Marker Therapeutics Inc

A Phase 1 Study of Patient-derived Multi-tumor-associated Antigen Specific T Cells (MT-601) Administered to Patients With Relapsed Non-hodgkin Lymphoma - Abstract This Application Presents MT-601, a Novel Multi-tumor Associated Antigen (mtaa)-specific T Cell Product for the Treatment of Non-hodgkin’s Lymphoma (NHL). NHL Is the Most Common Hematologic Malignancy With ~80,550 New Cases and >20,000 Deaths in the Us Expected in 2023. Adoptive T Cell Transfer, E.g., Car T Cells, Have Impressive Potency in NHL Yet Are Also Associated With Cytokine Release Syndrome (CRS) and Neurotoxicity. Additionally, Relapse Rates Are Up to 60% Post-car T Therapy Due to Low Antigen Levels or Loss of CD19 Expression. to Date There Are No Approved Therapies for NHL Patients Who Relapsed After Car T Cell Therapy, Resulting in a Huge Unmet Medical Need for Alternate Treatment Options for NHL. MT-601 Represents a Novel T Cell-based Immunotherapy That Simultaneously Targets 6 Tumor-associated Antigens (TAA) (prame, NY-ESO1, Survivin, MAGE-A4, SSX2, WT1) That Are Overexpressed in NHL But Absent or With Limited Expression in Healthy Tissue, Thereby Minimizing Tumor Escape and Enhancing Anti-tumor Response. Manufactured From Autologous Apheresis Material, MT-601 Recognizes Target Cells via Native T Cell Receptors by Interacting With Tumor Antigen-expressing Target Cells Presenting Antigen in the Context of Both Class I and Ii Hla, Leading to Killing of Tumor Cells Expressing Any of These Antigens and Recruiting the Patient’s Immune System in the Anti-tumor Response. Although Other Cellular Immunotherapies Attempt to Address CD19 Car T Cell Failures by Targeting 2-3 Antigens, They Are Limited by 1) Narrow Epitope Recognition, and 2) Leaving the Tumor Susceptible to Relapse. in Addition to Broad-spectrum Antigen Targeting, MT-601 Is the Only Cellular Therapy Being Explored in NHL Patients Who Relapsed Following Car T Therapy. Additional Advantages of MT-601 Include Out-patient Administration and No Genetic Engineering. Furthermore, Marker’s Multitaa-specific Technology Was Proven Clinically Safe in >180 Patients With Various Kinds of Cancer. in a Phase 1 Trial of Lymphoma Patients Using Multitaa-specific T Cells Targeting 5 Taas, Patients Had Durable Responses for Much Longer Than Those Typically Associated With Car T Cells (6 Years Versus 28 Months). Notably, Marker Recently Treated Our First Car T Cell Relapsed NHL Patient, Who Shows a Complete Response at 12 Weeks Post-infusion. Based on This Promising Clinical Data, Marker Proposes a Single-arm Phase 1 Clinical Study to Advance MT-601 for Patients With NHL That Relapsed After Third Line Car T Treatment and Do Not Have Other Approved Therapy Options. the Objective of Specific Aim 1 Is to Manufacture MT-601 and Execute the Clinical Protocol by Treating NHL Patients Who Have Relapsed After CD19 Car T Cell Therapy With MT-601. Specific Aim 2 Will Correlate Biological Characteristics in the Product Profile With Clinical Safety and Efficacy Outcomes. Successful Completion of This Grant Will Provide Clinical Proof of Concept for MT-601 as a Treatment for Car Relapsed NHL Patients, and Support Future Clinical Trials Leading to Future Bla Filing and Commercial Approval of MT-601.