Saul,
As promising as this appears to be, what investment thesis do you make of it? Are you going to bail out of NKTR based on this info? Are you going to buy something else in the pharma domain? From an investing perspective, what do you see as the actionable information and what direction should that action take?
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I don’t know enough about genetics nor the time to properly study the article right now, but a couple issues that I see would be that the tumors treated were either transplanted or all coming from a specific genetically susceptible mouse line.
My question would be whether spontaneous cancers in humans (or mice for that matter) would respond the same way. Do the very early cancer cells not elicit some kind of immune response, possibly the same response that is caused by the injections used in the study? In that case does the body somehow desensitize to tumors that develop spontaneously?
Very interesting nonetheless. We currently do procedures to locally treat tumors by directly placing a needle or probe into it through the skin using image guidance (usually to freeze or heat it to death). Pure alcohol is also used via direct injection to kill tumors. It would be trivial to adapt those therapies to inject the immune enhancing agents.
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These sort of studies come out regularly showing phenomenal success in animal studies
…
I can hear a sigh of relief throughout the mouse community. Yet for humans, much is yet to be determined.
🆁🅶🅱
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Hi Brittlerock, There’s nothing to invest in as far as I know as it’s all at the medical school. I think Nektar is on a very similar track, further along with their NKTR-214, and with only slightly less stunning results (for a solid-tumor anticancer medication). Here’s a quote from an article I read back in November:
They reported some data for this drug for solid tumors in combination with a drug called Opdivo from Bristol-Myers. NKTR-214 activates cancer-fighting T-cells, while Opdivo unmasks the cancer cells by hijacking the PD-1 protein, which is what usually helps cancer cells hide from the immune system. Opdivo uncovers the cancer cells while NKTR-214 activates the T-cells. Together, they’ve shown pretty stunning efficacy across a bunch of different cancers. There was 91% disease control rate in melanoma, 85% in kidney cancer. In lung cancer, 75% of the patients studied responded. . And the safety looks good so far, which is pretty awesome.
and here’s from HeartMD’s recent deep dive.
NKTR-214…an investigational immuno-stimulatory therapy designed to expand and activate specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of cell-surface PD-1 on these immune cells… This is meant to be complimentary therapy with checkpoint inhibitors…
This, like the Standard meds, is miles ahead of meds like Kite’s which require drawing blood from the patient, sending it off to have the T-Cells modified, shipping it back, and weeks from when you started, injecting it into the patient, with some patients getting so sick they actually can die from the treatment (granted, they were going to die from the illness anyway). For something you can invest in right now, Nektar seems to fit the bill.
Saul
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This, like the Standard meds, is miles ahead…
That, of course, was meant to be Stanford, and was corrected by my spell-checker.
https://sciencealert.com/cancer-vaccine-stanford-immunothera…
Just linking to the article again.
The specific limitation of this treatment is it is specific cancer type specific. So one for each cancer will be needed.
I am sure the tests were done using Abgenix mice, which have altered immune systems to be identical to the human system (as much as a mouse can be).
But as stated earlier, happy mice! Of Mice and Men, hoping we are more similar than is usually the case.
I think the investing take home is that many companies focusing on cancers susceptible to being treated in the manner of this treatment are subject to large stock drops pending the published results of Phase 1 from this trial, and in fact, from interim publications of this phase 1 trial.
I do not know, for example, if this treatment would be usable against blood cancers, as an example, given the protocol of how it is used.
But biotech investors are the most sophisticated of all investors. If results like this that knock on the territory of Celgene, BLUE, et al., it will not take long for these smart investors to react virulently to real and concrete news.
Thus, that is my investing advice.
Before panicking, first ascertain when the clinical trials will actually start. It looks like they are already recruiting, and if so, I assume they have been regulatorily approved to move forward.
If the case, find out how long recruitment is expected to take (I would guess pretty quickly given the notoriety of this treatment and the “miracle ness” of it).
I have no doubt if results like that KITE and BLUE and JUNO have shown in phase 1 are announced, just like they were for these other companies, there will be virulent reactions to the stock prices of the relevant companies. This first trial is lymphoma, and that is going to be right down the bullseye of where a lot of these treatments are aiming for in their lower hanging fruit.
Tinker
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I do not know, for example, if this treatment would be usable against blood cancers, as an example, given the protocol of how it is used.
Step 1: take some blood and capture of the the blood cancer cells.
Step 2: Reinject the cancer cells to form a tumor in the body.
Step 3: Inject the induced tumor with the 2 drugs to get the immune system to kill the inject tumor as well as all the cancerous cells circulating through the blood.
Chris
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Was trying to find the human trial on clinicaltrials.gov to track progress. Could this be it?
https://clinicaltrials.gov/ct2/show/NCT03410901
This one has Richard Levy as PI, same guy as mentioned in the article, and is for non hodgkins lymphoma, registered Jan 25 2018. I’m trying to figure out who owns the drugs being tested.
