Marker Therapeutics Receives $2.6 Million FDA Grant for Pancreatic Cancer Therapy
News related to:Marker Therapeutics, Inc · 3 min read
HOUSTON, Oct. 19, 2026 /CourierPR/ -- Marker Therapeutics, Inc., a clinical-stage immuno-oncology 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 multi-antigen recognizing (MAR)-T cell therapy, MT-601, in patients with locally advanced unresectable pancreatic cancer.
This award is part of a highly competitive federal funding initiative designed to advance treatments for rare diseases. In fiscal year 2026, the FDA received 66 applications and selected six projects for funding. Marker Therapeutics is among the six recipients, marking meaningful independent recognition and external validation of the scientific rationale underlying its MAR-T platform.
The Company's MAR-T cells are a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells can recognize hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. The additional non-dilutive funding from the FDA will further support Marker's efforts to advance MT-601 in an area of significant unmet medical need.
MT-601, the Company's lead product, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach to specifically target six different tumor antigens upregulated in tumor cells. The Company is currently investigating MT-601 in the Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are ineligible to receive anti-CD19 CAR-T cell therapies. Due to the broad target recognition profile of MT-601, the Company is exploring its potential application beyond lymphoma in patients with pancreatic cancer.
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 also received national coverage on Good Morning America (January 22, 2026). The study 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.
The FDA grant award further expands Marker's track record of securing competitive federal and state research funding to support the development of the Company's innovative MAR-T cell therapies. In addition to the FDA Orphan Products Clinical Trials grant, Marker has secured non-dilutive funding from the National Cancer Institute of the National Institutes of Health (Award Number R44CA295168), the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP250150), and the FDA Orphan Products Clinical Trials Grants program (Award Number 1R01FD008756-01).
Marker Therapeutics, Inc., based in Houston, Texas, 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 tumors. The Company's goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence.
The Company's unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research, including the National Cancer Institute of National Institutes of Health, U.S. Department of War, the FDA Orphan Drug program, and the Cancer Prevention Research Institute of Texas (CPRIT).
Forward-looking statements in this release are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties, and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q, and other SEC filings, which are available through EDGAR at www.sec.gov.