zedenoleucel (MT-401) / Marker Therap - LARVOL DELTA

ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov) - P2 | N=92 | Terminated | Sponsor: Marker Therapeutics, Inc. | N=47 ➔ 92 | Completed ➔ Terminated; Despite a plan to enroll ~195-210 participants, the ARTEMIS study was closed due to the long vein-to-vein manufacturing timeline of MT-401 after 38 participants received the autologous MT-401.

Enrollment change • Trial termination • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov) - P2 | N=47 | Completed | Sponsor: Marker Therapeutics, Inc. | Active, not recruiting ➔ Completed | N=180 ➔ 47 | Trial completion date: Aug 2024 ➔ Mar 2024

Enrollment change • Trial completion • Trial completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Marker Therapeutics, Inc. | Trial completion date: Jul 2027 ➔ Aug 2024 | Trial primary completion date: Jul 2024 ➔ Mar 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Marker Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

Marker Therapeutics Announces Clinical Program Updates and Pipeline Prioritization (GlobeNewswire) - P2 | N=180 | ARTEMIS (NCT04511130) | Sponsor: Marker Therapeutics, Inc. | "Marker is providing a clinical update on the Phase 2 ARTEMIS clinical study....A total of 8 patients with MRD+ AML after HSCT were enrolled and treated with MT-401....Of the 8 treated patients, 4 experienced a clinical benefit, with 3 showing a conversion to MRD-negative, and one patient showing a partial response with a logarithmic reduction of MRD levels by PCR....Of the 8 treated patients in the study, only 1 patient had documented disease progression and was taken to a second transplant....Marker intends to focus on a ready for use product from commercially available leukapheresis material and will discontinue the patient-specific part (ARTEMIS) of the AML program....We are currently working to initiate the clinical study and anticipate that the first patient with AML will be treated with MT-401 manufactured from healthy donors in the second half of 2024."

New trial • P2 data • Trial status • Acute Myelogenous Leukemia

European Medicines Agency Grants Orphan Drug Designation for MT-401 developed by Marker Therapeutics for the Treatment of AML Patients (GlobeNewswire) - "Marker Therapeutics...announced that zedenoleucel, its multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, was granted Orphan Drug Designation by the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) for the treatment of patients with acute myeloid leukemia (AML)....MT-401 utilizes a novel non-genetically modified approach that recognizes multiple antigens expressed on tumor cells, thereby designed to minimize tumor escape."

European regulatory • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics Reports MT-401 Non-Clinical Data in AML Cells after Hypomethylating Agent Administration (GlobeNewswire) - "Marker Therapeutics...today reports non-clinical data on its lead multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, which showed increased anti-tumor activity against an acute myeloid leukemia (AML) cell line after treatment with hypomethylating agents (HMA). Marker further announces that the Company has been awarded a $2 million grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program to support the development of MT-401 for the treatment of patients with AML after hematopoietic stem cell transplant (HSCT)....'In light of these encouraging results we are planning to incorporate these findings into our current AML clinical study to improve and empower our multiTAA-specific T cell outcomes. Details about the revised clinical study design will be announced in Q3 of 2023.'"

Clinical protocol • Financing • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics Reports Fiscal Year 2022 Corporate and Financial Results (GlobeNewswire) - "MT-401 PHASE 2 ARTEMIS (AML): Marker anticipates reporting a data readout of the MRD+ patient subset in the second half of 2023."

