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correct overall response rate branches out to mean:
1.) Complete response
2.) partial response
3.) stable disease
All those above translate into the overall response rate for a study.
I agree with you attilathehunt. Marker seems to be doing all the right moves.
Conference call moved up to 8:30 a.m. instead of after market close at 4:30 eastern. Things are looking better for Marker than I thought.
https://www.markertherapeutics.com/2019/07/marker-therapeutics-to-host-conference-call-and-webcast-to-review-interim-results-from-phase-1-2-clinical-trial-with-its-multitaa-t-cell-therapy-in-patients-with-pancreatic-adenocarcinoma/
yes I recommend people stay away. Before the latest stint for Inovio, Kim was touting other technology which ended up failing. Nothing of value ever comes from this biotech. I knew something was wrong when I never saw the HIV program not move forward. It was always stuck in the pipeline at phase 1/2 and never moved forward. It is a biotech for leaders to make salary.
The presentation at the plenary session for Marker we won't get to hear it won't be webast. The schedule conference call is to get Dr. Smaglo and other senior executives from Marker to discuss the results.
My guess is a PR may be issued in the morning before the opening bell and then later in the day that conference call explaining everything.
I wonder if many short-sellers are still insistent on staying short over the weekend. If so that's a bad move IMO. MRKR is presenting at a plenary session opening up the AACR 2019 conference. They were picked to present their findings by AACR.
read this:
"For those unable to attend the presentations at AACR, Marker will host a live investor event following the conference on Monday, July 22nd at 1:30 p.m. PST in San Francisco featuring Dr. Brandon Smaglo, as well as Marker senior management. A live webcast of the investor presentation will be available in the investors section of the Company’s website at https://www.markertherapeutics.com/ and will be available for replay following the event."
That means they will post it at the investors section under presentations before the event goes live. I don't think it's up yet.
Yes I agree, the 5 antigens being used is good news and what creates part of the durable response but as you noted the epitope spreading is what really sets this technology up to be a game changer.
As I have stated tumors are hetergenous in that they present multiple antigens and always change antigens on the surface to adapt making them harder to kill. Tumors also have a suppressive T-cell microenvironment as well. Being able to get MultiTAA to recruit the dormant immune system to target other antigens is ideal. Makes it harder for the tumor to stop imminent attacks from T-cells and other parts of the immune system.
The problem with CAR-T is that they are engineered in the lab. That means once the engineered CAR-T cells die out, the durable response ends up dying out as well. That's why if you see the Marker presentation you will see that with blood cancer MultiTAA was able to generate a more longer durable response and then you see Kite's CAR-T cells tart to drop off lower on the chart. That's the CAR-T cells dying off. They don't get passed on to other T-cells already in the patient's immune system.
Which is why also with Marker Therapeutics, which the CEO noted, that every patient that has achieved a complete response when given MultiTAA has not relapsed in cancer. That's because once it works as a complete response MultiTAA along with epitope spreading keeps the cancer from growing back.
Good things are coming for Marker, I'm glad I found this biotech after doing some heavy DD on it.
Well, someone else disagreed with me about the shelf. But IMO I considered the fact that they didn't use it yet.. bodes well for the upcoming data. Because Marker does supposedly have cash until 2020, but they could have raised cash now right away before data. No need to and that's confidence.
yes there is. Because if a hostile bid is put in place, Marker can put a poison pill and block such a transaction. Also, it provides better negotiating power for a better deal. For instance, a biotech low on cash can't negotiate a better deal than one that has the potential to walk away from the deal and come back at a later time.
In other words, MultiTAA is equipped with peptides that target only 5 antigens on a tumor (cancer cells). However, MultiTAA has what is known asn an epitope spreading effect, meaning that the treatment from the company recruits other parts of the immune system to also target the tumor and to target the tumor with different antigen targets. That's important because tumors are heterogenous in nature, meaning they display multiple antigens, and not only that but they are always changing/adapting antigens. Therefore, epitope spreading takes care of eliminating cancer cells where otherwise MultiTAA wouldn't get to target.
