NWBO stock has been depressed for a number of years after suffering a relentless short and distort campaign led by the so-called “Night King of Biotech” Adam Feuerstein. Feuerstein is a wanna-be journalist at Stat News. He specializes in spreading Fear, Uncertainty, and Doubt (FUD) on the most promising small-cap biotechs. You can read what he has done to CytoDyn here.
He may write under Stat News, but he is really employed by Big Pharma that wants to maintain their monopolies and quash any hopes a small-cap bio can bring a drug to market. By employing Feuerstein, they can depress the share price, prevent them from raising funds, and either drive them into bankruptcy or buy them on the cheap.
However, with NWBO stock, Feuerstein and Big Pharma are about to get their comeuppance. The shorts are about to be squeezed later this month in NWBO stock when the company will UNBLIND, UNVEIL, and ANNOUNCE, **finally,** the results of its THIRTEEN YEAR LONG PHASE THREE TRIAL OF DCVAX FOR GLIOBLASTOMA BRAIN CANCER.
As you can see from the chart below, the shorts are already starting to get nervous.
What’s exciting about NWBO stock is that it’s a former NASDAQ runner. Five years ago, NWBO stock traded at $8 before getting de-listed and landing on the OTC Markets. For the past four years, NWBO stock has languished under $.50 a share. As you can see from the chart below, major resistance is at the $1 level. We clear $1 on positive data and it’s blue skies ahead for NWBO stock.
First up, here’s a little background info for those not familiar with NWBO stock. Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe.
The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.”
The Company is also pursuing the development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Immunotherapy and DCVax-L
Immunotherapy is a broad term used for one way of treating cancer. It harnesses the power of the body’s immune system to treat cancer.
DCVax®-L is an immune therapy made from each patient’s dendritic cells and the specific signature of their glioblastoma (GBM). Dendritic cells are a type of immune cell that helps the body’s immune system recognize and attack foreign invaders or antigens. An invading microbe or pathogen is called an antigen. It is seen as a threat by the immune system and can stimulate an immune response. When an antigen enters the body, the immune system produces antibodies against it. This prompts the body’s own immune system to attack the GBM tumor. When reintroduced into the body, the DCVax®-L dendritic cell vaccine educates the immune system about which antigens to attack.
DCVax®-L is designed to treat all types of operable solid tumors, but the current phase 3 trial is for patients with a newly diagnosed GBM. NWB previously conducted a small phase 1 trial evaluating DCVax®-L in metastatic ovarian cancer.
NWBO Stock Headlines
DCVax-L is already getting a lot of attention. NWBO’s dendritic cell vaccine platform can potentially treat all solid tumor cancers. DCVax-L is designed to treat all operable solid tumor cancers. DCVax Direct is designed to treat all inoperable solid tumor cancers. GBM is the first indication NWBO will apply for approval. Listen to what Fox’s Dr. Marc Siegel had to say.
— Insider Financial (@InsidrFinancial) September 16, 2020
The master cell of the immune system is called a dendritic cell. The job of the dendritic cell is to identify anything bad in the patient’s body, pick up the information, process it, and present it to all of these other immune players, immune agents, in the immune army, so that they’re all activated to attack those bad things that the dendritic cell identifies.
The dendritic cell is actually very efficient at doing this. The dendritic cell, when it picks up the information about the tumor or the pathogen, presents it to the T-cells and activates the T-cells to spread out, fan-out, throughout the whole body looking for the bad thing to attack. And each one dendritic cell mobilizes hundreds of T-cells, both large numbers of T-cells and diverse T-cells to attack different biomarkers or antigens on the tumors or other pathogen or “bad thing.”
The approach that NWBO stock is taking in DCVax is following nature’s system. It’s using the dendritic cell as the active agent and having the dendritic cell mobilize all of those immune agents to work together to attack the tumor. In addition, it’s fully personalized. It uses the patient’s own immune cells and the patient’s own tumor tissue sample.
NWBO Stock 13 Year Trial
What most don’t realize is that NWBO stock has been doing this trial for 13 years now. The results have been a long time coming.