P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Early Results of MT-401 (Zedenoleucel) in Post-Transplant MRD+ aml Patients (ASH 2022) - "Interestingly, the tumor antigen composition by RNASeq identified an antigen expression profile that changes over time and inversely correlates with the presence of antigen-specific T cells, demonstrating the interplay of tumor cell immunogenicity and antigen-specific T cells. Conclusion s : The preliminary ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRD- indicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be beneficial."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Melanoma • Oncology • Solid Tumor • Transplantation • Wilms Tumor • BIRC5 • CD4 • CD8 • CTAG1B • NPM1 • PRAME • RUNX1 • WT1

Preliminary Results of MT-401 in Post-Transplant MRD+ AML Patients (SITC 2022) - "Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Melanoma • Oncology • Solid Tumor • Wilms Tumor • BIRC5 • CD4 • CD8 • CTAG1B • NPM1 • PRAME • RUNX1 • WT1

Rapid and simplified process for manufacturing multi-tumor-associated antigen specific T cells (SITC 2022) - "has developed MT-401, a multi-tumor-associated antigen (multiTAA)-specific allogeneic T cell product capable of recognizing multiple targets expressed on the tumor simultaneously, minimizing tumor escape...Conclusions These process improvements significantly reduced the number of interventions needed during manufacturing, thereby decreasing both the possibility of manufacturing failures and product manufacturing time, which translates to faster patient treatment. This sophisticated and rapid manufacturing approach has shown to be reproducible regardless of the tumor antigen combination, enabling the extension of this technology to other clinical indications."

Acute Myelogenous Leukemia • Oncology • BIRC5 • CTAG1B • PRAME • WT1

Preliminary Results of MT-401 in Post-Transplant Measurable Residual Disease Positive (MRD+) Acute Myeloid Leukemia (AML) Patients (SOHO 2022) - "The lead-in portion of the ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRDindicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be benefi cial."

Clinical • IO biomarker • Residual disease • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BIRC5 • CTAG1B • NPM1 • PRAME • RUNX1 • WT1

AML-109 Preliminary Results of MT-401 in Post-Transplant Measurable Residual Disease Positive (MRD+) Acute Myeloid Leukemia (AML) Patients. (PubMed, Clin Lymphoma Myeloma Leuk) - "The lead-in portion of the ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRD-indicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be beneficial."

IO biomarker • Journal • Residual disease • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • BIRC5 • CTAG1B • NPM1 • PRAME • RUNX1 • WT1

Marker Therapeutics Awarded $2 Million Grant from U.S. FDA to Support Marker’s Phase 2 ARTEMIS Trial of MT-401 in Post-Transplant AML (GlobeNewswire) - "Marker Therapeutics, Inc...announced that the Company has been awarded a $2 million grant from the U.S. Food and Drug Administration (FDA) Orphan Products Grants program to support its Phase 2 ARTEMIS trial of its lead multi-tumor-associated antigen (MultiTAA) T cell product candidate, MT-401, in patients with post-transplant acute myeloid leukemia (AML)....The FDA grant will support the Company’s treatment arm evaluating MT-401 in patients with post-transplant AML with minimal residual disease."

Financing • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov) - P2 | N=172 | Recruiting | Sponsor: Marker Therapeutics, Inc. | Trial primary completion date: Jul 2022 ➔ Jul 2024

Trial primary completion date • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov) - P2; N=172; Recruiting; Sponsor: Marker Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Safety Lead-In of Ph2 AML Study Results Using Zedenoleucel (ASGCT 2022) - "Zedenoleucel (also known as MT-401) is a non-genetically modified allogeneic multi-tumor associated antigen (mTAA)-specific T cell therapy with selectivity to multiple tumor antigens, PRAME, WT1, NY-ESO-1 and Survivin... Zedenoleucel was successfully manufactured using two different reagent vendors and was safely administered to 6 post-transplant AML patients with no DLTs noted. Preliminary evidence of anti-tumor activity with zedenoleucel was observed in the Safety Lead-in portion of the Phase 2 ARTEMIS study which further supports the promising Phase 1 ADSPAM data using mTAA-specific T cells. Specifically, the ARTEMIS results showed that administration of zedenoleucel converted an MRD+ patient to MRD- and suggests that AML patients could potentially benefit from administration of zedenoleucel."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • BIRC5 • CD4 • CD8 • CTAG1B • PRAME • RUNX1 • RUNX1T1 • WT1

