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Tuesday, February 22, 2022 7:26:41 PM

Re: None

Post# of 502457
ANALYSIS




Chiugray

Tuesday, February 22, 2022 6:32:52 PM

Re: flipper44 Post #445759

Post#
445971
of 445982
Thanks Flipper. Complex. I had to read thru several times to digest. Basically single agent treatment results in an adapting ecosystem can be optimized.

Formula: DCVax-l + CI + CSF1R (odd-3397) + poly ICLC.

- DCVax dendritic cells is the activation signal to get peripheral T-cells and B-cells to go into and kill tumor cells
- CI checkpoint inhibitors fight against the tumor’s defense mechanism of turning off the T-cells ability to see cancer cells (tumor sends PD-L1 to bind on the attacking T-cells)
- CSF1R (odd-3397) is the inhibitor that reduces CSF1R so there is less suppressing of the immune system and lowering of macrophage levels
- Poly ICLC is the chemical that induces inflammation, so the immune system goes there, and as such the total response is enhanced




flipper44

Member Level
Tuesday, February 22, 2022 7:33:35 AM

Re: dmb2 Post #445751

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445759
of 445981
First, they need the DCVax-l unblinded results to see if a dent in unmethylated is possible with that immunotherapy. Dr. Bosch thinks the blinded data seem to point toward some effectiveness there.

For years, although the latest spore trial is only now in the planning works, Dr. Prins and Dr. Liau have known the ultimate DCVax-l combination would likely be DCVax-l + CI + CSF1R (odd-3397) + poly iclc.

So, what does this mean for DCVax-l?

If DCVax-l has some level of efficacy against unmethylated, the likelihood is the above combination will enhance that impact.

I’d personally guess the most important reason would be the addition of csf1r to DCVax, because it removes most immunotherapeutic suppressing cells from the equation in the brain. They know this, interestingly, because of experiments to treat concussion. CSF1R can temporarily remove almost all regulatory micro glia from the brain. Micro glia are a type of macrophage.

As you know, suppressive macrophage also often crowd into the tumor once CI + DCVax-l are administered. This sets up a war between suppressive forces versus therapeutic t-cells cells. CSF1R temporarily can, for whatever length of time it is administered, eliminate the tolerant/suppressive cells from the equation.

How will this theoretically help remove unmethylated tumor cells? Well, if DCVax-l is even slightly predisposed to efficacy against unmethylated, imagine what it can do if the immune system is stopped from trying to elicit tolerance to the unmethylated cells. Right, it’s basically giving DCVaxl charged t-cells more time to work unperturbed by suppressive forces.

This in turn probably makes CI safer to use in combination with DCVax-l, because it does not cause a massive rush of tolerance inducing cells, and thus the chance for rapid progression, which CI can otherwise cause, is mitigated.

I’ll leave a return discussion for poly iclcs role in the combo for another time.
ae kusterer

Monday, February 21, 2022 9:53:10 PM

Re: None

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445718
of 445982

Do you see it any other way ?

UPDATE 2/21/22 , regarding: https://www.youtube.com/watch?v=Yyihecx6gDo


In her 2/15/22 presentation , Linda Liau talks about almost everything related to the phase 3 Dc Vax L trial , except the trial's actual results . That comes , AVC believes , in the next 1-30 days.There may be some press releases before the paper. Please read ATlnsider's comments in the link below. He connects dots suggesting that Kevin Duffy was loaned to NWBO by MRK( head of R and D, https://www.merck.com/news/merck-announces-retirement-of-dr-roger-m-perlmutter-dr-dean-y-li-appointed-as-president-merck-research-laboratories/ ) so that the protocol for the UCLA/Keytruda/Dc Vax L combo trial (https://clinicaltrials.gov/ct2/show/NCT04201873) was the most effective design . Net, net, Linda Liau's talk suggests that the UCLA trial has been a success . In addition, in this slide: (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167916520 ), she shows the formula of components for the next combo trial , which might be even more effective , moving Liau's iterative inventions closer to a high percentage of GBM cure cases.
ae kusterer

Monday, February 21, 2022 11:28:35 AM

Re: None

Post#
445669
of 445982
Atlanta breaks the code.Picking up on the Duffy timing is key.

ATLnsider Monday, 02/21/22 11:24:59 AM
Re: ae kusterer post# 445647 0
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of 445668
AEK, you will have to go all the way back to December 2019 when UCLA first posted the information about the ATL-DC (DCVax-L) and Pembrolizumab (Keytruda) clinical trial:

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

I do not believe it was pure coincident that Dr. Kevin Duffy left Merck in September 2019 to be hired by NWBio. Then 3 months later, UCLA starts the DCVax-L and Keytruda combo trial.

https://nwbio.com/nw-bio-expands-senior-management-team-with-dr-kevin-duffy-as-vice-president-medical-affairs-external-collaborations/



ae kusterer Monday, 02/21/22 08:56:19 AM
Re: None 0
Post #
445647
of 445669

ae kusterer Monday, 02/21/22 08:38:11 AM
Re: None 0
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Linda Liau at 3:56 in this 2/15/22 presentation discloses Merck as a grant donor to her clinic .Has she disclosed this relationship with Merck previously ?


https://www.youtube.com/watch?v=Yyihecx6gDo (LL 2/15/22 presentation)


In minutes 17-23, she describes the combo formula needed because "CIs on there own in GBM do not work". Therefore, is the rush to get the combo patent awarded to NWBO reflect an urgency pressured by negotiations with MRK?





https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167916520 (the prize that MRK wants to own/control?)









https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167910818 (transcript)


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167916677 (miscellaneous relevancy)


Horseb4CarT Friday, 02/18/22 04:20:05 AM
Re: Bright Boy post# 444970 0
Post # of 445094
The cherry on top is that treatments initially continue as per the phase 3 trial, which becomes new SoC, and then treatments change to the more efficacious DCVax combo cocktail treatments with the pdl1 partners (Merck, BMS, etc.) and the IL-7 drug, which looks very promising.

