Press Releases

Clinical study from Baylor College of Medicine demonstrates a favorable safety profile and up to 84.6% disease control rate in patients with pancreatic cancer in Arm A of the clinical study

Study highlights correlation between the clinical benefit and the expansion and persistence of Multi-Antigen Targeted T cells

HOUSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage immuno-oncology Company with the worldwide exclusive license of Multi-Antigen Targeted T cells (also referred to as Multi-Antigen Recognizing T cells, or MAR-T cells, by Marker), a technology developed at Baylor College of Medicine for the treatment of hematologic and solid tumors. A research team from Baylor College of Medicine has now published groundbreaking work in Nature Medicine investigating Multi-Antigen Targeted T cells in patients with pancreatic cancer.

The Phase 1/2 clinical study conducted at Baylor College of Medicine demonstrated encouraging objective clinical responses and a disease control rate of 84.6% when combining Multi-Antigen Targeted T cells with frontline chemotherapy (Arm A). In this arm of the study, median duration of response for patients achieving a partial or complete response was 7.5 months (range 3.5 – 16.6) with a median overall survival rate of 14.1 months suggesting a clinical benefit of combining Multi-Antigen Targeted T cells with standard chemotherapy.

Clinical results from this Phase 1 study demonstrated a favorable safety profile and potential synergistic effect when combining Multi-Antigen Targeted T cells with chemotherapy without affecting the toxicity profile. Chemotherapy was previously shown to break down the tumor’s supporting stromal cells, which act as a protective barrier, to facilitate T cell infiltration into the tumor and to boost anti-tumor response (Gao Z et al, Frontiers in Oncology, 2023).

The research group from Baylor also highlighted a correlation between the clinical effect and the expansion and persistence of infused Multi-Antigen Targeted T cells. The data showed that infused T cells were still present in patients 12 months post-treatment and found at higher frequencies in patients that responded to the investigational product.

“We congratulate the research team at Baylor College of Medicine on this outstanding work and encouraging results in patients with pancreatic cancer,” said Juan Vera, MD, President and CEO of Marker Therapeutics. “The data highlights the excellent safety profile of Multi-Antigen Targeted T cells and demonstrates that they can be used in combination with frontline chemotherapy. We believe that this clinical proof-of-concept study emphasizes the potential of Multi-Antigen Targeted T cells in pancreatic cancer and sets the stage for continued development toward addressing a critical unmet need.”

Dr. Vera continued, “At Marker, we have further advanced the technology, referring to it as MAR-T cells, and hope to build on the strong results observed in the Baylor study by increasing the number of target antigens, using higher cell doses, and by adding lymphodepletion to the study to further support the expansion of infused MAR-T cells. We are excited about our progress and anticipate clinical initiation of our pancreatic cancer program in the first half of 2026.”

The Company recently reported promising safety and efficacy results from its Phase 1 study investigating a MAR-T cell product (MT-601) in lymphoma (APOLLO study, Press Release, August 26, 2025). This study included several improvements compared to earlier trials resulting in a 66% objective response rate in patients with non-Hodgkin lymphoma, with 50% achieving complete response. Improvements from this clinical study will also be incorporated in the pancreatic cancer program.

The Company has secured 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) to support the pancreatic cancer program. We anticipate that using these allocated non-dilutive funds should allow the Company to proceed with the pancreatic program without affecting the Company’s runway and its efforts to advance MT-601 in patients with lymphoma in the ongoing Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897).

Reference
Benjamin L. Musher, Spyridoula Vasileiou, Brandon G. Smaglo, Catherine S. Robertson, Mengfen Wu, Tao Wang, Ayumi Watanabe, Manik Kuvalekar, Yovana Velazquez, Shamika Ketkar, Tamadar Al Doheyan, Penelope G. Papayanni, Aakash Shah, Natalia Lapteva, Bambi J. Grilley, George Van Buren, Premal D. Lulla, Helen E. Heslop, Cliona M. Rooney, Malcolm K. Brenner, and Ann M. Leen. Autologous multiantigen-targeted T cell therapy for pancreatic ductal adenocarcinoma (PDAC): results of a Phase I, three-arm, nonrandomized clinical trial (TACTOPS). Nature Medicine. doi:10.1038/s41591-025-04043-5

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 National Cancer Institute of the National Institutes of Health (Award Number R44CA295168), and the Cancer Prevention and Research Institute of Texas (CPRIT, Award Number DP250150).

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.

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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; the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma or pancreatic cancer. 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.

Media and Investor Contact
Marker Therapeutics, Inc.
+1 (713) 400-6400
investor.relations@markertherapeutics.com

Source: Marker Therapeutics