NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

TWO ZOOM PRESENTATIONS FOR LINDA LIAU YESTERDAY .


https://miami.zoom.us/j/93439097613?pwd=ZHNVaFh5YzRnZEpQcVJxbkplTE55QT09 (7am 3/31/22 Linda Liau presentation)

(did we hear that mesenchymal and methylated GBM patients live 5-10 years with Dc Vax L at 35:00?)

(7am 3/31/22)

flipper44
Member Level
Friday, April 01, 2022 8:15:46 AM
Re: Red_Right_Hand post# 455920


Post# of 455924 Go
The calculation is more likely closer to 50 / 232. Why? Because most very long lived patients from DC therapy do(have) not pfs event(ed), and because by two years from time zero enrollment in SOC trials, 97% to 100% of patients have pfs evented. I would not be here if those things were not true. So 20% to 23%, give or take, very long lived if 50 is from the trial.



Red_Right_Hand
Friday, April 01, 2022 8:05:17 AM
Re: NotSure2 post# 455907


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36:55 LL: "in our immunotherapy trials we have about 50 of them now, that are over 5 years, going on 10 years. and you're right, why did they live so long?"

50/331=15%


"Survival from GBM is poor; only few patients survive 2.5 years and less than 5% of patients survive 5 years following diagnosis."
https://www.ncbi.nlm.nih.gov/books/NBK470003/

(did we hear that mesenchymal and methylated GBM patients live 5-10 years with Dc Vax L at 35:00?)

(7am 3/31/22)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485274/ (mesenchymal/methylated paper)


https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6


https://pubmed.ncbi.nlm.nih.gov/21135147/ (mesenchymal)

Instead, patients with mesenchymal methylated tumors tend to live the longest when treated with DCVax-l. They’ve known this for a very long time from older studies and compassionate cases. Patients treated with chemotherapy tend to do better with methylated but do not help unmethylated at all. Therefore she’s saying immunotherapy trials should not be testing patients given chemotherapy for unmethylated tumors, but she is also saying the longest living patients in DCVax older studies, who typically have mesenchymal methylated mgmt plus tumors used to get, at best, two years from chemo, whereas dendritic therapy can take that out to ten years or more in a significant number of cases.

https://umiamihealth.org/sylvester-comprehensive-cancer-center/research/education-and-training/events-calendar/class-details?id=bca25d12-eabc-4d16-8247-b36f1e3bd1ce (5 pm 3/31/22)

Dr Bala
Member Level
Thursday, March 31, 2022 6:36:19 PM
Re: hope4patients post# 455830
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I joined the talk a bit late, but here are my impressions of LL's talk at the University of Miami (3/31/2022, 5 to 6 PM EDT):

1. She gave reasons why PFS is not the best end point indicator in GBM trials.
2. Essentially said that OS is the best indicator.
3. Said that it is not ethical to push patients into control arm in GBM trials.
4. Thus, the trials become single arm trials because of cross-over. Hence the need for comparison with ECAs.
5. Quoted the recent (February 2022) FDA paper on the ECAs.
6. Went more in-depth with the various ECAs and their stats. Apparently these are being used in the paper.
7. Kept silent on the P3 TLD and the journal paper. Probably was asked not to broach that topic.
8. No questions later on the P3 TLD later from the audience.
9. Talked on methylated vs. unmethylated, idh-mutation, ...
10. Emphasized that the GBM patient population size is small compared to the other types of cancer.

Recent NWBO News

There were two important points that came from yesterday's LL presentation. Longs have constantly debunked baseless claims that the ATL-DC vaccine used in the combo trial with Merck and part of SPORE was not in fact DCVax. At 5.40 in the presentation LL's slide clearly identifies the vaccine as DCVax. Also, as Lykiri pointed out LL confirmed with "Slide : Statistical analysis plan (SAP) for RCT with cross-over arm".
Linda Liau:
Quote:
"BEFORE the trial was unblinded this was the statistical analysis plan that was submitted to the FDA."
Both of these false claims have been constantly posted by those wanting to spread fear, uncertainty and doubt. Yet again they were wrong.

eagle8
Friday, April 01, 2022 4:48:25 AM
Re: Lykiri post# 455837
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Post# of 455927 Go

Quote:
Quote:
She went more in-depth into the details of the SAP with external control arms.


Dr Bala,

I agree, interesting presentations today at the University of Miami by Dr. Liau.

Slide : Statistical analysis plan (SAP) for RCT with cross-over arm.
Linda Liau:
Quote:
"Before the trial was unblinded this was the statistical analysis plan that was submitted to the FDA."



Thank you Lykiri.

This clearly shows, in my view, that the new endpoints and the comparison with external Placebos have been accepted by the FDA!
Not very nice for the cabal overhere.

Thanks again and best to you.


ATLnsider
Thursday, March 31, 2022 1:39:24 PM
Re: Lykiri post# 455716
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1.000
Post# of 455942 Go
Thanks Lykiri, some people believe that DCVax-L does not have any significant efficacy treating GBM patients. But, some people also believe the earth is flat.

