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.
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.
Progression Free Survival: Overall Survival: #of Patients: Glioblastoma Type: Phase
NWBO§26.4 Months 36.4 Months 20
(100% of Glioblastoma population)
16.9 Months 38.4 Months 16
HLA A1 & A2 +
(50%-75% of Glioblastoma population)
AGEN§17.8 Months 23.3 Months 46
Newly diagnosed Glioblastoma
CLDX§12.3 Months 21.8 Months 65
(30% of Glioblastoma population)
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.
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.
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 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.
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.
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.