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Apr 20, 2022 33 tweets 11 min read Read on X
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.
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.
4/ The relevant lecture, referred to above, given by #DrLindaLiau was on March 31, 2022 at University of Miami. '
5/ Below, I have linked to the lecture at a specific place of relevance to a question raised by some critics: Are the generic "ATL-DC" reference in the clinical trials database record AND the generic descriptor therein, "Autologous Tumor Lysate-Pulsed Dendritic Cell…
6/ …Vaccination", simply generic references to #DCVaxL? Or do they reference some yet unidentified and never discussed UCLA developed Vaccine X, that shorts would prefer it described.
7/ Planting this fog of potential confusion has become a means to an end, for shorts and their henchmen.

Well, here in the lecture by Dr Liau, is an indication that the vaccine in use by UCLA, in what I called the #DCVaxLComboTrial, is in fact DCVax:
8/ And just to be clearer, here is a screen shot, with the relevant text boxed for emphasis: Image
9/ In reference to the combination, the slide clearly states at the bottom of the boxed section, "Induction (DCVax) of T cell response + inhibition of PD-1/PD-L1 interactions (anti-PD-1) leads to TIM upregulation".
10/ Dr. Liau's lecture slide clearly indicates in the relevant descriptor label that the relevant vaccine in this combination trial is, in fact, DCVax. Therefore, ATL-DC in the combination trial is there labeled #DCVax.
11/ On a side note, the last point where the combination "leads to TIM upregulation", the issue is addressed with the addition of CSF-1Ri, which is discussed also in the combination patent and in previous UCLA press releases and a journal article as far back as 2017.
12/ I could have put much more but to keep things somewhat clear does take explanation and links. Less is more.
13/ This offers a recent baseline detail to be added to other recent observations by other investors and then this post can be added to either by me or others or incorporated into multiple threads or a single thread on the subject or used to discuss broader topics.
14/ This thread is all offered as my humble opinion of the facts, as I have observed them, and I am a current long investor in $NWBO.
15/ Addendum:

Here is a further reply on iHub including an even more conclusive bit of information from @FlemmingBruce showing that the dendritic cell vaccine in the #DCVaxLComboTrial is, in fact, #DCVaxL

investorshub.advfn.com/boards/read_ms…
17/ And for searchability:

trp.cancer.gov/spores/abstrac…

Quoting from the National Cancer Institute's SPORE grant description:
18/ "Project 1: Active immunotherapy combined with checkpoint modulation for glioblastoma

Project Co-Leaders:
Robert M. Prins, PhD (Basic Co-Leader)
Linda M. Liau, MD, PhD, MBA (Clinical Co-Leader)
19/ The overall goals of this research project are to investigate mechanisms of immune evasion following treatment with dendritic cell (DC) vaccines, and to develop rational combinations of immunotherapeutic strategies to overcome the immunosuppressive milieu of the brain tumor…
20/ …microenvironment.
21/ Our previous work strongly suggested that, in addition to inducing T-cell infiltration into brain tumors, DC vaccination may also create a pro-inflammatory environment within the tumor that induces the immigration of immunoregulatory antigen presenting cells (defined herein…
22/ …as iAPC) expressing high levels of PD-L1 and IL-10.
23/ These cells are phenotypically similar to the iAPC that dominantly attenuate the T-cell response to chronic viral infection, and may counteract the effective anti-tumor T-cell responses induced by DC vaccination within the tumor microenvironment via a mechanism involving…
24/ …PD-L1/PD-1.
25/ Furthermore, inhibition of iAPC using an anti-PD-1 mAb or a CNS-penetrant CSF-1R inhibitor (PLX-3397) in conjunction with tumor lysate-pulsed DC vaccination (DCVax-L), resulted in significantly prolonged survival in tumor-bearing animals with large, well-established…
26/ …intracranial (i.c.) gliomas."

Emphasizing again: "Furthermore, inhibition of iAPC using an anti-PD-1 mAb or a CNS-penetrant CSF-1R inhibitor (PLX-3397) in conjunction with tumor lysate-pulsed DC vaccination (DCVax-L), resulted in significantly prolonged survival..."
27/ Clearly, DCVax is what is referred to in the trial #DCVaxLComboTrial as "ATL-DC" because NWBO is not a sponsor, so using a generic designation made sense.

Further, I'd like to point to this excellent post by @sentimentstock on iHub:

investorshub.advfn.com/boards/read_ms…
28/ More on the SPORE grant:

UCLA brain cancer program designated a specialized program of research excellence by the National Cancer Institute

$11.4 million grant will help to advance work in prevention, detection and treatment

cancer.ucla.edu/Home/Component…
29/ More on the #DCVaxLComboTrial clinicaltrials.gov/ct2/show/NCT04… Note that in this trial, the control arm gets #DCVaxL, and the experimental arm gets #DCVaxL + $MRK's #Keytruda.
30/ And this is the main Phase 3 #DCVaxL trial for #Glioblastoma #GBM. Everyone is waiting for #TLD or top line data to be released any time now. clinicaltrials.gov/ct2/show/NCT00…

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More from @biosectinvestor

Jun 23, 2023
I think one way to think of $NWBO's vaccine as DCVax being a platform, #DCVaxL and #DCVaxDirect are descriptions of instantiations of DCVax. the patient's dendritic cells, One w/a lysate, in vitro, the other in vivo to the inoperable or metastatic tumors, by direct application.
If #DCVaxL is approved, & #DCVaxDirect is a less complex expanded patient dendritic cell infusion of the same sort, processed but substantially not genetically or otherwise modified, one has to wonder how much complexity should be involved in its ultimate "approval"?
If $NWBO had funding to do a follow-on trial from their Phase 1, for very late stage patients who have exhausted their options, this time allowing for broader application of #DCVaxDirect, AND, if they show survival benefit & various biomarkers as they've identified previously,
Read 12 tweets
Dec 21, 2022
$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…
"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."
..."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…
Read 13 tweets
Nov 25, 2022
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:
Read 13 tweets
Aug 12, 2022
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, 2022
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, 2022
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

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