Marker Therapeutics Inc (MRKR)

[Phantom Lord]

I've seen a few post recently addressing the fact that the new facility was not mentioned in the most recent presentation so I thought I would just post the information I received through communication with the company. I was less concerned with updates as to when the facility would be operational but rather the decision to move forward with an in house facility in the first place so this post won't contain any updates as to timelines. Just information as to what my initial thoughts were on the manufacturing facility and the companies thought process on bringing the manufacturing in house and why they chose to go in this direction.

My initial thought was why would the company spend money on a manufacturing facility when they haven't even started the PII trial yet. The fact that this is a pivotal PII trial with hopes of approval on its completion without the need of a PIII trial helps it make a little more sense but it still seemed like it was putting the cart before the horse a little bit. Something that was brought to my attention by a poster on another board was that the size of the facility at almost 50,000sqft of space seemed a bit overkill. Especially with the minimal space required for the G-REX manufacturing process. THIS video details the G-REX manufacturing process. Starting at 2:37 is where they detail the space required. They boast that the entire process can take place in two rooms and at full capacity can handle manufacturing for 100,000 patients per year. I doubt those two rooms are 25,000sqft each and even if they were the PII trial is only enrolling 160 patients and if their therapy is approved AML occurs at roughly 20,000 cases per year. Even if Marker gained 100% of the AML market they wouldn't need to run the manufacturing at full capacity. My thought was they either completely overestimated the size of the facility they needed or they have other plans that they have not detailed yet.

With the above mindset I reached out to the company for more details. The response I received is paraphrased below:

The manufacturing initiative has been developed over the course of the last two years to align the companies infrastructure with their clinical trial needs. The manufacturing build out was timed to calibrate to their planned enrollment in the AML trial to ensure they had adequate capacity to meet patient enrollment. They hold Baylor's GMP facility in high regard but with the planned PII AML trial enrolling 160 patients the enrollment rate would potentially exceed the capabilities of any academic GMP facility. They did look at other options including third party contract manufacturing organizations (CMOs), building a ground up brick and mortar facility, or using a pods-based approach which they ultimately decided on. They concluded that the company facility would be essential to ensure capacity and product quality for a sizeable PII trial and that the pods-based approach was the most cost effective option. Additionally, for the company to be able to advance this trial to a BLA, they need to manufacture most of the clinical trial product from the same facility that is used to manufacture commercial product in order to satisfy the FDA’s requirements. It was also pointed out that most other cell therapy companies have come do similar conclusions about bringing manufacturing in house.

Specifically relating to the size of the facility I was told that while they have not disclosed facility layout they have designed the facility primarily to ensure the capacity they require for immediate needs of the AML trial. Additional capacity can be brought online quickly and cost-effectively as their needs evolve. They also addressed the above referenced video on the G-REX manufacturing process. Apparently the video is Wilson Wolf's view of the automation "potential" for G-REX but apparently does not represent what is currently available.

Take this for what it's worth. We don't have a lot of information on the manufacturing facility so I just thought I would share what information I have been able to obtain.