by Travis Johnson, Stock Gumshoe | March 16, 2017 1:17 pm
The Disruptors and Dominators newsletter, one of the “entry level” letters from Weiss, is out pitching a “silver[1] bullet” company — a firm that has developed a universal cancer vaccine.
And, of course, they’ll tell you all about it — for your $49 subscription fee. Here at Stock Gumshoe, we’d like you to think things over first before you start tossing your credit card number around… so we’ll look at their clues, ID the stock for you, then you can decide if you want to sign up for editor Grant Wyslik’s letter (and no, I don’t know the track record — Frank Curzio[2] launched that letter about two years ago, during his very brief tenure at Weiss, but we haven’t seen it promoted all that often lately — Wyslik is fairly new and I’ve never written about him before).
So what is Wyslik pitching? Well, as you might imagine, it’s a smallish biotech stock… let’s get into the clues.
He says that it’s one of the companies developing a listeria-based vaccine, which has been an area of big immunotherapy[3] interest for quite a while (listeria, presumably because it’s such a deadly bacteria, provokes a strong immune response — so if you use a snippet or altered form of it, you can provoke the immune system response without the danger).
And there are plenty of other clues (which is good, because that doesn’t narrow it down to just one company), here’s a taste of the ad:
“But before this company was able to progress towards a vaccine against all cancers, a ‘universal cancer vaccine.’
“It first had to prove that its Trojan Horse vaccine could work against individual cancers.
“And that’s exactly what it’s been doing in clinical trials against a long list of cancers:
Cervical cancer
Prostate cancer
Breast cancer
Leukemia
Bladder cancer
Anal cancer
Head and neck cancers
Throat cancer
Stomach cancer
Colon cancer
Bone cancer“All in all, the company is developing vaccines for 20 different cancers.”
And some examples about performance of the immunotherapy in clinical trials:
“In a Phase 2 trial against late stage, metastasized cervical cancer the Trojan Horse vaccine increased patients’ survival rate by 50%.
“An amazing accomplishment. Considering chemotherapy is only able to increase survival rates by roughly 20%.
“Which explains why AstraZeneca, with a market cap of $70 billion, is now partnering with this company.
“They’re combining the Trojan Horse vaccine with AstraZeneca’s immunotherapy drug Durvalumab to attack cervical cancer, and also head and neck cancers.
“And still another cervical cancer therapy is now in Phase 3 trials — the last trial before approval.”
OK, so two cervical cancer therapies, one of which is a combination therapy with Durvalumab. That probably is enough of a clue, but let’s go on just to be sure.
“Merck & Co. is also partnering with this company. This time to attack prostate[4] cancer.
“They’re combining the Trojan Horse vaccine with Merck’s Keytruda immunotherapy drug.”
OK, so there’s another clue about what’s in the pipeline — and yes, Keytruda is a pretty high-profile immunotherapy, seemingly taking the lead from the other big immunotherapy drug that’s seen success of late, Opdivo from Bristol-Myers. (I don’t follow those closely at all, to be clear, that’s just what I read.)
The ad also lists some other collaborators for this “silver bullet” company:
“Aratana Therapeutics
“Mount Sinai School of Medicine
“Global BioPharma
“Memorial Sloan Kettering
“Brown University Oncology Group
“Baylor College of Medicine
“University of California, San FranciscoAre you getting our free Daily Update
"reveal" emails? If not,
just click here...“All told, this company has signed 16 agreements with different medical facilities to develop cancer vaccines based on its Trojan Horse vaccine.
“A vaccine platform that’s propelled this company’s stock to a 926% gain in just one year.”
OK, so fine — we’re getting really too many clues here. We don’t even need to change the oil[5] in the Thinkolator to get an answer for you: This is quite clearly Advaxis (ADXS)[6].
So what’s the story with that “bad things happen to good companies” part of the spiel? Here’s how Wasylik puts it in the ad:
“Why this company just may be the bargain investment of the decade — just as Amgen was when it traded for 10 cents a share …
“In October 2015, it was announced that a cervical cancer patient who had been injected with the Trojan Horse vaccine during Phase 2 trials …
“Had died.
