Marker Therapeutics Inc (MRKR)

[microcapbiotech]

From Investor Village:
"Post Clinical Update Clarification
After the company update last month, I reached out to Marker directly to try to get some clarification on a few things as well as try to get a little more insight into how they view all of their recent decisions. I have a lot of mixed feelings right now, but I’ll start with saying as much as the share price has been beaten down this company has more going for it now than it ever has. We just have to hope they can execute now.

They’ve spent a lot of time and energy on improving their manufacturing process over the last couple of years. These process improvements were always a large goal of the company. According to them, and they’re right, as a cell therapy company process is everything. Obviously, we need results but those won’t come if they don’t have their process locked down. As such, a lot of their focus has been getting their process to the point where they want it and feel comfortable that they’ll be able to get the results they need moving forward. The potency measure is six times better with the new manufacturing process and is capable of killing 4x the amount of tumor that the equivalent dose can kill with current process. You can’t argue that that shouldn’t work in the company’s favor. All of this remains to be seen but they should be done with the process improvements for the time being, aside from maybe mixing and matching different antigen targets, and should now be able to focus solely on the trials.

I was originally very frustrated with the adjustments to the PI AML trial as they are obviously causing a delay that we don’t need right now. With no real explanation as to why the trial design was adjusted it just left a lot of room for speculation. Mainly that the trial was failing, and they needed to figure out a way to fix it. I’m actually quite pleased with the clarification I received although it still doesn’t change the fact that this delay will probably cause us some pain short term. Basically, this is the original trial design they always wanted to have. Their intention from the beginning was to have the active group split into the two arms with one being frank relapse and the other being MRD+. When they were originally designing the trial, they had met with several key opinion leaders (KOLs). They all said, at the time, treating MRD+ patients would be damn near impossible due to the manufacturing timeline of the BCM process (36 days) as the window to treat these patients is fairly short. They got that manufacturing time down to 20 days which is most likely how they were able to turn the MRD+ patient MRD- which they weren’t actually trying to do in that safety lead in. With the new process being 9 days, they think they have an even better chance at treating these patients. As they should since this means the patients are being treated earlier in an already very short window. The reason this is so important is that if you can prevent post-transplant relapse the patient has a much better chance at success moving forward. An MRD+ patient is basically on their way to relapse but not quite there so by turning MRD- they essentially prevented that relapse from ever happening in the first place. That’s pretty big considering how difficult it is to treat patients with active disease.

The company seems to be very excited at the possibility to treat MRD+ patients. The following link is to a journal abstract from July of last year: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268140/. It just gives an overview of the challenges MRD brings when treating AML.

A search on clinicaltrials.gov for “measurable residual disease” and “minimal residual disease” turned up two active pharma company sponsored trials in MRD+ AML.

Novartis: PIb/II
https://clinicaltrials.gov/ct2/show/NCT04623216?cond=measurable+residual+disease&draw=2&rank=4

AMGEN: PI
https://clinicaltrials.gov/ct2/show/NCT02520427?cond=minimal+residual+disease+AML&draw=2&rank=30

This was just a brief search on my part, and I’m certainly no expert, but it does seem like there is not currently much competition when focusing on MRD in AML and there could be some validity to the company’s focus on these MRD+ patients as they are almost guaranteed to relapse if they receive no further treatment.

I’d love to hear anyone’s thoughts on this.