Marker Therapeutics Inc (MRKR)

[Inoviorulez]

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