Mit DCVax ins $$$-Wunderland?

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eröffnet am: 02.01.14 12:29 von: biotech1x1 Anzahl Beiträge: 39
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02.01.14 12:29 #1 Mit DCVax ins $$$-Wunderland?
Längst überfällig: ein Thread zu NWBO.
Mich wundert es, daß Northwest nicht schon in den Fokus hier gerückt ist. Deren Lead Drug ist extrem vielversprechend.
Lest hier:
http://www.forbes.com/sites/tommeyer/2013/12/27/.../?partner=yahootix
Toi Toi Toi  
02.01.14 12:36 #2 Würde gerne die Meinungen der Bio-Experten
hier lesen. Also an Biotechspezi, Chalifmann, Rudini, Balu, VanZant und alle, die ich hier vergessen habe gerichtet.
Meine Favoriten:
ARIA, GALE, AMRN, NWBO, MNKD und CYTR
 
02.01.14 15:34 #4 up gehts!
und zwei neue Artikel von zacks und seeking alpha  
02.01.14 16:35 #5 Kaum zu glauben
Echt schräg. Keiner hier hat dieses Teil aufm Schirm. Weiter gehts Richtung Norden...  
02.01.14 18:07 #6 Neuer Seeking Alpha Artikel

Dendritic Cell Vaccines: A Look Back At Clinical Trials Since 1999

http://seekingalpha.com/article/...cal-trials-since-1999?source=yahoo  
02.01.14 18:08 #7 Link von Zack's - sorry, vorhin vergessen
Northwest Biotherapeutics, Inc (NWBO) Sees Hammer Chart Pattern: Time to Buy?

http://finance.yahoo.com/news/...peutics-inc-nwbo-sees-125948546.html  
02.01.14 18:34 #8 Ein schöner Post auf YAFI
What makes me confident:
#1
"In the prior brain and prostate cancer Phase I/II trials which formed the foundation for reaching the Phase III trial stage, the clinical results with DCVax were striking. DCVax treatment delayed disease progression and extended survival by approximately one and a half years, rather than weeks or months as is typical with cancer drugs. In addition, DCVax was non-toxic: no serious adverse events related to the treatment were seen. These clinical results (both the efficacy and the lack of toxicity) are consistent with a large and growing body of scientific literature and clinical experience relating to the underlying biology involved."
und
#2
"In parallel with these developments in our Phase III brain cancer program, we have launched our DCVax-Direct program. During the first quarter of 2013, we continued and accelerated the manufacturing work and the preparations for launch of the Phase I/II clinical trial with DCVax-Direct for solid tumor cancers. The trial was launched in June 2013. The lead site is MD Anderson in Houston, Texas. As discussed below, MD Anderson in Orlando, Florida, is also open and enrolling, and other sites are in process. Target patients for inclusion in the trial include patients with breast cancer with brain metastases, melanoma, pancreatic cancer, liver cancer, colon cancer and other cancers. As is standard with this type of trial, the DCVax-Direct trial will not be blinded, and the early results will be visible as the trial proceeds. The primary objectives of this Phase I/II trial are to evaluate safety, dose levels and efficacy. The Phase 1 stage of the trial involves dose escalation and confirmation. The Phase 2 stage of the trial will focus on efficacy. The primary measure of efficacy will be regression (i.e., shrinkage or elimination) of the inoperable tumors. Such regression is a rapid endpoint: if it is going to occur, then it is anticipated to occur within a couple months of treatment. Since regression may be seen within just a few months of treatment, and since this Phase I/II trial is an open label, unblinded trial, it is anticipated that some initial results from the first patients may be seen by year end 2013 or early in the first quarter of 2014."