NWBO stock conducted this study at over 80 sites in 4 countries: the US, Canada, Germany, and the UK. Patient recruitment was initiated in 2007 and was paused from 2009 to 2011 for economic reasons. The midpoint of enrollment was reached in May of 2014, and the final patient was enrolled in November of 2015.
All patients were allowed to receive DCVax-L following tumor progression/recurrence, as well as other approved treatments per local practice. All parties (investigators, patients, and sponsor) remained blinded as to which treatment each patient had received prior to crossover. All patients who chose this option were given the active treatment on a re-start schedule with immunizations at Days 0, 10, and 20, and then months 2, 4, and 8, and every 6 months thereafter beginning with month 12, with Day 0 being the day of the first vaccination post-progression. To date, DCVax-L has been shipped for 286 patients (86.4%) in the trial.
Both the study treatment (DCVax-L) and placebo (PBMC) were prepared by Cognate BioServices, Inc. for all patients in the US and Canada, and by Cognate and the Fraunhofer Institute for Cell Therapy together for patients in Europe, during the chemoradiotherapy period before the baseline visit. The production of DCVax-L involved processing the resected tumor tissue into a lysate, and then collection, purification, differentiation, activation, and loading of the autologous DCs. In general, approximately 2 g of tumor tissue was needed to produce the full ten doses for the 36-month treatment and follow-up schedule. The vaccine was aliquoted in individual doses and cryopreserved at < 150 °C. The doses were stored centrally and shipped individually to the clinical trial sites.
To date, due to the crossover design, nearly 90% of the ITT population received DCVax-L at some point in the trial, due to the crossover design. DCVax-L is administered by intradermal injection in the arm, six times in year one and twice per year thereafter. It thereby imposes only a minimal burden on the patient.
According to Dr. Linda M. Liau, a picture is beginning to emerge from the blinded interim data which is consistent with an extended survival tail. For example, among the patients (n = 182) who were ≥ 36 months past their surgery date as of the date of this analysis, 24.2% (n = 44) were alive for ≥ 36 months and have a KM estimated median survival time of 88.2 months. Thus, it appears that patients who survive past certain threshold time points may continue onwards to unusually long survival times, similar to the findings in our prior Phase I/II studies of this DC-based vaccine. Further maturation of the trial data is needed to more fully reveal the extent of the long tail of the survival curve.
DCVax-L has shown a benign safety profile in this Phase 3 study, as it has consistently done in prior early-stage trials, and in a large group of patients treated on a compassionate use basis. The fact that only 7 of the 331 ITT patients (2.1%) experienced any grade 3 or 4 adverse events that were at least possibly related to the treatment makes this DC vaccine an especially well-tolerated treatment.
Dr. Liau’s conclusion is the addition of DCVax-L autologous dendritic cell vaccine to SOC is feasible and safe. Collectively, the blinded interim survival data suggest that the patients in this Phase 3 trial are living longer than expected.
For the life of me, I cannot understand why folks like Feuerstein have attacked NWBO stock for working towards cancer treatment. This is not only immoral and unethical but unholy. We should be about saving people’s lives, not attacking those that are trying to cure folks, and prolong life.
The recent data is that brain and other nervous system cancers are the 10th leading cause of death for men and women. Globally, over 241,000 people die each year as a result of brain or nervous system cancer, with GBM being the most common form of the disease. GBM has an incidence of two to three per 100,000 adults per year and accounts for 52 percent of all primary brain tumors.
Glioblastoma is the most common primary malignant form of brain cancer. Despite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment. The standard treatment for glioblastoma is surgery. The choice of drug therapy for glioblastoma is still limited to a handful of compounds.
If NWBO stock can be successful with DCVax-L, we should encourage and embrace what they are doing, not attack them. However, when you understand that Merck & Co.’s temzolomide is the preferred FDA-approved chemotherapeutic agent for glioblastoma, you realize that sinister forces are at work. Unfortunately, this is the underbelly of the biotech world, and more need to understand what is happening. Spread the word. Save lives. Root for NWBO’s success and not its failure. We see Northwest Bio as a stock with enormous potential in both financial and holy terms. The past 13 years have been a long road, but the payoff is just around the corner.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:NWBO or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.