HOUSTON, April 29, 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, today
announced that the United States Food and Drug
Administration (FDA) Office of Orphan Products Development has
granted Orphan Drug designation to MT-401, a multi-tumor-associated
antigen (MultiTAA)-specific T cell product for the treatment of
patients with acute myeloid leukemia (AML), following allogeneic
stem cell transplant.
"We are pleased that the FDA has granted orphan
designation to MT-401, our novel MultiTAA-specific T cell product
candidate and believe it is supportive of its potential to treat
post allogeneic stem cell transplant patients with AML—a
devastating and pervasive blood disease with a high medical need
for a treatment. In investigator-sponsored trials, our
MultiTAA-specific T cell product candidate was well-tolerated and
we have observed clinical benefit across various liquid and solid
tumors, suggesting the product candidate's ability to induce a
patient's own T cells to expand for a more durable anti-tumor
effect. We look forward to initiating our Company-sponsored Phase 2
study in patients with post allogeneic stem cell transplant AML,"
said Peter L. Hoang, President &
CEO of Marker Therapeutics.
Orphan designation is granted by the FDA Office of Orphan
Products Development to advance the evaluation and development
of safe and effective therapies for the treatment of rare diseases
or conditions affecting fewer than 200,000 people in the U.S. Under
the Orphan Drug Act, the FDA may provide grant funding
toward clinical trial costs, tax credits, FDA user-fee
benefits, and seven years of market exclusivity in the United
States following marketing approval by the FDA. The
granting of an orphan designation request does not alter the
standard regulatory requirements and process for obtaining
marketing approval. For more information about orphan designation,
please visit the FDA website at www.fda.gov.
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.