Beides von User fscatareli  
02.01.14 19:08 #9 Zur Info,$4,20 geknackt
Noch ein Artikel:

Why Northwest Biotherapeutics Is Different
---
  Company:§Progression Free Survival:
      NWBO§26.4 Months
      IMUC§        16.9 Months
      AGEN§17.8 Months
      CLDX§        12.3 Months
Standard of Care 6 Months
Complete Resection -
-----
http://seekingalpha.com/article/...apeutics-is-different?source=yahoo  
02.01.14 22:28 #10 Schlusskurs 4,35
Allen die dabei sind/waren herzlichen Glückwunsch. Die Reise dürfte weitergehen.
Man beachte ausserdem die neue Homepage von NWBO. Die Gerüchte zeugen von bevorstehenden News.  
03.01.14 13:53 #11 4,55 zur Eröffnung?
Wir werden es sehen. Erhoffe mir heute einen Angriff auf die 4,80. natürlich alles in $.  
04.01.14 17:54 #12 Kleine Verschnaufpause
Gestern haben einige MM und Shortseller versucht, den Kurs zu verbilligen. Z. T. mit Erfolg. Ein Minus von 2,76% ist daher hinnehmbar. Aber der Aufwärtstrend bleibt bestehen. Ein Angriff auf die 4,80 könnte Anfang der Woche erfolgen. Ein Tip: auf die neue Homepage gehen und stöbern. Liest man sich weiter in die Materie ein, darf man nicht zu euphorisch werden.  
06.01.14 14:35 #13 Einen guten Wochenstart!
Mal schauen, wie sich unsere NWBO heute so schlägt. Es kommen wahrscheinlich diese Woche noch News, passend zur neuen Webseite. Toi toi toi  
19.01.14 16:08 #14 Ab morgen gehts weiter mit unserer kleinen Pe.
Mal schauen, was vor dem 31.01. noch an News kommen...  
19.01.14 17:01 #15 ...
wie hoch siehst du das Kurspotenzial ?  
21.01.14 23:54 #16 nabend auch hier
kurspotential? kannst du dir aussuchen... erzkonservativ: $10; konservativ: $20; oder super optimistisch-geil: $250 (auch schon gelesen; autor ging von 10 Mrd. im Jahr aus geteilt durch knapp 38 mio aktien)
hängt alles von den Ergebnissen ab. aber das, was ich bisher gelesen und gehört habe reicht für mein all in heute. jeder sollte seine eigenen recherchen anstellen.
und nun zu dir: wie siehst du das potential? lg, biotech

ps: heute gings schon in die richtige richtung weiter  
22.01.14 16:34 #17 10$
lässt zu hoffen.

ich tippe auf 8$  
22.01.14 22:14 #18 kingobscene
heute sieht man wie es kurz vor den news hergehen kann. advaxis ging gestern auch runter, obwohl sogar auf nem tweet von einem "major licensing deal" für heute gesprochen wurde. was passierte? die meldung kam und der kurs ging hoch. das gleiche auch vor einiger zeit bei cytrx, bevor die phase 2 ergebnisse herauskamen. erst 10% runter, dann knapp 150% hoch in zwei tagen. nwbo hat extrem aussichtsreiche kandidaten in der pipeline. die werden das schon rocken. da gibt es andere unternehmen mit vergleichbaren outstanding shares und die stehen bei 100 oder mehr dolares, obwohl schlechtere aussichten, scheixx management, aber dafür top marketing. werbetrommeln können die rühren. nwbo kann halt dafür eventuell jede art von krebs heilen. auch nicht schlecht. und deine $8 würden mir schon reichen. aber wie sagt man so schön: gier frisst hirn. ich bleibe hier erstmal drin und warte auf mehr - etwa 3 trillionen ;-) mal sehen, wo meine grenze liegt (oben/unten). biotech  
23.01.14 00:24 #19 hab den $300 artikel
Northwest Biotherapeutics Poses Onyx Like Potential
Nov. 18, 2013 9:30 AM ET |  278 comments |  About: NWBO, Includes: AGEN, CLDX, IMUC, ONXX
Disclosure: I am long NWBO. (More...)
Northwest Biotherapeutics (NWBO) is a development stage oncology focused immunotherapy company currently in advanced and mid-stage clinical trials to treat several types of prevalent cancers as well as all solid tumor cancers. I first came across Northwest Bio through my past research on Onyx Pharmaceuticals (ONXX) and assessing Onyx's potential future competitors with comparable pipelines. Upon looking into Northwest Bio I gained an immediate interest as a result of several key factors. The first factor is that the company has received clearance from the FDA to initiate clinical trials for not 1, but all solid tumor cancers of any type. This is a significant event considering that the standard for the FDA is to approve clinical trials on a case-by-case basis per specific indication. The fact that the FDA has given Northwest Biotherapeutics an open runway to commence several clinical trials, each holding multi-billion dollar market values, all at once, was a major statement of regulatory support in my opinion. The second factor which came up in researching Northwest Biotherapeutics is the immensely positive data results that the company has received from its Glioblastoma(Brain Cancer) trial as well as its DCVAX-Direct data which showed a complete regression of all tumors in 80%-100% of animals treated with the therapy. It should be noted as well that these tumors did not re-grow. Last but certainly not least, a factor which I always take note of in any company I invest in is insider buying. In terms of Northwest Biotherapeutics insider trading, its CEO Linda Powers in the past 12 months has purchased 10,809,992 shares of her company's stock, making her the majority stakeholder in the company and bringing her ownership total to roughly 30% of the company's outstanding shares.

