NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

Just trying to figure out why the Dr.Liau-Musella webinar was pushed out to 11/29.A prior Twitter Tweet had said it was scheduled for 11/ 20 or 11/22 . Please post the answer. Her combo data released on 10/26/22 was very skinny , but very teasing . Amplification is needed . Moreover, how does 5 years of at least 5 combo trials get financed non dilutively?

https://twitter.com/AlMusella/status/1594804036271742988?cxt=HHwWmICxxcj08KEsAAAA

CaptainObvious

Re: None

Tuesday, November 22, 2022 4:42:37 AM

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537103
of 537143
https://virtualtrials.org/webinar/?fbclid=IwAR3fiiI08yASHYlrTP4_nVqIWf6wmxaCp8RxemrPH2RmAQaDKXjSljzs1wQ

Tuesday Nov 29, 2022 at 7pm Eastern:
Topic: DC-VAX
Speaker:Linda Liau, MD, PhD, MBA - the chair of the dept of neurosurgery at UCLA, and Professor and Director of the UCLA Brain Tumor Program. Dr. Liau's clinical expertise is in intra-operative functional brain mapping and use of intra-operative imaging for resection of brain tumors (gliomas, meningiomas, and metastatic tumors). Her research efforts are focused on the molecular biology of brain tumors, gene therapy, immunotherapy, and brain cancer vaccines.
Dr. Liau is the former Editor-in-Chief of the Journal of Neuro-Oncology.


https://nwbio.com/press-releases/

Tuesday, November 01, 2022 7:55:23 AM
Post# of 537079 Go
Dr.Linda Liau spoke at UPITT on 10/26/22. One of IHUB's NWBO posters who saw the slides(https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170325910) noted that one of Dr.Liau's five combination trials (Dc Vax L plus poly ICLC) was showing 50% of the patients living 10 years. GBM SOC offers 16 months MOS and 5% alive at 5 years.With GBM, is alive at 10 years remission or a cure ? Whether it's a checkpoint inhibitor or a TLR agonist , such as poly ICLC, all immunotherapies are more efficacious when coupled with Dc Vax L . As everyone knows from papers on Keytruda in GBM, it doesn't work.But when Keytruda is combined with Dc Vax L in GBM, then Keytruda is part of a working solution . Solid tumors represent 80 % of all cancer cases ; the other 20% are blood cancers . One analogy is that Dc Vax L is at the centerpoint of the axis of all immunotherapies, with a kaleidoscope of permutations and combinations all interacting with Dc Vax L; thus providing ever changing and improving combination immunotherapies.

ATLnsider

Re: None

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

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525614
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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 .( 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 . See cohort #3 )

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

(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.


ATLnsider

Re: norisknorewards post# 525810

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

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525818
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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



Monday, October 31, 2022 7:20:52 AM

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526230
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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170313367 (IHUB post 525614) (1)


https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170319105 (IHUB post 525818)(2)



https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170324870 (IHUB post 526081) (3)


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



Dendritic Cell Vaccine for Patients With Brain Tumors
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01204684
Recruitment Status : Active, not recruiting
First Posted : September 17, 2010
Last Update Posted : July 19, 2022
Sponsor:
Jonsson Comprehensive Cancer Center
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.

Condition or disease Intervention/treatment Phase
Glioma
Anaplastic Astrocytoma
Anaplastic Astro-oligodendroglioma
Glioblastoma
Biological: autologous tumor lysate-pulsed DC vaccination
Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod
Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC
Phase 2

Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma
Actual Study Start Date : October 8, 2010
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2025
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Vaccines
Genetic and Rare Diseases Information Center resources: Glioma Glioblastoma Oligodendroglioma Anaplastic Astrocytoma Neuroepithelioma
U.S. FDA Resources

Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: Tumor Lysate-pulsed DC vaccination
Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
Biological: autologous tumor lysate-pulsed DC vaccination
Experimental: Tumor lysate-pulsed DC vaccination+0.2% resiquimod.
Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod
Experimental: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.
Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).
Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC


Outcome Measures
Go to sections
Primary Outcome Measures :
Most effective combination of DC vaccine components [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
Time to tumor progression and overall survival [ Time Frame: 2 years ]

Eligibility Criteria
Go to sections
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
PATIENT ELIGIBILITY

Inclusion Criteria

Patients with newly diagnosed or recurrent glioma of WHO Grade III or IV {anaplastic astrocytoma (AA), anaplastic astro-oligodendroglioma (AO), or glioblastoma (GBM)} will be eligible for this protocol.
Patients must have had surgical resection at UCLA (University of California, Los Angeles), for which a separate informed consent was signed for the collection of their tumor prior to surgery.
After surgery, a pathological diagnosis of malignant glioma (WHO Grade III or IV) will need to be established.
Patients must be 18 years or older and able to read and understand the informed consent document. Patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
Patients must have a Karnofsky performance status (KPS) rating of > 60 prior to initiating treatment. Patients may be enrolled at a KPS of < 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of > 60 by the initiation of treatment.
Exclusion Criteria

