Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Pancreatic Cancer
20 January 2022 - 8:49AM
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 that the United States Food and Drug Administration (FDA)
Office of Orphan Products Development has granted Orphan Drug
designation to MT-601, a multi-tumor-associated antigen
(MultiTAA)-specific T cell product optimized for the treatment of
patients with pancreatic cancer.
“The FDA’s orphan drug designation underscores MT-601’s
potential as a treatment for pancreatic cancer, a cancer typically
diagnosed at an incurable advanced stage with a total overall
5-year survival rate of 10%,” said Peter L. Hoang, President &
CEO of Marker Therapeutics. “Our novel therapy has shown
encouraging results in an ongoing Phase 1 trial sponsored by
Marker’s partners at the Baylor College of Medicine. In results
reported at the 2020 American Society of Clinical Oncology (ASCO)
Virtual Annual Meeting, our therapy has demonstrated the potential
to safely produce durable responses in combination with
chemotherapy as a first-line treatment option for patients with
advanced or metastatic pancreatic adenocarcinoma. The results also
revealed that epitope spreading was consistent in responders to
Multi-TAA-specific T cells. Following MT-401 for the treatment of
post-transplant acute myeloid leukemia (AML), MT-601 is Marker’s
second novel MultiTAA-specific T cell product to receive orphan
drug designation and the first in a solid tumor indication,
underscoring the potential of Marker’s multi-antigen targeting T
cell therapy approach in both solid tumors and blood cancers.”
Marker developed MT-601, a new product targeting six
tumor-associated antigens (PRAME, NY-ESO-1, Survivin, MAGE-A4,
SSX2, WT1) highly expressed in pancreatic cancer. The Company
intends to initiate a Phase 1 multicenter study of MT-601
administered in combination with front-line chemotherapy to
patients with locally advanced unresectable or metastatic
pancreatic cancer. Marker designed the study to include an initial
antigen escalation period followed by a dose escalation period and
will enroll 20 – 25 patients for the study.
The Company plans to file an Investigational New Drug
Application (IND) for MT-601 for the treatment of pancreatic cancer
in 2022.
Orphan designation is granted by the FDA Office of Orphan
Products Development to advance the evaluation and development
of safe and effective therapies for the treatment of rare diseases
or conditions affecting fewer than 200,000 people in the U.S. Under
the Orphan Drug Act, the FDA may provide grant funding
toward clinical trial costs, tax credits, FDA user-fee
benefits, and seven years of market exclusivity in the United
States following marketing approval by the FDA. The
granting of an orphan designation request does not alter the
standard regulatory requirements and process for obtaining
marketing approval. For more information about orphan designation,
please visit the FDA website at www.fda.gov.
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. 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
its T cell therapies, we believe that our 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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IR and Media Contacts
Marker TherapeuticsNeda
SafarzadehVice President/Head of Investor Relations, PR &
Marketing(713)
400-6451investor.relations@markertherapeutics.com
Solebury
TroutInvestorsXuan
Yangxyang@soleburytrout.com
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Bonannoabonanno@soleburytrout.com
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