Marker Therapeutics Reports Pre-Clinical Data of its MT-601 MultiTAA-Specific T Cell Product Candidate in Lymphoma Cells
May 31 2023 - 6:30AM
Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage
immuno-oncology company focusing on developing next-generation T
cell-based immunotherapies for the treatment of hematological
malignancies and solid tumor indications, today announced
pre-clinical data from the Company’s multiple tumor-associated
antigens (multiTAA)-specific T cell product candidate MT-601 in
lymphoma cells, including CD19 CAR T refractory cells.
Although CAR T cell therapies targeting the CD19
antigen have gained acceptance as treatment for patients with
relapsed/refractory lymphoma because of their significant benefit
relative to the standard of care, up to 60% of patients treated
with CAR T therapies relapse within a year (Chong EA et al, N Engl
J Med, 2021).
MultiTAA-specific T cell therapy was
investigated in the Baylor TACTAL study, which enrolled patients
with both Hodgkin’s and non-Hodgkin’s lymphoma (Vasileiou et al, J
Clin Oncol, 2021). The multiTAA-specific T cell product used in the
TACTAL study was directed against five antigens and showed more
durable clinical responses. For example, some patients who attained
a complete remission (CR) with the multiTAA-specific T cell
treatment were still in remission at the 72 months follow-up,
suggesting a longer-lasting clinical benefit relative to published
results for CD19 CAR T therapies.
Given the high probability of antigen-loss
associated relapse seen with CD19 CAR T therapy, Marker believes
that its multiTAA-specific T cell product may result in durable
responses due to its ability to overcome antigen loss by targeting
more than one antigen. Data from the TACTAL study has demonstrated
that multiTAA-specific T cell products recognize cancer cells by up
to five antigens presented on cancer cells and continue to kill
even when cancer cells morph by downregulating the targeted antigen
to escape recognition.
Marker recently started to evaluate the safety
and efficacy of MT-601, a multiTAA-specific T cell product that
recognizes six antigens, including WT-1, a TAA that was not part of
the targeted antigens in the TACTAL study, in patients with
non-Hodgkin’s lymphoma who have either relapsed after receiving
anti-CD19 CAR T cell treatment or are ineligible for anti-CD19 CAR
T cell treatment (ClinicalTrials.gov Identifier: NCT05798897).
Marker believes that killing induced by a product directed against
six TAAs instead of five TAAs can potentially provide a more
durable solution. Prior to starting the clinical trial Marker
assessed the killing capacity of MT-601 in vitro in a lymphoma cell
line and demonstrated that MT-601 kills lymphoma cells regardless
of their CD19 expression levels.
“We have recently developed a long-term in vitro
model to monitor the interaction of T cells with cancerous cells.
Data from a lymphoma cell line utilizing this model demonstrated
that MT-601 inhibited growth of lymphoma cells as well as the
growth of CD19 CAR resistant lymphoma cells,” said Eric A. Smith,
Ph.D., Director of Research and Development at Marker Therapeutics.
Marker has posted further details about this preclinical study on
the Investor Relations section of its website.
Dr. Smith continued “Specifically, we have
developed an in vitro model which reproduces the CD19
antigen-negative tumor that causes relapse and observed the
following:
- In this in vitro model, 98% of
lymphoma cells were eliminated after initial administration of a
CD19-targeting CAR T cell product.
- While the CAR T cells significantly
controlled lymphoma cell growth, we observed that 3 weeks after the
start of anti-CD19 CAR T cell administration, a population of
lymphoma cells that were resistant to CD19 CAR T cell
administration started to grow.
- These CD19 CAR resistant lymphoma
cells were tested for CD19 expression and were shown to be negative
for the CD19 surface antigen, which explained why they were no
longer controlled with a second administration of anti-C19 CAR T
cells, thus recapitulating the antigen-negative relapse
observations in CAR relapsed/refractory lymphoma patients.
- However, when MT-601, with its
broad antigen recognition (Survivin, NY-ESO-1, WT-1, PRAME,
MAGE-A4, SSX2) was added to this anti-CD19 CAR T cell resistant
cell population complete growth inhibition was observed.
These data highlight that MT-601 has the
potential to eliminate tumors that are CD19 CAR T cell refractory,
indicating that MT-601 might offer a viable therapeutic option for
lymphoma patients that have relapsed from previous CAR T cell
interventions.”
“We are encouraged by the promising results of
our pre-clinical study of MT-601,” said Juan F. Vera, M.D.,
President and Chief Executive Officer at Marker Therapeutics.
“These pre-clinical findings reinforce previous TACTAL clinical
observations, highlighting the potential benefit of our innovative
multiTAA-specific T cell therapy in CD19 CAR T refractory lymphoma
patients. Our Investigational New Drug (IND) application for MT-601
for the treatment of patients with relapsed non-Hodgkin lymphoma
has been cleared by the FDA and we are excited to further explore
the potential benefits of MT-601 in our multicenter Phase 1
clinical trial, which was initiated in the first quarter of 2023.
We are continuing our detailed review of the scope of clinical
opportunities provided by MT-601 and look forward to providing an
update about our clinical strategy and anticipated milestones as
soon as possible.”
About multiTAA-specific T cells
Marker's multi-tumor associated antigen
(multiTAA)-specific T cell 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. Clinical trials that
enrolled more than 180 patients with various hematological
malignancies and solid tumors showed that the multiTAA-specific T
cell product was well tolerated, demonstrated durable clinical
responses, and consistent epitope spreading. The latter is
typically not observed with other T cell therapies and enables the
patient's own T cells to expand, potentially contributing to a
lasting anti-tumor effect. Unlike other cell therapies which
require hospitalization and close monitoring, 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. The cell
therapy technology Marker has 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 StatementsThis
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 of our product
candidates, including MT-601 for the treatment of patients with
relapsed non-Hodgkin lymphoma. 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.
ContactsTIBEREND
STRATEGIC ADVISORS, INC.InvestorsDaniel
Kontoh-Boateng(862) 213-1398dboateng@tiberend.com
MediaCasey McDonald(646)
577-8520cmcdonald@tiberend.com
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