Glioblastoma Multiforme

The two most advanced trials in the works at Northwest Biotherapeutics are two Phase III trials for Glioblastoma and Prostate Cancer. In terms of the company's Glioblastoma trial, thus far when looking at the combined data of overall survival, progression free survival and the number of patients, there is no question in my mind that it has shown the most dramatically positive results in comparison to any of its immunotherapy competitors and of course, the standard of care. Below is a comparison chart of the current Glioblastoma treatment trial data, as well as standard of care data.

Glioblastoma Candidates

Progression Free Survival: Overall Survival: #of Patients: Glioblastoma Type: Phase
      NWBO§26.4 Months 36.4 Months 20
All
(100% of Glioblastoma population)
Phase 3
IMUC
16.9 Months 38.4 Months 16
HLA A1 & A2 +
(50%-75% of Glioblastoma population)
Phase 2
      AGEN§17.8 Months 23.3 Months 46
Newly diagnosed Glioblastoma
Phase 2
      CLDX§12.3 Months 21.8 Months 65
EGFRvIII Positive
(30% of Glioblastoma population)
Phase 3
Standard of Care 18.8 Months
Complete Resection 16.7 Months
As you can see by the data while Immunocellular (IMUC) has shown 2 months longer overall survival in its previous Phase I trial for GBM, its average progression free survival for patients was nearly 10 months lower than that of Northwest Biotherapeutics. While I am bullish on the prospects of both companies due to the results seen using dendritic cell immunotherapy, I believe that Northwest Biotherapeutics vaccine holds the greatest investment opportunity as it is applicable to all Glioblastoma patients and thus far shows a much more drastic progression free survival figure than Immunocellular's ICT-107 therapy. I won't compare Agenus (AGEN) and Celldex's (CLDX) therapies to those of Northwest Biotherapeutics and Immunocellular since the data revealed thus far by these companies has been significantly less impressive thus far in my opinion.

Prostate Cancer

Currently Northwest Biotherapeutics is also approved to commence a pivotal Phase III trial for its immunotherapy to treat Prostate Cancer which is listed as being the #1 most prevalent form of cancer globally according to the American Cancer Society and CNN. Typically Prostate Cancer is treated through surgery, radiation, hormone therapy and/or chemotherapy. These techniques while minimally effective, rarely ever cure someone of cancer and in the end are extremely toxic and harmful to a patient's immune system and body. Northwest Biotherapeutics DCVax® Prostate therapy in its previous Phase II trial showed an extremely high PMSA antibody response as well as T-cell response to PMSA in over 80% of the patient's treated with the therapy. My expectation is that similar to the results in Glioblastoma, DCVax® Prostate could likely show a dramatic enhancement in progression free survival, as well as overall survival.