NO no, no. if the results are good for PC this company will at least be trading higher than 20 per share. That would give us a market cap of at least 1 billion which is feasible after phase 1/2 data that is solid in PC.
I agree, trust me if Marker Therapeutics doesn't raise before the results, then you can guarantee they will be good. Otherwise it would have been smarter to already have done the cash raise beforehand. But they won't do that if they know the stock is going to be higher after the presentation IMO.
If the pancreatic cancer results for MRKR are as good as I think they will be, not even shorts can stop the oncoming onslaught that will be coming.
From Maciste's point of view I see what he is saying about being cautious but it doesn't take a brain scientist to see all the hints on why data should be good. Which is why I don't agree with Maciste on this board at all.
1.) First, it's a plenary session. Plenary means opening of the entire conference. This is not some small presentation in a breakout room with an audience of 5 or 10 people. It's in the opening conference 8:00 a.m. to 10:00 a.m in front of the entire attendees/presenters at AACR 2019. I doubt that AACR would pick Marker's data if it was terrible data and or mediocre data.
2.) As many have mentioned before the CEO on youtube at the presentation talking about presenting data in solid tumors for pancreatic cancer kind of smirks a bit like he knows something but can't share it yet.
3,) Prior evidence of data shows that after patients become complete responders in blood cancer, they don't relapse. MultiTAA has proven to work well as good as if not better than CAR-T therapies.
4,) Epitope spreading. What's the #1 problem with targeting solid tumors? CAR-T therapies have trouble, like many other types of technologies/platforms because tumors are heterogenous in nature. They have a spread of multiple antigens on the cell surface. Considering that MultiTAA can target 5 antigens is the first good step. Even better epitope spreading allows other dormant parts of the immune system to attack other antigens on the cell surface not directed by MultiTAA therapy because of epitope spreading. The point is that it's hard for a tumor to evade therapy when it has multiple antigen targets being directed at it. The reason why CAR-T and other therapies fail is because they only can target one antigen at a time.
5,) The pancreatic cancer data was supposed to be presented at ASCO 2019. The reason why it wasn't is because they picked the wrong track where they couldn't release any clinical data. Think about that for a second, why rush to post earlier data at ASCO 2019 if it was bad? Wouldn't it better to wait to get more patients enrolled first? It's because they were excited to showcase the data.
6,) evidence #6 and probably the best I can point to. The company filed a $200 million shelf offering. If the data was not good they could have just implemented the cash raise now before the conference/data. Why wait for the bad data to tank the stock? then do a cash raise? IMO they are going to wait for data release and then raise cash as the stock price is expected to be higher.
7,) conference call on Monday after weekend presentation. Trust me on this management would not want to host a conference call a few days after the presentation if they weren't excited to retell the data/story of what they observed.
If anyone else can think of other pieces of evidence please post, but thank you keithamdMIC for your commentary you are spot on. As for Maciste I think they are a bit lost on what's going on here.
They don't need to start a new trial Despite targeting 5 antigens they observed that the MultiTAA tech was recruiting other parts of the immune system that were dorman targeting other antigens on the surface of tumor cells with epitope spreading. It's something that always happens and was observed in several studies already.
I would agree if it was a regular presentation. But it was chosen for the opening ceremony plenary session from 8:00 to 10:00 a.m. It is part of the plenary session chosen to open the AACR 2019 conference. I doubt it could have been chosen if data wasn't good. but thanks for sharing your thoughts and cautions on MRKR anyways but I don't agree with you. THe opening plenary session is chosen by board members at AACR for the best presentation data they see. They would not pick MRKR's presentation to open the conference if it wasn't good.
Between a plenary session means in front of the entire conference, all participants. It is not like a regular presentation that is in an individual room with several onlookers. I hope this clears it up for you somehow.....
True, but typically you would expect drug treatment arm to perform better than placebo. Placebo is typically a sugar pill. However, I have seen times where drugs are duds and have performed worse than placebo.
I think good things are coming down for the pipe for Marker Therapeutics. Plenary session is opening up the entire conference, has to be some impressive data.
