Marker Therapeutics, Inc. (Nasdaq: MRKR) announced on October 19, 2026, that it has been awarded a $2.6 million grant from the U.S. Food and Drug Administration (FDA) under the Orphan Products Clinical Trials grants program. The funding is intended to 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 competitive federal initiative designed to support clinical research for rare diseases. In fiscal year 2026, the FDA received 66 applications and selected six projects for funding. Marker was among the six recipients selected based on an independent scientific peer review of the scientific rationale, clinical trial design, and feasibility.
The grant will support the clinical development of MT-601, a multi-antigen recognizing (MAR) T cell therapy. The therapy is designed to recognize multiple tumor-associated antigens to address tumor heterogeneity and antigen escape. Marker is currently investigating MT-601 in the Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for patients with lymphoma who have relapsed after or are ineligible to receive anti-CD19 CAR-T cell therapies.
The company noted that the clinical development of MT-601 in pancreatic cancer builds on encouraging results from a Phase 1/2 study conducted at Baylor College of Medicine and published in Nature Medicine earlier this year. The findings demonstrated a favorable safety profile and a disease control rate of 84.6% in patients receiving multi-antigen targeted T cells in combination with frontline chemotherapy, with a median duration of response of 7.5 months and a median overall survival of 14.1 months.
Marker anticipates clinical initiation of its pancreatic cancer study in the first quarter of 2027. The company’s pancreatic cancer program is also supported by non-dilutive funding from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program and the Cancer Prevention and Research Institute of Texas (CPRIT).
