MT-401-OTS / Marker Therap - LARVOL DELTA

Marker Therapeutics…announced that the first patient has been treated in the Company’s OTS program, with encouraging preliminary safety data (GlobeNewswire) - "Marker is evaluating the safety and efficacy of escalating doses of MT-401...as an OTS product in the Phase 1 RAPID study....The first study participant received the OTS product at the initial dose level (100x106 cells) and was monitored for 28 days. The therapy was well tolerated with no treatment-related adverse events."

Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

RAPID: Safety of MT-401-OTS in Patients With Relapsed AML or MDS (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Marker Therapeutics, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2025 ➔ Jun 2025

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Marker Therapeutics Reports Year-End 2024 Corporate and Financial Results (GlobeNewswire) - "MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome): The Company anticipates clinical program initiation during the second half of 2025."

New trial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

RAPID: Safety of MT-401-OTS in Patients with Relapsed AML or MDS (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Marker Therapeutics, Inc. | Trial completion date: May 2029 ➔ Sep 2029 | Initiation date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: May 2029 ➔ Sep 2029

Trial completion date • Trial initiation date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Marker Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "PROGRAM UPDATES & EXPECTED MILESTONES: (i) MT-601 (Lymphoma):...The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to provide an update on safety and durability during the fourth quarter of 2024...; (ii) MT-601 (Pancreatic):...The Company expects to start the clinical program of MT-601 in patients with metastatic pancreatic cancer in 2025...; (iii) MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome): The Company...anticipates clinical program initiation during the first half of 2025."

New trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Pancreatic Cancer

RAPID: Safety of MT-401-OTS in Patients With Relapsed AML or MDS (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Marker Therapeutics, Inc.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Marker Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "PROGRAM UPDATES & EXPECTED MILESTONES: (i) MT-601 (Lymphoma):...The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expect to provide an update on safety and durability during the third quarter....(ii) MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome):...The Company...anticipates the clinical program initiation of MT-401-OTS during the fourth quarter of 2024."

Enrollment status • New trial • P1 data • Acute Myelogenous Leukemia • Hodgkin Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma

Marker Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome): Clinical program initiation of MT-401-OTS anticipated for the second half of 2024."

New trial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results (GlobeNewswire) - "MT-401-OTS:...Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023."

European regulatory • Acute Myelogenous Leukemia

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results (GlobeNewswire) - "MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome): (i) U.S. FDA has granted an Investigational New Drug (IND) to investigate MT-401 as an 'Off-the-Shelf' (MT-401-OTS) product in patients with AML or Myelodysplastic Syndrome (MDS)...; (ii) The Company has secured $2M in non-dilutive funding from the NIH Small Business Innovation Research (SBIR) program. These funds will support the clinical investigation of MT-401-OTS in patients with AML...; (iii) Clinical program initiation of MT-401-OTS anticipated for the second half of 2024."

Financing • IND • New trial • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Marker Therapeutics Reports Non-Clinical Proof-of-Concept Data and Update on Clinical Readiness for the MT-401 Off-the-Shelf Program (GlobeNewswire) - "In a set of in vitro experiments, the Research and Development team at Marker demonstrated anti-tumor activity of MT-401 OTS in a partially human leukocyte antigen (HLA) matched setting to kill THP-1 cells, an aggressive treatment-resistant Acute Myeloid Leukemia (AML) cell line....THP-1 cells were genetically modified to be bioluminescent, allowing long-term, undisturbed tracking of AML cell growth. THP-1 cell growth was followed for 5 days in the presence or absence of MT-401 OTS (manufactured from healthy donors matching 2/8 HLA alleles to THP-1 cells). Leukemic cell growth was significantly reduced when treated with MT-401 OTS....The U.S. Food and Drug Administration (FDA) has cleared the clinical protocol to investigate MT-401 OTS as a treatment in patients with r/r AML....Marker anticipates that the first patient will be treated with MT-401 OTS during the first half of 2024."

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

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