NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

ATLnsider

Re: None

Friday, October 28, 2022 11:48:36 AM

Post#
525614
of 525853
A doctor friend of mine, virtually attended the 10/26/2022 presentation by Dr. Linda Liau at the University of Pittsburgh. He confidentially shared 38 slides from the presentation with me. However, he said that Dr. Linda Liau and the University of Pittsburgh Department of Neurological Surgery do not want these slides released to the general public.

I will honor his request and I will not post these slides. However, I will make a few comments about the content of some of the slides:

(1) The DCVax-L Phase III trial results showed a significant increase of 228% in 5-Year overall survival (OS) for newly diagnosed GBM (ndGBM), and a increase of 217% in 30-Month survival for recurrent GBM (rGBM).

(2) Dr. Linda Liau presented slides that also showed some extraordinary OS results for the combination trials with DC Vaccine and other treatments. One slide was the combination with DC Vaccine plus poly-ICLC. The survival probability was about 50%, and the mOS was approaching 120 months or 10 years. This slide also showed Progression Free Survival (PFS) of almost 100 months (8.33 years).

(3) Two other slides showed that when a DC Vaccine is combined with a PD-1 inhibitor, for ndGBM it is better to treat with the PD-1 inhibitor on a neoadjuvant basis, and for rGBM, it is better to treat with the PD-1 inhibitor on an adjuvant basis

(4) For patients with rGBM, and treated with a DC Vaccine plus a PD-1 on an adjuvant basis, the mOS has not been reached yet, and it is approaching 800 days (26.67 months).

These combination results are spectacular, I know that some of the investors in NWBO do not fully understand or appreciate what they own. Some are looking forward to selling their shares at $2, $3, $5, $7, etc. That is their prerogative. Some want to sell the company at $20 per share. But, I believe the DCVax vaccine platform is truly transformative, and it is tumor agnostic, and should work to treat all or most solid tumor cancers, regardless of which organ the tumor is located in.
biosectinvestor
ATLnsider

Re: norisknorewards post# 525810

Saturday, October 29, 2022 1:11:35 AM

Post#
525818
of 526079
norisknorewards, these are not my slides, these are Dr. Linda Liau’s slides. Dr. Liau is the one reporting the extended survival. There were more than 1 clinical trial at UCLA that included these 3 cohorts: (1) DC Vaccine + Placebo, (2) DC Vaccine + resiquimod, and (3) DC Vaccine + Poly-ICLC.

I trust Dr. Liau’s extended survival numbers. I am certain that these numbers are not from the 2020 trial. The trial that you referenced does not include a DC Vaccine + resiquimod cohort, but that cohort was included on the slide.

The slide did not reference the clinical trial ID number, but here is a clinical trial that started in 2010:

https://clinicaltrials.gov/ct2/show/NCT01204684

ATLnsider

Re: Lykiri post# 525939

Saturday, October 29, 2022 7:03:10 PM

Post#
525963
of 526082
Lykiri, after reading your question, I went back and looked at the 2 slides in question. After reviewing the first slide again more closely, I now realize that it is referring to recurrent GBM, not newly diagnosed GBM.

I believe the first slide was based on the study, which is linked below, by Drs. Timothy Cloughesy, Linda Liau, Robert Prins, et al:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6408961/#__ffn_sectitle

This study results showed that rGBM patients who were treated with a PD-1 inhibitor as a neoadjuvant had increased overall survival compared to the rGBM patients treated with a PD-1 inhibitor on a adjuvant basis. However, it does not appear that any of the rGBM patients in this study were also treated with a DC Vaccine.

I am not 100% sure why Dr. Linda Liau specifically included this slide, and I did not have the benefit of, or access to any of her audio to go with the slides.

