Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Looks like the Dow is back down again. As to why we were not bouncing with the Dow, probably in part because our chart is broken, to put it kindly, lol. If you look at a weekly chart we were bouncing on support on the 50 week Exponential Moving Average since the start of November and this week crashed through it. Kinda ugly.
I imagine there is some tax-loss selling making things worse. And if the markets bounce back in January I imagine most money will likely flow into high quality names that had a significant correction before it finds its way into MRKR. Or we might snap back like a rubber band in early January, one never knows of course. . .
In the meantime, from Peter's Nov 28 presentation:
What are the key milestones for 2019?
<<Peter Hoang, President and Chief Executive Officer>>
Towards the end of the year, we do expect to have an amended clinical trial protocol at Baylor, which will allow us to actually accelerate the patient enrollment in the current AML study at Baylor. And actually expand that trial to two to four additional centers.
At ASBMT in February, that's the American Society for Blood and Marrow Transplant. We expect to have another data update that will include additional patients in the AML study. And there I think we will have a meaningful number of patients with additional information to update the investor community.
We expect around that time to have our pre-IND meeting for our pivotal Phase 2 study, the seamless pivotal Phase 2 with a filing of the IND no later than the early third quarter. We do expect to have first patient in that seamless Phase 2 before year-end. We expect that to be about 27 multicenter trial that should be able to read out within 18 to 24 months of initiation.
https://markertherapeutics.com/wp-content/uploads/2018/11/Evercore-HealthConX-Transcript.pdf
I like the "overweight" rating from PJC. I'm still sort of shocked at the quality of people involved with MRKR - Nobel Prize winners, Baker Brothers, our first-class CEO, the research hospitals where we're doing our clinical trials. And the results so far are so encouraging.
These prices are a gift to people cost-averaging their monthly buying of MRKR at $10 and under.
Not bad but as the comments say he could have done a much better job.
Erg61 correct me if I'm wrong but you're an "old timer" long on this board? If so then my guess is the day to day meanderings on low volume don't really mean much too you at this point, hence your joke. Having said that, I was impressed by how the past 6 market days the market shit the bed but we stayed steady.
Hi Flyingj. Below is the paragraph I think you are referring to and also a link to the FDA site detailing the process for approval for Vaccine/Biologics License Applicaion (BLA). I think the 10Q is sort of generically saying that the data from that particular Phase II would be part of an application at some point in the future, and not saying that they are necessarily currently preparing an application for the license. The FDA site makes it clear a Phase III is part of the process.
As for a time frame for approval, the estimated time for completion of this Phase II is December 2021 according to the clinical trial data at the link at the bottom. So even if they start an overlapping Phase III it is likely to be at least 4-5 years before they submit a BLA.
"
On June 21, 2016, we announced the initiation of a randomized four-arm Phase II trial of TNBC that is sponsored and conducted by the Company (FRV-002), enrolling women with stage I-III disease who have completed initial surgery and chemo/radiation therapy. This open-label, 80-patient clinical trial is designed to evaluate dosing regimens, pre-treatment, efficacy, and immune responses. The study is evaluating two doses of TPIV200 (a high dose and a low dose), each of which will be tested both with and without immune priming with cyclophosphamide prior to vaccination. Key data from the trial is expected to be included in a future Biologics License Application submission to the FDA for marketing clearance. We completed enrollment in late 2017 and are now treating and following the patients. An independent Data Safety Monitoring Board (DSMB) reviews the safety in this ongoing Phase II study; no safety issues have been identified to date. Details regarding this trial can be found at www.clinicaltrials.gov under the identifier number NCT02593227." Paragraph 2, p. 16
http://app.quotemedia.com/data/downloadFiling?webmasterId=102648&ref=12546966&type=HTML&symbol=MRKR&companyName=Marker+Therapeutics+Inc.&formType=10-Q&formDescription=Quarterly+report+with+a+continuing+view+of+a+company%27s+financial+position&dateFiled=2018-11-13#a_008
Vaccine Product Approval Process
https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicslicenseapplicationsblaprocess/ucm133096.htm
TNBC clincial trial:
https://clinicaltrials.gov/ct2/show/NCT02593227?term=NCT02593227&rank=1
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer Defined as Primary Tumor That is Her2-neu and Low (< 10%) ER/PR Nuclear Staining
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Man that presentation is chock full of incredibly good info! It answers at least partially some questions here about the future plans of the company.
This was particularly good to hear IMHO:
"We expect around that time to have our pre-IND meeting for our pivotal Phase 2 study, the seamless pivotal Phase 2 with a filing of the IND no later than the early third quarter. We do expect to have first patient in that seamless Phase 2 before year-end. We expect that to be about 27 multicenter trial that should be able to read out within 18 to 24 months of initiation" p. 7, paragraph 2.
Thanks for posting that BluMarlin.
