Marker Therapeut Stock Price, News & Analysis

Marker Therapeutics, Inc. (Nasdaq: MRKR) is a Houston, Texas-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 focuses on advancing its proprietary multi-antigen recognizing T cell (MAR-T) platform, a non-genetically modified cell therapy approach designed to expand tumor-specific T cells from a patient’s or donor’s blood.

According to the company, its MAR-T cell platform (formerly referred to as multiTAA-specific T cells) selectively expands T cells capable of recognizing a broad range of tumor antigens. These MAR-T cells can recognize hundreds of different epitopes within up to six tumor-specific antigens, which the company believes may reduce the possibility of tumor escape. Because the cells are not genetically engineered, Marker states that its product candidates may be easier and less expensive to manufacture and may have an improved safety profile compared to certain engineered T cell approaches, while still aiming to provide meaningful clinical benefits.

Core Technology and MAR-T Platform

MAR-T cells are central to Marker’s strategy. The platform uses non-genetically modified T cells that are expanded ex vivo to target multiple tumor-associated antigens. Marker reports that clinical trials conducted across various hematological and solid tumor indications have shown that its autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses in more than 200 treated patients. The company emphasizes the ability of MAR-T cells to recognize multiple antigens simultaneously as a way to address tumor heterogeneity and reduce the risk of relapse driven by single-antigen loss.

Marker’s MAR-T programs are supported by non-dilutive funding from U.S. state and federal agencies that support cancer research, including the National Cancer Institute of the National Institutes of Health, the Food and Drug Administration, and the Cancer Prevention and Research Institute of Texas (CPRIT). The company states that this funding strengthens its platform and helps preserve financial resources while it advances clinical development.

Lead Program: MT-601 in Lymphoma

Marker’s lead product candidate is MT-601, a multi-antigen recognizing T cell product that utilizes a non-genetically modified approach to target six tumor antigens that are upregulated in lymphoma cells: Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, and MAGEA-4. MT-601 is being investigated in the company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897), a multicenter, open-label study evaluating safety, optimum dose, and preliminary efficacy in patients with relapsed or refractory lymphoma who have either failed anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are not candidates for such therapy.

In updates from the APOLLO study, Marker has reported objective responses in patients with Non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL), including complete responses in a subset of heavily pre-treated patients. The company has also reported a favorable safety profile for MT-601, with no dose-limiting toxicities and no immune-effector cell associated neurotoxicity syndrome (ICANS) observed in the dose escalation cohort, and only limited low-grade cytokine release syndrome events. Marker has advanced APOLLO into a dose expansion phase, evaluating MT-601 at a pre-specified maximum dose level in patients with diffuse large B cell lymphoma (DLBCL) who have relapsed after or are ineligible for anti-CD19 CAR-T therapy.

Pancreatic Cancer Program

Beyond lymphoma, Marker is developing MT-601 for metastatic pancreatic cancer. The company has reported that it was awarded non-dilutive funding from the National Institutes of Health and CPRIT to support this program. Marker references clinical work from Baylor College of Medicine investigating multi-antigen targeted T cells in pancreatic ductal adenocarcinoma, which demonstrated encouraging disease control rates and a favorable safety profile when combined with frontline chemotherapy. Marker indicates that it has further advanced this technology under the MAR-T name and intends to incorporate improvements such as increasing the number of target antigens, using higher cell doses, and adding lymphodepletion to support T cell expansion in its pancreatic cancer program.

Off-the-Shelf MAR-T Program (MT-401-OTS)

Marker is also developing an Off-the-Shelf (OTS) MAR-T cell product, MT-401-OTS, for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). MT-401-OTS is a multi-antigen recognizing T cell product that targets four tumor antigens upregulated in cancer cells: Survivin, PRAME, NY-ESO-1, and WT-1. It is being evaluated in the company-sponsored Phase 1 RAPID trial (clinicaltrials.gov identifier: NCT06552416), a multicenter, open-label study of escalating doses in AML or MDS.

Marker has reported that the first patient treated in the RAPID study received MT-401-OTS at the initial dose level and that the therapy was well tolerated with no treatment-related adverse events during the initial monitoring period. The company describes the OTS approach as using commercially available leukapheresis material from healthy donors to build a cellular inventory designed to cover a large patient population with partially human leukocyte antigen (HLA) matched material. Marker notes that this approach has been validated and extensively tested in prior clinical work at Baylor College of Medicine in the context of virus-specific T cells.

Manufacturing and Collaboration

To support clinical development of MT-601, Marker has entered into a collaboration with Cellipont Bioservices, a cell therapy contract development and manufacturing organization (CDMO), for current good manufacturing practice (cGMP) manufacturing. Under this agreement, Cellipont provides technology transfer and cGMP manufacturing services to support scale-up and production of MT-601 for the APOLLO study. Marker states that this collaboration is intended to accelerate clinical supply and lay the foundation for potential later-stage development and commercial readiness.