The second slide was titled “Interim Survival Analysis of recGBM Patients”. There are 2 cohorts: (1) Neoadjuvant PD-1 + Adjuvant ATL-DC, and (2) Adjuvant ATL-DC + PD-1. The interim results of this study showed that the Adjuvant ATL-DC + PD-1 cohort experienced increased overall survival, and the mOS had not been reached as of the date of the analysis.

ae kusterer

Re: None

Saturday, October 29, 2022 5:02:59 PM

Post#
525949
of 526082
LOTS OF COMBO SALIENTS:
Lykiri
Re: ATLnsider post# 525614
Saturday, October 29, 2022 4:26:16 PM

Thanks for the summary ATLnsider.

You said:
(3) Two other slides showed that when a DC Vaccine is combined with a PD-1 inhibitor, for ndGBM it is better to treat with the PD-1 inhibitor on a neoadjuvant basis, and for rGBM, it is better to treat with the PD-1 inhibitor on an adjuvant basis.


I’m not aware of a clinical study in newly diagnosed GBM with the PD-1 inhibitor on a neoadjuvant basis + DC Vaccine.
Can you give more details about the study you're talking about?

In the new SPORE clinical trial (not started yet) Pembrolizumab will be given after surgery (on an adjuvant basis)

Clinical Trial: DC vaccine/Poly-ICLC +/- PD-1 blockade and CSF-1Ri in newly diagnosed GBM patients.

Initial Diagnosis
Initial Surgery
6 weeks XRT/TMZ
RANDOMIZE
3 different arms:
Group A : ATL-DC + Pembrolizumab + PLX 3397 (N=10) until progression.
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

All patients will be allowed to get PLX 3397 + Pembrolizumab 6-8 weeks after randomization.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168683019
You said:
(4) For patients with rGBM, and treated with a DC Vaccine plus a PD-1 on an adjuvant basis, the mOS has not been reached yet, and it is approaching 800 days (26.67 months).


It’s a small group of patients. A few patients died and the majority of the patients in the DC Vaccine + PD-1(adjuvant) group are censored between 4 and 24 months.

The Danish Dude

Re: None

Thursday, April 28, 2022 5:19:19 AM

Post#
463214
of 525948
The potential going forward from here is astounding. Will be wonderful with TLD and publication, but in the greater picture, this is but the initial hurdle to what will REALLY valuate NWBO in terms of a possible BO.

Why is TLD and publication just a "hurdle"? Because its success is "a given" by now. We have now proved beyond all doubt, that the ATL-DC vaccine in the UCLA+Merck combo trial with Keytruda IS DCVax-L. UCLA neurologist Stacey Green has confirmed that.

Why is TLD and publication just a "hurdle"? Because its success is "a given" by now. We have now proved beyond all doubt, that the ATL-DC vaccine in the UCLA+Merck combo trial with Keytruda IS DCVax-L. UCLA neurologist Stacey Green has confirmed that.

https://cancer.ucla.edu/research/ucla-brain-spore/research-projects



You do not continue a combo trial with a product, you have known has failed for a year.

At the contrary LL has shown extreme effect in all her "Targeting Resistance" presentations, about the combo trial, last March 31st.

And she confirmed it has gone into its last phase 2.



THAT is the real treat.

TLD success and publication.
Automation of manufactoring.
Able to supply demand.
Approval.

That will get the SP to the initial heights, that has been predicted.

But NOW, that is just the entré. The main course is Mercks proven "obsession" with DCVax-L, first shown when UCLA withdrew the first SPORE project 1 using Nivolumab as an inhibitor

Estimated Study Start: December 1st. 2019

https://clinicaltrials.gov/ct2/show/NCT03014804

and instead changed it to this using Keytruda

First Posted December 17th. 2019

https://clinicaltrials.gov/ct2/show/NCT04201873

With Kevin Duffy joining NWBO from Merck September 4th 2019.

In hindsight, researching and looking through all the dates and events and announcements, it is so telling, that Mercks interest in Keytruda+DCVax-L is where the real story is and what will drive the SP way up, what was initially believed possible.

I can't say, whether a deal is already brokered. IMHO I believe it has. The figure though will be negotiated from what NWBO brings to the table. That is what the 270 patents are for. The automation. That Advent is ready and able to start.