"And the really cool thing for me is that some of our best results are in indications that are currently inaccessible to CAR T treatment." p.2, paragraph 6.
I love seeing that statement in print. That is such a good summary of MRKR that maybe it should be stickied?
Marv keep in mind these were patients in the high risk/lower survival rate category for Multiple Myeloma who had two or more previous rounds of chemotherapy treatments that failed to stop the disease. So this is the first treatment that *at the very least* stopped the progression of the disease . Attaining Stable disease for these patients is not a trivial or an insignificant result. If these results hold up I think it would be very likely to get approved. At least this is the best of my understanding. It would be interesting to see what kind or results we would get with patients who have not undergone multiple chemotherapy treatments.
Hi Marv, I'm not sure exactly how to interpret the results but the fact that the 8 people in remission stayed in remission (except for 1) is good.
What seems impressive to me is that there were 10 individuals who had active disease and after treatment there was 1 that went into complete remission, 1 in a partial remission, and the remaining 8 had stable disease. I don't think the 10 with active disease, after having gone through a minimum of 3 previous treatment regimes, would spontaneously go into remission, partial remission, or convert to stable disease. I think our treatment made the difference.
I may be misunderstanding things so listen to Dr. Ann Lee's presentation again and it might help clarify things.
This link should start at the Multiple Myeloma part of Dr. Ann Lee's presentation. I don't know why it did not in the link I posted the other day:
Marv I'm not sure what you mean by "no longer in complete remission (CR)"? I assume you are referring to the poster LadyLuck posted?
In the Multiple Myeloma study only one person relapsed out of the (evaluable) six that were in CR.
The results for the group that had active disease sound impressive but are hard to evaluate without a comparison with an untreated control group, or without knowing what might be the expected outcome for those patients if they did not receive multiTAA-specific T cells to treat their active disease.
I think this is covered a fair amount in Dr. Ann Lee's presentation. It looks like they have added three more individuals to the Active Disease group between Dr. Lee's presentation and the current presentation in LadyLuck's post.
Here is the link set to start where she discusses Multiple Myeloma results:
""amenable to rapid approval.""
(in my best Austin Powers voice) YEAH Babay!
(thanks for the head's up LadyLuck!)
Thanks Eagle1, great job on the board Intro.
Buckboard, maybe you're thinking of TPIV200 clinical study, which is administered like a traditional vaccine (i.e. antigen + adjuvent):
"A Randomized Multicenter Phase II Trial to Evaluate the Safety and Immunogenicity of Two Doses of Vaccination With Folate Receptor Alpha Peptides With GM-CSF in Patients With Triple Negative Breast Cancer Defined as Primary Tumor That is Her2-neu and Low (< 10%) ER/PR Nuclear Staining"
https://clinicaltrials.gov/ct2/show/NCT02593227?term=TapImmune&rank=2
------------
There's also 4 dose TPIV100/110 for HER2/NEU Breast cancer study using antigen in a more traditional vaccine.
https://markertherapeutics.com/pipeline/tpiv100-110/
Buckboard here is a link to the presentation by Dr. Ann Lee set at 13:25, where she discusses the Marker Method:
Someone should update the Introduction. It's still for Tapimmune. People will think we're a bunch of heathens.
I agree Epicare. The 200 day Exponential Moving Average is at $6.74, and I believe the low yesterday was 6.76. I think this is reasonably good buying point from a TA prespective. I added this morning too.
Thanks Tripolar. It would be nice to have a strong partner like that. That's another reason I have confidence in this company, they rub elbows with talented people and companies. It gives us more credibility.
Thanks Phantom!
Tripolar, why do you think our ovarian cancer studies have a better chance of being marketed before Sellas TNBC vaccine?
Okay, this might be a dumb question but help dispel my ignorance. Does anyone know if Schiff bought/is buying for himself here or for Aisling Capital? If it was for Aisling wouldn't the registration be in there name? Schiff is a pretty smart cookie.
Yeah I have a feeling the under-valued label is not going to apply to MRKR much longer. I don't necessarily expect a rocket ride, but I think there will be gradual price appreciation until some sort of big news comes out.
"First immunotherapy success for triple-negative breast cancer"
https://www.eurekalert.org/pub_releases/2018-10/qmuo-fis101918.php
Not directly comparable because they use a monoclonal antibody but it gives an idea of how success is measured for triple-negative breast cancer.
"The new treatment combines standard weekly chemotherapy with the immunotherapy medication atezolizumab which is given once every two weeks. The combination works by chemotherapy 'roughening up' the surface of the cancer, which enables the immune system to better recognise and therefore fight the cancer as a foreign object...
" ... using a combination of immunotherapy and chemotherapy the body's own immune system can be tuned to attack triple-negative breast cancer, extending survival by up to ten months."
LMAO Twocan was $3 a Freudian slip? Also, is Twocan like "toucan" or "two cans" as in beer?
