HOUSTON, Jan. 3, 2019 /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 a year-end update in five
clinical trials using the Company's therapeutic products, LAPP and
MAPP multi-antigen targeted T cell (MultiTAA) therapies and
TPIV200, its Folate Receptor Alpha (FRα) peptide cancer vaccine
product candidate.
"We are pleased to provide an update on our progress in
advancing clinical trials using our therapeutic platform," stated
Peter L. Hoang, President & CEO
of Marker Therapeutics. "With our MultiTAA cell therapies, we
continue to build on the size and depth of our patient dataset.
These updates now bring our total reported number of patients to
72, up from 57 in our previously reported results. I believe this
represents one of the most extensive sets of clinical results in
cell therapy for cancer treatment and illustrates the potential
safety and clinical effects of MultiTAA T cells for patients
suffering from a number of terrible cancers."
"In our vaccine program, we continue to demonstrate our
commitment to excellence in our clinical execution," Mr. Hoang
continued. "Last year when I joined the company, I expressed that
we would work to improve our clinical efficiency, and I believe
that the completion of enrollment of our FRV-004 study in ovarian
cancer over six months ahead of schedule reflects our dedication to
that objective. In fact, we have now completed enrollment of our
last two clinical trials significantly ahead of projections,
reflecting the commitment of our management and clinical team to
execute multi-center studies effectively."
The Company reported clinical updates in three Baylor College of Medicine (BCM)-sponsored Phase
I/II clinical trials using its MultiTAA T cell therapies, LAPP and
MAPP:
Lymphoma
In the Phase I/II clinical trial in lymphoma, BCM has now
treated 15 patients with active disease who have failed an average
of four lines of prior therapy. Of these patients, five patients
experienced transient disease stabilization followed by disease
progression. Four patients have ongoing stable disease of between 9
to 24+ months following infusion of the MultiTAA-specific T cells,
while the remaining six have all had complete and durable responses
(4 months to 60+ months), as assessed by PET imaging.
- No relapses observed to date for any patient entering a
complete response (CR).
- Patients with active disease who have ongoing complete
responses after infusion of MultiTAA cells are now between 1 and 5
years in CR (ongoing).
- Several patients with stable disease show potential for durable
disease stabilization, with two patients observed to have stable
disease for over 9 months and 24 months, respectively.
- Responses in all six patients who entered a CR were associated
with an expansion of infused T cells as well as the induction of
antigen spreading.
- None of the treated patients developed cytokine release
syndrome, neurotoxicity or any other infusion-related adverse
events.
BCM has also treated 17 patients who had developed a CR
following their last treatment (adjuvant therapy) for lymphoma, and
all but two of these patients remain in remission (3-42 months
post-infusion). Monitoring has continued on all patients previously
reported, and none of these patients have yet relapsed with
disease. Average duration of remission for patients with a
continuing complete response (CCR) is over 26 months (ongoing),
versus 16 months (ongoing) as of the last patient update.
Multiple Myeloma
Marker Therapeutics also provided an update to the BCM-sponsored
Phase I/II clinical trial in multiple myeloma. Results were
presented at an oral presentation at the American Society of
Hematology (ASH) 2018 Annual Meeting.
- Ten patients with active disease were treated, including:
-
- One patient with a CR durable for approximately 29 months
before relapse, was subsequently given a second treatment infusion
of MultiTAA T cells, resulting in stable disease for 3 months
(ongoing) after the second treatment.
- Two patients achieved partial responses (PR) of between 14 and
22 months (ongoing) as of last follow-up.
- All seven remaining patients experienced stabilization of
disease following infusion of MultiTAA cells initially. Three
patients developed transient disease stabilization of between 3-7
months with subsequent progression, and four patients have ongoing
stable disease.
- Eight patients were treated in remission, with a median follow
up of 21 months. Only one patient has relapsed to date.
- Correlative studies show significant expansion of MultiTAA T
cells, as well as significant evidence of epitope spreading with
expansion of endogenous T cells specific for tumor-associated
antigens that were not targeted by the MultiTAA product.
- MultiTAA therapy appears to be safe and well-tolerated, with no
incidence of cytokine release syndrome, neurotoxicity or any other
serious adverse events related to the therapy.
Acute Lymphoblastic Leukemia
Marker Therapeutics also reported initial results from the
BCM-sponsored Phase I clinical trial in acute lymphoblastic
leukemia (ALL). In this study, patients were treated with MultiTAA
T cells as a maintenance therapy for patients in CR post-allogeneic
stem cell transplant. Leukemic relapse remains the major cause of
treatment failure in hematopoietic stem cell transplant (HSCT)
recipients.
- 10 patients have been enrolled and treated in this clinical
trial, with eight patients evaluable for response. To date, all but
one remains in CR, with patients ranging from 1 to 22 months in CCR
(ongoing). Because of the highly refractory nature of these
patients, the length of CCRs and the low rate of relapse amongst
these patients, the Company believes that these early results are
promising and may represent meaningful clinical benefit.