Rapid and Simplified Process for Manufacturing Multi-Tumor-Associated Antigen Specific T Cells (ASGCT 2022) - "MT-401 is a multi-tumor-associated antigen (multiTAA)-specific allogeneic T cell product capable of recognizing multiple targets expressed on the tumor simultaneously, minimizing tumor escape...These process improvements significantly reduced the number of interventions needed during manufacturing, thereby decreasing both the possibility of manufacturing failures and product manufacturing time, which translates to faster patient treatment. This sophisticated and rapid manufacturing approach has shown to be reproducible regardless of the tumor antigen combination, enabling the extension of this technology to other clinical indications."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Oncology • Transplantation • BIRC5 • CTAG1B • PRAME • WT1

Marker Therapeutics Reports Q1 2022 Operating and Financial Results (GlobeNewswire) - "...Phase 2 AML trial evaluating MT-401...Topline readout of Group 2 active disease is anticipated in Q2 2022....expects to dose the first patient with MT-401-OTS 2023."

P2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics to Present Four Posters on its T Cell-Based Immunotherapies at the 2022 International Society for Cell & Gene Therapy Annual Meeting (GlobeNewswire) - "Marker Therapeutics, Inc...today announced that the Company will present four posters on its Multi-Tumor-Associated Antigen (MultiTAA)-specific T cell therapies at the 2022 International Society for Cell & Gene Therapy (ISCT) Annual Meeting, being held May 4-7, 2022, in San Francisco....'In addition, we will present more detail on the clinical results from the six-patient safety lead-in stage of our Phase 2 AML trial, previously reported in February 2022, which demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD+ patient and induced epitope spreading.'"

Clinical data • P2 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics Announces that Data from Investigator-Sponsored Phase 1 Study With its MultiTAA-Specific T Cells to be Presented at the 2021 American Society of Hematology Annual Meeting (PRNewswire) - "Marker Therapeutics...announced that data from a Phase 1 study investigating its MultiTAA-specific T cells were selected for oral presentation at the 2021 American Society of Hematology (ASH) Annual Meeting. The results will be reviewed by investigators at the Baylor College of Medicine, Marker's research partner."

P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics Reports Third Quarter 2021 Operating and Financial Results (PRNewswire) - "We are pleased to announce that the first patients in Marker's Phase 2 AML trial have been dosed with study drug. Further, we are on track to enroll the first 20 patients of the trial in the fourth quarter, with the first data readout expected in the first quarter of 2022."

P2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Marker Therapeutics Awarded $13.1 Million Grant from the Cancer Prevention and Research Institute of Texas (PRNewswire) - "Marker Therapeutics...announced that the Company received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Company's Phase 2 clinical trial of its lead MultiTAA-specific T cell product MT-401. The CPRIT award is intended to support the adjuvant arm of the Company's Phase 2 clinical trial evaluating MT-401 when given as an adjuvant therapy to patients with acute myeloid leukemia (AML) following a hematopoietic stem cell transplant."

Commercial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics Reports Second Quarter 2021 Operating and Financial Results (PRNewswire) - "Anticipated Program Milestones: (i) AML Trial Milestones: Complete enrollment of 20 patients in main portion of Phase 2 trial in Q4 2021; Topline readout of Group 2 (active disease) in Q1 2022; (ii) Manufacturing Milestones: Manufacture MT-401 at Marker's new cGMP facility for Phase 2 AML trial in Q3 2021."

Commercial • Enrollment status • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Marker Therapeutics Announces Completion of Safety Lead-In Portion of Phase 2 Study in Post-Transplant AML (PRNewswire) - “Company continues to enroll patients in main portion of the Phase 2 trial with topline data from active disease group expected in Q1 2022…Marker Therapeutics, Inc…announced completion of the six-patient safety lead-in portion of the Company's Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant acute myeloid leukemia (AML).”

P2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology