Marker Therapeutics Initiates Phase 1 RAPID Study for OTS Immunotherapy

Marker Therapeutics has initiated a Phase 1 RAPID study to investigate the safety and efficacy of their Multi-Antigen Recognizing (MAR) T cells as an Off-the-Shelf (OTS) product. The initial patient has been treated with the product, which was well tolerated, with safety data consistent with other MAR-T cell studies. The study aims to accelerate the time to treatment for patients with hematological malignancies and solid tumors.

Houston, TX — Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company, has initiated the Phase 1 RAPID study to evaluate the safety and efficacy of their Multi-Antigen Recognizing (MAR) T cells as an Off-the-Shelf (OTS) product. The company announced that the first patient has been treated with the product, which was well tolerated, with safety data consistent with other MAR-T cell studies Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program^[1].

The RAPID study, conducted under clinicaltrials.gov Identifier: NCT06552416, aims to assess the safety and efficacy of escalating doses of MT-401, a multi-antigen recognizing T cell product targeting four antigens. The initial patient received the OTS product at the initial dose level (100x106 cells) and was monitored for 28 days without any treatment-related adverse events Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program^[1].

The OTS product will initially be tested in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), with the potential to be expanded to other indications. The company aims to remove the bottleneck of individualized product manufacturing, providing a fast treatment option for patients with aggressive and rapidly progressing diseases. The OTS product is designed to expedite treatment as fast as 72 hours, while also enabling broader scalability and accessibility of cell therapies at a lower per-dose cost Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program^[1].

Dr. Juan Vera, President and CEO of Marker Therapeutics, commented, "The initiation of our OTS program represents a major achievement. We believe that using commercially available leukapheresis material from healthy donors can facilitate large-scale manufacturing and expedite treatment. Looking ahead, we will remain focused on advancing our clinical investigation of MAR-T cells in lymphoma" Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program^[1].

Marker Therapeutics has secured non-dilutive funding from the Food and Drug Administration (FDA), 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 clinical investigation of the OTS product Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program^[1].

The company's unique T cell platform, strengthened by non-dilutive funding from U.S. state and federal agencies, is designed to introduce novel T cell therapies to the market and improve patient outcomes. Marker Therapeutics' goal is to prioritize the preservation of financial resources and focus on operational excellence Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program^[1].

For comprehensive coverage of Marker Therapeutics' developments, investors and traders can visit the dedicated news page at [stocktitan.net/news/MRKR/](https://www.stocktitan.net/news/MRKR/) Marker Therapeut Stock Price, News & Analysis^[2].