And Dr Liau and team will continue to refine the best combo, which very likely continues to require dcvax.

The combo patents should protect the dcvax/nwbo interests.




muee88 Monday, 02/07/22 11:45:00 PM
Re: flipper44 post# 441910 0
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of 442166
NWBO submitted a response on 2/2. The most recent rejection included several ancillary things needing to be taken care of. This looks like it will be allowed now, which is great!

14/533,879 | NWB1155367: COMBINATIONS OF CHECKPOINT INHIBITORS AND THERAPEUTICS TO TREAT CANCER




https://patentcenter.uspto.gov/#!/applications/14533879/ifw/docs ( see 4 pages 2/2/22) (applicant argument) (see "Conclusion")

https://patentcenter.uspto.gov/#!/applications/14533879
02/02/2022 REM Applicant Arguments/Remarks Made in an Amendment 4 Preview PDF / XML


flipper44 Member Level Thursday, 02/10/22 06:55:01 PM
Re: None 0
Post # of 443133
Yet more recent patent application action on another patent. Application number: 13/492,693

I apparently hadn’t checked this one since the Canadien version was granted.

Quote:
COMPOSITIONS AND METHODS FOR INDUCING THE ACTIVATION OF IMMATURE MONOCYTIC DENDRITIC CELLS 2943-P23US.CON Printer Friendly Version
Select New Case Application Data Transaction History Image File Wrapper Continuity Data Published Documents Correspondence Data Assignments Display Download References
Transaction History
Date Transaction Description
01-18-2022 Date Forwarded to Examiner
01-14-2022 Request for Continued Examination (RCE)
01-18-2022 Disposal for a RCE / CPA / R129
01-14-2022 Request for Extension of Time - Granted
01-14-2022 Workflow - Request for RCE - Beg

The Danish Dude Member Level Saturday, 02/12/22 11:54:58 AM
Re: None 0
Post # of 443626
Recap ATL-DC and Keytruda.

I'm quite tired of the constant arguing or insinuations, that ATL-DC in the combo trial with Pembrulizumab (Keytruda) is not DCVax-L.

It is.

BEYOND doubt.

I've now been through a lot of postings in search of when the debate started and in search of how many times, these insinuations have been refuted. I've tried to make a resumé below.

It's a lot, but its time to lay the insinuations to rest and move forward and have a point in time from where we can once and for all refute that.

ATL-DC in that GBM combo trial at UCLA with Keytruda, IS DCVAX-L.

Flipper started out in January 2021 mentioning this:

"Current on their website as of today. (Note: UCLA’s brain tumor website, unlike NWBO, keeps all areas current)

Quote:
Immunotherapies available at UCLA include:

Vaccines: Vaccines are among the most promising immunotherapies. Researchers at UCLA developed the first personalized vaccine for brain tumors (dendritic cell-based vaccine, or DCVax®). DCVax® has extended survival of many of our glioblastoma patients for more than a year, and some are thriving more than 10 years after their initial diagnosis.

Immune checkpoint (PD-1) inhibitors: We are exploring ways to stimulate certain white blood cells (T-cells) so they become more effective in attacking and destroying cancer cells. This therapy helps patients who have not had success with other treatments or are at risk for building a treatment resistance.

We lead and participate in multi-center trials for developing the next generation of brain cancer immunotherapies. Your physician will let you know if you are eligible for a trial. Learn more about our research and clinical trials."

https://www.uclahealth.org/braintumor/biologics


"I personally think UCLA wants the process to move forward. Patients are waiting."

And followed up with

"Safety matters a lot too, and the combo trial likely started out first year enrollment slowly to observe, study and evaluate trial parameters going forward. My guess here is that it is very tricky to time completion of a phase three trial with enrollment timing of the combo trial. I could expound, but I guess most people already know what those might be. I do see the recent UCLA PR on the combo trial as an indication it is ok to move toward enrollment completion for the combo trial now. I suspect they are witnessing something historic."

ATLnsider commented

"It is very telling that on this website page, UCLA lists the only 2 current immunotherapy treatment options at UCLA for brain cancer as: DCVax & PD-1 inhibitors.

Especially, considering that the only current open clinical trial, that is currently recruiting at UCLA for recurrent Glioblastoma, is ATL-DC (DCVax) plus Pembrolizumab (Keytruda).

It is all so plain to see, unless you refuse to see it, as some Bears on this board have chosen not to see this."



ATLnsider had another post

Quote:
"When we take a closer look at the UCLA - Merck Phase I clinical trial for recurrent Glioblastoma Multiforme (rGBM), with a treatment that combines an autologous tumor lysate-pulsed (ATL)-dendritic cell (DC) vaccine with Pembrolizumab (Keytruda), we can see the obvious fact that ATL-DC is the generic name for DCVax-L.

DCVax-L is the trademarked name for NWBio’s autologous tumor lysate (ATL) dendritic cell (DC) vaccine. ATL-DC is the generic name for DCVax-L. NWBio is not producing DCVax-L for this UCLA trial, through its commercial CMOs (Cognate & Advent Bioservices). This is a small Phase I clinical trial with only 40 patients, and there is only 1 clinical trial site (UCLA). There is no need for large-scale commercial production capacity for this trial. UCLA has the production capacity to make the vaccines on-site, in its own laboratory.

