HOUSTON, March 28, 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
provided a business and clinical update, as well as an overview of
upcoming milestones for 2019.
"Our MultiTAA T cell therapies have continued to generate
positive and compelling clinical data across various indications in
several ongoing investigator-sponsored clinical trials led by
Baylor College of Medicine (BCM). We
plan to advance a Phase 2 Company-sponsored clinical trial in
post-transplant acute myeloid leukemia (AML)—a disease area and
patient population for which there are limited treatment options.
We expect to finalize our clinical trial protocol in AML by the end
of the second quarter of 2019 and to submit our IND in the third
quarter, with the first patient enrolled by the end of the year,"
said Peter L. Hoang, President & CEO of Marker
Therapeutics.
Continued Mr. Hoang: "While our T cell therapies remain our
primary clinical focus, we are also advancing our T cell vaccine
candidates, TPIV200 and TPIV100/110, for the treatment of ovarian
and breast cancers. Overall, there are two Phase 2
Company-sponsored studies ongoing for TPIV200 in triple-negative
breast cancer and ovarian cancer, and we anticipate reporting
interim data from the ovarian cancer Phase 2 study in Q4
2019."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
- Acute Myeloid Leukemia Data -
-
- The Company reported a clinical update from a Phase 1
clinical trial in post-transplant AML in oral and poster
presentations at ASH in December and ASBMT and CIBMTR in February.
Results from the BCM-sponsored study showed that the treatment is
safe and well-tolerated and has the potential to mediate a
meaningful anti-tumor effect, as well as significant in
vivo expansion of T cells. Among the highlights from the
study, 11 out of 13 patients dosed with MultiTAA T cells as a
maintenance therapy after receiving allogeneic stem cell transplant
remain alive, ranging from 6 weeks to 2.5 years
post-infusion. Nine of these patients have never
relapsed after MultiTAA therapy and continue to remain in
complete remission (CR). Patients with active disease, overall
survival ranged from 4 and 21 months as compared to 4.5 months in
historical results after standard of care.
- Marker will pursue post-transplant AML as the lead
indication of its T cell therapy program. Based on findings
from various dose cohorts in the Phase 1 BCM-sponsored trial,
Marker has made a strategic decision to focus on post-transplant
AML, and plans to initiate pre-IND discussions with the U.S. FDA in
the second quarter of 2019, with an IND submission for the
Company-sponsored potentially pivotal Phase 2 study in the third
quarter. The multicenter study will evaluate clinical efficacy of
MultiTAA specific T cells in patients with AML or myelodysplastic
syndromes (MDS) in both the adjuvant and active disease setting,
following an allogeneic hematopoietic stem cell transplant (HSCT).
The dose administered will be the maximum tolerated dose from the
BCM-sponsored Phase 1 trial. In the adjuvant setting, patients will
be randomized 2:1 to either MultiTAA therapy at approximately 90
days post-transplant versus standard of care observation, while the
active disease patients will receive MultiTAA T cells as part of a
single-arm group.
- Lymphoma Data -
As reported in January, 2019:
-
- To date, no relapses have been observed for any patient
entering a complete response (CR);
- Patients with active disease are now between 1 and 5+ years in
CR after infusion of MultiTAA cells (ongoing);
- Several patients with stable disease show potential durable
disease stabilization, with two patients experiencing stable
disease for over 9 months and 24 months, respectively;
- Responses in all six patients who entered CR were associated
with an expansion of infused T cells, as well as induction of
antigen spreading.
- Acute Lymphoblastic Leukemia (ALL) Data -
As reported at ASBMT and CIBMTR in February:
-
- Patients are now up to 28 months in continued complete
remission (CCR);
- The one patient who experienced relapse displayed mixed
donor/recipient chimerism after transplant, but remained in CCR for
6 months;
- Patients who remain in CCR have been durable for between 4 to
28 months, with a median of 16 months.
- Multiple Myeloma Data -
As the Company reported in January, 2019, ten patients with active
disease have been 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.
Overall, across all indications, 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.
T Cell Based Vaccines
- Ovarian Cancer Data -
-
- As the Company reported in January, 2019, it has completed
enrollment in its Phase 2 study in ovarian cancer using TPIV200 as
a maintenance therapy for patients in their first remission after
surgery and platinum-based chemotherapy. To date, Marker has
enrolled, randomized, and treated 120 patients at 17 clinical
sites. The study completed enrollment six months faster than
anticipated and the Company expects to reach its planned interim
analysis trigger of 55 patients who have progressed before the end
of 2019.
- Triple Negative Breast Cancer Data -
-
- The Company also reported initial findings from its interim
analysis of its dose-finding study in 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.
Marker continues to advance the development of its proprietary
PolyStart™ platform, a nucleic acid-based technology with the
potential to increase the potency of our vaccines by conferring a
four-fold increase in expression of target-cell-specific, naturally
processed antigenic epitopes on a cell's surface. This approach
boosts helper and/or long-lived killer T cells, enabling their
potential to effectively seek out and destroy target cells.
CASH POSITION AND GUIDANCE
Marker reported cash and
cash equivalents totaling $61.7 million as
of December 31, 2018. Based on current operating plans, Marker
expects that current cash resources will be sufficient to meet
operating requirements into Q4 of 2020.
UPCOMING NEAR-TERM POTENTIAL MILESTONES
- Pre-IND discussions for AML with the U.S. FDA in Q2;
- First update in solid tumor program in Q2 concurrently with a
major medical meeting;
- IND submission for Company-sponsored Phase 2 AML study in Q3,
with first patient enrolled by end of 2019;
- Interim analysis readout in the TPIV200 ovarian trial in
Q4;
- Overall update on ongoing clinical trials in cell therapy at
end of 2019.
Business Update Call and Webcast
Marker management will host business update conference call and
webcast today at 5:00 p.m. EDT. To
access the call, participants should dial 1-855-238-2333 (domestic)
or 1-412-317-5215 (international) and refer to the "Marker
Therapeutics, Inc. call." The webcast will be accessible in
the Investors section of the Company's website
at www.markertherapeutics.com. The archived webcast will be
available for replay on the Marker website approximately two hours
after 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.
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 non-engineered multi-tumor antigen specific T cell
therapies; 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 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/marker-therapeutics-provides-business-and-clinical-update-300820608.html
SOURCE Marker Therapeutics, Inc.