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Once again, anyone can hear exactly what Dr. Ashkan actually said about the peer review:
Excellent post! The Brain Tumour Charity is a great source. Yes, the peer review will be crucial. I included the direct link to the full-context source from May:
https://www.thebraintumourcharity.org/media-centre/news/research-news/we-respond-to-promising-survival-data-from-phase-iii-trial-of-dcvax-l/
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
Yes! we await the independent peer review and SNO. Thankfully, those two developments are forthcoming—It won’t be too much longer.
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
https://soc-neuro-onc.org/
https://virtualtrials.org/dcvax.cfm
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal. In fact, Dr. Liau has authored over 170 peer-reviewed articles, several book chapters, and a textbook entitled Brain Tumor Immunotherapy. She is on the editorial boards of several scientific/medical journals and was the Editor-in-Chief of the Journal of Neuro-Oncology (2007–2017).
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
September 14, 2022 Update of NIH NCI Funding of Dr. Liau
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
9/14/2022
In a trial now underway, a dendritic cell vaccine is made from a participant's own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
"What I'm excited about is that we're seeing a growing number of long-term survivors in our patients treated with immunotherapy combinations," Dr. Liau says. "We're seeing some patients with certain combination immunotherapies that are living for many more years than would be expected. Currently, we're trying to find out what combination works best and for which patients."
I am sorry—I mentioned the NIH and its support for Dr. Liau, but I forgot to include the links. Please explore some of the links below to find the information that you need. Thanks!
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
https://virtualtrials.org/dcvax.cfm
Please review some of the links below. I believe you will discover that FDA-NIH has consistently supported DCVax and approved DCVax clinical trials including the current Keytruda combo study at UCLA which is also funded by Merck.
OS is the gold standard. Research this fact to verify it and to get greater context and a more clear understanding: PFS is a surrogate for OS and only used because its data are accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.
“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”
“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”
“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”
Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.
Quite simply:
You cannot mistake
the dead for the living.
That is why OS is the
gold standard.
“Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug”
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://virtualtrials.org/dcvax.cfm
Thank you for posting. In my view, often some stock shorts attempt to exploit SEC filings to manufacture and publish disinformation. Without its full context, any isolated SEC disclosure is a gross distortion of reality and is misleading. SEC filings are reliable, but they are SEC filings.
Research what these documents are and what their purpose is. Compare the SEC filings for other pre-commercial biotech companies and for well-established commercial companies. By comparison, in context, and with an informed perspective, you can understand their content and their actual significance.
Who on Earth has any guarantees of future events or full control over the choices and decisions of others? Is there any valuable company with zero risk? Apple? Tesla? Amazon? Pfizer? Even the best and the biggest have risks to report. NWBO is not yet commercial, yet some seem to expect it to have fewer risks than a commercial giant?
SEC filings are solid sources. To ensure a proper and accurate understanding of their meaning, they must be read in full and in context. Furthermore, the publication date must be considered for perspective in light of subsequent developments and relevant new circumstances.
Compare any company’s filing to NVCR’s filing which lists pages and pages of risks to investors that perhaps, in an expert’s opinion, might appear much more severe than anything in the NWBO filing as a pre-commercial company. Why not consult an actual expert and compare the business outlook of both companies side-by-side? Just look at all the risks to their future business and investors that Novocure has buried in their filing:
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25
https://www.sec.gov/edgar/browse/?CIK=0001072379
https://www.merck.com/investor-relations/financial-information/sec-filings/
I hear you. Maybe just try to relax and wait for the independent peer review and SNO. Those two forthcoming developments will clear up any uncertainty you have. It won’t be too much longer.
https://virtualtrials.org/dcvax.cfm
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
https://soc-neuro-onc.org/
The Celgene $74 billion deal is an interesting event in history to research and study. It’s enlightening to consider their science, safety/efficacy data, and price tag at buyout.
While I cannot make direct comparisons and I cannot make predictions, Celgene is one of many interesting history book stories to think about.
Immunomedics is another interesting recent acquisition. Gilead paid $21 billion for a technology that appeared far less impressive than DCVax if you consider their data.
