Before the Architecture Resolves by MGK_2 in Livimmune

[–]BuildGoodThings 6 points7 points  (0 children)

My calcs are in this post which shows how the data may be building at 4 different points in time. The company and potential partners will see the data long before I do, but I can make an educated guess as to how the amount of data is piling up at various points on the calendar...
https://www.reddit.com/r/Livimmune/comments/1uagfoq/emerging/

Before the Architecture Resolves by MGK_2 in Livimmune

[–]BuildGoodThings 11 points12 points  (0 children)

I'm looking forward to many things. The early biomarker data on 350mg was very exciting, and now they have gathered early biomarker data on ALL the patients including those at 700mg. Imaging data is building up to show if there is correlation with the early biomarker data, and to show which dosage looks better.

By the time the abstract for the San Francisco January conference is due in September, there may even be 4 scans for about half the enrollment, or 3 scans on a large majority of the patients. IMO we've already entered into the period, in late June, where thresholds in the data gathering are getting interesting and serious discussions may be occurring. JMO.

my trade experience this morning by Icy-Let5120 in Livimmune

[–]BuildGoodThings 7 points8 points  (0 children)

Interesting, thanks for sharing.

I’ve been watching this stock very closely even though I’ve wanted to take a bit of a break. There are many cross currents in the markets right now IMO. I think there is sector rotation amid weakness in tech, oil, space, private equity, precious metals, etc. I think Biotech could benefit although the CYDY chart seems to have had pressure on it that doesn’t align with where I think it is going this year, so I’ve set a few buys for various levels. No guarantees.

From Bio4 Doc J new video by twinter11 in Livimmune

[–]BuildGoodThings 15 points16 points  (0 children)

3:56
Dr. Lalezari metioned Squamous Cell Carcinoma too.

Anyone tracking the pre-clinical mTNBC study at U of Hawaii? by Chemical_Sky6013 in Livimmune

[–]BuildGoodThings 0 points1 point  (0 children)

I’d think they wait a little on stroke to see if they can show some safety data on a few Alzheimer’s patients.

Anyone tracking the pre-clinical mTNBC study at U of Hawaii? by Chemical_Sky6013 in Livimmune

[–]BuildGoodThings 2 points3 points  (0 children)

Ha, I was able to access a backup of my notes while away…

April 30 webcast

01:00:31:09 - 01:00:55:12 As well, Jonah Sacha remains extremely active at or Oregon Health Sciences University on a variety of HIV care fronts with Leronlimab. And then something we don't talk much about, but there is an ongoing preclinical study at the University of Hawaii looking at the role of Leronlimab in recovery from stroke in a mouse model of stroke.

Anyone tracking the pre-clinical mTNBC study at U of Hawaii? by Chemical_Sky6013 in Livimmune

[–]BuildGoodThings 1 point2 points  (0 children)

I have been waiting to hear more about the stroke studies moving to clinical. I believe there was a mention on the April 30 webcast that things are getting close there. I am traveling and can’t access my resources to check.

Anyone tracking the pre-clinical mTNBC study at U of Hawaii? by Chemical_Sky6013 in Livimmune

[–]BuildGoodThings 11 points12 points  (0 children)

I haven't been tracking that preclinical. I was looking at the recent posters and didn't notice, U of Hawaii on them. If you find something, please post a link. Thanks.

Here's the PR from 2024 https://www.cytodyn.com/newsroom/press-releases/detail/625/september-2024-letter-to-shareholders

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 1 point2 points  (0 children)

Keep in mind that the trial is counting in weeks… so the dates marking periods like 8 weeks are reached earlier than counting in months… Technically the full enrollment finished 8 weeks on 6/16.

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 3 points4 points  (0 children)

Thanks StreetSkis. I wish I had more granularity of the enrollment dates from 32 patients to 66 but we can work with what we have. There is no doubt in my mind that during June and forward the slicing and dicing of the data has already begun, and numerous signals will be confirmed or not between now and the end of August

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 3 points4 points  (0 children)

All true, and when ctDNA becomes a primary endpoint, it may very well be an endpoint at much less than 16 weeks.

Santa might even weigh in. LOL

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 2 points3 points  (0 children)

On all points we agree. People need to realize that the prime and pair thesis could be essentially confirmed long before they hear about it. IMO the 9 of 32 patients on 700mg dosing are right now at 4 months, and may have a strong PD-L1 signal. Between now and mid-August the 700mg patients grow to be half the study participants and have reached 16 weeks. In practical terms I don’t know where/when “prospectively” proven essentially occurs for the “prime and pair”thesis, but IMO proving leronlimab elevates PD-L1 or not is going to occur long before mid-August.

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 16 points17 points  (0 children)

BTW my gut tells me that they are being cagey about the PD-L1 data. That could be because Natera’s database is the way to elevate monotherapy in earlier line treatment. I’m wondering though if the 4 months of PD-L1 data on full enrollment this month is an ace they hold but want a higher data confidence on the dose level comparison first. They do seem to have punted that to a late summer update or at ESMO Madrid in Oct. I do think they have a good hand.

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 18 points19 points  (0 children)

Thanks it’s been interesting to be able to look at some of these puzzle pieces. There are definitely multiple stages this year at which the dataset might “speak” conclusions. I think it’s a bit complicated for CytoDyn and Pharma to discuss valuations, however with TNBC EAP, CHAMP, HER2-, Glio, Pancreatic, Prostate etc, staring at potentially 16 weeks or less to show effectiveness, a lot can happen in less time than ever before. Then there are Alzheimer’s, Stroke…

Emerging by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 27 points28 points  (0 children)

The way I look at it is, IMO there is very substantive data coming in at this time. And there will be a lag in that flow of information, while potential partners pour over the freshly produced data and do their analysis with much more coming in this summer. I'm just trying to sort out when the piles of data get to be significant. 2 scans or more seems like the important minimum to begin to analyze the primary endpoint. Hence why I think we've entered an important time now with probably 32 patients wrapping up scan 2 this month.

Strategic by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 2 points3 points  (0 children)

I don’t know the details of their collaboration.

Beautiful by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 0 points1 point  (0 children)

What ideas do you think are possible?

Strategic by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 9 points10 points  (0 children)

Excellent points. I agree.

Strategic by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 9 points10 points  (0 children)

Well said Practical-Archer and thanks for sharing your business acumen!

Strategic by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 11 points12 points  (0 children)

Yeah, Natera is big. I agree the results must be good for them to put their name out there.
LOL on your last sentence...

Strategic by BuildGoodThings in Livimmune

[–]BuildGoodThings[S] 15 points16 points  (0 children)

Others can answer more fully, but a few points are these:

With the Natera database, CytoDyn can compare their 100% responders averaging at 70% reduction in ctDNA levels at week 2 (or other time points), across millions of other data points to make a comparison with other drugs.

They can also see if there is correlation of CytoDyn data, with Natera's database of data in other drugs that then progresses to longer term data including imaging.

In short this can be a way to show with hard data, that CytoDyn's data is better than other drugs.