Marker Therapeutics gets $2.6M FDA grant for pancreatic cancer therapy

Marker Therapeutics, Inc. (Nasdaq: MRKR) has received a $2.6 million grant from the U.S. Food and Drug Administration through its Orphan Products Clinical Trials grants program to fund a Phase 1 clinical study of MT-601, its lead investigational T cell therapy, in patients with locally advanced unresectable pancreatic cancer.

The FDA's Orphan Products Clinical Trials grants program received 66 applications in fiscal year 2026 and selected six projects for funding. Applications undergo scientific peer review evaluating scientific rationale, clinical trial design, feasibility, and potential contribution to product development.

MT-601 is a non-genetically modified multi-antigen recognizing (MAR) T cell therapy that targets six tumor antigens. Marker is currently evaluating the therapy in its Phase 1 APOLLO trial for lymphoma and plans to initiate the pancreatic cancer study in the first quarter of 2027.

The planned pancreatic cancer study will incorporate an expanded antigen-targeting profile, higher T cell doses, and lymphodepletion, building on a Phase 1/2 study conducted at Baylor College of Medicine. That study, published in Nature Medicine in 2026, reported a disease control rate of 84.6%, a median duration of response of 7.5 months, and a median overall survival of 14.1 months in patients receiving multi-antigen targeted T cells combined with frontline chemotherapy.

"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," said Juan Vera, MD, President and Chief Executive Officer of Marker Therapeutics.

The FDA grant adds to existing non-dilutive funding Marker has secured for its pancreatic cancer program, which also includes support from the National Institutes of Health Small Business Innovation Research program and the Cancer Prevention and Research Institute of Texas.

You May Also Be Interested In

• Atlantic American faces Nasdaq delisting over late SEC filings
• Increasing unusual put option volume: BUG BORR APO SECZ DB EWZ
• Merck and Moderna melanoma drug combo cuts recurrence risk by 42%