I personally believe that UCLA, Merck & NWBio want to purposely hide, obscure & downplay the connections between the 3 entities, and hide this DCVax-L + Keytruda combination clinical trial in plain sight. This allows NWBio to focus on releasing TLD, and prevent Merck & NWBio from having to answer questions about the interest they may have in each other.

Take a look at how DCVax-L is described and named in the 2018 Journal of Translational Medicine article by Liau et. al., that published the interim blinded and blended results for the DCVax-L Phase III trial. Also, take a look at how ATL-DC is described and named on the clinical trials.org website. The 2 are exactly the same:"






Ex commented

"Was there really a UCLA PR I missed? Or are you talking a tweet that noted UCLA had it listed on their site with all the other trials they run?"

Senti also commented


"To your point that it’s time to complete enrollment in the combo trial... You’ll likely remember from the other day the Twitter post by the recurrent GBM patient Matt Henkel from Illinois who recently received the call from UCLA that he could enter the combo trial. He was most excited to know that he was sure to now receive DCVax-L, and hoped to get Pembro, too. But was most excited to be receiving DCVax. One might also note that Henkel did not reference the treatment as an “autologous dendritic cell vaccine”, but specifically called the treatment he’d be receiving “DCVax-L.”

Flipper answered

"Good point. I was just verifying from a UCLA public relations page, but of course I have no doubt Mr. Henkel is also proof positive, as is your conversation with Dr. Liau and Atlnsder’s links."


Flipper:

https://www.uclahealth.org/neurosurgery/art-vision-steve-lyons

Branster

"Flipper, seems that is the new trial with the anti-PD1 immune checkpoint inhibitor (Keytruda) from the statements LP is making.

"we recently opened a novel clinical trial to investigate the safety and efficacy of combining a personalized dendritic cell vaccine with an anti-PD1 immune checkpoint inhibitor, said Dr. Liau. Although we had tested both agents independently in the past, this is the first-in-human trial combining the two approaches in order to harness the immune system against brain cancer"

You would think Merck is in engaged with NWBO at this point...."

Flipper, here is the trial I believe.

https://clinicaltrials.gov/ct2/show/NCT04201873?term=cloughesy&draw=2

Flipper

"Again thanks. It never hurts to repost the trial link."

Branster

"flipper, oh okay gotcha, so what your make of the relationship between Merck and ULCA and NWBO and the TLD ?"

Flipper

"In the very recent PR, Dr. Liau confirmed the Autologous DC vaccination used in current combination trial is the same one they used before. The one they used before was DCVax-l. UCLA has a contract with NWBO regarding the DCVax platform."

ATLnsider then chimed in with Merck CEO Kevin Fraziers words from this article

https://www.fiercepharma.com/pharma/jpm-merck-not-complacent-but-we-re-not-desperate-for-deals-ceo-says

"For one, the company is looking ahead to coformulations, combinations and other routes of administration for Keytruda that could lengthen the PD-1 king’s patent life, to continue to focus on getting the best external science we can, both in oncology and outside oncology, to diversify our portfolio, and we’re going to continue to focus on that.”

Poor Man

"The four big questions for whether Merck or another BP will acquire NWBO:

1) Does DC Vax have value in its own right and how much
2) Does DC Vax have value in combo with another treatment
3) Does DC Vax threaten market share for Keytruda or any other treatment
4) How much would Merck or another BP pay that will still provide a meaningful risk adjusted return for shareholders

The bonus question is how many BP are in play for DC Vax?

The answer to question 3 is critical, since Merck has so much value hanging on Keytruda, they can’t afford to take a meaningful risk on Keytruda’s market share."

nsgmd5:

"here is a notable absence of NWBO on the clinical sponsor site - it looks like they have switched to Oncovir, Inc. Can someone give some color as to why UCLA would switch vaccine providers?"

ATLnsider:

"Also, nsgmd5, if you can read between the lines, and you know where to look, you will see the obvious connections between: UCLA, NWBio, Merck, DCVax & Keytruda. Take a look at the ATL-DC + Keytruda trial Sponsors & Collaborators on the clinical trials.org site link below:

UCLA - Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Phase One Foundation
Oncovir, Inc

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

Then take a look at who is the Phase One Foundation, and the money ($400,000) they gave to UCLA to conduct this study:

https://www.phaseonefoundation.org/latest-news/cancer-researchers-develop-immunebased-therapies-for-deadly-brain-tumors

Then, go to the above link and look for this paragragraph:

Quote:
The funding will help open a clinical trial testing a combination treatment strategy using checkpoint inhibitors in conjunction with a personalized dendritic cell vaccine, which was developed by Liau at UCLA



Then, touch the blue link in this paragraph, it says: “was developed by Liau”. This blue link will take you to this page:

https://newsroom.ucla.edu/releases/personalized-vaccine-increase-long-term-survival-glioblastoma

This page clearly shows you that the ATL-DC vaccine developed by Dr. Linda Liau is DCVax-L. It says the following:

Quote:
The vaccine, known as DCVax-L, uses a person’s own white blood cells to help activate the immune system to fight cancer


Ex commented February 8th. clearly wrong about "the Keytruda combo"

"In the trial ae_kust posted the arms were

ATL-DC + placebo : 11 months
ATL-DC + PolyICLI : 54 months
ATL-DC + Resquimid : 17 months

We can debate if ATL-DC "is" DCVax-L, but whatever it is UCLA likes to use PolyICLI with it. That is why the Keytruda combo also uses PolyICLI"

ATLnsider

Quote:
"Jack, the reasons UCLA is not using the name DCVax-L, and is using the name ATL-DC are:

(1) ATL-DC stands for autologous tumor lysate-pulsed (ATL)-dendritic cell (DC) vaccine. ALT-DC is the generic name, and DCVax-L is the trademarked name.