Every major global pharmaceutical company has recognized that cell-based immunotherapy is the future of cancer treatment, and they are looking to buy the best emerging technologies at precisely the right time.
History and precedent with regard to other clinical-stage biotechs can help shape our understanding of all the possibilities that could materialize for the DCVax platform technology and for the company’s technology to manufacture at large scale.
The MC at the time of acquisition is hard to predict for any company considering how quickly it can rise. For DCVax, the big picture is much more interesting and enlightening: What is the technology worth as a platform and in combo? Years of safety/efficacy data from 94 trial sites globally and years of compassionate use safety/efficacy data are together the most reliable indicators of value. DCVax is already efficacious, but further development of the technology, innovations of methods of use, and indications beyond GBM are valuable beyond measure.
Additionally, we need to factor in the unmet need of rGBM. The rGBM data was a breakthrough discovery as survival was doubled for a stage of the disease for which there is no treatment to extend life.
Furthermore, the capacity to manufacture at large scale is another amazing factor to keep in mind.
Immunotherapy is the future of cancer treatment. FDA believes without question that cell-based science is worth their support and will ensure that the United States will lead the world in technologies to better address cancer, extend life, and ultimately reach a cure.
Steinman’s discovery of the dendritic cell won the Nobel Prize some years ago, and Dr. Liau’s work built upon his discovery and led to the discovery of how the dendritic cell-based technology can extend life for the deadliest cancer known to humankind. Dr. Liau deserves a Nobel Prize for her work and has already earned a worldwide reputation as an immunotherapy pioneer and scientific genius.
Dr. Liau is building upon the discoveries of scientists who have preceded her in time, and she is enlightening the future of immunotherapy with her groundbreaking work.
“I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.” —Hippocratic Oath
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
https://virtualtrials.org/dcvax.cfm
https://soc-neuro-onc.org/
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://www.fda.gov/about-fda/fda-organization/richard-pazdur
https://www.annalsofoncology.org/article/S09237534(22)00006-0/fulltext
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
https://www.webmd.com/cancer/cancer-in-context/video/richard-pazdur
https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda
Thank you for asking. Yes, the FDA approves clinical trials to commence and they must retain approval throughout the trial to reach its conclusion. For example, there is currently a DCVax Keytruda trial that is the most recently approved study for DCVax and is underway at UCLA today.
The global clinical P3 study provided the scientific data, but the “testimonials” are simply beautiful to look at—that is the purpose of “testimonials.”
Many of the survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
Yes, FDA has been crucial and has approved multiple DCVax studies and they have approved the current Keytruda combo study. I also agree that SNO is significant, but don’t forget all the other institutions that were involved leading up to SNO 2022 and the forthcoming peer-reviewed publication: NIH, King’s College, UCLA, MHRA, and the Nobel Prize-winning discovery of the dendritic cell that led to the landmark development of the DCVax platform technology…
These and so many more..
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
https://virtualtrials.org/dcvax.cfm
https://soc-neuro-onc.org/
Thank you for reposting that again tonight. I believe it is advisable to wait for the independent peer-review. Licensed independent physicians and qualified skilled statisticians will explain the significance of this landmark trial, its design, and its data. Avoid social media disinformation and anonymous message board postings.
As always, we appreciate your opinions about DCVax. We also value the ideas of investors in competing technologies. We like to hear from all sides and never mind seeing repetitive reposts. It’s always good to review and refocus and consider important points more than just one time. I would add that the opinions of licensed oncologists are valuable too and we must be careful to avoid disinformation about medical topics posted online. Please do your own research and consult licensed professionals and trustworthy sources.
Please review some of the links below. I believe you will discover that FDA-NIH has consistently supported DCVax and approved DCVax clinical trials including the current Keytruda combo study at UCLA which is also funded by Merck.
OS is the gold standard. Research this fact to verify it and to get greater context and a more clear understanding: PFS is a surrogate for OS and only used because its data are accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.
“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”
“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”
“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”
Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.
Quite simply:
You cannot mistake
the dead for the living.
