HOUSTON, Feb. 25, 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 updated data from four clinical trials using the
Company's multi-antigen targeted T cell (MultiTAA) therapies. The
data was reviewed in oral and poster presentations at the
Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR
2019 which took place in Houston,
TX from February 20-24. Among
the highlights, were results from an ongoing study including
patients with acute myeloid leukemia (AML), which were reviewed in
an oral presentation by Dr. Premal
Lulla, M.B.B.S., Assistant Professor of Medicine,
Baylor College of Medicine.
"We continue to be highly encouraged by the clinical results
we've seen to date with our MultiTAA therapies. In AML, we believe
we are seeing increasing evidence of meaningful therapeutic benefit
for patients with limited treatment alternatives. Our MultiTAA
therapy appears to be safe and well-tolerated with the potential to
mediate a meaningful anti-tumor effect, in addition to
demonstrating a compelling correlation between therapeutic
responses, with superior in vivo expansion of our T cells,"
said Peter L. Hoang, President &
CEO of Marker Therapeutics. "Similarly, the studies ongoing in
acute lymphoblastic leukemia, or ALL, lymphoma and multiple myeloma
continue to demonstrate positive results, and are supportive of the
data we presented at ASH in December, importantly with no
additional disease relapses. Overall, this data update and our
update at ASH 2018 in December collectively have increased our
total reported number of patients to 78 as compared to the 57
patients we had reported as of November."
AML Study Results
In Arm A of the AML study, 13
patients at Baylor College of Medicine
were dosed with MultiTAA T cells as a maintenance therapy after
receiving allogeneic stem cell transplant. Results
demonstrated:
- 11 out of 13 patients 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), durable between
6 weeks to 2.5 years;
- Two patients saw local relapse in the central nervous system,
but in both cases these patients were successfully treated with
local therapy alone;
- One patient saw extramedullary relapse and was subsequently
treated in the active disease arm (Arm B) of the trial, generating
a CR that was durable for 13 months; and
- One patient relapsed 8 months after receiving MultiTAA T cells
but following a second allogeneic stem cell transplant this patient
remains alive in relapse 1.5 years following his initial T
cell infusion.
In Arm B of the AML study, 6 patients suffering from active
disease with relapsed/refractory (r/r) AML have been treated, with
1 patient having been treated twice for active disease with
MultiTAA T cells;
- 2 patients were non-responsive to MultiTAA therapy and
progressed with r/r disease;
- 1 patient developed a complete response (CR), which was durable
for 13 months; and
- 1 patient developed a partial response (PR) that enabled that
patient to receive a second allogeneic stem cell transplant;
-
- The patient who developed a partial response saw significant
tumor debulking, with circulating blasts reduced from over 50% to
15%.
- 2 additional patients who did not meet partial response
criteria experienced disease stabilization enabling a 2-month
delay to next-line therapy
-
- Of these patients with disease stability, one patient was
sufficiently stabilized to enable that patient to receive a second
allogeneic stem cell transplant. The second transplant eliminated
the patient's MultiTAA T cells. This patient was given a second
dose of MultiTAA T cells after initial disease relapse after the
second transplant, but progressed to another line of
therapy prior to any evaluable
response assessment to the subsequent dose of MultiTAA T
cells;
- The other patient who had disease stability saw
significant reduction in tumor burden, with a reduction in
circulating blasts from 70% prior to infusion of MultiTAA T cells,
to approximately 45% circulating blasts after MultiTAA
therapy.
- For patients in Arm B, overall survival ranged from 4 to 21
months after T cell infusions.
ALL Results
In addition to data from ongoing lymphoma
and multiple myeloma trials, also presented in an oral
presentation at the meeting were updated results from an ongoing
study in ALL. Updates from this trial included:
- Patients are now up to 28 months in CCR (Continued Complete
Remission);
- The only patient who has experienced relapse was a patient who
displayed mixed donor/recipient chimerism after transplant, but
remained in CCR for 6 months prior to relapse;
- Patients that remain in CCR have been durable for between 4 to
28 months, with a median duration of 16 months.
"We are very excited about the results we are seeing in our
early clinical trials. For patients with r/r AML, we believe that
MultiTAA therapies may produce meaningful improvements in
overall survival of patients who historically have had a dire
prognostic outlook," stated Mythili
Koneru, Senior Vice President of Clinical Development at
Marker Therapeutics. "In adjuvant settings for patients
currently in remission, I believe our early clinical results
suggest that we may be providing significant additional protection
against relapse and disease recurrence."
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 multi-tumor antigen specific T cell 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-announces-clinical-update-at-the-transplantation--cellular-therapy-meetings-of-asbmt-and-cibmtr-2019-300800573.html
SOURCE Marker Therapeutics, Inc.