But, we have to ask ourselves:

(1) Why would Dr. Linda Liau, Dr. Timothy Cloughesy, Dr. Robert Prins continue to treat their GBM patients with DCVax-L if it is not efficacious?

(2) Why would these preeminent neuro-surgeons & neuro-oncologists study DCVax-L in combination with other treatments (like Keytruda) if they did not believe that DCVax-L will be approved by global regulatory authorities, and be available to be used to treat GBM in combination with other approved treatment options?

(3) Why would Merck waste its time and resources to donate Keytruda for free, to be used in this combo study if Merck did not believe DCVax-L is efficacious?

(4) Why are Dr. Linda Liau, Dr. Robert Prins and NWBio applying for a combination patent for DCVax-L plus Keytruda and other PD-1 inhibitors?

Maybe the “flat earth people” are right, and Merck and these doctors are wrong. smile

Recent NWBO News
s


ae kusterer
Thursday, March 31, 2022 3:31:56 PM
Re: None
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Lykiri

Thursday, March 31, 2022 11:39:41 AM

Re: ae kusterer post# 455620

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455679
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ae kusterer,

LL’s presentation (Therapy-induced resistance in glioblastoma: New Concepts) included discussion on a new trial in newly diagnosed GBM patients they will be starting in the near future.

3 arms:
Group A : ATL-DC + Pembrolizumab + PLX 3397 (N=10)
Group B : ATL-DC + PLX 3397 (N=10)
Group C : ATL-DC + Pembrolizumab (N=10)

Pembrolizumab = 400mg (6 weeks)
PLX3397 = 100mg daily oral
ATL-DC = 2 wks x 3
Seamlessly con



ATLnsider

Thursday, March 31, 2022 1:52:13 PM

Re: hoffmann6383 post# 455748

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You’re right hoffmann6383, it’s a win-win proposition either if MHRA is first to approve DCVax-L, or if FDA is first by using Project Orbis and getting almost simultaneous regulatory approvals in Project Orbis countries, including the US, Canada, UK, Switzerland, Israel. etc.

My hope and belief is for Project Orbis.




Lykiri

Thursday, March 31, 2022 3:28:16 PM

Re: hoffmann6383 post# 455681

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hoffmann6383,

Feb.9, 2022
WCM Neurosurgery Grand Rounds: Dr Linda Liau.

Quote:
LL’s Disclosures:
° Within the past 12 months:
- Research grants/funding to institution:

° NIH
° Merck

- Advisory boards:

° Arbor Pharmaceuticals
° Clearpoint, Inc.
° InSightec

Thursday, March 31, 2022
LL’s presentation -Therapy-induced resistance in glioblastoma: New Concepts.
Quote:
LL’s Disclosures:

° Research grants/funding to institution:

- NIH
- Northwest Biotherapetucis

° Advisory boards:

- Actuate Therapeutics, Inc.
- Casa Colina Foundation
- Clearpoint Neuro, Inc.
- InSightec

Northwest Biotherapeutics is misspelled on LL's Slide 1.(Northwest Biotherapetucis)
s


hoffmann6383

Member Level
Thursday, March 31, 2022 1:04:46 PM

Re: None

Post#
455730
of 455784
Two very good tweets worth reading for those that haven't seen them:

$NWBO I am actually 100% (not 99%) sure that DCVax-L did not fail.... pic.twitter.com/IGlqavXEH2

— Mionaer (@Mionaer1) March 31, 2022

then read this 2nd:

$nwbo #dcvax #glioblastoma

THIS IS WHY 👇👇

"The group that got dendritic cell vaccination plus poly-ICLC had a 50% survival rate and now the majority of these patients are reaching 100 months and with not only survival but really no tumor recurrence."https://t.co/NRONj9Zu9z

— rj (@sharpie510) March 31, 2022

ATLnsider

Thursday, March 31, 2022 1:39:24 PM

Re: Lykiri post# 455716

Post#
455746
of 455783
Thanks Lykiri, some people believe that DCVax-L does not have any significant efficacy treating GBM patients. But, some people also believe the earth is flat.

But, we have to ask ourselves:

(1) Why would Dr. Linda Liau, Dr. Timothy Cloughesy, Dr. Robert Prins continue to treat their GBM patients with DCVax-L if it is not efficacious?

(2) Why would these preeminent neuro-surgeons & neuro-oncologists study DCVax-L in combination with other treatments (like Keytruda) if they did not believe that DCVax-L will be approved by global regulatory authorities, and be available to be used to treat GBM in combination with other approved treatment options?

(3) Why would Merck waste its time and resources to donate Keytruda for free, to be used in this combo study if Merck did not believe DCVax-L is efficacious?

(4) Why are Dr. Linda Liau, Dr. Robert Prins and NWBio applying for a combination patent for DCVax-L plus Keytruda and other PD-1 inhibitors?