Marker Therapeutics Announces Complete Response in First Lymphoma Patient Treated with MT-601 after CAR T Relapse
September 11 2023 - 7:00AM
Marker Therapeutics, Inc. (Nasdaq: MRKR) is 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 Marker is
announcing the preliminary results of the first participant treated
with MT-601, its multi-tumor associated antigen (multiTAA)-specific
T cell product targeting 6 TAAs, in the Phase 1 multicenter APOLLO
clinical trial. The APOLLO trial is investigating the safety and
efficacy of MT-601 for the treatment of patients with lymphoma who
have either failed or are ineligible to receive anti-CD19 CAR T
cell therapy.
This first APOLLO study participant had diffuse
large B cell lymphoma (DLBCL) and was enrolled into the Phase 1
dose escalation stage of the trial (Press Release, June 12, 2023)
after failing 4 prior lines of therapy, including anti-CD19 CAR T
cell therapy.
After relapse following anti-CD19 CAR T cell
therapy, the participant was treated with 2 doses of MT-601 at the
200 million cell dose level without prior lymphodepletion. MT-601
treatment was well tolerated with no reports of higher than Grade 1
treatment-related adverse events. The tolerability at this initial
dose level is consistent with the favorable clinical safety profile
and tolerability previously reported for other multiTAA-specific T
cell products. Eight weeks after the 2nd infusion of MT-601, the
participant demonstrated complete metabolic response based on
PET-CT scans.
Marker previously reported non-clinical
proof-of-concept data that showed that MT-601 has the potential to
eliminate lymphoma cells that are resistant to anti-CD19 CAR T
cells, highlighting the therapeutic potential of MT-601 in vitro
(Press Release, May 31, 2023).
“We are delighted to announce that the first
study participant treated in the APOLLO trial achieved a complete
response after treatment with MT-601,” said Monic Stuart, M.D.,
Chief Medical Officer of Marker Therapeutics. “This is a
significant initial step forward in our Phase 1 clinical trial and
highlights the potential benefit of MT-601 in patients who have
relapsed after anti-CD19 CAR T cell therapy. The patient will
remain under close observation as we continue to monitor long-term
treatment effects and the durability of response.”
“The complete response we have observed in this
CAR T relapsed patient with lymphoma marks a remarkable milestone
for Marker and our technology,” said Juan F. Vera, M.D., President
and Chief Executive Officer of Marker Therapeutics. “Our APOLLO
trial is an important area for MT-601 assessment, as up to 60% of
patients treated with anti-CD19 CAR T therapies relapse within one
year. While a complete response in our first patient treated with
MT-601 is certainly encouraging, the focus of the APOLLO study is
to continue to treat and evaluate additional participants in this
Phase 1 study.”
About MT-601MT-601 utilizes a
novel non-genetically modified approach that specifically targets
six different tumor antigens upregulated in lymphoma cells
(Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is
currently investigating MT-601 in the Company-sponsored Phase 1
APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the
treatment of lymphoma patients who are relapsed/refractory after or
ineligible to anti-CD19 CAR T cell therapies.
About APOLLO The APOLLO trial
(clinicaltrials.gov Identifier: NCT05798897) is a Phase 1,
multicenter, open-label study designed to evaluate the safety and
efficacy of MT-601 in participants with relapsed or refractory
lymphoma who either received anti-CD19 chimeric antigen receptor
(CAR) T cell therapy or are ineligible for anti-CD19 CAR T cell
therapy. The primary objective of this exploratory Phase 1 clinical
trial is to evaluate the optimum dose, safety, and preliminary
efficacy of MT-601 in participants with various lymphoma subtypes.
Under the APOLLO trial, eight clinical sites across the United
States will cumulatively enroll up to approximately 30 participants
during the dose escalation phase.
About multiTAA-specific T
cellsThe 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/donor’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 autologous and allogeneic
multiTAA-specific T cell products were well tolerated and
demonstrated durable clinical responses, and consistent epitope
spreading. The latter is typically not observed with other T cell
therapies and enables the potential contribution to a lasting
anti-tumor effect.
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 T cell
therapy technology developed by Marker 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 the T cells, Marker believes that its 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; the
timing, conduct and success of our clinical trials of our product
candidates, including MT-601 for the treatment of patients with
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
its forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release except as may be required by law.
ContactsTIBEREND STRATEGIC
ADVISORS, INC.
InvestorsDaniel
Kontoh-Boateng(862) 213-1398dboateng@tiberend.com
MediaCasey McDonald(646)
577-8520cmcdonald@tiberend.com
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