BMS 986178 sees to be a Bristol Myers drug. TLR9 Agonist SD-101 seems to be owned by, Dynavax, a publicly traded company (DVAX):
http://www.dynavax.com/our-pipeline/cancer-immunotherapy/sd1…
(I could be mistaken, this was just a quick search but Dynavax is mentioned in the original mouse paper at the end: http://stm.sciencemag.org/content/10/426/eaan4488/tab-pdf
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DVAX also mentioned here (I thought it sounded familiar)
https://www.fool.com/investing/2018/01/21/3-stocks-that-coul…
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Does not would like the same drug although very familiar methodology. Good place to start to finish me it. The trial may not even be registered yet.
Tinker
If they are enrolling patients, it’s registered.
The article specifies “shrinking “ tumors. But worth looking at the company specifically and see where they got that drug.
Good place to start looking anyways if that is not it.
I’m about to go out and about so I’m sure someone will beat me to it.
Tinker
In doing some more digging, this actually is the dynavax drug! ha!
They tried this before for Bcell follicular lymphoma in 2009, and failed.
https://clinicaltrials.gov/ct2/show/NCT00251394?term=dynavax…
They terminated a trial in Recurrent/Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation (they couldnt get 6 patients!)
https://clinicaltrials.gov/ct2/show/NCT01745354?term=dynavax…
Dynavax is also trialing it with Keytruda (I think? … its partnered with some checkpoint inhibitor) via inhalation… which reminds me way too much of Afrezza. ETA Sept 2020. Based on prior Afrezza results, I cant possibly see this becoming a thing. Some would use their inhaler way too much, some not as prescribed, others just wouldnt be able to use the delivery system correctly.
https://clinicaltrials.gov/ct2/show/NCT03326752?term=dynavax…
They did complete a trial in April 2017 (29 patients) for untreated Low-grade B-cell Lymphoma - no results posted, so doubt its a positive study at this point.
https://clinicaltrials.gov/ct2/show/NCT02266147?term=dynavax…
They are in a phase 1b/2, looking for 150 patients in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. In combination with Keytruda, with ETA 2020… now this seems like a reasonable trial, except… it started in Sept 2015, and they presented a whole 19 at ASH in 2017. So, probably going to come up way short of hopes.
https://clinicaltrials.gov/ct2/show/NCT02521870?term=dynavax…
http://files.shareholder.com/downloads/DVAX/5959399789x0x970…
They’re burning just over 20m a quarter with 190m in cash on hand – they just raised 169m last year. Oh, and they just reverse split not too long ago.
I’d be happy to give even odds that they will be super fast-tracked and rapidly approved.
It is entirely possible that dynavax, like many a hyped biotech, might have a short-lived hype cycle that makes some investors money. But rapidly approved and super fast-tracked? I’ll take the even money bet!
Dynavax is an overhyped pennystock, plain and simple.
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That certainly is disappointing.
Good lesson in not taking what the press writes as gospel or even close to truth.
So moving on again…
Tinker
https://clinicaltrials.gov/ct2/show/NCT03410901
Hold your horses people!
Does not appear that Donavan has anything to do w this clinical trial.
VitaminD certainly fond the correct trial and I have linked to it above.
Filed Jan 25. Recruiting 15 patients. Two approved drugs…etc.
This is th drug! Excellent searching.
However, Dynavax is not a sponsor of this trial. I did not find Dynavax or anything related to any commercial company linked to this trial.
I am. It a doctor, nor involved or trained in clinical trial procedure or methodology. So set me straight if I missed something.
This is not anyone’s drug but Ronald Levy and the cancer institute.
Thus, yes, keep hope alive and all.
Tinker
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Tinker, one of the drugs in that clinical trial they are looking at is SD-101, which appears to be the intra-tumoral injectable…
And SD-101 also happens to be the name of a drug on dynavax’s pipeline that does the same thing…
http://www.dynavax.com/our-pipeline/cancer-immunotherapy/sd1…
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Ahh, okay. Could be a Medivation like thing where a drug from left field, ignored for decades becomes the multi billion dollar drug to fix Alzheimer’s as an example. Medivation if I recall was a Dynavax like company when they got into the Alzheimer game, doing much of their work in Russia or something like that.
Thanks Fuma. Still worth watching this trial, but I agree not going to put money into such a penny type stock until there are actual results to match they hype.
Tinker
I eill do some more digging to see if I can clarify the relationship but if you look at the paper that started this thread (the mouse paper) they do acknowledge dynavax at the very end though not as a sponsor. I linked to the paper earlier.
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https://finance.yahoo.com/news/apos-not-too-buy-dynavax-1223…
stock is up 400 some percent over the last year apparently, and the new Hep B drug looks very promising. From the current valuation looks like low risk option on the cancer drug.
I can find no mention of this in their press releases and it seems as if we are some of the first people with investing interest to have even put the article and the company together.
However, it is unclear as to what Dynavax would get out of this drug, other than lending their own drug to the cocktail. Worth a deeper look.
Medication had a similar story, it does happen. usually not, but it does happen.
Tinker
They estimate 500m from the HepB vaccine.
The main advantage is 2 shots rather than 3. Shrug.
Add in that:
-Vaccines are usually low margin
-they have zero sales force
-they need cash through at least 2020 to keep them going and at the current rate of $20m/Q - which is almost certain to increase- they’ll run out well before results of their p1/2 ever sees ASH daylight.
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