Marker Therapeutics Announces FDA Clearance of IND for MT-601, the six-antigen targeted T Cell Therapy for the treatment of relapsed/refractory Non-Hodgkin Lymphoma
August 04 2022 - 4:37PM
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
cleared the Company’s Investigational New Drug (IND) application
for MT-601, a multi-tumor-associated antigen (multiTAA)-specific T
cell product targeting six antigens, for the treatment of patients
with relapsed/refractory non-Hodgkin lymphoma who have failed or
are ineligible to receive anti-CD19 CAR T cell treatment.
“This new clinical trial will build upon results that were
observed in the Phase I/II TACTAL study conducted by BCM, which
assessed the safety and efficacy of five-antigen-directed
multiTAA-specific T cell product,” stated Dr. Mythili Koneru,
Marker’s Chief Medical Officer. “In the TACTAL study, BCM observed
long-term CR rates that were comparable to recently approved CD19
CAR-T therapies, even at very low cell doses. Unlike CD19 CAR-T
cell therapies, patients receiving multiTAA-specific T cell product
had superior durability of response, without the severe toxicities
that commonly occur with other adoptive cell therapies, such as
cytokine release syndrome or neurotoxicity. Based on these results,
we believe that multiTAA-specific T cell products can be easily
administered in an outpatient setting without hospitalization.”
In the TACTAL study, patients were treated with
five-antigen-directed multiTAA-T cell product. Based upon the
safety profile observed with multiTAA-specific T cell therapies
containing WT-1 in multiple cancer indications, the FDA cleared in
the IND the addition of WT-1 as the sixth tumor-associated antigen
to the MT-601 product that will be used to treat patients in the
Marker sponsored study. In addition, the FDA has cleared Marker to
initiate its study at a dose level of 200 million cells per
infusion, versus the dose range of 10-40 million cells per infusion
used in the TACTAL study. This increase in the cell dose will be
possible due to Marker’s development and adoption of a 9-day
manufacturing process, which also accelerates the time to
treatment.
Dr. Koneru continued: “We believe that the most important
finding of the TACTAL study was that the administration of multiTAA
therapy consistently drove an enhanced immunological response from
the patient’s own immune system, which we believe was due to the
lack of lymphodepletion which allowed the patient’s own immune
system to play a part. We believe that this phenomenon, known as
epitope spreading, was critical in driving more durable responses
than have been observed with other cell therapies like TCRs and
CAR-Ts. It is notable that none of the patients who developed a CR
in the TACTAL study relapsed during the follow up period, and
several patients have been in CR for over five years at their last
follow-up. This contrasts strongly with the experience of CD-19
CAR-Ts, where up to 40% of patients are expected to relapse within
12 months of developing a complete response.”
Marker’s MT-601 Phase 1 trial will focus on r/r NHL patients who
have failed CD19 CAR-T therapy, or those who are ineligible for
treatment with those therapies. MT-601 targets a series of tumor
antigens other than CD19, offering patients a therapeutic
alternative even if their tumor has escaped by downregulating the
expression of CD19. For patients who cannot access CD19 therapies,
MT-601 has the potential to generate objective responses, with
tolerability and potentially longer duration of response.
“FDA clearance of our IND for MT-601 is a significant milestone
as we advance our pipeline in a number of Company-sponsored
trials,” said Peter L. Hoang, Marker’s President and Chief
Executive Officer. “We believe that MT-601, which targets six
tumor-associated antigens highly expressed in lymphoma, has the
potential to build upon results of the TACTAL study. We look
forward to initiating our Company-sponsored Phase 1 study next
year.”
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 Statements 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, including MT-601; 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 1 trial of MT-601. 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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& Marketing(713)
400-6451Investor.Relations@markertherapeutics.com
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