Dynavax Technologies Corporation Message Board

If 3.50 breaks look for 3.25... Company needs to say something soon....It is a bit tiring... I actually think IMUC looks much better technically. I just my CLDX today. Made 5 dollars in that. NWBO is the worst of the group.

Always was.. .

Watch out

Someone is also selling huge blocks... It can only be 2 persons/institutions. Either the last of those that took the secondary back in December or Sabby. As Sabby has a 9.6% stake they would have to file a form 4 so I doubt it is them. Instead, I think is a creditor that converted or someone from the Aegis Secondary. Whatever it is, it is really strange....

How are you? I thought the board needed a little levity hence the Tom Graham joke... but ..

Anyway, watch this NWBO... I have been long since 3 bucks.. strange action in it... Still long. I think she is a coiled spring. Great story. Not many companies out there are phase III for block buster drugs with less than a 100 million market cap but maybe that is telling... Anyway, I am awaiting news on their other trial for all inoperable solid tumors. It is a phase i/2 trial. Interesting stuff. Cheap company. just did a raise but still needs money. I am very very long it but again in at 3 bucks or so.... Just keep it on the radar.... any questions let me know. hope you are feeling ok but I know its hard.

This stock is so manipulated...

ouch....

Now back to that used car salesman Seth Grae.....The word on the street is that the Honorable Tom Graham has completely lost control of his low fat diet and today ordered an omelet replete with hash browns and a side order of spam from the local bodega located right downstairs. Straight off the AP newswire: Wiping the remnants of yolk from his salted lips, picking from his stained shirt what appeared to be crumbs of spam, Mr. Graham refused to acknowledge the outcry over his loss of self control. "What is the big #### deal!" Mr. Graham shouted as one reporter attempting to get as close as possible accidentally slipped on an eggshell lying upon the dirty bodega floor. Mr. Graham's agent declined to comment on the incident and insisted the contract with Wheaties was still valid.

Evidence Supports Clinical Effect and Positive Trial Outcomes

Oncology studies are notorious for Phase III trial failures following promising Phase I and Phase II data. The reasons are manifold, but we will focus on the available data, put it into clinical context, and draw on other strands of evidence to demonstrate why the Phase I data for ICT-107 and DCVax-L are so compelling.

The best way to appreciate just how outstanding the efficacy signals are from the Phase I studies of DCVax-L and ICT-107 in newly diagnosed GBM patients is to compare them to the treatment arm of the 2005 paper that defined the current standard of care.
Number of GBM Patients in study Standard of Care287 DCVax-L20 ICT-10716
Median Progression Free Survival (months) 7 23 17
Median Overall Survival (months) 15 35 38
2 Year Survival % 27 - 80
3 Year Survival % 16 55 55
4 Year Survival % 12 30 50
Median Age 56 51 52
The Phase I studies are small, uncontrolled and single center, but it is very difficult not to be captivated by the profound increase in median overall survival in both the ICT-107 and DCVax-L studies. For both vaccines, the median overall survival more than doubled, and three times as many patients were alive at three years compared to the standard of care. The investment community have every right to be skeptical given the small patient numbers and usual Phase I trial shortcomings. We discussed the data with Dr. Laszlo L. Mechtler, who serves as Medical Director of the Neuro-Oncology Department and the Headache Center at DENT Neurologic Institute. Dr. Mechtler has a good understanding of immunotherapies, being a leading recruiter in Celldex’s (NASDAQ:CLDX) vaccine studies for EGFRvIII-expressing GBM tumors. As with neurosurgeons that we have spoken to, he is unable to attribute the outstanding survival from either study to age or confounding factors. He said, “I have never seen results like these in GBM.” What excited Dr Mechtler beyond the overall survival data was the fact that this is not chemotherapy; cancer vaccines maintain quality of life with a very favorable side-effect profile. He says that these vaccines “offer the vision of hope.”
Even if the trial coordinators were biased and recruited the most favorable prognostic patients to the trials, something that is very difficult to do with the GBM population, it is most unlikely that these outcomes could have been achieved. Put another way, these are the most exciting data ever seen in GBM

