Discover and read the best of Twitter Threads about #dcvaxl
Most recents (20)
$NWBO #DCVaxL
The #PolyICLC adjuvant has already been approved for adjuvant use in other cancers. Under new FDA rules, real world data and validation of the results already seen may make it very easy not only to expand the label and access to #Hiltonol, but also ease insurance / Medicare if
If #DCVaxL is approved. It should be straightforward to add #PolyICLC $NWBO.
See, “Poly ICLC (Hiltonol®): an immune adjuvant targeting the Toll-like receptor 3 (TLR3) pathway; approved for subsets of patients with squamous cell carcinoma”
cancerresearch.org/treatment-type…
See, “Poly ICLC (Hiltonol®): an immune adjuvant targeting the Toll-like receptor 3 (TLR3) pathway; approved for subsets of patients with squamous cell carcinoma”
cancerresearch.org/treatment-type…
A lot of people are starting to notice IMHO. $NWBO #DCVaxL
Phase 3 results: $NWBO #DCvaxL
Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination w/Extension of Survival Among Patients w/[BOTH] #NewlyDiagnosed & #Recurrent #Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial #CancerVaccine
jamanetwork.com/journals/jamao…
Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination w/Extension of Survival Among Patients w/[BOTH] #NewlyDiagnosed & #Recurrent #Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial #CancerVaccine
jamanetwork.com/journals/jamao…
Mind blowing interim, unpublished data #DCVaxL data from UCLA #DrLindaLiau presentation for use with adjuvant #PolyICLC #TLR3Agonist #Hiltonol #glioblastoma #cancervaccine
Granted: Commercial manufacturing license (MIA) at Sawston, for CDMO Advent at the $NWBO owned factory for manufacturing #DCVaxL, it’s successful #cancervaccine for #GBM & any solid tumor ultimately.
Next step, Marketing Approval, BLA.
cms.mhra.gov.uk/mhra/mia/uk-mi…
Next step, Marketing Approval, BLA.
cms.mhra.gov.uk/mhra/mia/uk-mi…
Background:
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
From July 6, 2022
nwbio.com/northwest-biot…
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
From July 6, 2022
nwbio.com/northwest-biot…
Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients w/Newly Diagnosed & Recurrent Glioblastoma: Phase 3 Prospective Externally Controlled Cohort Trial | JAMA Oncology $NWBO #DCVaxL #Phase3
jamanetwork.com/journals/jamao…
jamanetwork.com/journals/jamao…
Commercial manufacturing license for designated contract manufacturing manager for Sawston, the $NWBO factory for manufacturing #DCVaxL, it’s successful #cancervaccine for solid tumors, first for #GBM
Next step, commercial marketing approval, BLA, etc.
cms.mhra.gov.uk/mhra/mia/uk-mi
Next step, commercial marketing approval, BLA, etc.
cms.mhra.gov.uk/mhra/mia/uk-mi
Background:
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
From July 6, 2022
nwbio.com/northwest-biot…
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
From July 6, 2022
nwbio.com/northwest-biot…
Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients w/Newly Diagnosed & Recurrent Glioblastoma: Phase 3 Prospective Externally Controlled Cohort Trial | JAMA Oncology $NWBO #DCVaxL #Phase3
jamanetwork.com/journals/jamao…
jamanetwork.com/journals/jamao…
Gene Expression Profile Correlates with T-Cell Infiltration and Relative Survival in Glioblastoma Patients Vaccinated with Dendritic Cell Immunotherapy from 2011, #DCVaxL with #PolyICLC #Glioblastoma #GBM
aacrjournals.org/clincancerres/…
aacrjournals.org/clincancerres/…
#DCVaxL & #PolyICLC #TLR3Inhibitor as adjuvant, have been an impressive combination since 2011:
Results: DC vaccinations are safe and not associated with any dose-limiting toxicity.
Results: DC vaccinations are safe and not associated with any dose-limiting toxicity.
The median overall survival from the time of initial surgical diagnosis of glioblastoma was 31.4 months, with a 1-, 2-, and 3-year survival rate of 91%, 55%, and 47%, respectively.
