Replies to post #582560 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

We will hit the 52W high and beyond when Merck trumpets the DcVaxL combo. LP is smart: Let the CI BPs do the talk.

[biosectinvestor]

Since Zavoico is the chairperson of the panel, and for NWBO, it feels like we are missing some news yet to come. Could be wrong, but I think it will likely come before that meeting. Hints suggest it could be quite meaningful. That NWBO has a representative who is chairing that session is not nothing. It suggests something significant is known by some people. Could just be our results. But it feels like it might be something else.

[ae kusterer]

SkyLimit2022 : Where did you see that the FDA is interested in 5/2 @NYAS?
Sunday, April 02, 2023 10:50:01 PM


582560

I hear you. You just need trustworthy sources. Merck and FDA seem interested in the NYAS event coming up in a few weeks. PD1 combo will probably be one of the most notable highlights this year!

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171539116
Bullish
BULLISH
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.



Re: Lykiri post# 582534

Sunday, April 02, 2023 9:45:17 PM

Post#
582543
of 582600
Group Leader : Prof. Denis Migliorini
Brain Tumor and Immune Cell Engineering Group – BTICE Group

Tumors arising in the brain are notoriously hard to treat. Intensive research in the last decade provided in depth characterization of the molecular profile of high grade gliomas, but unfortunately no impactful novel therapies. We contributed to immune based therapies for gliomas, especially in the identification of overexpressed cell surface markers of GBM in vivo and with the development multiepitopic vaccinations using synthetic peptides. We had the opportunity to translate our research into the clinic in an early phase trial where 19 patients with newly diagnosed GBM tumors were treated with the IMA950 peptide vaccine. We were able to demonstrate safety and immunogenicity. This endeavour led to another ambitious phase I trial using a personalized vaccination approach adapted to each patient’s tumor molecular profile.

Our next endeavour is to develop improved chimeric antigen receptor (CAR)-T cell approaches for glioma for the development of successful translational programs. T-cell engineering allows the construction of cell products harboring a high-affinity single-chain fragment variable (scFv) specific for a target of interest, fused to domains necessary for full activation and costimulation. CAR-T cell therapy in the context of brain tumors is promising because glioma is a good example of how specific improvements in trafficking, persistence, and resistance to the immunosuppressive factors related to the TME will be especially critical for success of engineered cellular therapies. We are fortunate to benefit from the generous support of the ISREC Foundation and to be part of the newly formed Swiss Cancer Center Léman (SCCL) which brings together fundamental, translational and clinical cancer research experts from Geneva and Lausanne. The SCCL federates skills and ressources at the cutting edge of the fight against cancer and allows us to integrate our efforts in a wide multidisciplinary community."


https://www.unige.ch/medecine/demed/en/groupes-de-recherche/denis-migliorini/

skitahoe

Re: Lykiri post# 582534

Sunday, April 02, 2023 9:52:47 PM

Post#
582545
of 582600
Lykiri,

There is no doubt that knowing all that's known today if a new trial were starting for DCVax-L it would have been done differently. There are a few Drs. willing to fight for NVCR's way of treating GBM patients, though they often don't say so. They'll say they have no conflict and recommend more testing, but I believe the regulators can see through what they're doing and saying.

It's sad, but a friend testifies in medical cases and while such people may not lie, they tell the story in the manner that benefits those who're paying them. That's what these so called experts are doing.

I believe that if the regulators ran the trials themselves the changes that were made would be little different. Pseudoprogression which can't be differentiated from actual progression completely invalidates a PFS goal. Overall survival was always a goal in the trial, and clearly it's the gold standard for judging trials. With the trial designed to cross over from the beginning it was clear that no real control group would exist for the OS goal, the trial wasn't changed to say this, it was there from the beginning. Certainly a few patients didn't cross over, but not enough to be a real control, and many very probably because they passed on before they had the opportunity to do so. Doctors who argue the trial was flawed because of this clearly have their own agenda,

Gary

SkyLimit2022

Member Level
Re: Lykiri post# 582534

Sunday, April 02, 2023 9:28:16 PM

Post#
582537
of 582600
Luckily for the naysayers who want more evidence, there are data beyond just the P3 and data from multiple clinical investigations. Here are some additional data highlights from compassionate use…

March 2023 presentation by Dr. Bosch:

http://nwbio.com/wp-content/uploads/NWBT-GBM-Summit-slides-3-15-23.pdf




The P3 was brilliantly executed and is more than adequate all by itself, but the application(s) for approval will require lots of paper clips and plenty of staples for all the extra pages that will be included—there is a voluminous catalog of supportive data that has been collected, analyzed, and validated.