And Baylor with the merger.
https://blogs.bcm.edu/2018/08/16/companies-merge-to-implement-baylor-college-of-medicine-developed-therapies-for-cancer/
"" With this technology in the hands of a merged company that has the resources to support clinical development, patients will have an opportunity to benefit from it."
Here is the presentation of the Marker vaccine data:
http://media.rampard.com/newsmakers/tapimmune/index.jsp
Just friendly reminders for longs, and FYI for those new to TPIV.
Eagle check out the exponential moving averages. We've had good support on the 20/50 day EMAs for both when we based in June/July and again in Sept to the present. The EMAs became resistance in August for the time we dipped below them. Also, looking at Volume-by-Price it looks like $8.50-$9 is major support.
On the weekly chart going back 4 years the 20 and 50 week EMA were acting as resistance the past few years and the 20 has been support since the break out in May.
Thanks for your posts Phantom, they're always interesting and informative.
One question I have about valuation and comparisons to Kite or others. When considering valuation, what kind of revenue stream is expected for the therapies we are developing and is the revenue we could generate comparable to what might be generated by Kite? I'm just not sure about any of these numbers. Any info you or anyone else might have in this regard would be appreciated.
Wow what an outstanding presentation. Very clearly presented, excellent comparison with competing therapies offered by other biotechs, and the scientific advisory board info shows that our therapy has got the attention of the creme de la creme of the immunotherapy field. Thanks Burrhead1!
Erg: re stop losses
I personally don't use them for positions in stocks I'm confident in, and I'm holding long term, like TPIV. IMO it's too easy to get stopped out on a short dip that hits for no apparent reason, and then miss buying back your position at a price lower than what you stopped out at.
I use them for trading, but I vary rarely trade, even in my IRAs. I have nothing against trading, it's a lot more fun than a gambling at a casino and you probably have better odd than at a casino, but I just don't have time for it. I have friends that trade a lot and are honest enough to tell me they lose more often than not. But of course they usually only talk about the trades that go well, just like my casino friends, lol.
If you have any questions about stop losses feel free to ask on this board, I'm sure there are many here who could help out. Or feel free to private message me and I'd be happy to answer any questions I can.
Good luck!
erg61, Likely a lot or people put in stop losses just around $9, which were triggered and started a small avalanche. We almost tagged the 50 day exponential moving average (EMA) which is at $7.97, and closed a penny over the 20 day EMA, which is at $8.25.
In the immortal words of Ronald Reagan, "Mr. Market, Tear Down This Wall!"
Or John Cougar Mellencamp, "And the walls, come tumbling down, and the walls come crumbling, crumbling."
Or J. Geils Band, " Jumpin' out of planes for the thrill of it all,
Then I bounce back and take a Piss On The Wall."
Buckysherm:" Might just be the sector. "
Still it is nice to see TPIV participate and to do so in such a strong fashion. It's not unusual to be in a small cap that is left behind on days like this.
LOL, yeah. I am very grateful for such problems. Thanks for reminding me.
Goddammit. Two more days and I'll have a boat load of cash going into my account and it was all earmarked for TPIV. Oh well, I'm glad I at least have a nice chunk of shares already.
Why Neombridge?
Dang it! As a contrarian I hate to see that kind of lopsided options activity (half lol).
"In all honesty we need some more shares added to the float so long term having some shares from this offering sold in the open market will only help us.
With the float as small as it is I would assume most of the shorting is retail."
I agree with you Phantom. Mutual funds and Hedge funds would prefer a stock with a higher float and certainly would not short something below $10 with such low trading volume.
Excellent presentation. I think this approach using multiple overlaping epitopes (as it recruits even very rare Tcell clones), and the persistence of the subsequent memory Tcell clones (vs CAR-T's limited to the individually modified Tcell lifespan) gives this therapy an enormous advantage and easily offers patients the best hope of long lasting remission compared to CAR-T approaches.
I wonder what exactly he means at 10:26 "this program has flown under the radar at Baylor." I'm assuming he meant the program at Baylor has flown under the radar of the oncology community in general, which might explain why other companies did not go after them.
Next best buy op at $4.50-$5.50?
With this run-up, TPIV held the 20 EMA for about a month until last Monday, when it closed just slightly under the 20 day EMA. Then Tuesday we fell a couple bucks and dropped below the 50 day EMA.
Next technical support looks to be between the 200 day SMA ($4.40) and the 200 day EMA ($5.30).
That price range may, or may not, seem reasonable based on fundamentals but that is what the technicals suggest to me.
---
On another subject. I read the recent SA article on Marker being a KITE killer and some of the comments suggested TPIV/Marker is a pump-and-dump. I literally LedOL at that. Yeah, Sloan-Kettering, Mayo Clinic, the distinguished BOD and management are all in on a pump-and-dump.