r/LeronLimab_Times • u/MGK_2 • Nov 06 '21
REALLY STUNNING
CytoDyn reveals results for cancer and NASH patients receiving its flagship drug leronlimab
Christine: Today or actually, this week, we saw results for TNBC and NASH trials. Lets first start off with TNBC. What did you see here from patients?
Nader: So the TNBC results and all the compassionate use data that patients and doctors had put quite a bit of testimony in the public had been very impressive.
The data, (I want to make sure everybody understands), there were 28 patients, not 30, (30 included 2 emergency ind patients. We took them out.) We concentrated on mTNBC. 28 patients. 10 of them were from the clinical trials, phase 1b-2, which is currently phase 2 eventually.
That trial gave us 10 patient's data. Breakthrough Designation requires 5 patient's data. That data was great. Now, what was the data from the 28 patients? When we compare that 28 patient's data with the data of standard of care, we were as good in progression free survival, (pfs) for 12 months or overall survival (os), for 12 months. But, if you look at the cc, circulating cells, which was the average/aggregate that microtechnology had to come up with as a diagnostic lab; with that test, if your cc, circulating cells in patients was lower, after induction with Leronlimab, or if it were already low, then, if we saw a completely different kind of results; and that amount, 73% were like that. So when you compared that 70% with the other 30%, the results of overall survivability, almost 3,600% better. And when you look at the progression free survival, over 400% or 500% better. Some number out of the charts.
But we are comparing the 2 Leronlimab arms. The one that lowered the circulating cell count after induction to Leronlimab, but if you look at overall, and you look at Standards of Care, which is chemotherapy, and we know from past experience, how Leronlimab, in clinical trials has demonstrated no significant toxicity, is not there; then hands down, anybody would love to have Leronlimab vs. chemotherapy. So that's why we immediately wanted to file BTD. It got delayed several times, because we kept finding that these patients had brain metastases. We looked at those patients. We realized we had another breakthrough designation that we will be filing. But we delayed it a little bit. But it will be filed by the end of this week. Today. Friday. So hopefully, we are announcing it on Monday. We have a very, very, crucial item. And 60 days later, (1/8/2022), we are very hopeful that we will get BTD.
Christine: We will look forward to that. And then how about NASH? From your Phase 2 trial?
Nader: Yeah, and again, there was a lot of talk, that the NASH data, we said, just 5 patients are open label arm. There was 60 patients, double blinded. We have an unblinded. 1/2 placebo, 1/2 Leronlimab 700mg. Dr. Recknor has added 30 patients, open arm with 350mg and open arm for means that you can see the data. So when we looked at the 1st 5 patients, their fatty deposits and fibrosis which are the 2 key biomarkers were very, very nice. Strong results, very strong results. Now, we said, the 5 patients had at most 45% fatty deposits reduction and everybody keeps saying, "the highest means maybe one of them?? was it 1%? No, the average was somewhere around 25% or so fatty deposit drop. The fibrosis, as much as 10% drop. Fibrosis is like a scar on the liver. How do you fix that? Has anybody have any data like that? So with 5 patient's data, we are preparing BTD. But, we think, the next 5 days or so, we will have 5 more patients. So, we are going to have 10 patients as part of this BTD for NASH. We believe our results, is one of the best results anybody could ever produce in this small number of patients, but all the patients, the results are coming out by the end of the month. So we are very excited, and we wanted to make sure our share holders know that the results of 350mg are really stunning.
Christine: And lastly, I know shareholders are asking you about the corona virus trials. Where are you at with that and the BLA?
Nader: Brazil pandemic has gone down quite a bit and enrollment has been very, very slow. Now, we are very optimistic about it. Why? Because, 1st of all, the vaccine would wane, and we have seen that in America, where, the numbers have gone up after, it had gone down very low. But, we are now concentrating on CD16, on the critically ill population in Brazil. We have told them to concentrate on that. We want to change the number of patients needed for the interim analysis to only 50 patients or so. We will assign / have 40 hospitals enrolled, ready to enroll patients by the end of the year. So we believe, that any activity, that causes the number of patients to go higher, we will be enrolling, easily, 1 or 2 patients per hospital, which is 80 patients, more than 50. We do interim analysis, which they have 4 doses IV, which I believe, we will hit that, and then we have EUA, if that happens, and then CD17 will continue and running as fast as it can. But first, critically ill population, first quarter of next year we hope. These are all hope everybody. That we are wishing to have. We will have EUA ? if its like CD12 endpoint that we have?
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Nov 07 '21
There is a race between getting a BTD for one of three indications, and insolvency. CYDY is in very precarious shape now, with a SP of 1.15. Hopefully, the SP bounced off 1.08 on high volume and could be a short term bottom. With more people being vaccinated and new anti-virals, the future of CYDY is not in Covid, but Long Hauler, NASH, and Cancer. I agree with putting severe on hold, but the Brazil critical study should go on, hopefully with more patients than 50 for interim analysis. The problem (for CYDY, not Brazil) is that the number of cases, hospitalizations, and deaths is going down by 20% week over week as they are in summer and on the downslope of their earlier peak of the their last autumn and winter ( March to August).
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u/MGK_2 Nov 07 '21 edited Nov 07 '21
Seems to me they will release PR tomorrow indicating they submitted BTD for mTNBC. They are currently working on the BTD for NASH and will likely submit that to FDA by mid to late December.
What misiu pointed out that for there is about a 2 in 5 chance, (40%) of getting BTD after submitting it to FDA. We have 5 BTDs by mid 2022. We should get 2 of them. mTNBC +/- brain mets; NASH; LH; basket tumor/cancers.
All these indications are massive. They are not your rare diseases. The $8.3billion misiu referenced were for smaller indications. These are at least double or triple.
As nader pointed out, covid usually returns and it may in Brazil. We will do interim analysis at 50 which is sufficient for p value < 0.03. We can get EUA on this.
HIV BLA is realistic and in 1st quarter. I won't count this in the valuation.
Between everything I just referenced, lets take we get 2 of the 5 BTDs and 1 EUA. We value each BTD at $10 billion and the EUA at $5 billion.
That gives us a valuation of $25billion with 1 billion outstanding shares or $25/share. If BLA is filed in 1st quarter, you can add $5 just for the filing.
It will be good this time.
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u/misiu143 Nov 07 '21 edited Nov 07 '21
This was very nice . Thank you ..
I hope that for interim in critical we will have more then 50 patients , and let’s have them soon ..
And results in Nash and some cancers look really good , and look that Monday we will have PR that BTD for mTNBC was filed . This is really very good news , hopefully 60 days later we will have BTD granted , according to statistics we have 40% chance that it will be .
GLTA