This is NWBOs year. In 6 months they will have 50 us sites (they already have 46); 6 sites in the UK and abut 12 in Germany. The company will be awaiting top line results from their phase 1/2 trial and should they be good it will validate the entire platform. A partner for the phase 3 Prostate trial will be found. Now the GBM market is a billion in Europe and a billion in the US. If the market value is typically 5 times peak sales, if we only look at DCVax Brain, then we are looking at a 10 billion dollar valuation. Let's assume they double the float-- sell another 25 million shares at 4 dollars and raise 100 million dollars. There would be 50 million shares out and a 5 billion valuation would give us a share price of 100. Now I know that sound silly but why? There were 2 phase 1 trials and each showed similar results. It's been shown that the chances these were random is almost 0. Like similar immunotherapies the vaccine has no adverse effects. Manufacturing issues have been solved and the batch production is cheap viz a vie DNDN. I think it's a steal down here with little to 0 downside risk.

First, nobody knows whether DCVax-l or Direct will be a success. But the phase i results were spectacular. Nobody refutes that. Now, we have 45 clinical sites in the US, UK on board and we are waiting for Germany. They have 3 manufacturing facilities one of which is the most preeminent institutional in the wold, Fraunhofer. Now just with that. As this is a phase III trial. As the market for GBM in the US and Europe is 1 billion respectively, just with this NWBO should have a 300 million dollar market cap or with 28 million shares out a price of about 12 dollars. Now I don't know where exactly they are with DCVax Direct, but the market for inoperable tumors is absolutely huge. Their Phase I/ii trial has a very broad indication. Moreover, the end point is tumor regression so per the company's PR results, once the trial begins, could be known within months. Moreoover, as the indication is broad, enrollment will be rapid. This is a steal IMHO below 5 dollars. The market will soon wake up to this.

You get the IP for free and a lottery ticket that it works but simply needs to be tweaked.... I think it goes to 1.70 in short order....

Fraunhofer, Kings College, Sara Cannon... no but I should listen to AF who has a BA in political science while our Chief Science Officer was head of Molecular Biology at the Dutch National Institutes of Health and our CEO is Phi Betta Kappa from Princeton and Harvard Law Grad and sits on the NIH grant committee as well as co-chairperson for the State of Maryland Stem Cell Research Department... but AF studied Machavelli...

This is actually quite important: Fraunhofer has 17,000 scientists and an annual budget of approx. 3 billion dollars. To think they have partnered with NWBO is rather astounding. Anyway, in the same annual report they cite NWBO and state the following:

