HOUSTON, March 3, 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 it has treated the first patient in the Company's Phase 2
trial of MT-401, its lead MultiTAA-specific T cell product
candidate. The trial is enrolling patients with acute myeloid
leukemia (AML) following an allogeneic stem cell transplant in both
the adjuvant and active disease settings.
"We are pleased to have dosed the first patient with MT-401 in
our Company-sponsored clinical trial, particularly in a patient
population in which there remains a critical unmet need," said
Mythili Koneru, M.D., Ph.D., Chief
Medical Officer of Marker Therapeutics. "Today, adult patients with
post-transplant AML have a 25 percent chance of 5-year survival. In
various investigator-sponsored Phase 1 trials at the Baylor College of Medicine, our MultiTAA-specific T
cell therapies have been generally well-tolerated and demonstrated
durable anti-cancer responses across a broad range of
cancers—including post-transplant AML. Based on these results, we
believe that MT-401 has the potential to become a meaningful
treatment option for patients suffering from this disease."
About the AML Post-Transplant Study
- Designed as a multicenter, Phase 2 trial to be conducted at
approximately 20 top cancer centers across the U.S.
- Planned total enrollment of 160 patients:
-
- 120 patients in the adjuvant disease group, randomized 1:1 to
either MT-401 at 90 days post-transplant versus standard of care
(observation)
- 40 patients in the active disease group as part of a single
arm
- Primary objective of relapse-free survival (RFS) for adjuvant
disease group
- Primary objectives of complete response (CR) and duration of
complete response (DOCR) for active disease group
- Topline readout of active disease group expected in Q1
2022
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 Statement Disclaimer
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; and the timing, conduct
and success of our clinical trials, including the Phase 2 trial of
MT-401, as well as clinical trials conducted by our collaborators.
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.