(2). DCVax-L trademark is owned by NWBio. NWBio is not formally participating in, or putting money in this trial with UCLA. NWBio is devoting its current resources to completing the TLD for the DCVax-L Phase III, and soon getting DCVax-L approved in 4 countries.

(3) The ATL-DC used in the current UCLA trail, is being manufactured by the UCLA GMP lab on its campus. It is not being manufactured by NWBio or its U.S. CMO, Cognate.

(4) The UCLA GMP lab is only authorized by the FDA to make small quantities of ATL-DC (DCVax-L) for small clinical trials. UCLA is not authorized or licensed to make mass commercial quantities of ATL-DC (DCVax-L). That will be done by Cognate (Charles River Laboratories).

I believe that (these are my opinions Jack), if the UCLA Phase I recurrent GBM trial using ATL-DC plus Keytruda proves successful, then UCLA, NWBio & Merck, will conduct a larger Phase II/IIII trial using approved DCVax-L plus Keytruda. Also, I believe they will probably test this combination (DCVax-L + Keytruda) in various other solid tumor cancers."


ATLnsider

Quote:
Dr. Bala, it is a shame that you & I have to keep repeating ourselves, and keep explaining why UCLA is saying ATL-DC instead of DCVax-L for the combination trial with Pembrolizumab (Keytruda).

Some posters are purposely trying to confuse & confound newbies, and trying to suggest that there is a wedge between NWBio & UCLA.

Thankfully, I do not believe many on this board are falling for this tactic. The fact that they are grasping for make-believe straws is a bullish sign in my opinion.

It tell me that top line data release is very near, and the Bears are in panic mode.
Quote:


ATLnsider

Quote:
Take a look at this video by Dr. Cloughesy at UCLA that was released about 2 months ago, then go to the 1:30 mark to see that DCVax (ATL-DC) is the dendritic cell vaccine that UCLA uses in combination with a PD-1 inhibitor (Pembrolizumab / Keytruda).

https://vimeo.com/492232511

Then go to the 27:35 minute mark to listen and see that Dr. Cloughesy also believe that DCVax can not only be used to treat GBM tumors, but it can be used to treat all solid tumor cancers.

Then go to the 31:10 mark to see what vaccines are used by UCLA to get the immune cell to the tumor to fight the tumor. The only dendritic cell listed is DCVax. Also, the peptide vaccines listed (ICT & CDX-110), have already failed their clinical trials for ndGBM.








Lykiri have this VERY interesting comment

UCLA Brain Tumor Virtual Conference (part 2)

Date Time: Mar 12, 2021 10:00 AM Pacific Time (US and Canada)

Here are a few questions answered by Nghiemphu, Phioanh Leia.

Quote:
Anonymous Attendee 10:23 PM
Can you discuss where you are with DCVax? Wasn't this invented and developed at UCLA?


Quote:
Nghiemphu, Phioanh [Leia] M.D. 10:31 PM
Please see recordings of Part 1 of our conference at https://www.uclahealth.org/braintumor/patient-education


Quote:
Al Musella 11:34 PM
Why do so many phase 3 trials fail after having success in phase 2?

Nghiemphu, Phioanh [Leia] M.D. 11:59 PM
There are inherent bias when enrolling in patients in small phase 2 trials, which is why therapies are usually not approved unless show efficacy in phase 3.


Quote:
Brad Silver 12:30 AM
When was chemo changes from 21/7 for 2 years to 5/23 for 1 year?

Nghiemphu, Phioanh [Leia] M.D. 12:40 AM
This may have been addressed in part 1 of our conference. We never really used 21/7 dosing.


Quote:
Brad Silver 12:31 AM
Does UCLA suggest clinical trials elsewhere for patients?

Nghiemphu, Phioanh [Leia] M.D. 12:40 AM
As best as we can but there are thousands out there and we usually refer patients to clinicaltrials.gov website.


Quote:
Anonymous Attendee 12:47 AM
I have a few questions about this trial at UCLA: Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
This trial with Merck’s Keytruda coupled with DC VAX L has been ongoing for about 14 months.

How many patients are enrolled to date?
Is there radiation or chemotherapy (temozolomide or avastin to help reduce swelling and prevent tumor growth)?
What has UCLA learned from this trial to date?
Can someone from the UK participate in this trial?
Why is the name of the vaccine “ATL-DC vaccine” and not DCVax-L? Are both generic the same?

Nghiemphu, Phioanh [Leia] M.D. 12:54 AM
As long as a patient can come to UCLA to have surgery for tumor resection and come to UCLA every 6 weeks for pembrolizumab or placebo infusion, they can be enrolled into this trial. It is ongoing and we are still enrolling patients. We do not have results as it is still too early. The vaccine names are different but it is the same vaccine.


Quote:
Anonymous Attendee 12:54 AM
Are you aware of changing endpoints over the course of a clinical brain tumour trial here at UCLA? And must the participant be informed about a changed endpoint?

Nghiemphu, Phioanh [Leia] M.D. 12:57 AM
Most of our current trials do not always change endpoints. Participants would be informed if there are procedural changes to the trial because of the changed endpoints.


Anonymous Attendee 01:13 AM
As part of an industry-wide review, the FDA persuaded PD-1/L1 players Merck & Co., Bristol Myers Squibb, Roche and AstraZeneca to remove four indications on the labels of cancer drugs, after the failure of post-marketing studies.
The expert panel will discuss data on three indications for Merck’s Keytruda, two for Roche’s Tecentriq and one for Bristol Myers’ Opdivo.