Subjects with an active infection.
Inability to obtain informed consent because of psychiatric or complicating medical problems.
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator.
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception.
History of immunodeficiency (e.g., HIV) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy.
Subjects with organ allografts.
Inability or unwillingness to return for required visits and follow-up exams.
Subjects who have an uncontrolled systemic malignancy that is not in remission.
Contacts and Locations
Go to sections
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204684


Locations
United States, California
University of Los Angeles, California
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
More Information
Go to sections
Publications:
Liau LM, Black KL, Prins RM, Sykes SN, DiPatre PL, Cloughesy TF, Becker DP, Bronstein JM. Treatment of intracranial gliomas with bone marrow-derived dendritic cells pulsed with tumor antigens. J Neurosurg. 1999 Jun;90(6):1115-24.
Liau LM, Prins RM, Kiertscher SM, Odesa SK, Kremen TJ, Giovannone AJ, Lin JW, Chute DJ, Mischel PS, Cloughesy TF, Roth MD. Dendritic cell vaccination in glioblastoma patients induces systemic and intracranial T-cell responses modulated by the local central nervous system tumor microenvironment. Clin Cancer Res. 2005 Aug 1;11(15):5515-25.
Prins RM, Liau LM. Cellular immunity and immunotherapy of brain tumors. Front Biosci. 2004 Sep 1;9:3124-36. Review.
Prins RM, Cloughesy TF, Liau LM. Cytomegalovirus immunity after vaccination with autologous glioblastoma lysate. N Engl J Med. 2008 Jul 31;359(5):539-41. doi: 10.1056/NEJMc0804818.

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01204684 History of Changes
Other Study ID Numbers: 10-000202
First Posted: September 17, 2010 Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Keywords provided by Jonsson Comprehensive Cancer Center:
dendritic cells
glioma
vaccine
glioma of WHO Grade III or IV
Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs


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NWBO
Northwest Biotherapeutics Inc (QB)
0.99
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Volume: -
Bid: 0.9ATLnsider

Re: thermo post# 537012

Monday, November 21, 2022 9:20:09 PM

Post#
537065
of 537138
This is true thermo. Also, all 4 of the regulatory authorities, in the US, Canada, UK and Germany, approved the DCVax-L Phase III clinical trial SAP, comparing OS for nGBM and rGBM patients to the OS of external control arms (ECAs), before data-lock and before unblinding.

In addition, the lead regulatory authority (FDA) for this multi-national Phase III trial, required NWBio to include a crossover option for all patients in this trial.

The trial was a complete success, and it met both the Primary and Secondary endpoints with statistical significance. DCVax-L will be approved by all of the regulators (US, Canada, UK, Germany and the rest of the EU), for both unmethylated and methylated nGBM and rGBM patients.
Bullish
BULLISH

H2R

Re: None

Monday, November 21, 2022 9:45:53 PM

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537072
of 537139
US Media coverage may be better served next week as opposed to this Thanksgiving week. NWBO is never is a hurry. They like to take their time to do what sounds right to them. We may be impatient to have a major US media coverage, from WSJ to NYT, from Fox to MSBNC. They may be trying to time the best window given SNO and the JAMA JA. Just a thought.

Not worried one bit about the latest Fraudstein piece. At this stage, pieces are falling in place nicely, although slowly.

Also, the current https://jamanetwork.altmetric.com/details/138571371/news moved up today. Now 74 news outlet, some in Europe. Anyways.

Best of luck to Patients, NWBO, and Longs!
Bullish
BULLISH


Basin Street Blues

Re: None

Tuesday, November 22, 2022 5:07:43 AM

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537104
of 537142
Stat News hit piece DID NOT appear on BBG News Heat .

You`ll see the AI toggle bar at the top , and you can see I`ve got mine set to allow anything and everything .

When the 10/5/22 hit piece was published it appeared all over the Bloomberg `News Heat` page , at the time I immediately complained, showing them screen shots of the presentation , their response to me in writing at the time was Stat News are an accredited news vendor and that the piece was quite obviously clock bait , so `tough`...

Ofcourse the ramification of his hit piece and the concerted selling of 6m shares on the bid and consequential 14% headline ... did appear



CaptainObvious

Re: None

Tuesday, November 22, 2022 4:42:37 AM

Post#
537103
of 537143
https://virtualtrials.org/webinar/?fbclid=IwAR3fiiI08yASHYlrTP4_nVqIWf6wmxaCp8RxemrPH2RmAQaDKXjSljzs1wQ

Tuesday Nov 29, 2022 at 7pm Eastern:
Topic: DC-VAX
Speaker:Linda Liau, MD, PhD, MBA - the chair of the dept of neurosurgery at UCLA, and Professor and Director of the UCLA Brain Tumor Program. Dr. Liau's clinical expertise is in intra-operative functional brain mapping and use of intra-operative imaging for resection of brain tumors (gliomas, meningiomas, and metastatic tumors). Her research efforts are focused on the molecular biology of brain tumors, gene therapy, immunotherapy, and brain cancer vaccines.
Dr. Liau is the former Editor-in-Chief of the Journal of Neuro-Oncology.