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You exploit SEC filings to manufacture 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 you 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.
https://www.sec.gov/edgar/browse/?CIK=0001072379
https://www.merck.com/investor-relations/financial-information/sec-filings/
Consider companies such as Merck, Pfizer, and Bristol Meyers Squibb. They develop medical products involving scientists and doctors. There is also a business and finance side that funds research, development, manufacturing, and acquisitions. Some people work on the science while others are experts on the business side.
Billionaire Robert Hefner is also on the business side of the DCVax platform technology as an investor. He is billionaire expert on other technologies of global value. Hefner is old and has been researchable for many years. He is business expert whom we can vet. We can scrutinize his judgment and his global work over many decades. We can verify his net worth and professional resume to decide whether his opinion about the DCVax platform technology is a significant and valuable opinion.
Everyone should do their own thorough research of trustworthy sources and not accept anonymous disinformation as true. An independent medical peer review is forthcoming. There are also published sources available now such as those pasted below and many others which anyone can find and evaluate for themselves.
https://soc-neuro-onc.org/
https://www.uclahealth.org/providers/linda-liau
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
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
The recent developments are heating up for sure. Yes, I 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/
September 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.”
March 2021–
Supported by the NIH’s Brain Initiative and the National Cancer Institute’s Specialized Program of Research Excellence (SPORE) grant, Dr. Liau is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases. Engaging in research also makes her more effective bedside, she says.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful…”
November 2022–
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
https://www.uclahealth.org/providers/linda-liau
https://virtualtrials.org/dcvax.cfm
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
Fact check:
Research it for yourself:
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/2022/09/14/brain-cancer-discovery-clinical-trials/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
Thank you for publishing the slides. You are correct—everyone should study and research ALL of the slides to properly understand the landmark trial. Everyone should do thorough research of trustworthy sources and not accept anonymous disinformation as true. I agree 100%.
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”
I know exactly what you’re thinking—You think that everyone should do their own independent research about the DCVax global P3 and research the clinical investigators who designed and led the trial.
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
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://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://virtualtrials.org/dcvax.cfm
Yes—FDA is an important consideration. Thank you for again bringing more awareness to the years-long significant and meaningful connections among FDA—NIH—NCI—Dr. Liau—DCVax. I believe you are correct to imply that everyone should research these connections for themselves as they are becoming increasingly interesting connections while we await the peer review and regulatory process. It is always wise to verify facts and conduct your own independent research. Disinformation on social media abounds.
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://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
September 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.”
March 2021–
Supported by the NIH’s Brain Initiative and the National Cancer Institute’s Specialized Program of Research Excellence (SPORE) grant, Dr. Liau is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases. Engaging in research also makes her more effective bedside, she says.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful…”
November 2022–
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
“The annual SNO meeting is the academic and educational nexus for the latest findings from all neuro-oncology subspecialties and disciplines.”
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://www.uclahealth.org/providers/linda-liau
https://soc-neuro-onc.org/
https://virtualtrials.org/dcvax.cfm
I know what you mean—people publish baseless speculation and disinformation. It is always wise to verify facts and conduct your own independent research. Disinformation on social media abounds.
NIH has supported Dr. Liau for 20 consecutive years and is today funding DCVax combo research with Merck.
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://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
September 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.”
March 2021–
Supported by the NIH’s Brain Initiative and the National Cancer Institute’s Specialized Program of Research Excellence (SPORE) grant, Dr. Liau is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases. Engaging in research also makes her more effective bedside, she says.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful…”
November 2022–
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
“The annual SNO meeting is the academic and educational nexus for the latest findings from all neuro-oncology subspecialties and disciplines.”
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://www.uclahealth.org/providers/linda-liau
https://soc-neuro-onc.org/
https://virtualtrials.org/dcvax.cfm
Yes, thank you—you are correct to point out that there is a lot of disinformation about the trial, and people need to independently verify the facts for themselves.
The trial was a brilliant success and the independent peer review is forthcoming.
