In 1996, Bill Clinton was re-elected President. That same year, Northwest Bio (OTCQB:NWBO) was founded. In 2002, one year after 9/11, Northwest launched the DCVax-L trial. In 2018, I covered NWBO for the first time, and I said their trial is going to announce data soon. In December 2020, after almost 18 months of nothing happening, I again covered the company after they announced data has been locked. I followed through with two more articles, each sounding more desperate than the former, each wondering when the data will be announced. This is my fourth article on NWBO in the last 10 months.
There has been no TLD.
Interestingly, Dr. Keyoumars Ashkan, a senior neurosurgeon at King's College Hospital in London and the principal investigator for the clinical trial of DCVax-L in the U.K, said on May 16 this year (starts at 31:33, the following quote is from 32:12 onwards) that:
“...but we did an analysis … whole patient population without breaking that blindedness...around 30% of patients who were living substantially longer than what we expected...like 7-8 years...best results we have seen in the clinic are about 2.5 - 3 years for glioblastoma patients...to have over a third of your study group living over 7 years would be called unusual.”
The good doctor goes on to say that he, of course, does not know whether these patients took the medicine or placebo. But GBM patients do not live that long:
The average survival time is 12-18 months - only 25% of glioblastoma patients survive more than one year, and only 5% of patients survive more than five years.
So for 30% of the patients to have lived 7-8 years is, like the doctor tells us, unusual.
The doctor also admits that for over a year before May, they haven’t been really very active, because of the pandemic. In this regard, in May itself, the company also said the following:
The process outlined in the Company’s October 5, 2020 announcement relating to the Phase III trial of DCVax-L is continuing to move forward. The process includes review and analysis of the raw data by independent statisticians and experts, and preparation of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts in preparation for public announcement and scientific publication.
The Company continues to be in a quiet period while this process is under way. The Company appreciates shareholders’ patience, and their understanding that the Company cannot make partial disclosures during this process and cannot comment on the Phase III trial schedule or its data until the announcement of the results. We remain committed to completing the full plan outlined on October 5, 2020.
Now, long-term biotech investors do appreciate the “quiet period,” especially since, all too often, a number of over-eager companies violate it, releasing bits and pieces of data and making the stock go through a violent rollercoaster ride. NWBO stock has, over the last year, stayed mostly rangebound, so that is a good side effect of the quiet period.
Long-term NWBO investors will know what Dr. Linda Liau, MD, PhD, MBA; W. Eugene Stern, Chair of the Department of Neurosurgery at the David Geffen School of Medicine at UCLA, said in 2016:
What achievement are you most proud of in your professional career? Developing the first cellular vaccine (DCVax) for brain cancer.
Much more interesting details about Dr. Liau are available here. More biography is available here, and a quote:
Chair of the Neurosurgery Department at the University of California, Los Angeles; second woman to chair a neurosurgery program in the United States; first woman to chair the American Board of Neurological Surgery; first woman president of the Western Neurosurgical Society; and one of only a handful of neurosurgeons elected to the National Academy of Medicine.
On the other hand, there’s the wait. Just last week, on the one-year anniversary of Northwest Bio announcing the locking of the data, STAT’s Adam Feuerstein came up with the following headline:
Feuerstein is an analyst who is sometimes liked, often hated, but usually taken seriously by regular biotech investors. I couldn’t read the article on STAT, however, the title reflects that Feuerstein is unwilling to commit either way. He blasts Northwest’s delay, but he hasn’t committed to calling the trial a failure...this time.
There are many more angles to DCVax; for example, its UCLA pedigree:
Immunotherapies available at UCLA include:
Vaccines: Vaccines are among the most promising immunotherapies. Researchers at UCLA developed the first personalized vaccine for brain tumors (dendritic cell-based vaccine, or DCVax®). DCVax® has extended survival of many of our glioblastoma patients for more than a year, and some are thriving more than 10 years after their initial diagnosis.
Long-term investors are aware of these things. On the positive side, there’s the pedigree, the big names, the hints of great results from the 2018 interim data publication, the absolutely untapped market; on the con side, there’s the delay and the silence. To quickly recap the 2018 data:
For the intent-to-treat (ITT) population (n = 331), median OS (MOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone.
Bottom Line
Yes, there’s been delay, and yes, like I said in an earlier coverage, a lot has changed in the GBM landscape since NWBO started its trial. The company also has just about $3mn in cash, which won’t last them longer than this year. I am guessing they will come out with the data before that happens - indeed the low cash may be a blessing for investors because it will make the company speed up things. Yes, a lot of this is confusing and downright troubling. However, if you put the pros and the cons of this investment side by side, and the reputation and weight of the various stakeholders, discoverers, commenters and so on, and the current low price of NWBO, I think a buy at these prices sounds like the smart thing to do. I am keenly aware of the risks, but right now, with the stock down a lot since my last neutral publication, I think the reward profile is stronger than the risk.
I am buying again.
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