Replies to post #583102 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Direct P1/2 that vanished after the P1 phase has no responses in any patient.

Blatant bullshit.

https://nwbio.com/nw-bio-presents-updated-data-from-dcvax-direct-phase-i-trial-at-5th-annual-smi-cancer-vaccines-conference-in-london/

The top 20% of these patients have so far exceeded 2 years of survival and are still alive. The longest survivor to date has reached nearly 3 years. See Attachment A for details.

The top 30% of these patients (including pancreatic, melanoma, lung, ovarian, sarcoma and other cancers) as a combined group have an average survival to date of 26.7 months, compared with an average of expected survival times of 12.3 months. Individually, these patients have also substantially exceeded their respective expected survival times. See Attachment B for details.

The continuing positive survival results correlate with underlying mechanisms of action and cellular and immune profiles, including phenotype analyses, relative production of a wide range of diverse cytokines by the dendritic cells. Additional positive observations include T-cell infiltration, and PD-L1 expression.

64% of the patients evaluable for PD-L1 checkpoint expression (14 of 22) showed either de novo or significantly increased expression of PD-L1 following DCVax-Direct treatment, indicating potential for combination of DCVax-Direct and checkpoint inhibitors.

The diverse cancers covered in this trial are responsible for approximately 800,000 new cases annually in the US and also at least 800,000 new cases in Europe. When these cancers reach the inoperable metastatic stage, there are no effective treatments available today.

Or, check this out:

https://nwbio.com/wp-content/uploads/ASCO-2019-Presentation-FINAL.pdf

[Doc logic]

exwannabe,

Gee exwannabe, I thought that immune response being linked to extended OS (beating hearts) was a response of note when utilizing immunotherapy. Even Keytruda is advertised that way. I guess some methods for determining response just can’t keep up with the changes going on. Maybe that’s exactly why changes with regulator guidance are going on!; ). Best wishes.

[flipper44]

Concerning DCVax-Direct: Exwannabe states

NCT01882946 is the Direct P1/2 that vanished after the P1 phase has no responses in any patient.

But these Physicians and Doctorates conclude the following (see below).

Vivek Subbiah; Ravi Murthy; David S. Hong; Robert M. Prins; Chitra Hosing; Kyle Hendricks; Deepthi Kolli; Lori Noffsinger; Robert Brown; Mary McGuire; Siquing Fu; Sarina Piha-Paul; Aung Naing; Anthony P. Conley; Robert S. Benjamin; Indreshpal Kaur; Marnix L. Bosch

Conclusions: Intratumoral aDC injections were feasible and safe. Increased production of specific cytokines was correlated with SD (stable disease) and prolonged survival, demonstrating a link between the functional profile of aDCs prior to injection and patient outcomes. Clin Cancer

https://aacrjournals.org/clincancerres/article/24/16/3845/277824/Cytokines-Produced-by-Dendritic-Cells-Administered

[dstock07734]

EX,

Is it deliberate that you didn't mention the following trial?

Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (DCVax-L EAP)
https://clinicaltrials.gov/ct2/show/NCT02146066?spons=northwest+biotherapeutics&draw=2&rank=2

https://www.uclahealth.org/departments/neurosurgery/expanded-access-protocol-treatment-glioblastoma-multiforme

Up to 99 GBM patients received the DCVax-L treatment in less than two years.

NCT01882946 is the Direct P1/2 that vanished after the P1 phase has no responses in any patient.

This is not true.

https://clinicaltrials.gov/ct2/show/NCT01882946?spons=northwest+biotherapeutics&draw=2&rank=3

The fabulous results from this trial were published.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6449174/

The PI for the trial was Dr. Subbiah who has been funded intensively by NWBO and he mentioned NWBO in the disclosure part in almost all his publications since 2013.
https://scholar.google.com/scholar?q=Subbiah+V+%2B+%22northwest+biotherapeutics%22&hl=en&as_sdt=0,44

[biosectinvestor]

I don't have time to rebut your nonsense. The Direct trial is written up and was very successful. But it was a Phase 1 safety trial. The trial was not formulated to actually TRY to show response rate. They injected only one tumor, patients were beyond normal care and on their way to hospice, and they gave various amounts and different methods to see what worked best. It was a safety trial. There is a reason Phase 1's are run like that, it's not run to establish efficacy, though they had amazing extension of survival... quit it with this kind of ridiculous nonsense.

As for other trials not being started, they have limited resources at the current time, and did not even fund the combination trial, which would have obviously have been a priority for DCVax-L, Dr. Liau being the main clinical driver of this technology. Further, the 21st Century Cures Act makes it far easier once you have an approval for a drug, to extend it to other indications than starting a trial from scratch for that new indication. So it's a waste of resources.

The DCVax platform is incredibly flexible and has hugely broad potential. But it is easy to misinform people about these various, previous efforts and make it seem otherwise. The reality is far more audacious.