HOUSTON, June 23, 2020 /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, announced
today that the United States Adopted Names (USAN) Council has
approved "zelenoleucel" as the nonproprietary
(generic) name for MT-401, a multi-tumor-associated antigen
(MultiTAA)-specific T cell product candidate for the treatment of
patients with acute myeloid leukemia (AML) following allogeneic
stem cell transplant in both adjuvant and active disease
settings.
"The USAN approval of zelenoleucel as the generic name for
MT-401 is another step forward for continued advancement of our
therapy," said Peter L. Hoang,
President & CEO of Marker Therapeutics. "MT-401, which received
Orphan Drug designation from the U.S. FDA in April, has shown
clinical benefit in patients with acute myeloid leukemia post stem
cell transplant in an investigator-sponsored trial. We are excited
about the continued clinical development of zelenoleucel and look
forward to initiating our Company-sponsored Phase 2 study in
patients with AML following transplant."
About USAN
The United States Adopted Names (USAN) Council is responsible
for selecting simple, informative and unique nonproprietary
(generic) drug names. The USAN Council establishes logical
nomenclature classifications based on pharmacological and/or
chemical relationships. In addition to one member-at-large and a
Food and Drug Administration (FDA) liaison, the council consists of
one representative from each of the following: The American Medical
Association, United States Pharmacopeia (USP) and the American
Pharmacists Association.
About MultiTAA-Specific T Cell Therapy
Marker's Multi-Tumor-Associated 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 of
T cells. It 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-specific T cells are 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 effectiveness of
these programs or the possible range of application and potential
curative effects and safety in the treatment of diseases; the
potential benefits of orphan drug designation; and the timing and
success of our clinical trials, 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. 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.