That is why OS is the
gold standard.
Most recent news and events:
https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
Dr. Ashkan, a world-renowned clinical trial expert and an advisor to the U.K. government, presents DCVax P3 data.
https://soc-neuro-onc.org/
Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial Plenary Abstract Presenter: Linda M. M. Liau, MD PhD
- University of California, Los Angeles
https://nwbio.com/press-releases/
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted. Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://youtu.be/Oq39FFUwKug
UCLA Presentaion
DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
Yes, you are correct that the FDA is crucial and I certainly would agree with that. The U.S. government (FDA-NIH NCI) is largely responsible for the development of the DCVax platform technology as they have always supported and funded Liau’s work. The 20 consecutive years of NIH funding of Dr. Liau have played a direct and crucial role in DCVax. Together with Merck, NIH is funding the DCVax doses going into arms TODAY in a study investigating its efficacy in combo with Keytruda.
FDA has approved multiple DCVax trials and their design including the ongoing Keytruda trial.
September 14, 2022 Update of NIH NCI Funding of Dr. Liau
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
9/14/2022
In a trial now underway, a dendritic cell vaccine is made from a participant's own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
"What I'm excited about is that we're seeing a growing number of long-term survivors in our patients treated with immunotherapy combinations," Dr. Liau says. "We're seeing some patients with certain combination immunotherapies that are living for many more years than would be expected. Currently, we're trying to find out what combination works best and for which patients."
https://cancer.ucla.edu/research/ucla-brain-spore
https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/
Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”
https://m.youtube.com/watch?v=Oq39FFUwKug
DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were SOC.
Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
https://clinicaltrials.gov/ct2/show/NCT04201873
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
https://soc-neuro-onc.org/
Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
https://virtualtrials.org/dcvax.cfm
Richard Pazdur, M.D. is the director of the FDA's Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA's regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
Pazdur has published more than 400 articles, book chapters and abstracts. In 2015, Fortune magazine named Pazdur as one of the 50 World’s Greatest Leaders. The American Association for Cancer Research recognized Pazdur with its Distinguished Public Service Award (2015) and the American Society of Clinical Oncology recognized him with the Service Recognition Award (2009) and the Public Service Award (2013). In 2015, Pazdur also received the Public Service Leadership Award from the National Coalition for Cancer Survivorship and also the Face of Hope Award from the LUNGevity Foundation. Most recently, in 2016, Pazdur was named to Massachusetts General Hospital Cancer Center’s “The One Hundred” list.
"Now we are in the era of immunotherapy"
-Richard Pazdur, MD
"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug
-Richard Pazdur, MD
"There's also been a revolution in tumor immunology. Before, in my early career, tumor immunology was looked at kind of as black magic, as witchcraft. Now it's accepted."
-Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
https://www.webmd.com/cancer/cancer-in-context/video/richard-pazdur
https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda
So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
https://m.youtube.com/watch?v=K9azZaIwOH8&feature=youtu.be
Other Relevant Links:
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://virtualtrials.org/dcvax.cfm
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Thanks for your perspective. I would like to offer a simple thought experiment to demonstrate my own perspective on the topic:
Would anyone prefer the appearance of PFS measured by an image or real survival measured in time? Of course survival matters more than a picture. Ask any dead person …
There are many sources online about this topic. For one example, review Liau’s recent Grand Rounds presentation:
Thank you for reposting that again. Wait for the independent peer-review. Licensed independent physicians and qualified skilled statisticians will explain the significance of this landmark trial, its design, and its data. Avoid social media disinformation and anonymous message board postings.
As always, we appreciate your opinions about DCVax. We also value the ideas of investors in competing technologies. We like to hear from all sides and never mind seeing repetitive reposts. It’s always good to review and refocus and consider important points more than just one time. I would add that the opinions of licensed oncologists are valuable too and we must be careful to avoid disinformation about medical topics posted online. Please do your own research and consult licensed professionals and trustworthy sources.
Please review some of the links below. I believe you will discover that FDA-NIH has consistently supported DCVax and approved DCVax clinical trials including the current Keytruda combo study at UCLA which is also funded by Merck.
