Marker Therapeutics Announces Clinical Program Updates and Pipeline Expansion
February 16 2022 - 4:30PM
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 an update on the Company’s clinical programs,
manufacturing processes and pipeline.
“We are excited to announce an improved T cell manufacturing
process, expansion of our pipeline into solid tumor and
off-the-shelf cell therapies, and encouraging results from the
six-patient safety lead-in stage of our Phase 2 AML trial, where
one MRD positive patient converted to MRD negative following
treatment with MT-401, Marker’s lead MultiTAA-specific T cell
product candidate,” said Peter L. Hoang, Marker’s President and
Chief Executive Officer. “Our new T cell manufacturing process,
which will be implemented in AML and additional planned trials, is
designed to produce a much more potent product with increased
antigen specificity and diversity and further reduces manufacturing
time to just nine days.”
Mr. Hoang continued: “Further, we are pleased to announce a
planned expansion of our pipeline into pancreatic cancer, our first
Company-sponsored trial evaluating MultiTAA cell therapy for the
treatment of solid tumors, and a Company-sponsored Phase 1 trial in
lymphoma. We are also excited to expand our AML trial with
MT-401-OTS, a scalable, off-the-shelf product candidate with the
potential to match patients to treatment in under three days.
Looking ahead, we plan to develop additional off-the-shelf product
candidates in other hematological malignancies and solid tumors,
with the goal of significantly improving access to promising cell
therapies.”
Safety Lead-in Results from Phase 2 AML Trial
The results of the safety lead-in stage of the Marker Phase 2
AML trial support the potential for MT-401 as a treatment option
for patients with AML in the post-transplant setting. The purpose
of the safety lead-in was to test the safety for patients using a
new reagent in the manufacturing process. Three patients were
treated with MT-401 using the legacy reagent and three additional
patients were treated with MT 401 using the new reagent. The safety
lead-in enrolled five patients with active disease: one MRD
positive patient and five frank relapse patients.
The initial results from the safety lead-in are as follows:
- No dose limiting toxicities,
cytokine release syndrome or neurotoxicity were observed. The
results were consistent with the safety data observed in more than
150 patients treated in the Phase 1/2 studies at the Baylor College
of Medicine.
- 1 MRD+ patient became MRD- after
infusion with MT-401
- No objective responses from the
frank relapse patients
- Immuno-monitoring data indicates the evidence of epitope
spreading after infusion of MT-401 in the patient who converted
from MRD+ to MRD-
The safety lead-in satisfied safety requirements with the FDA
and the main Phase 2 stage of the AML trial began enrolling in July
2021.
MultiTAA-Specific T Cell Therapy Manufacturing
The Company developed and is implementing a new nine-day
MultiTAA-specific T cell manufacturing process for its current
Company-sponsored Phase 2 AML trial as well as future clinical
trials using a patient-specific manufacturing approach. The new
manufacturing process marks additional manufacturing improvements
compared to the processes used in the Baylor College of Medicine
Phase 1/2 trials (36-day manufacturing time) and the current AML
trial (20-day manufacturing time). The new nine-day manufacturing
process enables increased antigen specificity and diversity, which
has exhibited a strong linear correlation to anti-tumor activity in
vitro. The new process produces a patient product that is four
times more potent, with the potential to greatly improve tumor
killing.
Pipeline Expansion
The Company plans to initiate additional Marker-sponsored
clinical trials across other indications. The Company has initiated
activities to support the advancement of the pipeline but beginning
any additional clinical trial is subject to the receipt of
additional funding:
- Patient-specific product candidates
- MT-601, a six-antigen product, for the treatment of pancreatic
cancer and lymphoma
- The Company intends to file
Investigational New Drug applications (INDs) for MT-601 in
pancreatic cancer and lymphoma in 2022 and expects to initiate
these trials in 2023
- Off-the-shelf (OTS) product
candidates
- Patients will be dosed using “banked” products based on human
leukocyte antigen (HLA) matching
- The OTS platform is designed to eliminate manufacturing wait
time and patient product can be shipped to patients
immediately
- High scalability where one donor has the potential to provide
more than 100 patient products
- An OTS program in AML is already approved under the Company’s
current Phase 2 AML IND. The Company is currently in the process of
developing its patient cell bank inventory and expects to dose the
first patient in 2023.
- The Company expects to expand OTS
clinical trials in other hematological malignancies and solid
tumors
- Preclinical / development activities
- Analyzing potential of a 12-antigen product
- Assessing potential of combination therapies for MT-401 and
MT-601
Webcast and Conference Call
Marker will host a conference call and webcast at 5:00 p.m. EST
today to discuss the clinical program updates. The webcast will be
accessible in the Investors section of the Company's website at
www.markertherapeutics.com. Individuals can participate in the
conference call by dialing 877-869-3847 (domestic) or 201-689-8261
(international) and referring to the "Marker Therapeutics Clinical
Program Update Call." The archived webcast will be available for
replay on the Marker website following the event.
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 and our preclinical
pipeline; the effectiveness of these programs or the possible range
of application and potential curative effects and safety in the
treatment of diseases; the potential commercialization of our
current and future product candidates; our manufacturing processes
and the efficiencies and cost thereof; our ability to use our cGMP
manufacturing facility to support clinical and commercial demand;
and our ability to secure additional funding on favorable terms.
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.
Investors and Media
Contacts
Marker Therapeutics:
Neda SafarzadehVice President/Head of Investor
Relations, PR & Marketing(713)
400-6451INVESTOR.RELATIONS@MARKERTHERAPEUTICS.COM
Solebury Trout:
MediaAmy
BonannoABONANNO@SOLEBURYTROUT.COM
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