HOUSTON, Aug. 19, 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 Company received notice of a Product Development
Research award totaling approximately $13.1
million from the Cancer Prevention and Research Institute of
Texas (CPRIT) to support the
Company's Phase 2 clinical trial of its lead MultiTAA-specific T
cell product MT-401.
The CPRIT award is intended to support the adjuvant arm of the
Company's Phase 2 clinical trial evaluating MT-401 when given as an
adjuvant therapy to patients with acute myeloid leukemia (AML)
following a hematopoietic stem cell transplant. The primary
objectives of the adjuvant arm of the trial are to evaluate
relapse-free survival after MT-401 treatment when compared with a
randomized control group.
"We are honored to have been approved by CPRIT for this award
which provides additional capital to support the clinical
development of MT-401 and external validation of our technology
from experts in the field who conducted business and scientific
diligence on behalf of CPRIT," said Peter
L. Hoang, President & CEO of Marker Therapeutics. "Our
MultiTAA-specific T cell therapy approach has shown encouraging
results in post-transplant AML in clinical studies, and we are
pleased to advance the clinical development of MT-401 in our Phase
2 trial."
About the Cancer Prevention and Research Institute of
Texas
To date, CPRIT has awarded $2.9
billion in grants to Texas
research institutions and organizations through its academic
research, prevention and product development research programs.
CPRIT has recruited 237 distinguished researchers, supported the
establishment, expansion or relocation of 43 companies to
Texas and generated over
$5.7 billion in additional public and
private investment. CPRIT funding has advanced scientific and
clinical knowledge and provided 7.4 million life-saving cancer
prevention and early detection services reaching Texans from all
254 counties. On November 5, 2019,
Texas voters overwhelmingly
approved a constitutional amendment to provide an additional
$3 billion to CPRIT for a total
$6 billion investment in cancer
research and prevention.
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 our use of our cash and cash equivalents, future
operating expenses and capital expenditure requirements.
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.