HOUSTON, May 29, 2020 /PRNewswire/ -- 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 updated clinical results from an ongoing
investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the
Company's MultiTAA-specific T cell therapy in patients with
advanced or metastatic pancreatic adenocarcinoma. Data from a
cohort of patients receiving MultiTAA-specific T cell therapy in
combination with standard-of-care chemotherapy in the first-line
setting (Arm A), were reviewed today by lead investigator,
Brandon G. Smaglo, M.D., FACP, as
part of a poster session during the 2020 American Society of
Clinical Oncology (ASCO) Virtual Annual Meeting. ASCO is being held
from Friday, May 29 through
Sunday, May 31, 2020.
"Pancreatic cancer is one of the most deadly forms of cancer
today, with the mortality rate remaining relatively unchanged over
the past several decades despite ongoing research and treatment
advances," said Dr. Brandon G.
Smaglo. "With a growing body of data, we continue to be
encouraged by the potential of MultiTAA-specific T cell therapy, in
combination with standard-of-care chemotherapy, to safely produce
durable responses in patients with advanced pancreatic cancer. In
this study, a number of patient responses occurred after the period
in which a chemotherapy-driven response would typically occur,
suggesting MultiTAA's potential to produce added benefit in this
patient population. Additionally, we also observed induction of the
endogenous immune system – or epitope spreading – suggesting that
the benefits of MultiTAA may extend beyond the targeted antigens
and further contribute to a long-lasting anti-tumor effect."
Presentation Title:
"A phase I
trial targeting advanced or metastatic pancreatic cancer using a
combination of standard chemotherapy and adoptively transferred
nonengineered, multiantigen specific T cells in the first-line
setting (TACTOPS)"
Study Design:
Arm A is evaluating the safety
and potential efficacy of using MultiTAA-specific T cells in the
first-line setting for chemo-responsive patients with pancreatic
adenocarcinoma. Patients in Arm A receive at least three months of
standard-of-care chemotherapy (gemcitabine/nab-paclitaxel or
FOLFIRINOX) – the period during which a response to chemotherapy
would typically occur – before receiving up to six administrations
of MultiTAA-specific T cells in conjunction with chemotherapy.
Summary of Interim Results
Between June 2018 and December
2019, 13 patients have been treated, each of whom received
up to 6 monthly infusions of
1x107 MultiTAA-specific T cells/m2 in
conjunction with ongoing first-line chemotherapy and without prior
protocol-associated lymphodepletion. For 12 of the 13 patients,
sufficient cells for all six planned doses were generated; two
doses were available for the remaining patient.
- Out of the 13 evaluable patients (best overall response):
-
- 4 patients experienced objective responses after administration
of MultiTAA cells;
-
- 1 patient experienced a radiographic complete response
occurring at month 9 after starting chemotherapy;
- 3 patients experienced partial responses per RECIST occurring
at 6-9 months after starting chemotherapy;
- 6 patients experienced stable disease;
- 1 patient experienced a mixed response (some lesions increased
in size and others decreased for a net zero change in size of tumor
lesions);
- 2 patients experienced disease progression;
- For 9 of the 13 patients, the cancer was controlled for a
period longer than historical controls relative to the type of
chemotherapy used;
- 5 patients enrolled in the study were not administered
MultiTAA-specific T cells, either because of disease progression (4
patients) which made them ineligible for treatment, or because
insufficient starting material from the patient was available for
manufacturing (1 patient);
- Evidence of epitope-spreading was observed in all responders,
suggesting that the MultiTAA T cell therapy triggered the
recruitment of a broader endogenous immune system response for
improved anti-tumor activity;
- No infusion-related reactions, cytokine release syndrome or
neurotoxicity was observed.
Mythili Koneru, M.D., Ph.D.,
Chief Medical Officer of Marker Therapeutics commented: "We are
pleased with these interim results, which demonstrate
the potential of our therapy to simultaneously recognize and
target multiple antigens. As the tumor microenvironment varies from
patient to patient, the ability to address these differences may
offer a significant benefit to patients. While these results
represent a small patient population, we look forward to generating
additional data that may support MultiTAA's future development in
this challenging disease area."
The TACTOPS poster and corresponding recorded presentation by
Dr. Smaglo will be available on demand through the ASCO20 Virtual
Scientific Program on the ASCO website beginning on May 29,
2020, at 8:00 a.m. EDT.
Conference Call and Webcast
Marker will host a conference call and webcast on Monday, June 1st at 8:00
am EDT featuring Dr. Brandon
Smaglo, as well as Marker senior management, to discuss the
data. The webcast will be accessible in
the Investors section of the Company's website at
markertherapeutics.com. Individuals can participate in the
conference call by dialing 877-407-8913 (domestic) or 201-689-8201
(international).
The archived webcast will be available for replay on the Marker
website following the event.
About MultiTAA-Specific T Cell Therapy
Marker's
Multi-Antigen Targeted (MultiTAA) 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. In early clinical
trials, the multi-antigen approach has been well tolerated and
shown to enhance tumor destroying capability and is one of the
first therapies to consistently demonstrate epitope spreading –
inducing the patient's own T cells to expand, potentially
contributing to a lasting anti-tumor effect. Unlike other cell
therapies which require pre-conditioning regimens and
hospitalization, MultiTAA is 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. 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 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; the
potential benefits of orphan drug designation; and the timing and
success of our clinical trials, 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. 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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SOURCE Marker Therapeutics, Inc.