Marker Therapeutics Awarded $2 Million Grant from U.S. FDA to Support Marker’s Phase 2 ARTEMIS Trial of MT-401 in Post-Transplant AML
September 13 2022 - 7:00AM
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 that the Company has been awarded a $2 million grant from
the U.S. Food and Drug Administration (FDA) Orphan Products Grants
program to support its Phase 2 ARTEMIS trial of its lead
multi-tumor-associated antigen (MultiTAA) T cell product candidate,
MT-401, in patients with post-transplant acute myeloid leukemia
(AML).
The FDA grant will support the Company’s treatment arm
evaluating MT-401 in patients with post-transplant AML with minimal
residual disease. MT-401 was granted Orphan Drug Designation for
the treatment of patients with AML following allogeneic stem cell
transplant in 2020.
"We are pleased to receive this Orphan Products award from the
FDA to further clinical development of our multi-antigen targeted T
cell therapy in AML, a rare disease with limited treatment options
after a stem cell transplant," said Dr. Mythili Koneru, Marker’s
Chief Medical Officer. “In our Phase II ARTEMIS study for patients
with post-transplant AML, we have observed promising results
amongst the MRD+ patients, suggesting that MT-401’s unique and
differentiated targeting technology can potentially reach MRD
positive patients before relapse. This grant will enable us to
further advance our development of MT-401 to potentially treat a
patient population where no treatments have been approved. We look
forward to further exploration in this patient population.”
About Marker's Phase 2 ARTEMIS Trial 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.
About the U.S. FDA Orphan Products Grants
ProgramThe FDA’s Orphan Products Grants Program awards
grants to clinical investigators to support the development of safe
and effective medical products for patients with rare diseases. The
program has supported clinical research since 1983 and has funded
clinical trials that have facilitated the approval of more than 70
products.
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 StatementsThis
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; and the
timing, conduct and success of our clinical trials, including the
Phase 2 trial of MT-401. 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.
Contact:Neda SafarzadehVice
President/Head of Investor Relations, PR & MarketingMarker
Therapeutics(713)
400-6451investor.relations@markertherapeutics.com
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