Data collected from the P3 and ECA comparison only comprise a fraction of the clinical efficacy data that exist for murcidencel today. DCVax-L has been studied in multiple trials—only one of those trials relied on an ECA, and that ECA included over a thousand well-matched contemporaneous patients.

All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All the DCVax-L trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

dstock07734

Member Level
Re: Lykiri post# 582523

Sunday, April 02, 2023 9:16:49 PM

Post#
582535
of 582600
Olivier is not even an expert on GBM. He is such a lightweight in academia. Just look his publications. Pretty soon he will find out this paper only brings stigma to his reputation instead of the fame he is looking for.

https://scholar.google.com/citations?hl=en&user=6FBeQT4AAAAJ


Roman516

Re: Maverick0408 post# 581311

Wednesday, March 29, 2023 4:07:20 PM

Post#
581566
of 582600
NWBO Value based on UK and Canada for starters.

Per your comments "No acquiring company would pay more than 2-3 X of the SP. So the question is how do they get to $5-7 before acquisition?"

"There is no buying support from big investors. If TLD or JAMA or MIA didn’t do it, why would it be any different with MAA?"

My calculations are based on fact that once DCVax-L is approved, via Market Authorization (MA), the current stock price could easily rise above $5 in a few months if not weeks.
If this is the case, NWBO's stock could be listed on the NASDAQ, DOW. Once this occurs,
more Institutional buys will drive the stock price even higher. In addition, the current pharmaceutical companies would seek partnerships with NWBO in order to try to maintain their S-Curve sales markets. Why, because the S-Curve market sales for the current SOC chemo and radiation will start to decline at a rapid rate, IMPO.

Let’s say that DCVax-L is approved, and manufacturing and sales ramp up is aggressive for the cancer market based on four S-Curve phase periods, Introduction, Growth, Maturity, and Decline. Let's say the average product life cycle for an Oncology drug, 14 years.

S-Curve stages;
(Intro Phase) = .01 to .1, 1% up to 10%
(Growth Phase = .1 to .4, 10% up to 40%
(Maturity Phase) = 0.4 to 1, 40% up to 100%
(Declining Phase) = 1 to 0.7, 100% down to 70%

There are approximately 6970 cases of brain cancer in the UK per year.
There are approximately 3600 cases of brain cancer in the Canada per year.

https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/
https://www.wcrf.org/cancer-trends/worldwide-cancer-data/

Say DCVax-L costs $180,000.

Sales in the UK and Canada could amount to the following, per year.
(Intro Phase) = $104 million
(Growth Phase = $ 627 million
(Maturity Phase) = $ 1.67 billion
(Declining Phase) = $ 1.67 billion

If UK approvals also apply to the EU market, then here are some estimates.

Sales in the EU market could be amount to the following, per year.
(Intro Phase) = $ 385 million
(Growth Phase = $ 2.31 billion
(Maturity Phase) = $ 6.17 billion
(Declining Phase) = $ 6.17 billion

If DCVax approvals also apply to the entire world brain cancer market, then we are looking 3X above the EU market numbers, $40 billion to $120 billion per year sales in the next few years. The bottom line is that no company could afford to buy NWBO based on the DCVax product market potential. BWT, this is based only on DCVax-L approvals. If we add in DCVax-D approvals plus DCVax-L for all solid tumor cancers, we are looking at the potential company worldwide sales in the $300 billion to $500 billion range per year and could be 2X these estimates. If you include all solid tumors in animals, you could easily add $billion to the above numbers. So, the value of NWBO stock price and company worth over the average 14-year time period would far exceed any buyout, IMPO.

Over the last 45 years, I have been blessed to have helped multiple program operations and marketing teams sustain $100's of billions in market sales. I pray that NWBO will in fact receive their (MA) in a few weeks and be able to help many cancer patients all over the world. As for the longs who know the true value of NWBO, WOW this is going to be worth $$$ soon, few months and $$$$$$ in a few years, IMPO. Please do you own research regarding NWBO's market potentials with respect to the overall cancer markets.

Roman516

Re: Maverick0408 post# 581311

Wednesday, March 29, 2023 4:07:20 PM

Post#
581566
of 582600
NWBO Value based on UK and Canada for starters.

Per your comments "No acquiring company would pay more than 2-3 X of the SP. So the question is how do they get to $5-7 before acquisition?"

