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HyGro,
Dr. Liau has joined the SAB at NWBO!
Combo is King!
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172749240
Yes, that’s a good idea! Thanks HyGro!
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
HyGro,
Thanks for the reply. Dr. Linda Liau is now on the NWBO SAB! Exciting times!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172875571
learningcurve2020,
I have been recommending the JCI article that you provided for us recently. It is highly relevant and has further enlightened our understanding of the significance of the DCVax-L cell-based technology as a platform.
Combo is King!
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh #CancerResearch #Cancers #cancermoonshot #GBM #Immunotherapy #oncology $nwbo #murcidencel #DCVax #CellTherapy https://t.co/BnJHM3myP9 Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
The DCVax-L cell-based platform technology is a fascinating medical innovation to research and read about. In combination with other technologies, it is even more intriguing!
Combo is King!
https://www.jci.org/articles/view/169314
https://doi.org/10.3171/2020.12.FOCUS20954
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/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
FDA is of course the focus, but I think that the U.K. will prove vastly significant too! King’s College and the Specials Program and MHRA developments are all very significant!
Additionally, I recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology. Stay tuned!
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172639755%5B/color%5D
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
Seek trustworthy full-context sources and independently verify facts. Consider statements published online from those who disclose their conflicts, and weigh opinions critically.
ex,
Thanks for the reply. Yes, it is exciting to see immunotherapy combos emerging from clinical trials with brilliant efficacy—Combo is King!
Nobody seems to ever mention the DCVax-L P3 without also mentioning the UCLA combo!
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
You are again reposting disinformation from Reddit and your assertions are mixed up and misleading, but thank you for again highlighting the combo study that is ongoing at UCLA today …
Combo is King!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172749240
Seek verifiable sources and consider refocusing on what matters. I believe that you are distracted from the vast significance of Liau’s work and the further development of this technology in combination with other technologies. DCVax-L is already supported by peer-reviewed clinical evidence, but there is much more to the story that is yet to unfold, and the SP will follow the regulatory developments worldwide.
Targeted individualized combo therapies are emerging as the defining feature of a new era of oncology. Just look at the impact that PD1 blockade technology has had on the field of oncology in recent years!
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
The P3 study of the DCVax-L cell-based platform technology is a landmark trial.
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
LC,
You are 100% correct—that would be stupid!
Seek trustworthy full-context sources and verify statements posted online. Do your own research.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172848430
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
LC,
Thanks for the reply. Anyone may email the company, and there is nothing that needs to be settled.
https://doi.org/10.3171/2020.12.FOCUS20954
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thanks for the reply, but you are again reposting disinformation from Reddit.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172749240
Seek verifiable sources and consider refocusing on what matters. I believe that you are distracted from the vast significance of Liau’s work and the further development of this technology in combination with other technologies. DCVax-L is already supported by peer-reviewed clinical evidence, but there is much more to the story that is yet to unfold, and the SP will follow the regulatory developments worldwide.
Targeted individualized combo therapies are emerging as the defining feature of a new era of oncology. Just look at the impact that PD1 blockade technology has had on the field of oncology in recent years!
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
The P3 study of the DCVax-L cell-based platform technology is a landmark trial.
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thank you for highlighting the NIH and the vast significance of Liau’s work and the further development of this technology in combination with other technologies. DCVax-L is already supported by peer-reviewed clinical evidence, but there is much more to the story that is yet to unfold.
Targeted individualized combo therapies are emerging as the defining feature of a new era of oncology. Just look at the impact that PD1 blockade technology has had on the field of oncology in recent years!
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
The P3 study of the DCVax-L cell-based platform technology is a landmark trial.
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
HyGro,
What do you think about the interim survival data of the UCLA combo study?
Merck is doing the Pragmatica trial that is described in the NCI interview linked below.
https://www.urotoday.com/video-lectures/asco-gu-2023/video/3244-new-nci-fda-unit-aims-to-streamline-drug-development-for-cancer-patients-michael-morris.html
https://www.cancer.gov/types/lung/research/pragmatica-lung-cancer-trial
Exactly.
Yes, the original study took many years because they captured OS data and participants lived long, but any studies following commercialization could be much more swift.
DCVax-L has such a solid safety profile—I think that it can move rapidly through clinical investigations for other cancers once it is initially approved for GBM.
This was another insightful idea that was sparked by learningcurve2020’s comment yesterday about the possibility of future combinations with
DCVax-L
https://www.urotoday.com/video-lectures/asco-gu-2023/video/3244-new-nci-fda-unit-aims-to-streamline-drug-development-for-cancer-patients-michael-morris.html
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
brazen22,
You are never going to see the FDA or MHRA allow trials to treat patients like lab rats.