Is that an issue for the ongoing combo trial keytruda and dcvax-l?

Nghiemphu, Phioanh [Leia] M.D. 01:19 AM
these treatments are supported by the clinical trial and not affected by the FDA panel which have to do with FDA provisional approvals. Neither vaccine nor pembrolizumab are indicated for brain cancer.


ATLnsider

Quote:
Here is more evidence that UCLA is using DCVax in the combo trial with Keytruda (Pembrolizumab). Most of us already know that UCLA is using DCVax combined with Keytruda, by there are a few here trying to spread FUD.

Quote:
"patients will all receive the DCVax, but they may or may not receive the Pembrolizumab"


You can hear this around the 43:10 minute mark:

https://vimeo.com/529196354


Exwannabe in June 2021

Quote:
Merck is not "footing the bill" for the UCLA combo trial. They are providing the drug and presumably some tech support.

I would estimate the number of other trials is over 500.

EDIT: By the way, Pembrolizumab is not the brand name. It is the formal "chemical" name and what many would call the "generic" name. Keytruda is the brand name.

And ATL DC is not a generic name, it is just a description. There is no formal generic name and not even a brand name. There is no way in the world "ATL DC" would be the generic name nor "DCVax-L" would be the brand name


Dr. Bala answer to Ex

"No need to confuse the issue. ATL DC is the same as DCVax-L. ATL DC is being used by UCLA in their Project I Combo Trials."

Longfellow95 answers Ex:

Quote:
No need to confuse the issue. ATL DC is the same as DCVax-L. ATL DC is being used by UCLA in their Project I Combo Trials./quote]

Biosectinvestor

Quote:
ATL-DC is definitively DCVax-L and here is why…

Here is the clinical trial:

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

Sponsor:
Jonsson Comprehensive Cancer Center
Collaborators:
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Phase One Foundation
Oncovir, Inc.

Key collaborator is Phase One Foundation.

Here is the press release for Phase One’s finding of this trial.

https://www.phaseonefoundation.org/latest-news/cancer-researchers-develop-immunebased-therapies-for-deadly-brain-tumors


“The funding will help open a clinical trial testing a combination treatment strategy using checkpoint inhibitors in conjunction with a personalized dendritic cell vaccine, which was developed by Liau at UCLA. The team hopes by combining the two treatments they will be able to create a new way to treat people with brain cancer, as well as develop new ways to track the immune response.

“We already have had preliminary success using checkpoint inhibitors to treat patients in a previous clinical trial,” said Cloughesy, who is also a scientist at the Jonsson Cancer Center. “By combining the two immune-based treatments, we hope to bring in more T-cells that will attack cancer cells that would otherwise go unnoticed by the body’s immune system.””

There is a link to the relevant “dendritic cell vaccine, which was developed by Liau at UCLA”, and that link goes here:

https://newsroom.ucla.edu/releases/personalized-vaccine-increase-long-term-survival-glioblastoma

“An international study led by UCLA researchers has found that a personalized vaccine may help people with glioblastoma, the deadliest form of brain cancer, live longer. The vaccine, known as DCVax-L, uses a person’s own white blood cells to help activate the immune system to fight cancer.”

The reference to the checkpoint inhibitor in that PR links here:

https://newsroom.ucla.edu/releases/recurrent-glioblastoma-immunotherapy-before-surgery

“Dr. Timothy Cloughesy, Aaron Mochizuki, Robert Prins and scientists at six other centers found that people treated with pembrolizumab prior to surgery lived for an average of more than a year.”

It is relatively easy to draw the connections.

Additionally, see this clarification via UCLA

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164217398


Hspooner

Quote:
I took it right off her slides from the last talk, 35:15, when she was talking about the trial.
https://www.youtube.com/watch?v=fMxjVRRSdXE/quote]

Exwannabe January 2022

Quote:

Will we see data from that [combo] trial? Will there be updates? If so, when? I remember Flip talking about certain milestones/days that we might get some info?

You are asking about this trial run by UCLA that combines DC with Poly-ICLI and Keytruda. A 40 patient 3 arm P1 in rGBM.

Presently listed as recruiting with an estimated primary completion date Aug 2024.

That does not mean you get the results then. As has been documented here repeatedly, schools are slower to get results published than corporations. I would think mid 2026 would be about the earliest to hope for.

As a comparison, the earlier P1 combo by UCLA started recruiting in Aug 2011. It completed recruitment Jan 2015. Interim results presented at SNO in 2017(?).

The next update you will get should be about March '22. UCLA follows the law and provides the required annual updates to the US trial registry.

BTW, Flipper argues this trial completed enrollment in late 2020. I find this hard to believe as they subsequently updated the registry and it still says enrolling, also the UCLA website itself lists the trial as open and enrolling. Scroll about half way down


Lykiri

Quote:
exwannabe,

Last patient in the UCLA-Merck combo trial was enrolled around May 21, 2021.
Happy New Year!

May 21, 2021
Officially enrolled in the clinical trial! For anyone wondering, the trial has 3 components. 1. Surgery 2. Personalized vaccine made with my tumor cells (you can google DCVAX If you want to know more!) 3. An immunotherapy drug called Keytruda (it’s possible that I will be in the control group and only receive a placebo).

On Tuesday I’ll have my first infusion of the immunotherapy drug and surgery is scheduled for June 7. About a month after the surgery I’ll receive three doses of the vaccine across 6 weeks. I’ll be spending most of the summer in Los Angeles.

Thank you all for helping me to manifest this and for reaching out about places to stay while I am here! We are excited and relieved to have arrived here finally!


