Full Press Release Details
Therapeutics Provides Business and Clinical Update
T cell therapies continue to demonstrate positive clinical data across multiple indications in investigator-sponsored trials-
plans IND submission for Company-sponsored Phase 2 AML study in the third quarter, with first patient enrolled by the end of 2019-
update in the solid tumor program planned for second quarter-
to host business update call and webcast today at 5:00 p.m. EDT-
Houston, TX -March 28, 2019- 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.
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.
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."
Targeted (MultiTAA) T Cell Therapies
As reported in January, 2019:
at ASBMT and CIBMTR in February:
As the Company reported in January,
2019, ten patients with active disease have been treated, including:
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
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.
POSITION AND GUIDANCE
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
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
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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 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.
Marker Therapeutics, Inc.