Relatively New Program at FDA:
CDER’s Accelerating Rare disease Cures (ARC) Program via @YouTube
$NWBO #DCVaxL #GBM #orphandesignation
CDER’s Accelerating Rare disease Cures (ARC) Program via @YouTube
$NWBO #DCVaxL #GBM #orphandesignation
Accelerating Rare disease Cures (ARC) Program
CDER's ARC Program | Center for Drug Evaluation and Research (CDER)
fda.gov/about-fda/cent…
CDER's ARC Program | Center for Drug Evaluation and Research (CDER)
fda.gov/about-fda/cent…
From 2020: Brown establishes new Cancer Center dedicated to research, clinical developments | Brown University $NWBO #DCVaxL
Dr. Wafik El-Deiry brown.edu/news/2020-09-2…
Dr. Wafik El-Deiry brown.edu/news/2020-09-2…
His presence at this news conference was a significant sign of support and probably one reason why it was so high profile, at least locally. #DCVaxL $NWBO #BrownUniversity
Lifespan WPRI News Conference, Jan 6, 2022 Transcript
Lifespan WPRI News Conference, Jan 6, 2022 Transcript
$NWBO #DCVaxL
Interesting given some additional information in attached documents to that page, which I will include below this as a thread.
UK NICE updated status:
"DecisionAwaiting decision"
nice.org.uk/guidance/topic…
Interesting given some additional information in attached documents to that page, which I will include below this as a thread.
UK NICE updated status:
"DecisionAwaiting decision"
nice.org.uk/guidance/topic…
"Timing Issues...
Given the current absence of phase III trials for DCVaxL but the pending results of a phase III RCT trial, this NICE single technology appraisal would be better completed following publication of that study."
Given the current absence of phase III trials for DCVaxL but the pending results of a phase III RCT trial, this NICE single technology appraisal would be better completed following publication of that study."
..."Comment noted. NICE aims to publish guidance on cancer drugs within 90 days of marketing authorisation. Any requirements for potential delays will be taken into account as appropriate."
nice.org.uk/guidance/gid-t…
nice.org.uk/guidance/gid-t…
‘I’m just carrying on’: vaccine gives brain cancer patient years of extra life
The revolutionary DCVax-L vaccine has allowed Nigel French to live a normal life seven years after a brain cancer diagnosis #DCVaxL $NWBO #CancerVaccine #Glioblastoma #Phase3
theguardian.com/science/2022/n…
The revolutionary DCVax-L vaccine has allowed Nigel French to live a normal life seven years after a brain cancer diagnosis #DCVaxL $NWBO #CancerVaccine #Glioblastoma #Phase3
theguardian.com/science/2022/n…
Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma $NWBO #DCVaxL #CancerVaccine #GBM
A Phase 3 Prospective Externally Controlled Cohort Trial
jamanetwork.com/journals/jamao…
A Phase 3 Prospective Externally Controlled Cohort Trial
jamanetwork.com/journals/jamao…
More long-term Survivors, $NWBO #DCVaxL a personalized general therapeutic #CancerVaccine to treat any kind of solid tumor cancer anywhere in the body.
Exploring Adjuvants with #DCVaxL: POLY ICLC TLR 3 Agonist adjuvant discussion, #DrLindaLiau, early trial P 1. Using adjuvants w/ #DCVaxL $NWBO #Murcidencel #DCVax
Survival Data w/Adjuvants, small early trial:
Survival Data w/Adjuvants, small early trial:
Fuller Discussion re early trial with #DCVaxL + adjuvants, including Poly ICLC:
Re single agent checkpoint inhibitors, without DCVaxL, in Glioblastoma:
$NWBO #DCVaxL New name #murcidencel
SNO Abstract, just released, for presentation by #DrLindaLiau on November 20th:
Background: Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years.
SNO Abstract, just released, for presentation by #DrLindaLiau on November 20th:
Background: Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years.
We evaluated in a phase 3 trial whether adding an autologous tumor lysate-loaded dendritic cell vaccine (murcidencel) to SOC extends survival. Patients and
Methods: Newly diagnosed glioblastoma patients were randomized 2:1 to either murcidencel or placebo.
Methods: Newly diagnosed glioblastoma patients were randomized 2:1 to either murcidencel or placebo.
Under a crossover design, all patients could receive murcidencel following tumor recurrence. All parties remained blinded regarding treatments before recurrence. Patients thus received murcidencel at new diagnosis (nGBM) or at recurrence (rGBM) following crossover from placebo.
Northwest Biotherapeutics Announces -
Approval of Pediatric Investigation Plan (PIP) by MHRA
#DCVaxL $NWBO newsfilter.io/a/8ae27d3f0428…
Approval of Pediatric Investigation Plan (PIP) by MHRA
#DCVaxL $NWBO newsfilter.io/a/8ae27d3f0428…
“The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L.”
“The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. On August 17, the Company received final approval of the PIP from the MHRA.”
Dr. Keyoumars Ashkan #DrKeyoumarsAshkan Surgeon & professor, and he also ran the European trials for #DCVaxL from $NWBO
Professor Ashkan performs life-saving awake brain tumour surgery while patient plays violin! via @YouTube
Al Musella, President, Musella Foundation for Brain Tumor Research & Information, Inc., a 501(c)3 nonprofit, re #DCVaxL : “ The results are outstanding.