May 28, 2021
Two years ago today, May 28, 2019, I had my first craniotomy to remove a large brain tumor in my right frontal lobe (yes, it looks like it's on the left in the MRI images). I had ZERO clue how my life would change from that point forward. After surgery the tumor was confirmed as a Grade IV Glioblastoma (GBM), which is a highly aggressive brain cancer. Needless to say, I've learned a lot about the medical field since then. As most of you know, 2019 brought a series of hell-ish experiences - a surprise second craniotomy for an infection, the SHINGLES (the icing on the cake I didn't order) complete with severe pain from post herpetic neuralgia, a blood clot, lymphedema, not to mention six weeks of daily chemotherapy and radiation. Somehow, I survived. With the love and support of my EXTRAORDINARY COMMUNITY of family and friends. I am incredibly grateful for everyone who helped me through this journey.

Here we are in 2021 and I'm preparing for my third craniotomy on June 7th at UCLA Medical Center in Los Angeles, CA. I'm still in shock that this is happening again and so relieved that I was able to be given the LAST SPOT in the clinical trial, which I hope will lead to a cure for Glioblastoma. We need it - too many people are suffering from this horrible disease. I'll be honest - I kinda feel pissed off AF that I'm even climbing this mountain. AGAIN. I dream of the day when I'm not an "inspiring," "brave," and "resilient" "warrior." I'm ready to be "Just Jenn" again!

Housing update: Thanks to my awesome support in Southern California, we have found places to stay while my mom and I out there for the majority of the summer. There aren't enough words to express how profoundly grateful I am.


MY WORDS about bidding war.

BMY acquired Celgene in 2019 for $74B and in this article from Jan. 2021

https://www.cnbc.com/2019/01/03/bristol-myers-to-buy-celgene-in-a-74-billion-deal.html

It says

https://www.fiercepharma.com/pharma/jpm-21-m-a-still-a-top-priority-at-bristol-myers-as-ceo-eyes-midsize-deals

“We will continue to look for midsize bolt-on deals that further strengthen our object to grow the company into the second half of the decade,” he said. As of the third quarter, Bristol Myers had about $22 billion in cash, and it expects to have $45 billion to $50 billion in free cash flow around 2021 to 2023."



A gallimaufry of pulchritudinous terpsichorean burlesque, followed by a veritable floribundum of perfect and plentitudinous prestidigitation and a show of verisimilitudinous, violent, ventriloquial virtuosity.



Evaluate Member Level Friday, 02/11/22 04:29:34 PM
Re: flipper44 post# 443105 0
Post # of 443513
Quote:
Yet more recent patent application action on another patent. Application number: 13/492,693
I apparently hadn’t checked this one since the Canadien version was granted.
Quote:
COMPOSITIONS AND METHODS FOR INDUCING THE ACTIVATION OF IMMATURE MONOCYTIC DENDRITIC CELLS


Also found here:
https://patents.google.com/patent/EP3072958A1/en
includes Worldwide Application - Japan - in 2021 (JP2021045176A) - Legal status = Granted.
as seen here: https://patents.google.com/patent/JP2021045176A/en
2021-03-25 Publication of JP2021045176A

GLOBAL DOSSIER:
https://globaldossier.uspto.gov/#/result/publication/WO/2007067782/1

PATENTSCOPE:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2007067782
includes:
Canada 04.06.2008 2632263 Granted 11.01.2022

https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2632263/summary.html
(45) Issued = The date an application becomes a patent. 2022-01-11




flipper44 Member Level Friday, 02/11/22 12:19:41 AM
Re: RedneckHoosier post# 443170 0
Post # of 443306
Merck makes Temodar. Merck makes Keytruda. Merck was the sponsor of the DCVax-l combo trial with Keytruda. Merck’s former employee went to work for NWBO at the same time NWBO was developing its SAP. He was there when they likely needed matches for their ECA arm, and left once the data locked and likely needed no further matches. He went back to work for Merck. The combination patent, if granted will last until 2035. The DCDirect patent applications, one granted recently, another apparently on its way, it looks like, will also last until about 2035. DCVax-l for GBM, if approved, will have 10 year market exclusivity. Flaskworks, is pumping out patents for automated closed system dendritic manufacturing. DCVax-Direct’s upcoming likely patent grant, not only selects for patient’s best DCs, it can enhance DCs manufactured from patients with otherwise inadequate DCs. Merck is the first, and perhaps only Company that has obtained approval for treating cancers with a genetic tumor trait, no matter where the tumor originated in the body. Seems like a match.

The patent office asked NWBO to choose the specific type of checkpoint inhibitor it intended to use. NWBO chose Monoclonal antibodies against programmed cell death-1 (PD-1). Keytruda is one of those. (So is Nivolumab)

See below:
Quote:

In late 2019, Merck, a pharmaceutical company that manufactures Temodar (the brand name version of the drug), decided to remove the drug from its patient prescription assistance program (PAP). Pharmaceutical company PAPs allow low-income patients, or patients that are uninsured or underinsured, to receive Temodar at discounted or no cost.

Because there are now a number of generic forms of temozolomide on the market — as well as multiple ways to access prescription drugs contingent on insurance coverage and various health plans’ benefit designs — the impact of this decision on brain tumor patients is not yet fully understood. However, we do know, anecdotally, that some patients now face higher out of pocket costs and some clinician-researchers are worried about the impact on patients’ ability to participate in clinical trials.