If you prefer a randomized placebo design, then you’ll love the pembrolizumab PD1 blockade combo study that is ongoing at UCLA today. The study has a placebo design because the placebo participants are receiving DCVax-L as the best available therapy for rGBM.
https://classic.clinicaltrials.gov/ct2/show/NCT04201873
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
brazen22,
Yes, I read that one. In my view, it is very similar to your other posted citations that all make the case for phase 4 investigation. Data should be gathered in support of all newly commercialized drugs, and I think that any physician would support further data collection — phase 4 can also lead to further development and broader application across oncology or perhaps beyond oncology.
The reason why we cannot expect a placebo design is because GBM is somewhat unique, and a placebo design would require trial physicians to treat participants without clinically appropriate compassion.
The UCLA combo study is using a placebo design because the placebo participants are receiving a treatment that is efficacious for rGBM.
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
brazen22,
I highly recommend that you study the article that learningcurve2020 provided for us yesterday. It is highly relevant and will help enlighten your understanding of the significance of the DCVax-L cell-based platform technology.
Combo is King!
https://www.jci.org/articles/view/169314
HyGro,
You posted a hundred times referring to the Keytruda combo with “DCVax-L” Now you want us to believe that it’s not DCVax-L?
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Although your post includes disinformation from Reddit, we do appreciate that you highlighted the pembrolizumab combo study once again.
Try to avoid the distractions and refocus on the vast significance of Liau’s work and the further development of this technology in combination with other technologies. DCVax-L is already supported by peer-reviewed clinical evidence, but there is much more to the story that is yet to unfold …
https://www.jci.org/articles/view/169314
Targeted individualized combo therapies are emerging as the defining feature of a new era of oncology. Just look at the impact that PD1 blockade technology has had on the field of oncology in recent years!
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
The P3 study of the DCVax-L cell-based platform technology is a landmark trial.
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
HyGro,
Your statements are verifiably false. Read the UCLA article:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
aesop1, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh
Yes, the PIP is a prerequisite for MAA and the PIP was approved by MHRA.
https://markets.businessinsider.com/news/stocks/northwest-biotherapeutics-receives-final-approval-of-pip-from-mhra-1031700904
It is also noteworthy that the U.K. has been supporting compassionate use through their Specials Program, and MHRA recently granted the MIA license in March.
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
Thanks again for posting the article from Imperial College London News yesterday!
https://www.gov.uk/guidance/guidance-on-project-orbis
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
brazen22,
I agree 100% that it is wise to seek and consider the professional and independent opinions of more than one physician.
Yes, I saw the whole video when it was posted online. He suggested vaguely that he wasn’t the only one who wanted further data. I cannot comment on who those others might be, but I would consider the opinions of all those who disclose their conflicts, and I would weigh their statements critically.
Yes, further investigation is a valid request and a valid basis for an opinion. The only issue is that GBM is somewhat unique, and a placebo design would require trial physicians to treat trial participants without clinically appropriate compassion.
Published peer-reviewed literature is the most reliable source of information about clinical trials because the peer-reviewers are selected by the journal and those reviewers are independent.
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.jci.org/articles/view/169314
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
brazen22,
I only saw one doctor in the video that you posted aside from the interviewer, but I would consider the opinions of all those who disclose their conflicts and I would weigh their statements critically.
Yes, further investigation is a valid request and a valid basis for an opinion. The only issue is that GBM is somewhat unique, and a placebo design would require treating trial participants without clinically appropriate compassion.
At least we’re discussing licensed doctors now, so that’s a step up!
Published peer-reviewed literature is another reliable source.
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
brazen22,
Thank you—this is a bit of progress! Dr. Malkin has some conflicts as I believe he’s involved in developing other GBM treatments, but his views are still valid as the opinion of one individual.
I saw the interview and I think he’s making the case for phase 4 investigation. Data should be gathered for all newly commercialized drugs and I think any physician would support further investigation.
He commented on only one of the clinical trials involving DCVax-L, and I would be interested to hear his commentary on the others, especially since the release of the interim survival data for the pembrolizumab combo study that is ongoing at UCLA today.
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
brazen22,
Compare those results to the smallpox
This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
— JAMA Oncology (@JAMAOnc) February 15, 2023
learningcurve2020,
Thanks for the reply! You raise an excellent point!
I agree—with so many solid tumor cancers, the DCVax-L platform technology will be studied well into the future. Keytruda is the perfect example of this—Pembrolizumab is a blockbuster drug and has been included in many more clinical trials for years following its original approval and commercialization so many years ago!
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.jci.org/articles/view/169314
brazen22,
Thanks for reposting your ideas again, but you are misinformed. Seek credible full-context sources, including published peer-reviewed literature and licensed oncologists.
PFS is an intermediate endpoint that can only predict the hard endpoint of OS.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172692156
learningcurve2020,
Thank you for posting the article that links to JCI! I think that PD1 blockade technology in combo with the DCVax-L cell-based platform technology will reshape the field of immunotherapy in oncology! It will be exciting to see more clinical data following the recent release of interim results from the UCLA pembrolizumab DCVax-L combo study!
https://www.jci.org/articles/view/169314
Targeted individualized combo therapies are emerging as the defining feature of a new era of oncology. Just look at the impact that PD1 blockade technology has had on the field of oncology in recent years!
