TapImmune Inc. common stock (NASDAQ: MRKR) made it official that it has recently completed the six-patient safety lead-in portion of the Company’s Phase 2 trial of MT-401. The lead MultiTAA-specific T cell product candidate for the treatment of post-transplant acute myeloid leukemia (AML).
Chief Medical Officer of TapImmune Inc. common stock (NASDAQ: MRKR) comments on the developments
“We are pleased with the results of the safety lead-in portion of the trial, in which all six patients met the safety endpoints following infusion of our MultiTAA-specific T cell therapy,” said Mythili Koneru M.D., Ph.D., Chief Medical Officer of Marker Therapeutics. “We are currently enrolling patients in the main portion of our first Company-sponsored trial and continue to activate clinical sites across the U.S. We are looking forward to further advancing MT-401 in this disease setting. Despite recent advances in how hematological malignancies are treated, patients remain in urgent need of new therapeutic options.”
About the study
The Phase 2 AML Post-Transplant Study aims to determine the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease setting. As part of the trial, nearly 120 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus standard-of-care observation. In addition, close to 40 patients with the active disease will receive MT-401 as part of the single-arm group.
Objectives of the trial
According to sources, one of the critical objectives of the respective trial is to analyze relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease patients. In addition, the trial also aims to study the overall survival and graft-versus-host disease relapse-free survival. The trial aims to study overall response rate, duration of response, progression-free survival, and overall survival for the active disease group as part of the other objectives.
A source from TapImmune Inc. common stock (NASDAQ: MRKR) informed that in April 2020, the FDA granted Orphan Drug designation to MT-401 to treat patients with AML following allogeneic stem cell transplant.