“Immediately, the FDA[7] banned any further tests using the vaccine.
“The reaction on the street was swift and merciless….
“The company’s stock dropped a heart-wrenching 79.21%….
“It was revealed that the Trojan Horse vaccine played absolutely no part in the patient’s death….
“The FDA promptly lifted the ban.
“Did Wall Street, much less the average investor notice, or care? No.
“They had already moved on to other things….
“And now this company’s stock is moving higher without the small investor ….”
That clinical hold was from October-December of 2015, so it wasn’t actually all that dramatic a period for Advaxis stock — it had already fallen from a peak of about $27 to roughly $10 before that. I don’t know what the news flow was at the time, or why it fell, and it doesn’t seem like it had that dramatic a fall — the drop from peak to trough was about 80%, from June of 2015 to February of 2016, but that’s going from several months before the clinical hold to a couple months after the hold was lifted, so clearly the clinical hold wasn’t the only issue. The shares fell to about $10 on the clinical hold news, bounced around a bit while folks digested that, then bounced back up to $12 or so after the hold was lifted… and got cut in half again after that (biotech in general was falling back then, too, for whatever that’s worth).
The big “universal vaccine” stuff is not as far along in the pipeline as the partnerships with Merck and AstraZeneca, but it revolves around their deal with Amgen. More from the ad:
“Amgen apparently believes it’s a road worth traveling.
“Which is why it …
“Bought $25 million worth of this company stock
“Paid $40 million to this company in cash, upfront
“Agreed to provide 100% funding for all development and commercialization expenses of the vaccine
“Agreed to pay $475 million in milestone payments
“Plus, make royalty payments into the mid double-digits on all future global sales”
That’s the deal that Advaxis made with Amgen for the MINE program, which they hope to start Phase 1 trials for this year. There’s an interesting story about it here from last Summer[8] if you’d like some background.
MINE (My Immunotherapy Neo-Epitopes) is the latest iteration of the “personalized” cancer vaccine — I guess you can call it a “universal” vaccine if you want, but it’s manufactured individually for each patient, using a biopsy of the tumor. They describe it in broad terms here[9]. It sounds pretty cool and promising, but I know nothing about this stuff — they all sound cool and promising, and so far it seems as though the individually manufactured “personalized immunotherapies” have had trouble getting through to commercial development (Dendreon and Argos Therapeutics come to mind, though it’s quite possible that there are successes I’m unaware of).
And with that, I’ll leave you to cogitate and thinkify on your own — do you expect great things for Advaxis when they start trials with Amgen this year? Think their collaborations will go well or poorly? See some gold[10] at the end of the clinical trial process? Let us know with a comment below.
P.S. Dr. KSS[11], who writes about biotech stocks for the Irregulars, has been very negative about ADXS in the past[12]. The stock also has a very high short ratio, about 30% of the float is sold short (that ratio has often been high for them). And, perhaps coincidentally, Advaxis was also touted as a small immunotherapy name by Frank Curzio, the prior editor of Disruptors and Dominators, for a previous newsletter of his retirement[13]-millionaire/its-going-to-be-the-apple-of-cancer-therapy-in-the-next-20-years/">when he worked for Stansberry in 2014.
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In the age of Cellectar, and checkpoint inhibitors, and NK cells with bispecific mAbs used in tandem, going the route proposed by Advaxis for one’s cancer makes about as much sense, is as appealing as, oh say putting Tang powder in cold water for breakfast when you could have fresh-squeezed OJ. It’s a clunky, fossilized, washed up, fuliginous approach that either doesn’t work or works badly. Eight track tapes or Super Audio CD? Black and white TV with a set-top antenna or 4K curved screen with a fiber input? It’s nothing but taking your immune system that has already FAILED against your tumor (as evinced by the fact you’ve got that tumor), dunking its head in tumor antigens and yelling, Now get it right this time! How many times must tumor cell vaccines fail before even the swindler class of biotech merchants moves on?