OS is the gold standard.
Anyone can research to verify that PFS is a surrogate for OS and only used because its data is 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:
Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.
The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.
Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
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://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://nwbio.com/press-releases/
More recent news and events:
I definitely know what you mean—The global trial was led by two world-renowned clinical trial experts, each with connections to their respective government’s regulators.
So, thank you for again bringing more awareness to the years-long significant and meaningful connections among FDA—NIH—NCI—Dr. Liau—DCVax. I believe you are correct to imply that everyone should research these connections for themselves as they are becoming increasingly interesting connections while we await the peer review and regulatory process. It is always wise to verify facts and conduct your own independent research. Disinformation on social media abounds.
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://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
September 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.”
March 2021–
Supported by the NIH’s Brain Initiative and the National Cancer Institute’s Specialized Program of Research Excellence (SPORE) grant, Dr. Liau is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases. Engaging in research also makes her more effective bedside, she says.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful…”
November 2022–
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
“The annual SNO meeting is the academic and educational nexus for the latest findings from all neuro-oncology subspecialties and disciplines.”
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://www.uclahealth.org/providers/linda-liau
https://soc-neuro-onc.org/
https://virtualtrials.org/dcvax.cfm
Thank you for once again highlighting this aspect of the P3 that is often misunderstood. The crossover trial design was approved by the FDA because it makes sense for GBM obviously. The FDA, the P3 investigators, and others have recently spoken on this topic.
The Crossover design was ethical, clinically appropriate, and approved by the FDA. It is also common sense to not withhold treatment from those facing imminently fatal disease recurrence.
"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
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.
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Pazdur previously served as the director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research and will continue to serve in OHOP as acting director. This Office was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer, as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging. As director of OHOP, Pazdur facilitated coordination of oncology activities across all FDA Centers and ensured an ongoing outreach and collaboration between the FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government. Pazdur was the director of the Division of Oncology Drug Products from September 1999 to May 2005.
Prior to joining the FDA, Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Pazdur was on the faculty of the M. D. Anderson Cancer Center from 1988 to 1999. During his tenure at the M. D. Anderson Cancer Center, Pazdur held administrative positions of assistant vice president for academic affairs, associate director of clinical trials administration (Division of Medicine) and director of educational programs (Division of Medicine).
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.
https://virtualtrials.org/dcvax.cfm
Thank you for reminding us about Pazdur’s position on this point:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
"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
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 previously served as the director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research and will continue to serve in OHOP as acting director. This Office was formed in 2005 to consolidate the review of drugs and therapeutic biologics for the diagnosis, treatment, and prevention of cancer, as well as the review of drugs and therapeutic biologics for hematologic diseases and for medical imaging. As director of OHOP, Pazdur facilitated coordination of oncology activities across all FDA Centers and ensured an ongoing outreach and collaboration between the FDA, the National Cancer Institute, and other cancer-related organizations within and outside of the government. Pazdur was the director of the Division of Oncology Drug Products from September 1999 to May 2005.
Prior to joining the FDA, Pazdur was professor of medicine at The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Pazdur was on the faculty of the M. D. Anderson Cancer Center from 1988 to 1999. During his tenure at the M. D. Anderson Cancer Center, Pazdur held administrative positions of assistant vice president for academic affairs, associate director of clinical trials administration (Division of Medicine) and director of educational programs (Division of Medicine). Pazdur served on the faculty of Wayne State University, Detroit, Michigan from 1982 to 1988.
Pazdur received his bachelor’s degree from Northwestern University (Evanston, Illinois), his M.D. from Loyola Stritch School of Medicine (Maywood, Illinois), and completed clinical training at Rush-Presbyterian St. Luke’s Medical Center (Chicago, Illinois) and the University of Chicago Hospitals and Clinics.
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.
https://virtualtrials.org/dcvax.cfm
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.
As usual, your postings always remind me of the most relevant fact regarding the exemplary global P3 and how it was carried out over the years to its successful completion: 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://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.
https://www.uclahealth.org/providers/linda-liau
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
Thank you for reminding us of these relevant facts!