OS is the gold standard. Research this fact to verify it and to get greater context and a more clear understanding: PFS is a surrogate for OS and only used because its data are accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.
“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”
“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”
“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”
Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.
Quite simply:
You cannot mistake
the dead for the living.
That is why OS is the
gold standard.
Most recent news and events:
https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
Dr. Ashkan, a world-renowned clinical trial expert and an advisor to the U.K. government, presents DCVax P3 data.
https://soc-neuro-onc.org/
Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial Plenary Abstract Presenter: Linda M. M. Liau, MD PhD
- University of California, Los Angeles
https://nwbio.com/press-releases/
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted. Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://youtu.be/Oq39FFUwKug
UCLA Presentaion
DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
Yes, you are correct that the FDA is crucial and I certainly would agree with that. The U.S. government (FDA-NIH NCI) is largely responsible for the development of the DCVax platform technology as they have always supported and funded Liau’s work. The 20 consecutive years of NIH funding of Dr. Liau have played a direct and crucial role in DCVax. Together with Merck, NIH is funding the DCVax doses going into arms TODAY in a study investigating its efficacy in combo with Keytruda.
FDA has approved multiple DCVax trials and their design including the ongoing Keytruda trial.
September 14, 2022 Update of NIH NCI Funding of Dr. Liau
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
9/14/2022
In a trial now underway, a dendritic cell vaccine is made from a participant's own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
"What I'm excited about is that we're seeing a growing number of long-term survivors in our patients treated with immunotherapy combinations," Dr. Liau says. "We're seeing some patients with certain combination immunotherapies that are living for many more years than would be expected. Currently, we're trying to find out what combination works best and for which patients."
https://cancer.ucla.edu/research/ucla-brain-spore
https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/
Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”
https://m.youtube.com/watch?v=Oq39FFUwKug
DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were SOC.
Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
https://clinicaltrials.gov/ct2/show/NCT04201873
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
https://soc-neuro-onc.org/
Across the pond from Dr. Liau, Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
https://virtualtrials.org/dcvax.cfm
Richard Pazdur, M.D. is the director of the FDA's Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA's regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
Pazdur has published more than 400 articles, book chapters and abstracts. In 2015, Fortune magazine named Pazdur as one of the 50 World’s Greatest Leaders. The American Association for Cancer Research recognized Pazdur with its Distinguished Public Service Award (2015) and the American Society of Clinical Oncology recognized him with the Service Recognition Award (2009) and the Public Service Award (2013). In 2015, Pazdur also received the Public Service Leadership Award from the National Coalition for Cancer Survivorship and also the Face of Hope Award from the LUNGevity Foundation. Most recently, in 2016, Pazdur was named to Massachusetts General Hospital Cancer Center’s “The One Hundred” list.
"Now we are in the era of immunotherapy"
-Richard Pazdur, MD
"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug
-Richard Pazdur, MD
"There's also been a revolution in tumor immunology. Before, in my early career, tumor immunology was looked at kind of as black magic, as witchcraft. Now it's accepted."
-Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
https://www.webmd.com/cancer/cancer-in-context/video/richard-pazdur
https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda
So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
https://m.youtube.com/watch?v=K9azZaIwOH8&feature=youtu.be
Other Relevant Links:
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://virtualtrials.org/dcvax.cfm
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Yes, and some specific named sources too! The forthcoming peer review will include some names as well. Excellent point!
https://virtualtrials.org/dcvax.cfm
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
Me too! I agree 100%
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
https://virtualtrials.org/dcvax.cfm
Thanks for the post. I believe that the sources linked below can help clear up any misunderstanding.
The P3 was designed and led by clinical trial experts, both with long-standing connections to their respective government’s regulators. Liau has been directly supported by FDA-NIH NCI for 20 consecutive years and continues to receive their support.
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal. In fact, Dr. Liau has authored over 170 peer-reviewed articles, several book chapters, and a textbook entitled Brain Tumor Immunotherapy. She is on the editorial boards of several scientific/medical journals and was the Editor-in-Chief of the Journal of Neuro-Oncology (2007–2017).
