Full Press Release Details
Therapeutics Provides Updates of its Lead Clinical Programs
Reports clinical data updates with MultiTAA
T cells in lymphoma, multiple myeloma and acute lymphoblastic leukemia
Reports completion of enrollment for
TPIV200 Phase II study in ovarian cancer
Reports interim immunogenicity findings
of TPIV200 Phase II study in triple negative breast cancer
TX - January 3, 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 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 (FR ) peptide cancer vaccine product candidate.
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
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.
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.
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.
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.
Therapeutics also reported key updates from clinical studies of TPIV200, its Folate Receptor Alpha (FR ) peptide cancer vaccine
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.
Negative Breast Cancer
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.
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."
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,
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.
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 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.
Marker Therapeutics,