HOUSTON, Feb. 11, 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 U.S. Food and Drug Administration (FDA) has
lifted the clinical hold on Marker's planned trial investigating
safety and efficacy of its novel MultiTAA T cell therapy in
patients with post-transplant acute myeloid leukemia (AML).
Marker previously announced on November
12, 2019, that the FDA placed the trial on clinical hold.
The FDA requested additional information and technical
specifications for two legacy reagents supplied by third parties
used in the MultiTAA-specific T cell manufacturing process. The
technical specifications and data requested by the FDA could not be
produced by the original suppliers. The Company identified
alternative suppliers, satisfying the Agency's request.
Based on data Marker provided, the FDA permitted the Company to
initiate its AML trial, beginning with a safety lead-in portion.
The FDA placed a partial clinical hold on the trial for the use of
the MultiTAA-specific T cell product manufactured using one of the
reagents supplied by the alternative supplier, until the final data
and certificate of analysis for the reagent are reviewed and
accepted by the Agency. The safety lead-in portion of the trial is
expected to enroll approximately six patients as part of the
amended trial design. Three patients will be dosed with
MultiTAA-specific T cells manufactured using the legacy reagent,
and three patients will be dosed with T cells manufactured using
the reagent from the alternative supplier.
Marker currently estimates that the alternative supplier will
deliver the final reagent, along with the final data and
certificate of analysis required by the FDA, by the end of the
second quarter of 2020. Marker anticipates to complete enrollment
of the first three patients and submission of the final technical
specifications and comparability data of the new reagents to the
FDA during the second half of 2020, thereby satisfying the
requirements for lifting the partial hold on the clinical trial.
Given this expected timing, Marker does not currently expect the
partial clinical hold to significantly impact site and patient
enrollment of the AML trial.
The safety lead-in will be followed by the 160-patient
randomized portion of the study at approximately 20 transplant
centers. Group 1 will comprise 120 adjuvant (disease-free)
patients, with the primary endpoint of relapse-free survival of
patients receiving MultiTAA-specific T cell therapy versus a
control group. Group 2 will comprise 40 active disease patients in
a single arm, with primary endpoints of complete remission and
duration of complete remission.
"With a clear path identified for getting our study of
MultiTAA-specific T cell therapy underway in patients with AML,
we're focused on addressing the remaining requirements from the FDA
and enrolling up to 20 clinical centers to conduct our Phase 2
trial," stated Peter L. Hoang,
President and CEO of Marker Therapeutics. "We appreciate the
productive dialogue with the FDA throughout the process and look
forward to advancing MultiTAA-specific T cell therapy for patients
with post-transplant AML in a randomized and multicenter clinical
trial."
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 the MultiTAA
programs or the possible range of application and potential
curative effects and safety in the treatment of diseases;
expectations regarding our supplier's delivery of the final
reagent, data and certificate of analysis required to advance the
MultiTAA program for AML; and expectations regarding, among other
things, the timing, design and success of our clinical trials,
including the AML trial, 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.