DCVax-Direct

While both of Northwest's Biotherapeutics Brain and Prostate cancer trial results have been extremely impressive thus far, what I have found to be the most impressive data from any cancer study I have ever seen, is the company's animal studies using DCVax®-Direct. In multiple pre-clinical studies using DCVax-Direct on animals with various different types of cancers, 80% to 100% of animals injected with DCVax-Direct into their tumors had a complete clearance of their tumors, which did not regrow. I believe these results persuaded the FDA to give clearance for the company to initiate a Phase I/II trial for all inoperable tumors in any type of cancer with this therapy. As I said prior, this is an extreme rarity of leeway which was given by the FDA and is what I see as a big vote of confidence in the DCVax platform's potency in fighting cancer. This trial was designed to be un-blinded which means that data could role out literally any day/week/month as new significant developments arise. I believe that the company designed the trial to be un-blinded because it is confident the therapy will continue to show dramatic effects in destroying tumors and the company is looking to get as much attention as possible directed at its treatment which is a potential game-changer for cancer treatment.

Onyx Comparison

Onyx Pharmaceuticals is a cancer focused biotechnology company that was recently bought out by Amgen for approximately $10B after receiving accelerated approval by the FDA after positive data from a Phase II trial. While Onyx holds a comparable pipeline to Northwest Biotherapeutics being that both companies have several cancer targeting treatments in the pipeline, the biggest similarity both companies have in common are their Phase II, un-blinded, tumor addressing cancer trials. Like Northwest Biotherapeutics, Onyx's Phase II trial for its drug Kyprolis™ was un-blinded and addressing tumors. Being that Kyprolis was granted early approval from just Phase II trial data, which was extremely unimpressive data in my opinion, I see a good probability that with positive data from Northwest Bio's un-blinded DCVax-Direct trial, the company could be granted accelerated approval for the treatment without needing to undergo a Phase III trial prior.

Valuation

In terms of Northwest Biotherapeutics valuation, the company is sitting to enter enormous, multi-billion dollar markets if its therapies receive FDA approval. This is due to the fact that Cancer is the 2nd leading cause of death in the world and the company's pipeline is addressing all solid cancer tumors. Onyx Pharmaceuticals which hosts a similar pipeline, yet has shown what in my opinion are un-impressive Kyprolis™ results thus far, was eventually bought out for over $10B prior to ever selling one drug on the market. That being the case, what I see in store for Northwest Biotherapeutics shareholders is what could potentially be the largest asymmetrical trade in the biotech space today. With just a $1B valuation which is 10% of what Onyx was sold for, Northwest Biotherapeutics stock would be roughly $29 a share. At the $10B valuation which Onyx was bought out for, Northwest Biotherapeutics shares would be nearly $300.

Conclusion

Data from Northwest Biotherapeutics clinical trials should be rolling in upon the materialization of significant results. While risks certainly come along with investing in the company, my opinion is that the share price has an enormous runway for appreciation. Along with what has so far shown to be an extremely impressive immunotherapy platform with blockbuster potential, I am just as much impressed with the company's management and CEO Linda Powers who graduated Princeton Magna Cum Laude prior to graduating Harvard Magna Cum Laude. I will go on record stating my belief that Northwest Biotherapeutics does in fact have a groundbreaking cancer technology on its hands based on the data I've reviewed and that it could certainly be a triple-digit stock in the future if clinical results are positive.  
25.02.14 11:03 #21 hier meldet sich keiner der Ariva Experten weil
es einfach zu schlecht bestellt ist um NWBO,finanziell am Ende und die Daten voll gehypt,das kann nicht mehr lange gutgehen,dann kommt das böse Erwachen .....

"Let's squash this silly notion that the blowup of ImmunoCellular Therapeutics'  (IMUC_) dendritic brain tumor vaccine last week is an isolated incident without negative consequences for Northwest Biotherapeutics  (NWBO_) and its nearly identical dendritic brain tumor vaccine.

I hate to break the bad news to Seeking Alpha contributor Josh Ginsburg, but Northwest's DCVax is not different from ImmunoCellular's ICT-107. DCVax will fail just like ICT-107 failed because dendritic cancer vaccines are too weak to overcome cancer's innate ability to overpower or evade the body's immune system.