The wait is one fat building up behind the curtains of a major BO and Linda Powers goes for MAXIMUM EXIT.

If you believe $30-40 a share to be expensive, and a fantasy, you ought to study what DCVax-L can do to this, both in terms of good and bad for Merck.



You ought to study the amount of Keytruda and Opdivo comparisons from this from 2016.

https://science.org/content/blog-post/keytruda-vs-opdivo-no-contest

No contest. Keytruda best checkpoint inhibitor

And recent studies.

"A real-world comparative study between nivolumab and pembrolizumab was conducted.

Nivolumab did not differ from pembrolizumab in efficacy and safety."



https://www.sciencedirect.com/science/article/abs/pii/S0169500222003890

2025 predictions.

Top 10 drugs by annual revenue in 2025

https://www.europeanpharmaceuticalreview.com/article/102539/top-10-drugs-by-annual-revenue-in-2025/

1. Keytruda – $22.2 billion
4. Opdivo – $12 billion

Bristol Meyers Squibb has drugs 2, 3 and 4. Merck can NOT afford to loose Keytrudas dominance.

Merck has been conservative in its Mergers and Acquisitions compared to BMY and the last two CEO's has been confirming they are ready and able to invest BIG and pay premium and go into bidding war, to get the right product/technology.

Or rather PLATFORM.

Because there is also the joker ... DCVax-Direct.

So no ladies and gentlemen.

I believe a BO is coming and that a BO below $30 a share is INSANELY cheap compared to what DCVax-L will be worth to Merck.

Have a nice month of May and may all longs prosper!


ae kusterer

Re: None

Saturday, October 29, 2022 9:28:16 AM

Post#
525864
of 525949
Await @NeuroOncin Tampa. (corrected copy)
https://twitter.com/StevenBremMD/status/1585935660241805312(Dr.Liau at UPENN 10/27/22)
https://twitter.com/PittNeurosurg/status/1583827661167595525( Dr.Liau at UPITT 10/26/22)
https://twitter.com/StevenBremMD/status/1585938560263237632

Great dinner last night with Dr. Linda Liau, with food for thought on the bright future of immuno-oncology for treatment of #glioblastoma. Pictured (left to right) are Yi Fan,
@DrLeeBrainSurg
, Linda Liau,
@NdukaAmankulor
,
@DanielYoshor
,
@StevenBremMD
. Await
@NeuroOnc
in Tampa.

PQR : 525801
ATL: per your comment, below are the approved Approved PD-1/PD-L1 inhibitors

Name Target Approved
Nivolumab PD-1 2014
Pembrolizumab PD-1 2014
Atezolizumab PD-L1 2016
Avelumab PD-L1 2017
Durvalumab PD-L1 2017
Cemiplimab PD-1 2018
Dostarlimab PD-1 2021

The BPs selling the above are the likely bidders for NWBO I suspect.


Member Level
Re: norisknorewards post# 525810

Saturday, October 29, 2022 9:23:26 AM

Post#
525862
of 525863
The 2019 trial is the combination trial that includes Keytruda as well as Poly ICLC. There is a long existing set of trials that involved Poly ICLC and Resquimod with DCVax-L, one in the Phase 1 era that had 23 patients and was published and another ongoing Phase 2 trial with 60 patients just updated this July, started in 2010, that is active, not recruiting, scheduled to end 2024-2025. So there are 3 trials with Poly ICLC (including the 2 ongoing) and 2 with Resquimod as well (including 1 ongoing and the phase 1), with Poly ICLC and Resquimod all referred to as TLR agonists, generally, and in patent materials.

First study, with 23 patients, published in 2012: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071163/

Here is the ongoing 2010, Phase 2 study, with 60 patients, https://clinicaltrials.gov/ct2/show/NCT01204684?term=POLY+ICLC&cond=GLIOBLASTOMA&cntry=US&draw=2&rank=7

Here is the combination study, started in 2019: https://clinicaltrials.gov/ct2/show/NCT04201873