process transfer and manufacture of the immuno- therapeutic dCvax® l-drug
The American biotechnology company Northwest Biotherapeutics Inc. is planning to conduct a phase III placebo-controlled clinical trial to examine the efficacy of their immunotherapeutic DCVax®-L. DCVax®-L is an advanced therapy medicinal product (ATMP) based on autologous dendritic cells to treat glioblastomas, a particularly aggressive type of brain tumor. The therapeutic agent already has been and is being successfully used in clinical trials in the USA. As part of the project, the existing GMP manufacturing process, including quality controls, was transferred to Leipzig by the American manufacturing company Cognate BioServices Inc., where it was also adapted to the European legal foundations which are stricter in some respects. Once
all of the documents have been issued (i. e. manufacturing formula / instructions / protocols, product specifications,
test instructions / protocols, specifications), the next stage focusses on the manufacturing and quality control of several test batches in order to structure the manufacturing process and quality controls in the Fraunhofer IZI‘s clean rooms
and quality control laboratories. The next step was process validation, which included the fully documented manufactur- ing and quality control of three validation batches. Besides process validation, the validation of analytical methods to detect identity, purity, efficacy and safety has begun and
/ or already been carried out. Above all, this includes the validation of: Flow cytometry, the regulation of in vitro efficacy by means of the COSTIM bioassay, testing bacterial endotoxins, and examining sterility. Very complex methods such as flow cytometry and COSTIM bioassay will continue
to be validated in 2013. Furthermore, it was necessary that leukapheresis procurement facilities and neurosurgical tumor procurement centres were qualified to guarantee high-quality procurement and testing of patients‘ autologous base materials. The required authorization for tissue procurement
in accordance with Section 20b (2) of the German Drug Act for the procurement of tumors presents a particular challenge here. A manufacturing authorization specifically for DCVax®-L and DCVax® placebo was issued in July 2012 in accordance with Section 13 of the German Drug Act as a result of this complex work, following a two-day acceptance inspection
by the responsible pharmaceutical supervisory authorities (Landesdirektion Sachsen and the higher federal authority Paul-Ehrlich-Institut). Once this manufacturing permit had been obtained and additional necessary preliminary work carried out (e. g. the authorization application for the clinical trials by the sponsor Northwest Biotherapeutics, development / validation of additional quality controls and / or improvement of existing quality controls), the focus in 2013 should move to the manufacture, quality control and provision of the clinical investigational products for Germany and the UK.

The department head at Fraunhofer is Dr. Gerard Schneidgeknect. In April of this year, in the Fraunhofer annual report he stated the following regarding NWBO:

Once this work has been completed, we aim
to obtain initial manufacturing authorization in accordance with Section 13 of the German Drug Act (AMG) for the new clean rooms, which also entails an official inspection. For this to happen, it is likely that one of the existing manufacturing projects from the established facility will initially be expanded in order to achieve an increased throughput of investigational medicinal products.
For several years now, two large-scale projects focusing on the development of new cancer therapies have been handled within the department together with inter- national industry partners. What successes were able to be achieved in this area in the 2012 reporting year? In 2012, we were able to move both projects forward to a stage which, from a regulatory, substantial and logical perspective, will enable the clinical trials planned by our project partners to commence in 2013. This was achieved by implementing certain measures, for example obtaining the necessary manufacturing authorization in accordance with Section 13 AMG and various import licenses in accordance with Section 72 AMG, training new members of staff, and qualifying new external premises for storage and packaging in BIO CITY Leipzig, which were then integrated into our manufacturing authorization. Furthermore, the manufacturing and testing documentation was optimized and harmonized in line with
the project partners‘ other manufacturing sites involved around the world. Comparability studies were carried out with the project partners‘ other manufacturing sites and the validation of analytical methods was driven forward. As far as I can see, there should be nothing else standing in the way of the clinical trials!

I am writing this on an IPhone and you can no longer provide links so I suggest if you want more information you just google what I'm talking about. I think it was in 2007 when Catherine Dunn, who was diagnosed with ovarian cancer privately funded The Ovarian Cancer Initiative. The funding help to capitalize a trial using DCVax-l in patients with stage IV ovarian cancer. The trial took place at Penn and the lead investigator was Dr. George Coukos-- search NWBO press releases and you will find this. Now one of the woman enrolled was Elizabeth Tomasson (sp?). Google her name and ovarian cancer and read the story of he miraculous recovery. 6 patients were enrolled and then they ran out of funding. I believe unfortunately Ms. Dunn died. Anyhow, the Penn study (Google autologous dendritic cell vaccine Coukos Bosch) is I believe a variation of this theme. The point of all this is: don't let AF tell you otherwise. The company is closer than the market price would have you realize.

I say institution because he is hiding his/her bid.... He is taking all you are willing to sell at 3.55 and now 3.58. As I sat on the bid moreover at 3.58 it took me 2 hours to get filled on just 7,000 shares. I was given 100 and 200 share lots.... I don't know. But it looks good for now