The scientific community and most of Wall Street know this and have moved on from dendritic cancer vaccines. Today's buzz is antibody-based cancer immunotherapy -- the PD-1s and PDL-1s of Bristol-Myers Squibb (BMY_), Merck (MRK_), Roche (ROG_) and others which are showing incredible results in large clinical trials. A bit farther back but no less exciting is the work being done by academic researchers and Novartis  (NVS_) with engineered T cells -- so-called CAR-T immunotherapy.

Last February, I explained in great detail why data from two early studies of Northwest Bio's DCVax in patients with glioblastoma multiforme (GBM) were sloppy, wrong and wildly misleading. Twenty GBM patients were handpicked for treatment with DCVax in these two phase I studies, so of course they outperformed expectations. The median progression-free survival of 26 months and median overall survival of 36 months touted by Northwest Bio as evidence of DCVax efficacy are not real. These DCVax data are a mirage which will vanish once Northwest Bio stops issuing endless promotional press releases and finally gets around to analyzing the much larger phase III study.

Seeking Alpha's Larry "Smith on Stocks" Smith was wrong about Northwest Bio last February and he's still wrong today when he whistles past ImmunoCellular's graveyard.

The bull thesis on ImmunoCellular's ICT-107 was also based on super-duper data from a small phase I study. Sixteen patients with newly diagnosed GBM were treated with ICT-107 at the prestigious Cedars-Sinai Medical Center in Los Angeles. The results were reportedly spectacular, including median overall survival of more than 38 months. Some ICT-107 patients were still alive five years after treatment. Historically, similar GBM patients enrolled in other, larger clinical trials only lived an average about 18 months, therefore ICT-107 be responsible for the prolonged survival benefit.

Um... no. Last week, ImmunoCellular announced negative results from its 124-patient phase II study of ICT-107 in GBM patients. Sure enough, the GBM patients treated with placebo lived about 18 months, as expected. The patients treated with ICT-107 survived only two months longer, on average.

What happened to the 38-month median overall survival data from the phase I study of ICT-107? Poof! Gone. A fantasy.

Don't expect any better outcome from Northwest Bio's DCVax"

MFG
Chali

P.S. Auch bei Dendreon hat die Technologie nicht den durchbruch gebracht !  
11.03.14 23:50 #22 Chalif - du schreibst einfach Blödsinn.
NWBO ist super gut drauf. Die letzten Meldungen haben dies mehr als gezeigt, ebenso wie der Kurs. Für alle die dabei sind: Gratulation! Ich bin selbst woanders investiert und trauere mit einem Auge NWBO hinterher. Nach einem guten Gewinn (bei MEDL) sollte der Rückkehr zu NWBO nichts mehr im Wege stehen. biotech  
03.04.14 09:58 #23 Auch hier einen wunderschönen guten Morgen
NWBO wehrt sich gegen die Anschuldigungen AFs, was für meinen Geschmack noch zu lasch ausfällt. Hier würde ich mich über eine gerade Linke gefolgt von einem Kinnhaken freuen. Der Typ muss weg, erzählt nur Quatsch und stellt sich - wie bei dem AdCom Liveblog zu MannKind gesehen - danach so abfällig hin, daß man selbst sein "Ich gebe zu, Ihr hattet Recht" nicht ernst nehmen kann. Ein waschechter Zubereiter eines nahrhaften Shortseller-Bodens - nicht mehr , nicht weniger. Dummerweise fressen ihm viele Amis aus der Hand. Welch eine Schmach.
Über den Fortgang von NWBO dürften wir uns weiterhin freuen. Das MM hat mich hier erst im Nachhinein überzeugt. Die Pipeline gleich von Anbeginn. Die nächsten Ergebnisse sollten bald kommen. biotech  
15.12.14 11:08 #24 mal schauen
12.02.15 21:31 #25 Guten Abend zusammen
Ich habe heute Abend die erste Tranche gekauft. 1000 Stück zu 5,78$  
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