Marker Therapeutics Announces Dosing of First Patient in Phase 2 Trial of MT-401 in Acute Myeloid Le
Wednesday, March 3, 2021
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Marker
Therapeutics Announces Dosing of First Patient in Phase 2 Trial of
MT-401 in Acute Myeloid Leukemia Following Stem Cell Transplant March 3, 2021
Topline readout of active disease group in AML trial expected in Q1 2022
Houston, TX – March 3, 2021– 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 it has treated the first
patient in the Company’s Phase 2 trial of MT-401, its lead
MultiTAA-specific T cell product candidate. The trial is enrolling
patients with acute myeloid leukemia (AML) following an allogeneic stem
cell transplant in both the adjuvant and active disease settings.
“We are pleased to have dosed the first patient with
MT-401 in our Company-sponsored clinical trial, particularly in a patient
population in which there remains a critical unmet need,” said Mythili Koneru,
M.D., Ph.D., Chief Medical Officer of Marker Therapeutics. “Today, adult patients
with post-transplant AML have a 25 percent chance of 5-year survival. In various
investigator-sponsored Phase 1 trials at the Baylor College of Medicine, our MultiTAA-specific
T cell therapies have been generally well-tolerated and demonstrated durable
anti-cancer responses across a broad range of cancers—including post-transplant
AML. Based on these results, we believe that MT-401 has the potential to become
a meaningful treatment option for patients suffering from this disease.”
About the AML Post-Transplant
Study
- Designed as a multicenter, Phase 2 trial to be
conducted at approximately 20 top cancer centers across the U.S.
- Planned total enrollment of 160 patients:
- 120 patients in the adjuvant disease group,
randomized 1:1 to either MT-401 at 90 days post-transplant versus standard of
care (observation)
- 40 patients in the active disease group as part
of a single arm
- Primary objective of relapse-free survival (RFS)
for adjuvant disease group
- Primary objectives of complete response (CR) and
duration of complete response (DOCR) for active disease group
- Topline readout of active disease group expected
in Q1 2022
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.
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; and
the timing, conduct and success of our clinical trials, including the
Phase 2 trial of MT-401, 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. 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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