HOUSTON, Jan. 13, 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 it has completed the construction and qualification
of its cGMP manufacturing facility in Houston, TX, located near the George Bush
Intercontinental Airport. The facility will allow production of
MultiTAA-specific T cell products according to U.S. Food and Drug
Administration (FDA) guidelines and is designed to be scalable
using modular processes. The Company has initiated the technology
transfer process and expects the cGMP manufacturing facility to be
fully operational in the first half of 2021.
"We are committed to the rapid advancement of our lead product
candidate, MT-401, which, based on our novel MultiTAA-specific T
cell technology, could potentially transform how patients with AML
are treated," said Peter L. Hoang,
President & CEO of Marker Therapeutics. "With the recent
initiation of our Phase 2 study in post-transplant AML, this new
facility will assist with the timely manufacture of MT-401. In
addition, the modular processes may enable cost-effective
scalability, thereby supporting the manufacturing of
MultiTAA-specific T cell products in future hematological and solid
tumor trials, as well as the potential commercialization of our
products."
The manufacturing of Marker's MultiTAA-specific T cell therapy
for AML begins with collecting T cells from healthy donors. The T
cells are subsequently sent to Marker's facility, where Marker
isolates and selectively expands naturally occurring T cells that
can recognize up to five unique tumor antigens. These
tumor-specific T cells are then cryopreserved and shipped to
clinical centers to be infused into the patient.
Prior to completing the tech transfer and receiving regulatory
approval for the cGMP manufacture, Marker will continue to
manufacture its MultiTAA-specific T cell therapy at the
Baylor College of Medicine to support
the Company-sponsored AML trial.
About MultiTAA-Specific T Cell Therapy
Marker's
Multi-Antigen Targeted (MultiTAA) platform is a novel,
non-genetically modified cell therapy approach that selectively
expands tumor-specific T cells from a patient's blood capable of
recognizing a broad range of tumor antigens. In early clinical
trials, the multi-antigen approach has been well tolerated and
shown to enhance tumor destroying capability and is one of the
first therapies to consistently demonstrate epitope spreading –
inducing the patient's own T cells to expand, potentially
contributing to a lasting anti-tumor effect. Unlike other cell
therapies which require pre-conditioning regimens and
hospitalization, MultiTAA is designed to be administered in an
outpatient setting.
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 conduct and
success of our clinical trials, as well as clinical trials
conducted by our collaborators; the timing and success of the
technology transfer process related to our planned manufacturing
facility and the receipt of regulatory approval for the related
cGMP; our manufacturing processes and our ability to use our
current and planned manufacturing facilities 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.