Won’t it be nice when you’re proved wrong? Perhaps Advaxis won’t be the one to do it–there are a number of companies working on this sort of approach, which is anything but antiquated. The simple truth is that standard chemotherapy destroys the patient’s immune system and often a small amount of the cancer survives only to come back later. Either supporting the immune system or using specific drug deliver systems will be the way of the future, while pumping patients full of drugs that indiscriminately kill any rapidly dividing cell will be a thing of the past. Old science is always resistant to cutting edge research. Again, not sure if Advaxis will succeed or not, but their approach is a brilliant way to kill cancer specific to the patient while supporting rather than harming the immune system.
Standard chemotherapy = water + NaCN + yellow food coloring
MINE = non-GMO organic fresh oranges freshly squeezed to make juice
Join the discussion Why not try PMCB-CELL IN A BOX. I THINK THIS IS THE REAL DEAL.. LMK
So why is Amgen putting $65mm into it?
That’s my point too….
I’m fairly sure the treatments you list are all therapeutic, whereas Advaxis’s focus is prophylactic, specifically the prevention of recurrence. This is possible because of the body’s durable immune response to listeria. While its true that most of ADXS’s trials have been therapeutic, this is more due to FDA requirements than anything else. Its single ongoing phase 3 trial, AIM2CERV, is trying to prevent recurrence of cervical cancer. A similar effort is underway in anal cancer, with encouraging results so far.
Your assertion that Lm therapy won’t work because the patient’s immune system has already failed is a bit confusing, because we all know many deadly cancers don’t produce significant antigens. If they did they wouldn’t be deadly. This is why we have things like HER2 antibodies (Herceptin). ADXS’s Lm platform is an antibody delivery mechanism and an adjuvant.
The company hasn’t produced any evidence suggesting its vaccines don’t work. Every trial I’m aware of has been positive, though not stellar. I suspect we won’t see great therapeutic results until the NEO and HOT programs get underway, for obvious reasons. Perhaps the data is misleading or falsified as you suggest, but if so insiders have held their shares quite closely, only selling for tax purposes.
I’m invested in Advaxis, and hope to see them succeed. If you have a real, technical bear case for them I’d like to hear it. If their tech isn’t going to work I’d prefer to get out while I’m ahead.
Also, its worth noting that ADXS’s vaccines are being used in conjunction with checkpoint inhibitors. They’ve shown increased efficacy in pre-clinical trials. Unfortunately the one stage 1 trial being run with durvalumab was almost ruined by the clinical hold. There was however one PR which progressed to a CR after the hold was lifted and dosing could start again.
http://www.advaxis.com/wp-content/uploads/2015/11/Slomovitz-et-al_AXAL_Durv-combo-poster_SITC-2016.pdf
What a wonderful word! Dr KSS, I have long now enjoyed your discourses and comments for their style, breadth and erudition. My classical education appears to have overlooked the word for soot, fuligo; its original English meaning also fits quite well, but the murkiness or darkness it captures now is special, particularly as I look out of my Shanghai window
There is more to the equation than efficacy, Dr. and you neglect to mention side effects and cost. Unfortunately the therapies you’re talking about as being more effective are also much more costly. Treatment costs will be well north of $100K for many of the ones you mentioned. Can society bear this cost? I highly doubt it. This seems to me to be an attempt to bankrupt individuals just before they are to die. And let’s not forget also that we’re not just talk about the American health care system, but the worlds. India, where cervical cancer is practically endemic, would NEVER be able to afford these treatments. (A select few may engage in reverse medical tourism and come to the US) Advaxis vaccines cost less than $10 a dose – you read that right – about the cost of 2 cups of coffee. This technology, which has NEVER failed a clinical trial, can be brought all over the world and offered to all people and the cost can be adjusted to reach the most people possible.
We can also have a discussion on cytokine release syndrome, which requires some of the treatments you mention to be given in an ICU setting. Advaxis vaccines rarely cause more than a grade II reaction and are given in an outpatient setting.
And lets not also forget that because this is a different mechanism of action, there are clinical trials now underway that use combination treatments. Kinda of like stepping on the gas and releasing the breaks to get the best response.
Also, you don’t mention how this tech might work in the infectious disease realm, where the patients do have an intact immune system.
So let’s wait and see before you rush to judgment on how bad this approach is.