Marker Therapeutics also reported key updates from clinical
studies of TPIV200, its Folate Receptor Alpha (FRα) peptide cancer
vaccine product candidate.
Ovarian Cancer
Marker Therapeutics reported that it had completed enrollment in
its Phase II study in ovarian cancer (Study FRV-004), using TPIV200
as a maintenance therapy for patients in their first remission
after surgery and platinum-based chemotherapy. Marker has enrolled,
randomized, and treated 120 patients at 17 clinical sites. The
study completed enrollment six months faster than anticipated. The
Company expects to reach its planned interim analysis trigger of 50
patients who have progressed by the end of the second quarter of
2019, with interim data reported by year end.
- Enrollment of this study was completed over six months ahead of
schedule, reflecting ongoing management initiatives to improve and
enhance clinical operations efficiency.
- Marker had previously projected the initiation of its interim
analysis to begin in Q4 2018, triggered by the 50th
patient to progress following treatment. Despite faster than
expected enrollment of patients in this study, as of the end of
December fewer than 50 patients had progressive disease. As a
result, Marker now expects to reach its planned interim analysis
trigger by end of the second quarter of 2019, with interim data
reported by year end.
Triple Negative Breast Cancer
Marker Therapeutics also reported initial findings from its
interim analysis of its dose-finding study (Study FRV-002) in
patients with triple negative breast cancer, using TPIV200 as a
maintenance therapy for patients in remission following first-line
therapy. The four-arm study included low and high dose TPIV200 with
or without cyclophosphamide.
- Of 27 patients evaluated to date for immunogenicity, 26 showed
significant immune response to the vaccine treatment. Of 80
patients treated at 11 clinical sites, 11 have shown disease
progression to date following treatment with TPIV200.
"These additional clinical results strongly augment our
existing, previously disclosed patient dataset. In patients who
were treated for active disease in lymphoma, we continue to see
long-lived, ongoing complete responses that are now durable beyond
five years and have yet to observe a patient who achieves a CR
subsequently relapse," said Dr. Richard
Kenney, Acting Chief Medical Officer of Marker Therapeutics.
"Notably, in the adjuvant lymphoma patients we have also not seen
any additional relapses, with several patients now beyond four
years in their continuing complete response. While the median
progression-free survival has not yet been reached in any of these
trials, observationally it appears that the time to progression for
patients receiving MultiTAA T cell therapy may compare favorably
with results reported in CD19 and BCMA-targeted CAR-T studies in
lymphoma and multiple myeloma, without inducing the toxicities
normally associated with gene-modified adoptive cell
therapies."
"Given the highly refractory nature of the patients with acute
lymphoblastic leukemia treated, we believe the preliminary results
appear to be very promising, with only one patient having relapsed
to date," continued Dr. Kenney. "These early results may indicate
that MultiTAA therapy may be able to drive clinical benefit for
these patients without the need for donor-lymphocyte infusions
(DLIs), and the associated risk of graft versus host disease
(GvHD). Finally, our clinical sites have been very supportive of
our Phase II vaccine studies in ovarian and breast cancer, and
their rapid enrollment is a credit to our Principal Investigators
and clinical investigative sites, as well as our clinical
operations team. We are pleased with the progress in building our
clinical development infrastructure and believe we can leverage
that experience to drive our upcoming MultiTAA T cell studies
efficiently."
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.
Once infused into patients, this population of T cells attacks
multiple tumor targets and acts to activate the patient's immune
system to produce broad spectrum anti-tumor activity. Because
Marker does not genetically engineer its T cells, when compared to
current engineered CAR-T and TCR-based approaches, its products (i)
are significantly less expensive and easier to manufacture, (ii)
appear to be markedly less toxic, and (iii) are associated with
meaningful clinical benefit. As a result, Marker believes its
portfolio of T cell therapies has a compelling therapeutic product
profile, as compared to current gene-modified CAR-T and TCR-based
therapies.
Marker is also advancing a number of innovative peptide- and
gene-based immuno-therapeutics for the treatment of metastatic
solid tumors, including the Folate Receptor Alpha program (TPIV200)
for breast and ovarian cancers and the HER2/neu program
(TPIV100/110) for breast cancer, currently in Phase II clinical
trials. In parallel, we are developing a proprietary DNA expression
technology named PolyStart™ that can enhance the ability of the
immune system to recognize and destroy diseased cells.
For additional information, please call toll free at (904)
862-6490 or visit: markertherapeutics.com
To receive future press releases via email, please
visit: https://markertherapeutics.com/email-alerts/
Follow us on Twitter @MRKRTherapeutic, or follow us
on Facebook.
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 and development activities
relating to our multi-tumor antigen specific T cell therapies,
including our LAPP and MAPP programs; our TPIV200 and TPIV100/110
programs and our PolyStart™ program; 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 and success of our clinical trials, as well as MultiTAA T
cell clinical trials conducted by Baylor
College of Medicine. 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/marker-therapeutics-provides-updates-of-its-lead-clinical-programs-300772712.html
SOURCE Marker Therapeutics, Inc.