 is a de novo protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19 and blocks infection of human cells. The design and characterization of NL-CVX1 in under three months underscores the speed and versatility of Neoleukin's de novo protein platform.

In June 2021, in response to the evolving COVID-19 therapeutic landscape, including the widespread availability of effective vaccines, Neoleukin suspended plans to advance this research program into clinical trials.
http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-second-quarter-2021-financial

So it appears that they have suspended it for now, since there are other treatments available.
But I wonder if with the new (nu) variant, they will revive their plans? It could be more effective than the others.
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Message 103563 - Posted: 27 Nov 2021, 14:13:07 UTC - in response to Message 103543.  

NL-CVX1

NL-CVX1 is a de novo protein that binds to the spike protein of SARS-CoV-2, the virus that causes COVID-19 and blocks infection of human cells. The design and characterization of NL-CVX1 in under three months underscores the speed and versatility of Neoleukin's de novo protein platform.

In June 2021, in response to the evolving COVID-19 therapeutic landscape, including the widespread availability of effective vaccines, Neoleukin suspended plans to advance this research program into clinical trials.
http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-second-quarter-2021-financial

So it appears that they have suspended it for now, since there are other treatments available.
But I wonder if with the new (nu) variant, they will revive their plans? It could be more effective than the others.


Thanks! Bad news unfortunatelty. June was before the delta variant became dominant in the US, I believe?

Our current vaccines work, but the surge of infections in highly vaccinated regions show they're not enough to reach herd immunity. It's possible we will need more than vaccines to defeat this virus.
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Message 103565 - Posted: 27 Nov 2021, 14:24:47 UTC - in response to Message 103563.  

Our current vaccines work, but the surge of infections in highly vaccinated regions show they're not enough to reach herd immunity. It's possible we will need more than vaccines to defeat this virus.

Yes, exactly. Also, a lot of people wait until they end up in the hospital to take it seriously. Some don't even get the message then.
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Message 104185 - Posted: 11 Jan 2022, 19:49:12 UTC
Last modified: 11 Jan 2022, 19:49:26 UTC

http://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-clinical-collaboration-merck
Neoleukin Therapeutics Announces Clinical Collaboration with Merck to Evaluate NL-201 in Combination with KEYTRUDA® (pembrolizumab)

Looks promising!
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Message 105934 - Posted: 14 Apr 2022, 9:52:20 UTC

Neoleukin Therapeutics Announces Preclinical Data for NL-201 at American Association for Cancer Research (AACR) Annual Meeting

https://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-preclinical-data-nl-201
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Message 107757 - Posted: 15 Nov 2022, 11:13:18 UTC
Last modified: 15 Nov 2022, 11:13:55 UTC

They are discontinuing NL-201... From their presentation it seems like they are looking a their COVID drug again, though I'm not sure.

https://investor.neoleukin.com/news-releases/news-release-details/neoleukin-therapeutics-announces-third-quarter-2022-financial

Bad news again for de novo protein design drugs. Icosavax' stock has also plummeted. Their Covid vaccine has been approved but seems less efficacious than the MRNA vaccines.
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Message 107758 - Posted: 15 Nov 2022, 12:07:52 UTC - in response to Message 107757.  
Last modified: 15 Nov 2022, 12:08:23 UTC

That's terrible news.

I remember this article on the vaccine in which some South Korean health officials questioned the efficacy of the vaccine without the booster.
http://www.koreabiomed.com/news/articleView.html?idxno=14354
Regardless, the vaccine works but it arrived too late considering many people have already been vaccinated and we have bivalent vaccines available.
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Message 107759 - Posted: 15 Nov 2022, 13:23:30 UTC - in response to Message 107758.  

That's terrible news.

I remember this article on the vaccine in which some South Korean health officials questioned the efficacy of the vaccine without the booster.
http://www.koreabiomed.com/news/articleView.html?idxno=14354
Regardless, the vaccine works but it arrived too late considering many people have already been vaccinated and we have bivalent vaccines available.


It is :( I hope the technology will still prove its worth in future drug design.
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Message 107760 - Posted: 15 Nov 2022, 15:27:28 UTC - in response to Message 107759.  

+1
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Message boards : Rosetta@home Science : Neoleukin Therapeutics Receives Clinical Hold Letter from U.S. FDA Related to CMC Assay Development for NL-201



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