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:
Fuller Discussion re early trial with #DCVaxL + adjuvants, including Poly ICLC:
Re single agent checkpoint inhibitors, without DCVaxL, in Glioblastoma:
This is a paper from 2010, presenting the early Adjuvant data Phase 1, and patients were both nGBM and rGBM, so not all the same. #DCVaxL Poly ICLC, a TLR 3 Agonist.

See Table 1, therein, for specifics on which patients were which:

ncbi.nlm.nih.gov/pmc/articles/P…
Follow-up Paper on Phase 1 patients, including nGBM and rGBM, as well as Glioma patients, #DCVaxL + various adjuvants.
CTIM-18. DENDRITIC CELL VACCINATION IN CONJUNCTION WITH ADJUVANT TLR-3 AGONIST ADMINISTRATION ENHANCES PRO-INFLAMMATORY IMMUNE RESPONSES AND IS ASSOCIATED WITH EXTENDED SURVIVAL IN MALIGNANT GLIOMA PATIENTS , November 2020 academic.oup.com/neuro-oncology…
This is a larger and ongoing follow-up adjuvant trial: Larger #DCVaxL #Adjuvant trial, which is ongoing, here: clinicaltrials.gov/ct2/show/NCT01…
This is an ongoing clinical trial including #PolyICLC + #Keytruda with #DCVaxL, where DCVax-L without Keytruda is the placebo arm.

clinicaltrials.gov/ct2/show/NCT04…
And here are the final results of the #DCVaxL Phase 3 trial without any adjuvant or immunotherapy combination jamanetwork.com/journals/jamao…
These various trials and data suggest a possibility that use of Adjuvants and combination therapy with #DCVaxL could further enhance the potential for extending survival of patients with #Glioblastoma #GBM or #Gliomas.
The above JAMA Oncology paper suggests that "Treatment with DCVax-L can potentially be combined with a wide range of other treatment agents (including checkpoint inhibitors, cytokines, targeted therapies, chemotherapies, or oncolytic virus therapies)."
Approval by regulators of #DCVaxL would open up the door to a more rapid opportunity, with real world data and other advances under the 21st Century Cures Act, to evolve treatment quickly and possibly make more rapid advances in the treatment of brain tumors.

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More from @biosectinvestor

Aug 12
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.
Read 6 tweets
Jun 22
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…
A trial with a combination #DCvaxL #PolyICLC and #Keytruda is already in process at UCLA. This is some of the early research on that combination $NWBO $MRK
Read 7 tweets
Jun 21
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.
Read 32 tweets
Jun 5
$NWBO never unblinded: 3/31/17 Opinion, Judge George J. Hazel, US District Court of Maryland, Southern Division, Motion to Dismiss, Granted - “Plaintiffs' additional argument that Defendants were trying to "bury" interim efficacy results is undercut by the record itself.
A review of the record in its entirety leaves as the only reasonable inference that the data monitoring committee had reviewed only safety data from the Phase III trials, not efficacy data.”
casetext.com/case/lerner-v-… Federal District Court Decision, Chad A. Lerner, Plaintiff vs Northwest Biotherapeutics, Defendant, p22.

Quote:
Read 20 tweets
Mar 19
Let's explore a new accelerated pathway to licensing for new drugs in the UK #MHRA #ILAP
The MHRA Innovative Licensing and Access Pathway is open for business

The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). #MHRA #ILAP

gov.uk/government/new…
Innovative Licensing and Access Pathway (ILAP)

"A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access." #MHRA #ILAP

gov.uk/guidance/innov…
Read 14 tweets
Jan 24
$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:
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…
Read 11 tweets

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