Clinical and Research Foundations

Marker emphasizes that its origins at Baylor College of Medicine and the clinical experience with multi-antigen targeted T cells inform its current programs. The company notes that clinical trials enrolling more than 200 patients across various hematological and solid tumor indications have shown that its autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. In addition, Marker highlights scientific observations from its APOLLO study, including evidence that lymphodepletion can improve the expansion and persistence of MAR-T cells in vivo, which the company believes may influence anti-tumor activity.

Business Focus and Funding

Marker describes itself as a clinical-stage company that prioritizes the preservation of financial resources and focuses on operational excellence as it advances its pipeline. The company reports that it has received non-dilutive grant funding from multiple U.S. state and federal agencies, including the National Cancer Institute of the National Institutes of Health, the Food and Drug Administration, and CPRIT, to support programs such as MT-601 in lymphoma and pancreatic cancer and MT-401-OTS in AML and MDS. Marker also reports raising capital through equity offerings, including use of an at-the-market (ATM) facility, to extend its cash runway while continuing clinical development.

Stock and Regulatory Status

Marker Therapeutics, Inc. trades on Nasdaq under the ticker symbol MRKR. The company files periodic and current reports with the U.S. Securities and Exchange Commission (SEC), including Form 10-K, Form 10-Q, and Form 8-K filings. Recent Form 8-K filings have covered topics such as clinical updates from the APOLLO study, initiation of the OTS program, financial results, changes in the company’s independent registered public accounting firm, and the appointment of a new member to the board of directors.

FAQs about Marker Therapeutics, Inc. (MRKR)

• What does Marker Therapeutics, Inc. do?
  Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company based in Houston, Texas, that develops next-generation T cell-based immunotherapies. Its programs focus on hematological malignancies and solid tumors using its multi-antigen recognizing T cell (MAR-T) platform.
• What is the MAR-T cell platform?
  The MAR-T cell platform (formerly known as multiTAA-specific T cells) is a non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s or donor’s blood. These cells can recognize hundreds of epitopes within up to six tumor-specific antigens, which the company believes may reduce the chance of tumor escape and support durable responses.
• What is MT-601?
  MT-601 is Marker’s lead MAR-T cell product candidate. It targets six tumor antigens upregulated in lymphoma cells—Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, and MAGEA-4—and is being investigated in the Phase 1 APOLLO trial for patients with relapsed or refractory lymphoma who have failed or are not candidates for anti-CD19 CAR-T cell therapy.
• What is the APOLLO study?
  APOLLO (NCT05798897) is a Phase 1, multicenter, open-label clinical trial sponsored by Marker to evaluate the safety, optimum dose, and preliminary efficacy of MT-601 in participants with relapsed or refractory lymphoma. The study includes a dose escalation phase followed by a dose expansion phase in patients with diffuse large B cell lymphoma who have relapsed after or are ineligible for anti-CD19 CAR-T therapy.
• Does Marker have programs beyond lymphoma?
  Yes. Marker is developing MT-601 for metastatic pancreatic cancer with support from non-dilutive funding awarded by the National Institutes of Health and CPRIT. The company is also advancing MT-401-OTS, an Off-the-Shelf MAR-T product targeting four tumor antigens, in the Phase 1 RAPID trial for patients with relapsed acute myeloid leukemia or myelodysplastic syndromes.
• What is MT-401-OTS and the RAPID trial?
  MT-401-OTS is an Off-the-Shelf MAR-T cell product targeting Survivin, PRAME, NY-ESO-1, and WT-1. It is being evaluated in the Phase 1 RAPID trial (NCT06552416), a multicenter, open-label study in patients with relapsed AML or MDS. Marker has reported that the first treated participant tolerated the therapy well with no treatment-related adverse events during the initial monitoring period.
• How is Marker’s work funded?
  Marker reports a combination of non-dilutive grant funding from U.S. state and federal agencies and capital raised through equity offerings. Grant support has been awarded for programs in lymphoma, pancreatic cancer, and the Off-the-Shelf MAR-T initiative, and the company has also used an at-the-market equity facility to raise additional funds.
• Where is Marker Therapeutics headquartered?
  Marker Therapeutics, Inc. is headquartered in Houston, Texas. Its SEC filings list a Houston address as the principal office location.
• On which exchange does MRKR trade?
  Shares of Marker Therapeutics, Inc. trade on the Nasdaq stock market under the ticker symbol MRKR.
• What regulatory filings does Marker submit?
  Marker files annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K with the U.S. Securities and Exchange Commission. Recent 8-K filings have disclosed financial results, clinical trial updates, changes in the company’s independent auditor, and board-level appointments.