Marker Therapeutics Awarded $2.6 Million FDA Orphan Products Development Grant to Advance MT-601 in Pancreatic Cancer
Key Highlights
- ➤Marker Therapeutics (MRKR) awarded $2.6 million FDA grant for MT-601 pancreatic cancer trial
- ➤FDA selected six projects from 66 applications for fiscal-year 2026 funding
- ➤MT-601 pancreatic cancer study expected to begin in first quarter of 2027
- ➤Prior study showed 84.6% disease control rate and 14.1-month median overall survival
- ➤MT-601 study reported 7.5-month median response duration in pancreatic cancer
Expert Statements
Juan Vera, President and Chief Executive Officer of Marker Therapeutics
“We are honored to be among the six recipients selected for funding through the FDA’s highly competitive Orphan Products Clinical Trials grants program.”
Juan Vera, President and Chief Executive Officer of Marker Therapeutics
“This award represents meaningful independent recognition and external validation of the scientific rationale underlying our MAR-T platform and its potential application in pancreatic cancer.”
Juan Vera, President and Chief Executive Officer of Marker Therapeutics
“Our technology is designed to recognize multiple tumor-associated antigens, offering a differentiated approach to addressing tumor heterogeneity and antigen escape, while maintaining the favorable safety profile observed in more than 200 patients treated across our clinical programs in hematologic malignancies and solid tumors.”
Juan Vera, President and Chief Executive Officer of Marker Therapeutics
“The additional non-dilutive funding from the FDA will further support our efforts to advance MT-601 in an area of significant unmet medical need.”
Dr. Vera, President and Chief Executive Officer of Marker Therapeutics
“These encouraging clinical findings provide a strong foundation for the development of MT-601 in pancreatic cancer, particularly given the limited outcomes with current treatment options.”
Dr. Vera, President and Chief Executive Officer of Marker Therapeutics
“For context, a recent clinical trial evaluating standard frontline chemotherapy regimens in metastatic pancreatic cancer reported median overall survival of 9.2-11.1 months and median duration of response of 5-7.3 months.”
Dr. Vera, President and Chief Executive Officer of Marker Therapeutics
“Through our company-sponsored study, we aim to build on our previous observations from the Baylor study by incorporating an expanded antigen-targeting profile, higher T cell doses, and lymphodepletion to potentially enhance T cell expansion, persistence, and clinical outcomes.”
Dr. Vera, President and Chief Executive Officer of Marker Therapeutics
“The FDA grant provides important non-dilutive funding and further recognition of the scientific rationale and development potential of our program.”
Dr. Vera, President and Chief Executive Officer of Marker Therapeutics
“We anticipate clinical initiation of our study in pancreatic cancer in the first quarter of 2027 and look forward to advancing MT-601 as a potential treatment option for patients with a significant unmet medical need.”
HOUSTON, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), is a clinical-stage immuno-oncology company developing multi-antigen recognizing (MAR)-T cell therapies under an exclusive worldwide license from Baylor College of Medicine for patients with cancer. Today, Marker announced that the Company has been awarded $2.6 million from the U.S. Food and Drug Administration (FDA) through its Orphan Products Clinical Trials grants program. The funding will support a Phase 1 clinical study evaluating the Company’s lead investigational MAR-T cell therapy, MT-601, in patients with locally advanced unresectable pancreatic cancer.
The FDA’s Orphan Products Clinical Trials grants program is a highly competitive federal funding initiative designed to support clinical research that may advance the development of treatments for rare diseases. Applications undergo independent scientific peer review, including evaluation of scientific rationale, clinical trial design, feasibility, and potential contribution to product development. In fiscal year 2026, the FDA received 66 applications and selected six projects for funding.
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