HOUSTON, Jan. 5, 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 that the U.S. Food and
Drug Administration (FDA) lifted the partial clinical hold on the
Company's Phase 2 trial investigating the safety and efficacy of
MT-401, Marker's lead multi-tumor-associated antigen
(MultiTAA)-specific T cell product candidate for the treatment of
post-transplant acute myeloid leukemia (AML).
"We are pleased to move forward with our Phase 2 AML trial of
MT-401, which we believe may provide a safe and effective treatment
option for patients with post-transplant AML over the standard of
care," said Mythili Koneru, M.D.,
Ph.D., Chief Medical Officer of Marker Therapeutics. "During the
partial clinical hold, we continued to open clinical centers to
enroll patients in the first half of the safety lead-in of our
Phase 2 trial. With the FDA's decision, we will now be able to
seamlessly enroll patients in the second half of the safety
lead-in, as well as the remainder of the trial. We look forward to
working with our clinical sites to continue enrolling
patients."
The multicenter Phase 2 AML study is evaluating clinical
efficacy of MT-401 in patients with AML in both the adjuvant and
active disease setting, following an allogeneic stem-cell
transplant. 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 about 40 patients with
active disease will receive MT-401 as part of the single-arm
group. The trial also includes a safety lead-in expected to
enroll six patients.
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 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; the
impact of the COVID-19 pandemic; 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; our
manufacturing processes and our ability to use our in-house
manufacturing facility to support clinical and commercial demand.
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.