Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Pancreatic Cancer

Rhea-AI Summary

Marker Therapeutics (NASDAQ:MRKR) announced that the FDA has granted Orphan Drug designation to MT-601, a T cell product targeting pancreatic cancer. The designation highlights MT-601’s potential to treat a disease with a low 5-year survival rate. The product targets multiple tumor-associated antigens and is in a Phase 1 trial showing promising results. The company plans to initiate a multicenter study combining MT-601 with chemotherapy and file an Investigational New Drug Application in 2022. Orphan designation may provide various benefits, including market exclusivity.

Positive

• FDA Orphan Drug designation for MT-601 enhances its development prospects.
• Promising results in Phase 1 trials indicate potential efficacy in treating pancreatic cancer.
• Targeting multiple tumor-associated antigens may lead to broader treatment options.

Negative

• None.

HOUSTON, Jan. 19, 2022 (GLOBE NEWSWIRE) -- 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.

To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.

IR and Media Contacts

Marker Therapeutics
Neda Safarzadeh
Vice President/Head of Investor Relations, PR & Marketing
(713) 400-6451
investor.relations@markertherapeutics.com

Solebury Trout
Investors
Xuan Yang
xyang@soleburytrout.com

Media
Amy Bonanno
abonanno@soleburytrout.com

FAQ

What is the significance of the FDA's Orphan Drug designation for MRKR?

The FDA's Orphan Drug designation for MRKR's MT-601 underscores its potential as a treatment for pancreatic cancer, enhancing its development and market prospects.

What are the expected benefits of the Orphan Drug designation for MT-601?

Orphan Drug designation may provide MRKR with grant funding, tax credits, and seven years of market exclusivity after FDA approval for MT-601.

What clinical trial is MRKR planning for MT-601?

MRKR plans to initiate a Phase 1 multicenter study of MT-601 combined with chemotherapy for patients with locally advanced or metastatic pancreatic cancer.

When does MRKR plan to file an IND for MT-601?

MRKR intends to file an Investigational New Drug Application for MT-601 in 2022.