Quote:
Temodar was first approved for the treatment of certain malignant brain tumors in 1999. It was further approved to treat newly diagnosed glioblastoma, and subsequently became part of the standard of care for these patients, in 2005. It is not uncommon for companies that held the original patent on a brand name drug to make the decision to begin reducing their investment in that drug once their period(s) of market exclusivity begins to expire, as lower-cost alternatives begin to cut into sales of the brand name product. In recent years, a number of generic drug makers began producing lower-cost versions of temozolomide.
. https://blog.braintumor.org/press_releases/update-on-patient-prescription-assistance-for-temodar-temozolomide/






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Home > Boards > US OTC > Biotechs > NorthWest Biotherapeutics Inc. (NWBO)



ae kusterer

Followed By 42
Posts 2686
Boards Moderated 0
Alias Born 02/27/2016


ae kusterer

Sunday, February 20, 2022 12:42:03 PM

Re: None

Post#
445508
of 445982
HEAVY, HEAVY SUNDAY RESEARCH:



pgsd Sunday, 02/20/22 04:43:33 AM
Re: None
Post #
445462
of 445507
Published online 2022 Jan 20:-

"In conclusion, A machine learning model successfully predicted the IDH mutation status of gliomas, and the resulting clusters properly reflected the metabolic status of the tumors"

Akifumi Hagiwara,1,2,3 Hiroyuki Tatekawa,1,2,4 Jingwen Yao,1,2,5 Catalina Raymond,1,2 Richard Everson,6 Kunal Patel,6 Sergey Mareninov,7 William H. Yong,7 Noriko Salamon,2 Whitney B. Pope,2 Phioanh L. Nghiemphu,8,9 Linda M. Liau,6 Timothy F. Cloughesy,8,9 and Benjamin M. Ellingson

ATLnsider Sunday, 02/20/22 12:51:30 PM
Re: hoffmann6383 post# 445463 0
Post #
445510
of 445510
hoffmann6383, the rules for uplifting to each of the 3 major exchanges (AMEX, NASDAQ, and NYSE) are slightly different for each exchange. For example, I believe that NWBio would qualify to uplist to the NYSE based on Standard Two or Standard Three relatively quickly after TLD, the journal article, more clarity on the regulatory pathways for DCVax-L approval in all 4 regions (US, UK, Canada, Germany and the rest of the EU, and a capital raise.

Quote:
Standard Two: A company may qualify for listing under Standard Two if the company has: (i) shareholders’ equity of at least $4 million; (ii) at least a 2 year operating history; (iii) a minimum share price of $3; and (iv) a public float of at least $15 million.

Standard Three: A company may qualify for listing under Standard Three if the company has: (i) shareholders’ equity of at least $4 million; (ii) total market capitalization of at least $50 million; (iii) a minimum share price of $2 per share; and (iv) a public float of at least $15 million.

Alternatively, NWBio could decide to meet the up listing requirements of the AMEX or the NASDAQ. Either way, I believe there is already a plan in place to uplist NWBO shares soon.

https://bradshawlawgroup.com/how-does-my-otc-company-graduate-to-the-nyse-mkt/


Investor
"Visualization of tumor heterogeneity and prediction of isocitrate dehydrogenase mutation status for human gliomas using multiparametric physiologic and metabolic MRI" Published online 2022 Jan 20


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776874/


Lykiri Sunday, 02/20/22 07:12:50 AM
Re: DocLee post# 445461 0
Post #
445469
of 445508
DocLee,
Try this one: https://www.mdpi.com/2072-6694/10/10/372/htm

IMO, it shows that it's almost impossible for another group to replicate an effective dendritic cell therapy because they don't possess the 'technology specifics' of DCVax that are proprietary to NWBO.
From the study:
Quote:
Thirdly, even if a number of groups are working on similar DC vaccination technologies, the production protocols are never exactly the same. One driver is the complexity of the production process that involves multiple steps in Good Manufacturing Practice (GMP) cell processing facilities. Thus, in light of encouraging prior data by other groups [14,15,47,56], the disappointing results of this trial might stem from DC production differences. For instance, DCs in this study were matured with LPS/IFN?, while other groups do not have this step in their production protocol [47,51,56]. Future studies should compare different DC production techniques to clarify the possible relevance of technological specifics. DC production quality per se—following our predefined production protocols and technologies mentioned above—did not seem to be an influencing factor based on the functional DC vaccine analyses that we made (see Section 2. Results).

Interesting remarks from Flipper44
Quote:
They injected into the node, which, unfortunately, does not allow the natural final dendritic migration activation. (flipper44)

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144037723

Regarding injection internodally versus injection interdermally, and how dendritic cells perform better, activate better, and migrate better when injected intradermally see post sentiment: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144040212

Flipper’s post 192523 about a DC Train: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144041171


