Marker Therapeutics Inc (MRKR)

[Phantom Lord]

Y'all need to settle down. The panic that I have seen this morning in not only the market but across the message boards is laughable. First of all the company had nothing to do with AACR posting the abstract. That was all AACR. Look at the AACR website. How many other abstracts from this weekends conference have been posted? There is a reason they chose to post this abstract. For everyone saying that the company mismanaged this, AgAiN, it wasn't on the company. It was on AACR. And even then they technically didn't do anything wrong. The embargo ended at 12:00 this morning. It would have been nice if they just waited for the presentation but AACR can do what they want to do.

Now on the the "data" that we can see. That's not all of it. There will be more complete data presented tomorrow. So from what we know, 1 CR. Do y'all know how rare CRs are in pancreatic cancer? Ridiculously rare. And we saw one in 7 evaluable patients. If you don't think that is good then GTFO of here. In addition to that CR, directly from AACR's website, "Seven of the nine patients who received the T-cell therapy alongside chemotherapy were evaluable for response. Five of those seven have had responses for longer than six months from the time of starting the T-cell therapy. The responses for these five patients are all ongoing." You don;t think that's significant? Come on.

You can't just look at the data and evaluate it on it's own. It needs to be compared to standard of care. We all know this. What's the standard of care for pancreatic cancer? You've got chemo, surgery, and two therapies; Folfirinox and Gemcitabine. Just to get it out of the way, these options are soooooooooo toxic. You know where we stand on that front. So, chemo. If you are going to see responses to chemo it’s going to be, roughly, within the first 3 months. If you don’t get much response then chemo likely isn’t going to help you. I think we know enough about standard chemotherapy so I’m not going to focus much on it other than that.

On to Folfirinox. HERE is a journal on one of its studies. This is probably the most toxic of all approved therapies. It’s a combination of 5 chemo agents so this makes sense. You’re getting the side effects of each agent. Below is taken directly from the journal entry linked above (My emphasis in bold):

Results: Fifty patients (18 LAPC and 32 MPC) were enrolled, with a median age of 55 years (IQR 49-66) and WHO performance status of 0/1. FOLFIRINOX was given as first-line treatment in 82% of patients. Dose modifications were applied in 90% of patients. The median number of completed cycles was 8 (IQR 5-9). Grade 3-4 toxicity occurred in 52% and grade 5 toxicity in 2%. The response rate was 25% (12% in LAPC, 32% in MPC). Median overall survival and progression-free survival were 14.8 and 10.3 months in LAPC, and 9.0 and 5.9 months in MPC, respectively. Overall 1- and 2-year survival was 65% and 10% in LAPC and 40% and 5% in MPC. Within the LAPC group, 6 patients (33%) underwent local ablative therapy and 1 patient (6%) a resection, leading to a median survival of 21.8 months.

I believe to date there has only been one CR in patients treated with Folfirinox. That’s with a long treatment history and a whole heck of a lot more patients dosed than we have. Out of our small sample size we already have a CR. Let that sink in.

Now for Gemcitabine. HERE and HERE are some publications on it. The second one of these being a trial where Gemcitabine was given as a treatment only after Folfirinox. Highlights from these publications are below (again, my emphasis in bold):

Results: 28 pts were included in our analysis. Median age was 55 years (38-75), and 19 pts (67%) were male. The median ECOG was 1 (0-2). Pts received a median of 9 cycles of FOLFIRINOX as first line treatment (1-27), with an objective (ORR) response rate of 39%. The median number of second-line Gemcitabine cycles was 3 (1-8), with an ORR of 3%, and a 17% rate of disease control (stable disease + partial response). Five patients (18%) discontinued second line Gemcitabine due to toxicities and the remaining 23 (82%) due to disease progression. Median overall survival was 5.6 months (0,36-11,5) and median progression-free survival was 2 months (0.2-7.7). Grade ≥ 3 toxicities with Gemcitabine were experienced by 18% of the patients. No treatment-related deaths were reported.

Results: The median age of patients was 55 years (range 44–82 years). Based on RECIST criteria, there were 5 cases of stable disease (45%) and 6 cases of progressive disease (55%) among the 11 assessable patients. The median survival time was 189 days (range, 84 to 409 days), the 1 year survival rate was 18% in all 17 patients. Grade 3–4 toxic side effect was leucopenia only (29%) and was easily managed without infection.

Like I mentioned. We don’t have all the data yet. We will get more tomorrow. Be on the lookout for a PR and then we’ll get a more detailed explanation on Monday. Things to look for in the full data set when it is released other than response rates are overall survival and tumor volume. I’d be willing to bet that the patients in this trial are a lot further along compared to survival expectations. As we all know the outlook for pancreatic cancer patients is pretty bleak and I think we will have a better picture once the full data set is released. Someone posted on another message board yesterday screenshots from Facebook from people receiving treatment from Dr. Smaglo. The post claimed their father had his tumor shrink by roughly 35% if I remember correctly. That’s a big deal.

We are seeing responses that are not typical for patients with pancreatic cancer. This sell off is completely unwarranted and I really hope the shorts are taking this opportunity to cover. If the “news” and subsequent drop in SP shook you this morning then you need to do a little more research. More comprehensive data will be seen tomorrow.