TPIV 200 with ovarian cancer is set to report phase 2 results Q4 of 2019. I believe they had to wait for 55 events first. The longer it takes to get to the events the better the data remember that. That's because events means progression/death. If they hit the 55 events fast, that means patients are dying faster on treatment.
But based on estimates they expect interim update for ovarian cancer Q4 of 2019 or end of 2019.
"On January 10, 2017, we announced the initiation of a Company-sponsored Phase II study in platinum-sensitive ovarian cancer patients (FRV-004). This multi-center, double-blind efficacy study is designed to evaluate TPIV200 compared to GM-CSF alone in a randomized, placebo-controlled fashion during the first maintenance period after primary surgery and chemotherapy. We have opened multiple clinical sites and enrollment of the 120 patients has been completed ahead of schedule. The 120th subject was given the study drug on December 10, 2018. Safety is reviewed by an independent DSMB quarterly and an interim efficacy analysis is planned in 2019, once 55 patients have progressed. Details regarding this trial can be found at www.clinicaltrials.gov under the identifier number NCT02978222."
then TPIV 200 for TNBC is being done by DOD government.
"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 cyclophosphamide prior to vaccination. Key data from the trial are 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"
and here is some preliminary data for TNBC:
"The Company reported initial findings from its dose-finding, four-arm Phase 2 clinical trial in triple negative breast cancer, including low- and high-dose TPIV200 with or without cyclophosphamide. Of 27 patients evaluated for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 14 have shown disease progression, as of April 30, 2019, following treatment with TPIV200."
This TNBC program with TPIV200 is looking good. Look at the fact that only 14 patients have shown disease progression out of 80 over that period of time as of April 30, 2019. if you divide 66/80 = you get an ORR of 82%. Now when the data matures this number may slightly go down as patients progress/die. The thing is this program looks good.
More information is found in the SEC Filing under programs.
https://www.sec.gov/Archives/edgar/data/1094038/000114420419025316/tv520511_10q.htm
SRPT shareholders though had to go through a reverse stock split, but management was smart. They waited until they had news.
First reverse stock split then same day released the 6MWT for DMD which caused the stock to go from 3 per share to 12 per share. Then it climbed and fell throughout the years bouncing around 20 to 30 per share. Finally made it's trajectory after FDA approval. But SRPT was pure luck.
There was dissension at the FDA. Janet wanted to approve the drug, but others wanted to reject the drug. That caused the one guy to resign from the FDA.
Anyways MRKR is in good shape. I see it with a future regardless of targeting solid tumors. It's safe and effective which can easily be used as an adjuvant treatment/maintenance treatment with anything.
They are likely to tap the shelf that was implemented, but if they got the goods on PC data the price will be much much higher.
Now that is a statement I have to agree with. Anyways, I think it should be good data. Don't see why not considering the plenary session that Marker is presenting is from 8:00 a.m. to 10:00 a.m that day. It's the opening act of the conference for oral presentation. I can't imagine it would be accepted as highlighted plenary session for entire conference if data was bad IMO.
Sorry about that, but if data on July 20 2019 is very good for PC then this MRKR takes off.
Short-sellers will do everything in their power to bring it down on low volume. However, the way I view it is the more shorts there are the bigger the squeeze if the PC data is solid. They will propel MRKR higher if they are forced to cover at higher prices.
I pointed out the other day that there were about
27,337,350 shares short before the Pfizer buyout of Array Biopharma. That's crazy when you think about it.
Yes I am, I can't see why not. I mean they are going to present the data at a plenary session first of all. Then a poster presentation from noon to afternoon. Then after that a call on July 22, 2019 to discuss the data. I don't see why they would rehash such data multiple times if it's bad. Even then look for evidence of a cash raise. If they don't raise any cash before the presentation then prepare for lift off.
Because traders/investors are nuts.
Look at Array Biopharma, just got bought out by Pfizer.
Now, look at its short volume 2 days before buyout
6/14/2019 27,337,350
So it had a 27 million + short volume 2 days before Array was bought out by Pfizer. People short for the heck of it, but they get burned all the time.
Another time I can think of was Tobira as well and then it squeezed from 4 per share all the way to 30 per share.