antihama Sunday, 02/20/22 09:36:14 AM
Re: None 0
Post #
445477
of 445510
Superficially about Moderna but really about UKs role as a pharma
hub
Quote:
UK and Moderna Appear to Be Heading for Manufacturing Altar
Published: Feb 14, 2022 By Alex Keown
In a post-Brexit world, Moderna could become a key lynchpin of the U.K. pharma sector. The Boston-based company is reportedly in talks with the government to establish mRNA manufacturing facilities in that country, as well as collaborating with health authorities on clinical trials.
A report from the Financial Times highlights the potential role Moderna could play in boosting the U.K.’s life sciences landscape and that country’s aim to become a global hub for biopharma – a position the government of the country was pushing for prior to its departure from the European Union in 2020. Moderna is considering establishing multiple U.K. sites in London, Oxford and Cambridge. Sites in these prime locations will put Moderna in “prime position” to collaborate with some of the UK.s top researchers on vaccines and therapeutics.
The new manufacturing facility is expected to be adaptable in order to pivot to face emerging viral threats, such as the SARS-Cov-2 virus that propelled Moderna to the forefront of vaccine development.
“The UK is ideally placed to become a life sciences superpower, and collaboration with world-leading companies is crucial to this,” U.K. Health secretary Sajid Javid said following a meeting with Stéphane Bancel, Moderna’s chief executive officer.
For Moderna, the move to open a site in the U.K. comes amidst the company’s planned expansion for mRNA manufacturing. Last year, the company announced its plans to open a state-of-the-art manufacturing facility in Canada to provide direct access to mRNA vaccines for the COVID-19 pandemic and future viral threats and respiratory viruses.
Likewise, the company has announced plans for manufacturing facilities in Africa, as well as Australia. In Europe, Moderna partnered with Sanofi to manufacture its mRNA vaccine for COVID. The France-based company was manufacturing the company’s vaccine during the height of the pandemic.
If the company follows through on its plans, the Financial Times said Moderna will, in addition to staffing its sites, also “hire people to run clinical trials with the NHS.” The U.K. government hopes the large patient databases maintained by the National Health Service will be a selling point for pharmaceutical companies. With the patient pool, the government hopes companies will be enticed to use the information in order to “carry out clinical trials more cheaply and quickly,” according to the report.
When the U.K. left the European Union two years ago, the impact on the pharmaceutical industry was significant. The country’s life sciences industry now accounts for about 3% of global pharma sales and no longer offers an automatic gateway to the much larger E.U. market.
A key issue to the U.K. landscape is that its regulatory hurdles are now separate from the EU. U.K. government ministers have increased concern regarding the extra red tape some companies may have to go through in order to receive regulatory approval in that country.
https://www.biospace.com/article/moderna-eyes-uk-manufacturing-facility/?utm_campaign=Newsletter%20%7C%20GenePool&utm_medium=email&_hsmi=203864289&_hsenc=p2ANqtz-8xm9947l-rDpYYKrcg9FBD13OUxxjB4kQ-iMyGyjxwyeHqB-B0i7z8KkYDYB5cCVPcxx85HdJXDykDk61jZl49OyVjWw&utm_content=203864289&utm_source=hs_email


Lykiri Sunday, 02/20/22 07:12:50 AM
Re: DocLee post# 445461 0
Post #
445469
of 445510
DocLee,
Try this one: https://www.mdpi.com/2072-6694/10/10/372/htm

IMO, it shows that it's almost impossible for another group to replicate an effective dendritic cell therapy because they don't possess the 'technology specifics' of DCVax that are proprietary to NWBO.
From the study:
Quote:
Thirdly, even if a number of groups are working on similar DC vaccination technologies, the production protocols are never exactly the same. One driver is the complexity of the production process that involves multiple steps in Good Manufacturing Practice (GMP) cell processing facilities. Thus, in light of encouraging prior data by other groups [14,15,47,56], the disappointing results of this trial might stem from DC production differences. For instance, DCs in this study were matured with LPS/IFN?, while other groups do not have this step in their production protocol [47,51,56]. Future studies should compare different DC production techniques to clarify the possible relevance of technological specifics. DC production quality per se—following our predefined production protocols and technologies mentioned above—did not seem to be an influencing factor based on the functional DC vaccine analyses that we made (see Section 2. Results).

Interesting remarks from Flipper44
Quote:
They injected into the node, which, unfortunately, does not allow the natural final dendritic migration activation. (flipper44)

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144037723

Regarding injection internodally versus injection interdermally, and how dendritic cells perform better, activate better, and migrate better when injected intradermally see post sentiment: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144040212

Flipper’s post 192523 about a DC Train: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144041171
Recent NWBO News

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Kona Gold Beverage, Inc Expands Sales Team KGKG Aug 8, 2022 9:00 AM

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Mru Patel Appointed Non-Executive Director of Axis Technologies Group, Inc. AXTG Aug 5, 2022 9:00 AM

HealthLynked to Premier "Forever: The End of Aging" Medical Documentary atCMX CinéBistro Theater in Naples, Florida on August 28th HLYK Aug 5, 2022 8:00 AM

Progressive Care Announces Shareholder Conference Call and Business Update on August 11, 2022 RXMD Aug 5, 2022 7:15 AM

IGEN announces Net Profit for Second Quarter 2022 IGEN Aug 5, 2022 7:08 AM

Kaya Holdings to Seek Licenses for First Ever State Legal Psilocybin Manufacturing and Facilitation Service Centers in Oregon KAYS Aug 4, 2022 12:44 PM

American Rebel Holdings Completes Acquisition of Champion Safe Company, Solidifying A Leading Position in Safe Industry AREBW Aug 4, 2022 10:27 AM

OTC: ILUS, ILUS International (Ilustrato Pictures International Inc), Summarizes Its Second Quarter of 2022 Results, Including a 588% Revenue Increase Over the Same Period in 2021 ILUS Aug 4, 2022 10:19 AM

New Intranet- and Cloud-based Monitoring and Management Interface Enhances ResGreen's BotWay Software RGGI Aug 3, 2022 10:53 AM

Todos Medical Initiates Validation Plan for PCR-based MonkeyPox Test at CLIA/CAP Clinical Testing Laboratory Provista Diagnostics TOMDF Aug 3, 2022 9:48 AM

EV TECHNOLOGY GROUP ANNOUNCES AGREEMENT TO ACQUIRE UP TO 100% OF FABLINK GROUP, SPEARHEADING FUTURE GLOBAL GROWTH EVTG Aug 3, 2022 9:39 AM

PSYC Corp's Psychedelic Spotlight Surpasses One Million Page Views for Third Consecutive Month PSYC Aug 3, 2022 8:30 AM

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