I don’t Believe there is much new here. Dr Coley discovered the immuno therapy value of Toxins when a patient in his ward who had a serious cancer caught a staff infection from a nearby patient. When his patients 104 fever cleared, his cancer was gone. Enter “Coley’s Toxin”. That was in the late 1880’s. Coley’s Toxin was used up until chemo came on the scene in the following century.
Figure it out… About $150 for a Colsy’s injection versus $1600 ea for 16 carboplatin drips. Drug companies are not going to go through the process if all they can make is $150. They need to have something to patent for big bucks income.
I know this from first hand. I was diagnosed in 2001 with a 98% fatal lung cancer – Small Cell Carcenoma left upper lobe. I endured the horrible chemo regimen, chest and brain radiation and was nearly killed in the process. The cancer was gone but I was nearly gone too.
Unfortunately, the death of my immune system and the propensity for these cancers to return, I was again diagnosed with a recurrent tumor 14 months later. Recurrent small cell tumors are not really treatable since the additional treatment would most likely be ones death.
Knowing this, I went to a Mexican cancer clinic that used Coley’s Toxin among other things not allowed by the FDA and left the clinic 30 days later in complete remission and have remained so since March 2003.
Over the many years, none of my doctors have been other than flabbergasted that I was still alive, yet none of them ever asked how the Mexican clinic did it. They don’t know and they don’t want to know. Our system needs a drastic change.
I wonder how you get a patent on a process discovered in 1890?
Great to hear your success story. Really great!
I agree 100% with your thinking – but the ones in charge don’t want to hear your story – they are robots under the control of Big Pharma, government agencies, insurance companies. All of these players walk to the tune of money money money.
If they do manage to get a patent for Coley’s Toxin, they will bury it.
Coley’s Toxin is a mixture of dead bacteria. This will certainly stimulate the immune system, as bacteria tend to be covered in antigens. However it would lack the targeted nature of ADXS’s Lm technology, which secretes cancer-specific antibodies into the cytoplasm of antigen presenting cells.
KSS: Do you know why some of the biggest biotech-companies like Advaxis then, and you don’t? If they commit such huge capital into the company there has to be some value to it, but they might have totally missed on this one.
Pharma does what Phsrma does. There are natural substances that cure many end stage patients. The Gerson Clinic uses mostly an organic diet and oxygenization. The clinic I went to uses Coley’s Toxin, Oxygenixation, Laetril, Dendriidic cell treatment, an autologus vaccine made from the patients own blood.
Since I was fighting a recurrence I guess you could call it both therapeutic and prophylactic. Anyway, with so many effective alternate procedures, the major difference is that Pharma can’t patent them. They research for ever looking for the “Big Deal”, not necessarily the big cure.
One major advantage of the holistic treatments is that they don’t run out of steam. If they begin to shrink the tumor, just keep doing what you are doing. Can’t do that with most Pharma products.
An example. remember Martha Stewart? Her ill-fated investment was Imclone which proposed a treatment for late stage colon cancer. Turns out the cost was $35,000 and it might extend ones life by a few months. I’ll pass thanks.
I am seeing one after another of the fund raising commercials for Children’s hospital showing beautiful young children with limbs missing and various deformities. Truly, I nearly cry when I see it. I have personally seen bone sarcomas and the like vanish using the same treatments I had.
Pharma ignores these things. My wish is that the insurance companies allow patients to choose alternative if they wish and fund it.
A well intentioned lady was chased through California by the police trying to get her son to Mexico for alternative treatment. She was arrested for child abuse and the treatment never took place.
Anyone interested in my story, check out http://WWW.SurvivingSmallCell.com.
65 mill, peanuts, biotech and biopharma company’s are obliged to spend on research and place bets throughout the industry on possible breakthroughs otherwise they need to rely totally on there own R&D, china is moving very fast in funding new bio’s http://eqibeat.com/top-20-chinese-bio-pharma-stocks-market-cap/
I think NWBO beats all of these to the market and is the stock that truly has taken a huge beating. Rock bottom right now with final FDA approval on phase 3 trials pending. Expect this to be the biggest market mover of 2017.