Thank you for once again highlighting the verifiable NIH NCI support for DCVax which includes both historical support and current support today.
The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Many independent physicians have reviewed the immunotherapy work of Dr. Liau. Verify it for yourself.
The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.
Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”
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://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
Dr. Pazdur, FDA:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
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
The U.S. government (FDA-NIH NCI) is largely responsible for the invention and development of the DCVax platform technology. 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.
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”
Yes—the DCVax P3 was a breakthrough trial. The discovery of the dendritic cell was a Nobel Prize winning discovery years ago, and now the rGBM DCVax discovery is equally or more significant as a landmark discovery in the science of immunotherapy and oncology.
Clinical trials are about discovery. Discoveries are especially important for something like rGBM for which there is no treatment to extend life. Did you ever consider how the extremely profitable drug Viagra was discovered? The sildenafil compound was originally developed by Pfizer for the treatment of hypertension (high blood pressure) and angina pectoris (chest pain due to heart disease). During the heart clinical trials, researchers discovered that the drug was more effective at inducing erections than treating angina.
Were the erections an invalid discovery? Should the erections have been ignored? Should Pfizer have have not been allowed to make billions of dollars on sildenafil as an erection medication because it was being studied as a hypertension medication? Of course not. It was a discovery. FDA approved the drug and it was a discovery worth countless billions.
Thank you for posting an excerpt of the latest update from the NIH NCI funded work at UCLA. Here is the link so that everyone can read the entire article:
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
Thank you for again highlighting the exemplary design of the innovative, compassionate, and clinically appropriate P3 that is often misunderstood. The FDA, the P3 investigators, and others have recently spoken on this topic.
“Crossover was necessary for feasibility and ethical reasons:
—Necessary for enrollment and retention of patients in an era when immune therapies are not yet generally viewed as promising for cancer
—Important to justify all patients undergoing invasive leukapheresis procedure
—No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis”
"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
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.
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
OS is the gold standard and was always an endpoint.
Anyone can research for themselves to verify that PFS is a surrogate for OS and only used because its data is 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.”
The landmark trial was a brilliant success and the independent peer review is forthcoming.
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
Most recent news and events:
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
Yes—I agree 100% that peer review is of great value to the medical community and patient community. The forthcoming DCVax peer review will have a significant impact and will be the most reliable source in advance of FDA advisory.
Dr. Liau has authored over 170 peer-reviewed research articles, along with 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).
"Peer review has been the foundation of scholarly publishing and scientific communication since the 1665 publication of the Philosophical Transactions of the Royal Society. The benefits and advantages of peer review in scientific research, and particularly medical research, are manifold and manifest."
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
“The annual SNO meeting is the academic and educational nexus for the latest findings from all neuro-oncology subspecialties and disciplines.”
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://www.uclahealth.org/providers/linda-liau
https://soc-neuro-onc.org/
https://doi.org/10.3171/2020.12.FOCUS20954
https://virtualtrials.org/dcvax.cfm
That’s actually a wise statement, HyGro. You have been listening to me after all. You are correct—the forthcoming peer review will be a reliable source.
So, you do believe in the great value of peer review. That makes sense.
Dr. Liau has authored over 170 peer-reviewed research articles, along with 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).
"Peer review has been the foundation of scholarly publishing and scientific communication since the 1665 publication of the Philosophical Transactions of the Royal Society. The benefits and advantages of peer review in scientific research, and particularly medical research, are manifold and manifest."
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
“The annual SNO meeting is the academic and educational nexus for the latest findings from all neuro-oncology subspecialties and disciplines.”
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://www.uclahealth.org/providers/linda-liau
https://soc-neuro-onc.org/
https://doi.org/10.3171/2020.12.FOCUS20954
https://virtualtrials.org/dcvax.cfm
Dr. Liau is a renowned clinician of impeccable integrity. That’s important to understand whenever you mention “suspicions.” I am quite sure that you were not referring to the journal, its authors, or any of the reviewers chosen by the journal, but I wanted to highlight Dr. Liau’s well-deserved worldwide reputation.
