Replies to post #29751 on Marker Therapeutics Inc (MRKR)

[floridajim1]

Perhaps Phantom would care to weigh in on this comment.

[Speedo_48]

FYI - this is what Pablo posted on Yahoo:

There's a TPIV100 paper with the results for ph1 https://clinicaltrials.gov/ct2/show/NCT01632332 ( "Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer" )

It's https://sci-hub.tw/10.1158/1078-0432.CCR-19-2123 ( "Rapid Generation of Sustainable HER2-specific T-cell Immunity in Patients with HER2 Breast Cancer using a Degenerate HLA Class II Epitope Vaccine" )

The follow-up study (ph2, 480 participants, 5 years) is https://clinicaltrials.gov/ct2/show/NCT04197687( "TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery" )

> Results: Twenty-two subjects were enrolled and 20 completed all six vaccines. The vaccine was well tolerated. All patients were alive at analysis with a median follow-up of 2.3 years and only two experienced disease recurrence. The percent of patients that responded with augmented T-cell immunity was high for each peptide ranging from 68% to 88%, which led to 90% of the patients generating T cells that recognized naturally processed HER2 antigen. The vaccine also augmented HER2-specific antibody. Immunity was sustained in patients with little sign of diminishing at 2 years following the vaccination.

> Conclusions: Degenerate HLA-DR–based HER2 vaccines induce sustainable HER2-specific T cells and antibodies. Future studies, could evaluate whether vaccination during adjuvant treatment with trastuzumab-containing regimens improves patient outcomes.

> Clinical outcomes: Although the trial was not designed to evaluate clinical outcomes, all patients remain alive at last vital status follow-up with a median of 2.3 years following trial enrollment (range, 0.1–3.4 years). With a median of 26.8 months of disease assessment follow-up, only two patients developed recurrence (one nodal recurrence 11.9 months and one in-breast recurrence 26.6 months, after trial enrollment). This translated into a 2-year DFS rate of 94.7% [95% confidence interval(CI), 68.1%–99.2%]. The in-breast recurrence was deemed likely a new primary rather than a local recurrence as the new lesion occurred in the opposite quadrant of the breast (9 vs. 2 o’clock position). The patient who developed nodal recurrence did not complete the vaccination treatment and only received four vaccinations. There were no distant recurrences.