HOUSTON, July 6, 2021 /PRNewswire/ -- 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).
"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 Marker's Phase 2 AML Post-Transplant Study
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.
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SOURCE Marker Therapeutics, Inc.