Marker Therapeutics receives $2.6 million FDA grant for MT-601 pancreatic cancer trial

Marker Therapeutics, Inc. (Nasdaq: MRKR) has secured a $2.6 million award from the U.S. Food and Drug Administration to fund a Phase 1 clinical study of its lead investigational therapy, MT-601, in patients with locally advanced unresectable pancreatic cancer. The funding comes from the FDA's Orphan Products Clinical Trials grants program, a competitive federal initiative that supports research for rare diseases.

The FDA's selection process involves independent scientific peer review, evaluating the scientific rationale, trial design, and feasibility of proposed projects. In fiscal year 2026, the agency received 66 applications and selected only six projects for funding. Marker Therapeutics is one of the six recipients. Juan Vera, MD, President and Chief Executive Officer of Marker Therapeutics, stated that the award represents independent recognition of the company's multi-antigen recognizing (MAR)-T cell platform.

MT-601 is a non-genetically modified T cell product designed to target six specific tumor antigens: Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, and MAGEA-4. The company's approach aims to address tumor heterogeneity and antigen escape by recognizing multiple targets simultaneously. Vera noted that the platform has demonstrated a favorable safety profile in more than 200 patients treated across various hematologic malignancies and solid tumors.

The development of MT-601 for pancreatic cancer builds on prior results from a Phase 1/2 study conducted at Baylor College of Medicine, published in Nature Medicine in 2026. That study reported a disease control rate of 84.6% in patients receiving multi-antigen targeted T cells combined with frontline chemotherapy. The median duration of response was 7.5 months, and the median overall survival was 14.1 months. For comparison, standard frontline chemotherapy regimens in metastatic pancreatic cancer have reported median overall survival rates between 9.2 and 11.1 months, with median durations of response ranging from 5 to 7.3 months.

Marker Therapeutics has also secured non-dilutive funding from the National Institutes of Health (NIH) Small Business Innovation Research program and the Cancer Prevention and Research Institute of Texas (CPRIT) to support this program. The company plans to initiate its company-sponsored Phase 1 study in pancreatic cancer in the first quarter of 2027. This upcoming trial will incorporate an expanded antigen-targeting profile, higher T cell doses, and lymphodepletion to potentially enhance T cell expansion and persistence.