Full Press Release Details
Marker Therapeutics Announces Clinical Program
Updates and Pipeline Prioritization
Strategic prioritization of clinical programs
with focus on MT-601 in patients with lymphoma
MultiTAA-specific T cell therapies demonstrate
clinical safety and positive clinical data across multiple indications
Marker provides updates supporting the clinical
benefits of MT-401 in patients with measurable residual disease (MRD)
Houston, TX - January 8, 2024 -
Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based
immunotherapies for the treatment of hematological malignancies and solid tumors, today announced a restructuring of its clinical programs
and a strategic prioritization of its multi-tumor associated antigen (multiTAA)-specific T cell product pipeline. In addition, the Company
reported a clinical update on the Phase 2 ARTEMIS study investigating MT-401, a multiTAA-specific T cell product, for the treatment of
patients with acute myeloid leukemia (AML).
Following the non-dilutive transaction with Cell
Ready (Press Release, May 1, 2023), Marker has made significant progress on clinical and corporate restructuring with the objective
of accelerating the commercial development of our unique multiTAA technology. The Company today announced the prioritization of MT-601
in chimeric antigen receptor (CAR) relapse patients with lymphoma (APOLLO; clinicaltrials.gov identifier: NCT05798897). This strategic
decision was made based on 1) the Company's promising non-clinical and clinical data using the multiTAA technology in lymphoma,
and 2) the lack of an approved treatment for patients who experience relapse after treatment with CD19 CAR T (up to 60% within a year;
Chong EA et al, N Engl J Med, 2021), which is a clear unmet medical need and provides an opportunity for accelerated product development.
Highlights from the Lymphoma Study
Clinical Efficacy in Patients with Lymphoma
in Previous Clinical Trial
Non-Clinical Proof-of-Concept Data
Durable Response in CAR Relapsed Patient with
CD19-targeting CAR T cell therapies are associated
with severe side effects and toxicities, and up to 60% of patients with DLBCL relapse within a year (Chong EA et al, N Engl J Med, 2021).
Additionally, the FDA is investigating CAR T therapies for the potential risk of inducing secondary cancers (U.S. Food and Drug Administration,
Nov 28, 2023). To date, multiTAA-specific T cell therapies have been well-tolerated in over 200 patients in clinical trials, and
Marker believes that, unlike CAR T cells, multiTAA-specific T cells could represent a safer therapeutic option due to their non-genetically
engineered approach that selectively expands tumor-specific T cells from a patient's/donor's blood without the risk of mutagenesis.
Promising Clinical Observations and New Directions
with MT-401 in Patients with MRD in AML
Today, Marker is providing a clinical update on
the Phase 2 ARTEMIS clinical study (clinicaltrials.gov identifier: NCT04511130), and the direction it will pursue. This multicenter study
is evaluating the safety and efficacy of MT-401 in patients with AML after allogeneic hematopoietic stem cell transplantation (HSCT).
A total of 8 patients with MRD+ AML after HSCT
were enrolled and treated with MT-401. None of the 8 treated patients experienced a drug related adverse event. Of the 8 treated patients,
4 experienced a clinical benefit, with 3 showing a conversion to MRD-negative, and one patient showing a partial response with a logarithmic
reduction of MRD levels by PCR. One patient has not yet had the first assessment post treatment. Of the 8 treated patients in the study,
only 1 patient had documented disease progression and was taken to a second transplant. The other 3 patients were taken off the study
for reasons unrelated to the clinical outcome.
Obtaining timely consent and re-accessing HSCT
donors for apheresis for the manufacture of MT-401 caused delayed patient accrual and patient eligibility issues. Consequently, the rapid
progression of disease contributed to some patients to withdraw from the study prior to administration of study product. Therefore, to
streamline resources and to reduce time to treatment, Marker intends to focus on a ready for use product from commercially available leukapheresis
material and will discontinue the patient-specific part (ARTEMIS) of the AML program.
"We are encouraged by the clinical observations
in patients with MRD in our AML study," said Juan Vera, M.D., President and CEO of Marker Therapeutics. "The data demonstrate
the safety of MT-401 and provide evidence that MT-401 could benefit patients with MRD+ AML."
Dr. Vera continued: "Decreasing the time
to treatment is critical when it comes to the treatment of patients that suffer from rapidly progressing cancers, such as patients with
MRD in AML, which typically advances rapidly into frank relapse with poor outcomes. We believe using commercial leukapheresis material
from healthy donors can bypass the bottleneck associated with donor identification and facilitate large-scale manufacturing. This approach
is expected to not only reduce manufacturing costs, but also expedite time to treatment to as little as 72 hours. We are currently working
to initiate the clinical study and anticipate that the first patient with AML will be treated with MT-401 manufactured from healthy donors
in the second half of 2024."
The Company previously announced that the FDA
has cleared the clinical protocol to investigate a ready for use MT-401 product manufactured from healthy donors in patients with AML,
and a cellular inventory has been established with continuous efforts to expand this inventory (Press Release, Aug 7, 2023).
Marker has secured non-dilutive funding to support
the clinical investigation of a ready for use MT-401 product in patients with AML. Using these allocated funds will allow the Company
to proceed with the ready for use program without affecting the ongoing Phase 1 APOLLO study and the capital runway of the Company into
the fourth quarter of 2025.
In addition, the Company has an Investigational
New Drug (IND) application cleared by the U.S. FDA for a Phase 1 trial to investigate MT-601 in patients with pancreatic cancer in combination
with first-line chemotherapy. The clinical advancement of this multicenter study will be pending additional funding from non-dilutive
sources, including grant activities.
"The strategic restructure of our multiTAA
pipeline reflects our ongoing commitment to innovate and deliver groundbreaking treatments," said Dr. Vera. "The decision
to shift our focus on MT-601 in patients with lymphoma is based on our promising non-clinical and clinical observations. Lymphoma is a
highly competitive landscape with numerous companies striving to compete with CAR T cell therapies. However, our approach differs by targeting
multiple antigens and focusing on a unique niche: patients who have experienced CAR T cell relapse or are ineligible for CAR T therapy."
Dr. Vera continued: "We believe that MT-601
could address the unmet medical need in this patient population. Developing a product in this patient population is commercially attractive
due to the well understood natural history, the unmet medical need, and the lower number of competing trials. Assuming we continue to
see promising results in our APOLLO study, this would allow us to accelerate the development of MT-601 in CAR relapse patients with lymphoma."
About multiTAA-specific T cells
The multi-tumor associated antigen (multiTAA)-specific
T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor's
blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 200 patients with various hematological
malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated
durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables
the potential contribution to a lasting anti-tumor effect.
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. The T cell therapy technology developed by Marker 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. This
population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's
immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer the T cells, Marker believes
that its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered
CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio
of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
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