Over 200% increase in the 5 year survival rate for newly diagnosed Glioblastomas as well as in the 30 month survival for recurrent Glioblastoma. There has been some unfair criticism of the trial on the internet -but watch the video and get the details directly from the source!
The same criticism happened after every major trial for brain tumors this century.
Dendritic Cell Vaccine for Patients With Brain Tumors - Full Text View - ClinicalTrials.gov
#AdjuvantStimulus #PolyICLC
Ongoing #DCVaxL trial with Adjuvant stimulus, will likely further improve outcomes with #DCVaxL $NWBO clinicaltrials.gov/ct2/show/NCT01…
#AdjuvantStimulus #PolyICLC
Ongoing #DCVaxL trial with Adjuvant stimulus, will likely further improve outcomes with #DCVaxL $NWBO clinicaltrials.gov/ct2/show/NCT01…
Some quick thoughts on $NWBO and #DCVaxL. DCVaxL is designated an #OrphanDrug, for an #OrphanDisease, #Glioblastoma. This provides a bunch of benefits which are off topic for this thread.
My main point is to suggest that patients needing #DCVaxL may likely qualify for either of two funds in the UK, the #InnovativeMedicinesFund or the #CancerDrugsFund, which together have £640M allocated to provide early coverage to patients in the UK's NHS.
The UK charity, BrainTumorResearch.org recently put out a PR about the new program in the UK for rare diseases, which is modeled on an already existing program called the #CancerDrugsFund.
$NWBO DEDUCED RECKONING: Northwest Bio reports Phase 3 results.
#DCVaxL
@joanlappin
finance.yahoo.com/news/deduced-r…
#DCVaxL
@joanlappin
finance.yahoo.com/news/deduced-r…
1/ "Only 5% of glio patients survive for five years. So how stunning is it for DCVAX-L to see life expectancy at 60 months rise from 5.7% to 13%, an increase of 228%. Some patients have seen total remission glio and are cancer free more than a decade after treatment.
2/ For example, Brad Silver participated in the Phase 1 trial 17 years ago and is cancer free now."
DCVax-L Phase 3 Trial Results
Final Top Line Results, Phase 3.
Delivered 5/10/22 to the New York Academy of Sciences by
Dr. Paul Mulholland, MBBS, MSc, PhD, FRCP, University College Hospital, UK
#DCVaxL $NWBO #TLD
via @YouTube
Final Top Line Results, Phase 3.
Delivered 5/10/22 to the New York Academy of Sciences by
Dr. Paul Mulholland, MBBS, MSc, PhD, FRCP, University College Hospital, UK
#DCVaxL $NWBO #TLD
via @YouTube
If you watch this by idea closely, you’ll note that the trial coins not proceed ethically UNLESS it was a crossover style. But all the patients lived longer including the recurrent ones who got access to #DCVaxL late. THAT was their placebo arm originally. There is no way in hell
, in my opinion, that a regulator is going to push a drug company into a crossover trial ethically, and then say, oh, man, your drug is so successful in making everyone live longer, but there is nothing that can be done. You fail! That’s not how regulation works.
1/ Re $NWBO and #DCVaxL aka "ATL-DC" in brief:
#DrLindaLiau, principal investigator for a Phase 3 #DCVaxL trial recently gave a lecture covering the #DCVaxLComboTrial with #Keytruda.
#DrLindaLiau, principal investigator for a Phase 3 #DCVaxL trial recently gave a lecture covering the #DCVaxLComboTrial with #Keytruda.
2/ $NWBO and UCLA have a patent application pending approval for immunotherapy combinations with #DCVaxL.
3/ The #DCVaxLComboTrial appears to be intended to further the patent process and also to likely advance new commercial opportunities, including potential partnerships, for $NWBO. Many commentators have suggested some obvious potential partners.
$NWBO #DCVaxL With regard to Dr. Roger Stupp being a consultant at $NWBO as they move toward the reveal of their top line data for Phase 3, publication and application to the FDA for approval, the BLA, adding him to the team I think is quite significant.
I made these points with other investors, so am sharing here.
This is ALL IMHO, and I own shares in $NWBO:
This is ALL IMHO, and I own shares in $NWBO:
Since the Stupp Protocol established the Standard of Care (“SOC”) for the industry, and NWBO needs a placebo arm that is consistent with the Standard of Care, Stupp, being the father of the Standard of Care, now joining to advise and consult not only makes sense, it is…
