Cancer Rx totally eliminates tumors

Investment Analysis Clubs Saul’s Investing Discussions
1

Am I the only one who actually read this amazing world-changing press release that Sooner AJ linked to? Wow! This is absolutely incredible! Follow the link and read the article!!!

This press release changes everything in cancer therapy. Maybe I’m wrong, but I’d guess that Kite and Juno might not have even been been bought out if this was released a year ago. (Perhaps no one would have bothered. They will soon be obsolete).

Thanks so much for sharing this, SoonerAJ. This wasn’t Off Topic at all. Greatly appreciated.

Saul

Injecting minute amounts of two immune-stimulating agents directly into solid tumors in mice can eliminate all traces of cancer in the animals, including distant, untreated metastases, according to a study by researchers at the Stanford University School of Medicine. Activating T cells in tumors eliminated even distant metastases in mice, Stanford researchers found. Lymphoma patients are being recruited to test the technique in a clinical trial.

The approach works for many different types of cancers, including those that arise spontaneously, the study found. The researchers believe the local application of very small amounts of the agents could serve as a rapid and relatively inexpensive cancer therapy that is unlikely to cause the adverse side effects often seen with bodywide immune stimulation…

The approach worked startlingly well in laboratory mice with transplanted mouse lymphoma tumors in two sites on their bodies. Injecting one tumor site with the two agents caused the regression not just of the treated tumor, but also of the second, untreated tumor. In this way, 87 of 90 mice were cured of the cancer… The researchers saw similar results in mice bearing breast, colon and melanoma tumors…

Human studies are now underway.

32 Likes
2

Saul,

I didn’t see your post when I posted. Obviously, we agree. It kind of feels like a horse race for me in my mid-50’s. I hope they find cures to what I get before I get it. I don’t know of anyone who gets to your age or mine without wishing this technology could have been available for a loved one when they needed it.

The rate of change in technology, medicine, automation, and AI juxtaposed against a world with degrading water, increased anti-biotic resistance of bacteria, and increasing strife is strangely wonderful and terrifying at the same time.

bulwnkl

9 Likes
3

¯_(?)_/¯

These sort of studies come out regularly showing phenomenal success in animal studies. To better understand success rates:

Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000. Not very good odds.

https://www.medicinenet.com/script/main/art.asp?articlekey=9…

Injecting tumors is not new: Genitope, CancerVax, Oncophage, and BioVax have been around for over a decade, some for close to 2 decades. None really panned out in human trials.

11 Likes
4

Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5 drugs that are tested in people is approved. The chance for a new drug to actually make it to market is thus only 1 in 5,000. Not very good odds.

Fuma, Maybe you didn’t read the article. This is already in human studies. It’s already one of the 5 out of 5000! Then the question is: Will it be the one out of five that gets approved. A lot better odds.

And its animal results weren’t “extension of survival by three months” as so many cancer therapies are, or “20% show partial remission”. It was 87 out of 90 TOTALLY cured, including all metastases. Without the side effects. I’d be happy to give even odds that they will be super fast-tracked and rapidly approved.

Saul

7 Likes
5

Your data point is true for small molecule drugs in general and injecting tumors is not new, BUT we have recently made progress with humans injecting variants of the polio virus into human brain tumors , CAR-T (Google JUNO & KITE), and treatments based on biologics and genetic information is exploding.

To go from the animal study to people is 3-6 years, and the current success rates for biologics from animals to preclinical is about 8%.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3902221/

The eventual approval rate for biologics in Phase 1 is from 5% to 26.1% depending on the indication (p. 8 in the attached report)

https://www.bio.org/sites/default/files/Clinical%20Developme…

While it’s not a done deal and while it is dicey to presume this will a treatment anytime soon, we have come a LONG way from the 1000:1 odds. This therapy, the outcome, and the way that the biologic attacked the cancer is stunning. I wouldn’t be surprised if we are discussing clinical results on this within 5 years.

Odds are getting better, a lot better, every day.

Best,

bulwnkl

6 Likes
6

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?

4 Likes
7

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.

5 Likes
8

These sort of studies come out regularly showing phenomenal success in animal studies

:mouse2: :mouse2: :mouse2: :mouse2: :mouse2: :mouse2: :mouse2: …

I can hear a sigh of relief throughout the mouse community. Yet for humans, much is yet to be determined.

🆁🅶🅱

6 Likes
9

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

4 Likes
10

This, like the Standard meds, is miles ahead…

That, of course, was meant to be Stanford, and was corrected by my spell-checker.

11

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

1 Like
12

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

1 Like
13

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

11 Likes
14

DVAX also mentioned here (I thought it sounded familiar)

https://www.fool.com/investing/2018/01/21/3-stocks-that-coul…

3 Likes
15

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

16

If they are enrolling patients, it’s registered.

17

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

18

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.

16 Likes
19

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

20

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

1 Like