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
The P3 study of the DCVax-L cell-based platform technology is a landmark trial.
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
aesop1, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh
Thanks for posting the article from Imperial College London News!
https://www.gov.uk/guidance/guidance-on-project-orbis
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
exwannabe, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh
Thanks for posting about MHRA! The regulatory agency across the pond is highly relevant and very significant in light of the recent news…
I recommend that you also keep an eye out for the forthcoming NICE appraisal of the DCVax-L cell-based technology.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
HyGro,
Thanks for reposting that again, but you are still misinformed …
Are you referring to the DCVax-L cell-based platform technology and the independent peer review of the landmark P3 study that was published in JAMA Oncology?
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
For information about the ECA/crossover design, endpoints, and the SAP, please review the video recording of Dr. Ashkan at ASCO 2022 and the JAMA Oncology podcast recording of Dr. Liau. Both recordings are included at the links below.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172692156
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
Thanks for reposting your thoughts again, but you are still mixed up.
For information about the ECA/crossover design, endpoints, and the SAP, please review the video recording of Dr. Ashkan at ASCO 2022 and the JAMA Oncology podcast recording of Dr. Liau. Both recordings are included at the links below.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254048
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171254756
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172692156
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
HyGro,
Thanks for the reply.
Are you referring to the DCVax-L cell-based platform technology and the independent peer review of the landmark P3 study that was published in JAMA Oncology?
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172692156
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
— JAMA Oncology (@JAMAOnc) February 15, 2023
brazen22, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh #CancerResearch #Cancers #cancermoonshot #GBM #Immunotherapy #oncology $nwbo #murcidencel #DCVax #CellTherapy https://t.co/BnJHM3myP9
I hear you—we are all eagerly anticipating press on regulatory advisory.
FDA is of course the focus, but I think that the U.K. will prove vastly significant too! King’s College and the Specials Program and MHRA developments are all very significant!
Additionally, I recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology. Stay tuned!
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172639755%5B/color%5D
exwannabe, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
It sounds like you need some better sources. I recommend JAMA Oncology, UCLA, Brown University, and King’s College.
Doctors at the Lifespan hospital were on the news again earlier this month highlighting the unmet medical need of GBM and the need for more approved treatment options. They again referred to DCVax-L as a medical “breakthrough” just as they did at the press conference following the publication of the independent peer review.
One of the greatest aspects of immunotherapy such as DCVax-L is that it may be efficacious in combination with a number of other therapies. The pembrolizumab combo is the most exciting and noteworthy combination therapy in my opinion, and I hope that we will see more PD1 combo studies with the DCVax-L platform for cancers beyond nGBM and rGBM.
https://www.lifespan.org/centers-services/brain-and-spine-tumor-center
https://www.wpri.com/health/brain-breakthrough-ri-researchers-working-to-make-progress-against-glioblastoma/
Refocus from distractions and consider the integrity of the science.
https://www.fda.gov/drugs/development-approval-process-drugs
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
exwannabe,
Randomized setting? Are you referring to the randomized setting of the combo study at UCLA?
The DCVax-L cell-based platform technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
Exactly!
Thanks for the reply!
From your link on page 4:
https://www.fda.gov/media/71195/download
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172692156
Grip,
Thank you for reposting your opinion again.
The company is still very small, but the leadership are formidable and tenacious. The independent peer review took a long time too, but it was successfully completed and published in JAMA Oncology, and it is an asset as we move further into the regulatory process.
The CEO has been quite an effective and successful leader of a small clinical-stage biotech. She is responsible for leading the company to the point where NWBO now has a valuable cell-based platform technology that has completed all three phases of clinical investigation. PD1 combo and platform potential represent additional value beyond the P3...
DCVax-L has been investigated in other clinical trials and is currently being studied in combo with PD1 blockade at UCLA, and this novel technology will be studied in other combos and other cancers too. The CEO put the company in a position where these forthcoming developments are possible. After successful commercialization, we can learn a lot more about this technology as a platform.
The leadership team have positioned the company well globally and they have secured a solid comprehensive worldwide patent portfolio. The results presented in the JAMA publication represent the greatest prospective value that NWBO has ever had since the company was founded.
In my opinion, JAMA Oncology put Northwest Bio on the radar of institutional investors, and MHRA will likely be the next tipping point.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171297915
https://www.lifespan.org/centers-services/lifespan-cancer-institute
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
brazen22, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
Thanks for asking!
Here are some progress updates and news headlines that are a bit more recent than the 2018 article that you posted. I’m sure that you will find these recent developments representative of the greatest prospective value that the company has had since its founding:
https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143