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
I didn’t miss it. You were indicating that you did not ask about any of these things:
Dr. Stupp is responsible for the current SOC for GBM, but he asserts that his protocol does not work at all for rGBM (recurrent). https://www.feinberg.northwestern.edu/faculty-profiles/az/profile.html?xid=37377
https://www.youtube.com/embed/aHBkOhkKsrk
Dr. Stupp asserts that rGBM is a “major unmet need” (minute 13:35) He highlights that no SOC treatment works for recurrent & that survival is always the same with current therapies (14:36). He asserts that bureaucracy obstructs new advances.
https://virtualtrials.org/dcvax.cfm
https://soc-neuro-onc.org/
You’re welcome. Thank you for posting.
https://www.youtube.com/embed/aHBkOhkKsrk
Dr. Stupp asserts that rGBM is a “major unmet need” (minute 13:35) He highlights that no SOC treatment works for recurrent & that survival is always the same with current therapies (14:36). He asserts that bureaucracy obstructs new advances.
https://virtualtrials.org/dcvax.cfm
https://soc-neuro-onc.org/
Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial Plenary Abstract Presenter: Linda M. M. Liau, MD PhD
- University of California, Los Angeles
Oh, I thought you were interested in hearing about how there is no approved treatment for rGBM that extends life. The only treatments are for comfort. Avastin is approved for rGBM but its clinical data seem to have not demonstrated any benefit in terms of survival as indicated in the graphics posted below. I thought you were asking about the significance of an unmet medical need and orphan designation, but perhaps others will be interested:
https://www.youtube.com/embed/aHBkOhkKsrk
Dr. Stupp asserts that rGBM is a “major unmet need” (minute 13:35) He highlights that no SOC treatment works for recurrent & that survival is always the same with current therapies (14:36). He asserts that bureaucracy obstructs new advances.
That is an excellent question. Thank you for asking again. The significance of an unmet need and orphan status is quite meaningful with regard to the P3 safety and efficacy results which represent a desperately needed achievement.
We are talking about GBM and rGBM. The latter does not have a “SOC” to extend life at all. Dr. Stupp created the SOC for GBM and he admits that SOC is useless for rGBM.
https://www.youtube.com/embed/aHBkOhkKsrk
Dr. Stupp asserts that rGBM is a “major unmet need” (minute 13:35) He highlights that no SOC treatment works for recurrent & that survival is always the same with current therapies (14:36). He asserts that bureaucracy obstructs new advances.
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products
https://virtualtrials.org/dcvax.cfm
https://soc-neuro-onc.org/
Autologous tumor lysate-loaded dendritic cell vaccination improves survival in patients with newly diagnosed and recurrent glioblastoma: survival results from a phase 3 trial Plenary Abstract Presenter: Linda M. M. Liau, MD PhD
- University of California, Los Angeles
No, they have different roles in pursuit of a common goal. NIH helps to develop drugs and FDA approves drugs.
Source links for some of the most recent and commonly cited Pazdur quotes and FDA references:
https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda
https://t.co/tdSq98eqIK
https://rwe.flatiron.com/video/real-world-evidence-fda
https://www.fda.gov/about-fda/fda-organization/richard-pazdur
https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Do your own research to understand the relationship between FDA and NIH in recent years. Their relationship is quite fascinating and it’s interesting to research exactly how they operate. Thank you for bringing a spotlight to this topic.
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
Your questions are helpful. They remind us of the great value of full-context direct sources. NWBO investors are quite interested in the FDA and NIH at this stage of the years-long game. I have included the source links for some of the most recent and commonly cited Pazdur quotes and FDA references:
https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda
https://t.co/tdSq98eqIK
https://rwe.flatiron.com/video/real-world-evidence-fda
https://www.fda.gov/about-fda/fda-organization/richard-pazdur
https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
You are correct. Thank you for helping to clarify his position on external controls and placebo in trials involving deadly diseases. It is really important to understand what the leader of the FDA has to say about that. His recent article linked below includes a wealth of information which everyone can read in full context for themselves.
