Marker Therapeutics Awarded $2.6 Million FDA Orphan Products Development Grant to Advance MT-601 in 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.
“We are honored to be among the six recipients selected for funding through the FDA’s highly competitive Orphan Products Clinical Trials grants program,” said
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
The clinical development of MT-601 in pancreatic cancer builds on encouraging results from a Phase 1/2 study conducted at
“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,” commented
About the FDA Orphan Products Clinical Trials Grants Program
The
About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.
About MT-601
The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in tumor cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker 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 Company’s pancreatic cancer program is supported by the
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based 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 was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’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. Marker’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).
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Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including neldaleucel (MT-601) for the treatment of patients with pancreatic cancer or lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which 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. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.
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