Full Press Release Details
Marker Therapeutics Announces Completion of
Safety Lead-In Portion of Phase 2 Study in Post-Transplant AML
Company continues to
enroll patients in main portion of the Phase 2 trial with topline data from active disease group expected in Q1 2022
2021-Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the
development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications,
today announced completion of the six-patient safety lead-in portion of the Company's Phase 2 trial of MT-401, its lead MultiTAA-specific
T cell product candidate, for the treatment of post-transplant acute myeloid leukemia (AML).
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 Marker's Phase 2 AML Post-Transplant
The multicenter Phase 2 AML study is evaluating
the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease
setting. In the adjuvant setting, approximately 120 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus
standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group.
The primary objectives of the trial are to
evaluate relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active
disease patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival
while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival
and overall survival.
In April 2020, the FDA granted Orphan
Drug designation to MT-401 for the treatment of patients with AML following allogeneic stem cell transplant.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology
company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies
and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific
T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of
T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system
to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our
product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and
TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell
therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
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Forward-Looking Statements
This release contains forward-looking statements for purposes of the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's
expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to
any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements
include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things:
our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell
therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment
of diseases; the timing, conduct and success of our clinical trials, including the Phase 2 trial of MT-401; and the overall market opportunity
for our product candidates. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could
cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are
not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through
EDGAR at www.sec.gov. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global
economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events
or otherwise, after the date of this press release.