Marker Therapeutics Inc (MRKR)

[hanscott]

Micro are you confusing this AML study this PR is referring too with the Pancreatic Cancer study?


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My notes from the Piper Jaffray Conference Dec 3:

read at your own risk or listen yourself
https://event.webcasts.com/starthere.jsp?ei=1273932&tp_key=6680b5ceb5


Trial Design AML: to start early next year. AML= about 26K new cases a year. Trial has 120 patients, 60 adjuvent (T Cells), 60 Std of Care
First Line therapy is induction therapy, line of individual therapies (demethylating agents, flip 3 inhibitors, "IDH/IBH/IVH???" inhibitors)
- Curative for about 20% of patients. Mostly intended simply to buy you time.
Most - 80% end up at last resort - Bone Marrow Allotransplant. 4 1/2 Month survival expectation, by 6-9 Mo most reappear with frank relapse.
Donor Leukocyte Infusion -DLI- is the only therapy available that Peter knows of for pos-alloransplant.
DLI Poor outcome - 5-10% overall response rate, vey high risk of toxity,

All AML transplant patients (120 patients)- at the time of transplant patient enrolled and make cells
90% survival post transplant.
two goals (22:38 min) = Maintenance Therapy for non-relapse post transplant Patients and Frank Relapse Patients
Adjuvent Arm = "designed as maintainance therapy"= First T Cells given at 90 days post transplant

Monitor for Relapse/Relapse-Free-Survival
"Meaninful Outcome" = if we see a month or two increase of Relapse Free Survival

AML Frank Relapse Patient Arm (40 patients) = relapse w/i 90 days of transplant.
-Get TCells immediately, have about a 4 1/2 mo survival expectation
Measure CR rate in Frank Relapse.

IF we get better than 10% CR rate = should be approvable product

AML Std of Care Patient Arm - cross to Active Disease Arm when relapse


Financial = Cash enough to fund through 2020.
Cash burn depends on timing of clinical trials - because clinical trials burn cash, the delay stretches how long cash