Dr. Liau has authored over 170 peer-reviewed research articles, along with 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).
"Peer review has been the foundation of scholarly publishing and scientific communication since the 1665 publication of the Philosophical Transactions of the Royal Society. The benefits and advantages of peer review in scientific research, and particularly medical research, are manifold and manifest."
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
“The annual SNO meeting is the academic and educational nexus for the latest findings from all neuro-oncology subspecialties and disciplines.”
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://www.uclahealth.org/providers/linda-liau
https://soc-neuro-onc.org/
https://doi.org/10.3171/2020.12.FOCUS20954
https://virtualtrials.org/dcvax.cfm
Yes, I know what you’re thinking and I agree that waiting for the peer review is likely a wise move from a business perspective.
Dr. Liau has authored over 170 peer-reviewed research articles, along with 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://virtualtrials.org/dcvax.cfm
Thank you for another thought-provoking post … Yes, the regulatory process is moving forward. The U.K. seems to be taking the lead in progress toward commercial approval, and Pazdur’s FDA will move after a filing. The company seems to want the peer review to be published before anything else in the U.S.
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://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://nwbio.com/press-releases/
No, I was referring to the 20 consecutive years of NIH funding support of Dr. Liau’s brilliant work and the successful development of DCVax technology.
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
Yes, follow the money …
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Many independent physicians have reviewed the immunotherapy work of Dr. Liau. Verify it for yourself.
The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.
Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”
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/
I prefer not to talk about it … I am not a qualified source or oncologist … I instead like to post factual sources like these below. I can sometimes be repetitive with my factual source posts, but I am responding to repetition with repetition of my own, and that seems appropriate when the focus of the conversation goes astray. “The main thing is to keep the main thing the main thing” —Stephen Covey
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”
That’s my point. The trial was run by experts. I am not concerned about historical registry updates outside of the landmark trial. Some months back, the registry was getting all the attention while the breakthrough discovery was getting none. I think that should be reversed.
https://virtualtrials.org/dcvax.cfm
Specifically, I was responding to all the noise around the NIH registry update…
When you consider the fact that the global trial itself was led by two world-renowned clinical trial experts, it’s difficult to see why the NIH registry matters at all.
When you consider that the trial led to the discovery that DCVax doubles rGBM survival, it is difficult to see why the NIH registry matters at all.
When you consider the future implications beyond GBM/rGBM in terms of immunotherapy and oncology as a science, then the historical schedule of NIH registry updates seems like a distraction or means of spreading disinformation.
What prompted my post specifically was the mention of the NIH clinical trial registry. I was making the point that the trial data were like a blinding dawn of discovery and new light, while the registry is like the dark shadow cast by a single blade of grass. I’d rather enjoy the daylight than focus on a tiny shadow that has long since disappeared.
Thanks for asking.
https://virtualtrials.org/dcvax.cfm
The Celgene buyout 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.
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.
Yes, it was The Journal of Neuro-Oncology. So, Dr. Liau is also an expert in the medical peer-review process. She has extensive experience on both sides—both as author and as editor.
https://www.springer.com/journal/11060/
She was the editor-in-chief of a medical journal for 10 or 11 years …
That is a really interesting fact as we await the publication.
Any disinformation about the trial, its design, or its data. Anyone who reflects on those two factual points can see the truth.
The value of DCVax extends light years beyond just those two factual points, but we don’t even have to consider that.
There are two simple and independently verifiable facts that can clear up this line of disinformation: 1. Liau & Ashkan are clinical trial experts. 2. rGBM has no treatment at all.
Below are pasted factual starting points to verify these two points. There are many other searchable sources beyond these:
1. Liau and Ashkan are both world-renowned CLINICAL TRIAL EXPERTS:
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
Thoughtful post as usual … Here are some more thoughtful and recent factual sources and news links:
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”