Marker Therapeutics, Inc. has announced exciting new non-clinical data on its lead multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401. After treatment with hypomethylating agents (HMA), MT-401 showed increased anti-tumor activity against an acute myeloid leukemia (AML) cell line.
To further support the development of MT-401 for the treatment of AML patients after hematopoietic stem cell transplant (HSCT), the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program has granted the Company a $2 million grant. These exciting developments showcase incredible potential for utilizing MT-401 in the fight against AML and possibly other types of cancer.
In March 2023, Marker reported exciting clinical updates from the ARTEMIS trial (clinicaltrials.gov identifier: NCT04511130). This trial focuses on the revolutionary MT-401 T cell therapy designed to specifically target four different antigens upregulated in acute myeloid leukemia (AML) but minimally expressed on normal cells.
It has shown tremendous potential in providing a much-needed benefit to patients with AML who have measurable residual disease (MRD+) after hematopoietic stem cell transplantation (HSCT). Encouraged by this success, Marker is continuing to investigate further opportunities to improve outcomes for AML patients.
Harnessing the power of multiTAA-specific T cell therapy with agents that make cancer cells more visible to cancer killing cells can offer a promising tactic to battle AML. When combined with agents like 5’-Azacytidine and Decitabine, which inhibit DNA methylation, the upregulation of tumor suppressor genes and inhibition of oncogenes takes effect. Moreover, tumor antigens, including MT-401-specific tumor antigens, which are typically silenced by DNA methylation, are also upregulated due to the HMAs, providing an effective defense in the fight against AML.
Marker’s Laura S. Angelo, Ph.D., and her team explored the potential of MT-401 to enter the fight against aggressive, treatment-resistant acute myeloid leukemia (AML) cells in a set of in vitro experiments. Through applying HMA to THP-1 cells, the team tested MT-401’s effectiveness in inhibiting or eliminating the cells. Promisingly, the results of this non-clinical study demonstrate MT-401’s capacity, and they can be found posted on Marker’s Investor Relations section.
Marker’s Laura S. Angelo, Ph.D., and her team explored the potential of MT-401 to enter the fight against aggressive, treatment-resistant acute myeloid leukemia (AML) cells in a set of in vitro experiments. Through applying HMA to THP-1 cells, the team tested MT-401’s effectiveness in inhibiting or eliminating the cells. Promisingly, the results of this non-clinical study demonstrate MT-401’s capacity, and they can be found posted on Marker’s Investor Relations section.
In this innovative in vitro model of AML using bioluminescent THP-1 cells, treatment resistance to 5′-Azacytidine was overcome with the combined administration of MT-401 – a newly engineered therapeutic agent produced from HLA-matched donors. After exposure to both HMA and MT-401, a significant decrease in THP-1 cell growth was observed, suggesting a synergistic effect that could offer a promising approach for patients post-HSCT. Remarkably, this novel combination approach may provide improved targeting of AML antigens, such as Survivin, while minimizing potential systemic effects.
The exciting results of the recent study suggest that treatment of AML using HMA therapy could significantly improve clinical outcomes by upregulating expression of vital tumor antigens and thus increase tumor inhibition and killing. Following these positive findings, Marker Therapeutics is planning to incorporate these results into its ongoing AML clinical study to maximize the potential of its multiTAA-specific T cell product. Details regarding the revised clinical study design will be announced in the third quarter of 2023.
Marker recently received a $2 million grant from the NIH to support a nationwide multi-center Phase 2b clinical trial in AML patients following HSCT. This trial aims to evaluate the efficacy and safety of MT-401, a drug that was granted orphan designation by the U.S. Food and Drug Administration, when administered after pre-treatment with HMAs. Additionally, the trial will include immune monitoring of patient samples. It is hoped that this trial will provide new insight into the use of MT-401 for the treatment of acute myeloid leukemia.
We are delighted to announce the receipt of an SBIR grant from the NIH to support our clinical Phase 2b study in AML patients. Acute myeloid leukemia (AML) is a rare disease with limited treatment options available after stem cell transplant. Our previous Phase 2 ARTEMIS trial indicated promising results for AML patients who were MRD+ post-transplant, suggesting that MT-401 could potentially be beneficial for this patient population before relapse. The SBIR grant will be a major help in our endeavors to further advance our clinical trial, explore the benefit of HMA administration before MT-401 therapy in patients who have had HSCT and have no approved treatments to date.
About the NIH SBIR Program
The NIH Small Business Innovation Research (SBIR) Program is an incredible investment, with more than $1.2 billion from Research & Development Funding allocated to small businesses throughout the United States. Through the NIH SBIR funding, countless life-changing innovations are propelled from idea to production, from bench to bedside – including research tools, diagnostics, digital health, drugs, and medical devices. These funds help many small businesses acquire the capital they require to take their ideas and transform them to marketable products. Incredible opportunities await, so don’t miss your chance to revolutionize healthcare!
About multiTAA-specific T cells
MultiTAA-specific T cell therapy is a revolutionary way of treating cancer without the use of genetic modification. Evidence from clinical trials of 180+ patients with different types of cancer have shown that autologous and allogeneic multiTAA-specific T cells can provide effective and long-lasting protection from tumors, even surpassing current treatments.
Moreover, the procedure is designed to be conducted in an outpatient setting, allowing for patient comfort and convenience. These T cells have the potential to not only make a lasting impression on tumor cells, but also enable the possibility of a future free of cancer.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is revolutionizing the immuno-oncology landscape with their development of next-generation T cell-based immunotherapies that can be used to treat hematological malignancies and solid tumors. Unlike gene-modified CAR-T and TCR-based therapies, Marker’s cell therapy technology relies on the expansion of non-engineered, tumor-specific T cells that recognize and attack tumor targets.
Resulting in a product with a more appealing profile, Marker believes that their product will offer patients meaningful clinical benefit with reduced toxicities and easier, more cost-effective manufacturing. Be sure to keep an eye out for Marker’s breakthrough therapies that may be game-changing for cancer treatment in the years to come.
Forward-Looking Statements
Matinas BioPharma is thrilled to announce the release of its non-engineered multi-tumor antigen specific T cell therapies for the treatment of diseases. This exciting advancement has the potential to offer a range of curative effects and safety in the treatment of diseases, and the Company’s current clinical trials of its product candidate, MT-401, for the treatment of patients with AML will be sure to provide insight and guidance on the effectiveness of this groundbreaking therapy. We are optimistic that the success of this innovative solution will improve the quality of life of many individuals around the world.