You are correct—the head of the FDA cannot and does not publicly comment on any specific drug candidate or investigational new technology that will come before the FDA for evaluation. Pazdur’s words were not in reference to any specific drug or technology. He was speaking in general terms:
“Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug
-Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Thank you for requesting further clarification. Pazdur’s words were not in reference to any specific drug or technology. He was speaking in general terms:
“Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug
-Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
You are correct—my posting was unclear and confusing. Thank you for requesting clarification.
Let me repost to clarify:
Please consider the sources linked below and research whether there is anyone more experienced, talented, and qualified to conduct a cancer study than Dr. Liau and Dr. Ashkan.
Explore the links below relating to Dr. Pazdur of the FDA. Pazdur’s words are included below inside quotation marks. His words are also included in his article: https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
I suggest that you also research how the external contemporaneous controls were selected by an independent firm. Consider that the crossover was not only approved by the FDA as clinically appropriate, it was required. In my view, the FDA’s job is to protect trial participants. When a trial participant with deadly GBM is presenting symptoms of progression, they must be allowed to crossover. Forcing any patient to remain as a placebo subject would be insane and gruesome. Additionally, nobody would agree to it.
Both Pazdur and Liau have explained the obvious—nothing could ever be studied for the deadliest diseases if placebo is required.
For one example, review Liau’s recent Grand Rounds presentation beginning around minute 36:00.
When a trial participant with deadly GBM is presenting symptoms of progression, they must be allowed to crossover. Forcing patients to remain as a placebo subject would be insane and gruesome. Additionally, nobody would agree to it.
Both Pazdur and Liau have explained the obvious—nothing could ever be studied for the deadliest diseases if placebo is required.
For one example, review Liau’s recent Grand Rounds presentation beginning around minute 36:00.
The Pazdur quotes are in “quotes.” Don’t mistake my words for his.
I was listing topics to research.
It really is not all about shares—it’s about human life and easing the suffering of the most vulnerable. I am invested for both health and wealth, but it is important to maintain a balanced perspective that takes into account the fact that our investment is also about medical science. The best understanding of DCVax as an investment will follow an understanding of the science. This is why we are all eagerly awaiting the peer review.
Don’t misunderstand— I love the discussions about share price and I participate in those discussions too … I’m just hoping to see more on the science side soon.
https://virtualtrials.org/dcvax.cfm
https://soc-neuro-onc.org/
Thanks for reposting your opinions again. Please consider the sources linked below and research whether there is anyone more experienced, talented, and qualified to conduct a cancer study than Dr. Liau and Dr. Ashkan.
Additionally, explore the links below relating to Dr. Pazdur of the FDA. Research how the external contemporaneous controls were selected by an independent firm. The crossover was not only approved by the FDA as clinically appropriate, it was required.
The P3 was designed and led by these two clinical trial experts, both with long-standing connections to their respective government’s regulators. Liau has been directly supported by FDA-NIH NCI for 20 consecutive years and continues to receive their support.
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal. In fact, Dr. Liau has authored over 170 peer-reviewed articles, several book chapters, and a textbook entitled Brain Tumor Immunotherapy. She is on the editorial boards of several scientific/medical journals and was the Editor-in-Chief of the Journal of Neuro-Oncology (2007–2017).
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
Simply beautiful…
I love science and I love public research institutions and public institutions of education. In light of the decades-long relationship between NIH and UCLA in support of Dr. Liau, I find their mission statement especially meaningful and beautiful. Someone posted this mission statement earlier today, and it really illuminates the DCVax story beautifully in my view…
https://www.nih.gov/about-nih/what-we-do/mission-goals
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
That’s right—everyone needs to do their own research to understand the relationship between FDA and NIH in recent years. Their relationship is quite fascinating and it’s interesting to research exactly how they operate. Thank you for bringing a spotlight to this topic.
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
Yes! I believe that is exactly correct—that is the mission of the NIH and that is exactly what they strive to do when investing public tax dollars. Thank you for posting that!
NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.