Replies to post #749811 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

How many tumor specific antigens can Provenge present to immune system?

You and your buddies are trying to make things look so complicated in the hope of tricking and deceiving people. In the case of DCVax-L, things are rather simple.

Is there another company which has the technology enabling dendritic cells to present hundreds of tumor-associated antigens to immune system? The answer is no. NWBO is the only company on this planet that has the technology. Unlike other immunotherapy treatment, DCVax-L can trigger massive and sustainable t-cell infiltration into tumor site.

That's why I can say with 100% certainty that the technology adopted in the following trial is the same pulsing technology for the combo trial.

Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
https://clinicaltrials.gov/study/NCT00923351

Adjuvant Immunotherapy to Improve Outcome in High-Risk Pediatric Sarcomas
https://aacrjournals.org/clincancerres/article/22/13/3182/79179/Adjuvant-Immunotherapy-to-Improve-Outcome-in-High

Autologous tumor lysate, cell therapy, and CYT107
Tissue was obtained via percutaneous core needle biopsy and/or fine needle aspiration (n = 26) or surgical resection (n = 3).

Results: Forty-three patients enrolled and 29 received immunotherapy. The regimen was well tolerated. Intent-to-treat analysis demonstrated 5-year OS of 51% with significant differences based upon histologic group (63% vs. 0% for Ewing/rhabdomyosarcoma vs. other sarcomas) and response to standard therapy (74% no residual disease vs. 0% residual disease). Five-year intent-to-treat OS of patients with newly diagnosed metastatic Ewing/rhabdomyosarcoma was 77%, higher than previously reported in this population and higher than observed in a similar group treated with an earlier adjuvant immunotherapy regimen (25% 5-year OS). T-cell responses to autologous tumor lysate were identified in 62% of immunotherapy recipients, and survival was higher in those patients (73% 5-year OS with vs. 37% without immune response, P = 0.017). Immune reconstitution, measured by CD4 count recovery, was significantly enhanced in subjects treated with recombinant human IL7.

[froggmister]

First, the FDA did not say outright no to the first of the two phase 2 trials Dendreon tried to push across the line. The ADCOM, including Pazdur, said yes, 13 to 4, but the FDA, seeing that they had another phase 2 that was going read out in a year, decided to wait for those results- much to the chagrin of us Dendreonites. The second trial was positive and the results have been confirmed by a second large study called PROTECT that ran from 2011 to 2017. So for years the market was pricing Provenge to fail but the market was wrong. Dendreon failed spectacularly but that’s a bigger story.

Regarding the stock price, it varied between $3 and $8 a share for years before approval. Most Dendreonites like me had an average share price around $5 so those of us that sold at the top got a 10 bagger. I sold half and wish I had sold all of it, but I learned valuable lessons. I believe Northwest Bio did too.

Why do I believe that? Because in 2010 NWBio was still headquartered in the northwest, in Bothell, Washington and was led by interim CEO Larry Kenyon. The move to Maryland and naming of Powers as CEO occurred the following year in 2011. The Seattle biotech scene was tight knit. LP has commented on learning from Dendreon’s mistakes.

Someone posted on here that manufacturing was the big issue with DNDN. It was, at best, the #3 issue. The #1 issue by far was pricing and reimbursement, along with skepticism about immunotherapy in general. Keep in mind Provenge was the first ever immunotherapy approved by the FDA; since then over 50 immunotherapy drugs have been approved by the FDA.

For Northwest Bio, how pricing reimbursement is handled is still to be determined - hopefully they learned some lessons.

The other big factor in DNDN’s demise was competition in the mCRPC space. NWBO has a massive advantage here. Even when DNDN hit their high watermark of about $6 billion market cap was well known that their drug was, at best, the third best treatment of new treatments coming onto the market - Zytiga and Xtandi were both looming and quickly grabbed market share.

Patience and patients,
Frogg

[Investor082]

Probably a 100% spike at best on the day of UK approval. That too if we are lucky. Does not apply to you since you are not long.

UK is 20 times smaller than a US market. No hiring is another indication of what LP thinks about the commercialization potential in the UK in 2025.

I don’t know where the buyers are going to come from. Quite a few folks want to sell at UK approval news though.