"There is no buying support from big investors. If TLD or JAMA or MIA didn’t do it, why would it be any different with MAA?"

My calculations are based on fact that once DCVax-L is approved, via Market Authorization (MA), the current stock price could easily rise above $5 in a few months if not weeks.
If this is the case, NWBO's stock could be listed on the NASDAQ, DOW. Once this occurs,
more Institutional buys will drive the stock price even higher. In addition, the current pharmaceutical companies would seek partnerships with NWBO in order to try to maintain their S-Curve sales markets. Why, because the S-Curve market sales for the current SOC chemo and radiation will start to decline at a rapid rate, IMPO.

Let’s say that DCVax-L is approved, and manufacturing and sales ramp up is aggressive for the cancer market based on four S-Curve phase periods, Introduction, Growth, Maturity, and Decline. Let's say the average product life cycle for an Oncology drug, 14 years.

S-Curve stages;
(Intro Phase) = .01 to .1, 1% up to 10%
(Growth Phase = .1 to .4, 10% up to 40%
(Maturity Phase) = 0.4 to 1, 40% up to 100%
(Declining Phase) = 1 to 0.7, 100% down to 70%

There are approximately 6970 cases of brain cancer in the UK per year.
There are approximately 3600 cases of brain cancer in the Canada per year.

https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/
https://www.wcrf.org/cancer-trends/worldwide-cancer-data/

Say DCVax-L costs $180,000.

Sales in the UK and Canada could amount to the following, per year.
(Intro Phase) = $104 million
(Growth Phase = $ 627 million
(Maturity Phase) = $ 1.67 billion
(Declining Phase) = $ 1.67 billion

If UK approvals also apply to the EU market, then here are some estimates.

Sales in the EU market could be amount to the following, per year.
(Intro Phase) = $ 385 million
(Growth Phase = $ 2.31 billion
(Maturity Phase) = $ 6.17 billion
(Declining Phase) = $ 6.17 billion

If DCVax approvals also apply to the entire world brain cancer market, then we are looking 3X above the EU market numbers, $40 billion to $120 billion per year sales in the next few years. The bottom line is that no company could afford to buy NWBO based on the DCVax product market potential. BWT, this is based only on DCVax-L approvals. If we add in DCVax-D approvals plus DCVax-L for all solid tumor cancers, we are looking at the potential company worldwide sales in the $300 billion to $500 billion range per year and could be 2X these estimates. If you include all solid tumors in animals, you could easily add $billion to the above numbers. So, the value of NWBO stock price and company worth over the average 14-year time period would far exceed any buyout, IMPO.

Over the last 45 years, I have been blessed to have helped multiple program operations and marketing teams sustain $100's of billions in market sales. I pray that NWBO will in fact receive their (MA) in a few weeks and be able to help many cancer patients all over the world. As for the longs who know the true value of NWBO, WOW this is going to be worth $$$ soon, few months and $$$$$$ in a few years, IMPO. Please do you own research regarding NWBO's market potentials with respect to the overall cancer markets.


Re: Lykiri post# 582523

Sunday, April 02, 2023 9:12:13 PM

Post#
582534
of 582600
Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma: What happened to the evidence?
Authors: T. Olivier , D. Migliorini


https://www.sciencedirect.com/science/article/pii/S0035378723009190
Denis Migliorini@MiglioriniDenis
Neuro Oncologist, Brain tumor Immunologist, passion about immune cell engineering
March 19
Join us for the upcoming French Society of Neurology conference in Paris. The line up is impressive!
Extremely honored to present updates on our research alongside pioneers in neuro oncology and neurosurgery with Roger Stupp, Hugues Duffau, Martin Van den Bent among others



Oncology Division - Geneva University Hospital@DOncologie
Oct.4, 2022
Join us for Prof. Roger Stupp's Lecture tomorrow! Pr Stupp is a pioneer in innovative drug development for brain tumors, 2 FDA approved therapies are based on his research for #Glioblastoma. He will be hosted by Pr Migliorini Denis


https://twitter.com/DOncologie/status/1537316021639471104/photo/1
Check out the latest @Cancer_Cell Voices revisiting the current state of vaccine development for cancer. Among other experts Piere Yves Dietrich and Pr. Denis Migliorini discuss promise and challenges for brain tumors.


Martin van den Bent@MartinvdenBent
Critical review of the report on the DCvax-L trial: the trial did not meet its prospectively defined endpoint and post-hoc analyses with poorly selected external controls do not replace a proper prospective trial