Traders don't know what they are playing with.
So I have done some research on MRKR. Many are questioning the pancreatic cancer data and why ASCO didn't accept the abstract submission. Most of you know but just in case some of you don't know this is why they rejected the submission.
"Trials submitted to this session are ongoing and have not reached pre-specified endpoints for analysis. As such, inclusion of results would be improper and is strictly forbidden"
https://meetings.asco.org/am/trials-progress-abstract-submission-guidelines
They wanted to release clinical data and it wasn't allowed. However, it caused the stock to tank by 11% at that time and the price had been lower soon after that. I guess it created a nice buying opportunity though IMO.
That's good news, the more shorts piled in, the bigger the short-squeeze for MRKR if the pancreatic cancer data hits a home run.
I guess that's left to interpretation on which arm was promising for MRKR. There are about 3 arms in the study. However, any arm achieving responses would be seen as huge.
Having said that there are many other hints on why I think there will be good results for the pancreatic cancer data:
1.) The company filed a $200 million shelf offering and hasn't diluted yet. If it goes all the way near results and the company still hasn't raised cash yet, that leads me to believe that the data is going to blow our minds in a good way. Of course this could change before data but we shall see.
2.) It's being presented at a Plenary session - Plenary session is the opening of the conference where everyone gathers in one big room before broken down into other small rooms. I don't think they would present bad data in front of the entire conference.
3.)As many have suggested like you have rwwest, the CEO laid out that quote you posted from March 28, 2019. In addition, many point to the SACHS video where he is smirking saying he is excited to show pancreatic cancer data.
4.) Conference on data that Monday after conference. I doubt that they would rehash failed/bad clinical data again on Monday July 22, 2019.
5.) The company let the data mature, but they wanted to rush the data out the door at ASCO at a much earlier time point. If the data was bad they wouldn't have rushed to release it at ASCO a few months ago. More specifically, if the data was rotten/bad the company could have just released a PR they didn't/wouldn't need to present it at ASCO or AACR.
With solid pancreatic cancer data? I could see $23 to $25 per share IMO in the same day. It will take a few months to build up to $50 per share but It could start to run.
The Russell 3000 holds a lot of stocks in an index they buy and sell lots of stocks every year. Since MRKR made the final cut they bought up that huge volume of shares after-hours.
It starts On Monday July 1, 2019.
Yah sometimes on low volume or late print it boosts a stock like that. I mean I hope big volume comes in for MRKR on Thursday and higher share price but it's not guaranteed.
A notice of effectiveness means that the SEC office has reviewed the application and has accepted it. That's all that means. Now Marker can implement a cash raise whenever it wants to not that it has been accepted. From my view, I'm hoping they have the good for PC data at plenary session at AACR 2019 and will wait then. They may very well do a cash raise sooner we shall find out soon enough.
Penny flippers, traders, momentum buyers bailing really. But in the grand scheme of things doesn't matter if the PC data at Plenary session is really good. Gains for them will be chump change if PC data is good for MRKR.
Every biotech stock has it's fair share of short-sellers but it doesn't matter in the endgame. Didn't Array Biopharma have a massive amount of short-sellers?
6/14/2019 27,337,350
5/31/2019 27,471,518
5/15/2019 23,609,401
Not necessarily. Conditional approval would have to fall on a phase 2 study.
For instance the post-transplant AML study using MultiTAA is a phase 1/2 study. The phase 2 study for post-transplant AML is set to begin Q3 2019. If that data ends up meeting endpoint that would e conditional approval for post-transplant AML.
The pancreatic cancer study is a phase 1/2 study. That means Marker will need to run a phase 2 study with a small group of patients probably 20 or 30 patients. Then if that study meets the primary endpoint, it's possible accelerated approval can be given.
I never seen an instance where the FDA allows for accelerated approval after a phase 1/2 study.
Plus today wasn't a good market overall, about 11 of the 15 biotechs I track were in the red.
Correct only 15 minutes but plenary session is in front of the entire conference.
To add there is a poster presentation later in the day at 12:00 and then on Monday a conference call with investors and senior management.