Tony Butler

Jackson Harvey

Matt Biegler

Matthew Biegler

Yun Zhong

Jordyn Fantuzzi

Joseph Catanzaro

Kristen Kluska

Ted Tenthoff

- Marker Therapeutics, Inc. announced on **October 6, 2025**, that the **first patient has been treated** in its **Off-the-Shelf (OTS) Program** evaluating **MT-401**, a Multi-Antigen Recognizing (MAR)-T cell therapy, in a **Phase 1 RAPID study**.  **[1094038_0001104659-25-096935_tm2527906d1_8k.htm:0]** **[1094038_0001104659-25-096935_tm2527906d1_ex99-1.htm:0]** **[1094038_0001104659-25-096935_tm2527906d1_ex99-1.htm:1]** 
- The initial patient tolerated the therapy **well with no treatment-related adverse events**, which is consistent with the favorable safety profile previously reported for MAR-T cells.  **[1094038_0001104659-25-096935_tm2527906d1_ex99-1.htm:0]** 
- The OTS product aims to provide a **fast treatment option** for patients with aggressive diseases, potentially expediting treatment to as fast as **72 hours**, and enabling **broader scalability** and **accessibility** of cell therapies at a **lower per-dose cost**.  **[1094038_0001104659-25-096935_tm2527906d1_ex99-1.htm:0]** 
- The OTS program is supported by **non-dilutive funding** from the Food and Drug Administration (FDA), the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program, and the Cancer Prevention and Research Institute of Texas (CPRIT), which will not affect the company's financial runway or its efforts on its lead asset, MT-601.  **[1094038_0001104659-25-096935_tm2527906d1_ex99-1.htm:0]** **[1094038_0001104659-25-096935_tm2527906d1_ex99-1.htm:1]**

Marker Therapeutics Announces First Patient Treated in Off-the-Shelf Program

- Marker Therapeutics reported positive Phase 1 clinical results for **MT-601** in relapsed lymphoma from its APOLLO study, demonstrating a **50% complete response rate** and **66% overall response rate** in non-Hodgkin lymphoma patients.  **[1094038_tx_379376_2]** 
- The study highlighted an **excellent safety profile** for MT-601, with **no dose-limiting toxicities** or ICANS, and only mild (Level 1) Cytokine Release Syndrome observed, even at the highest dose of **400 million cells**.  **[1094038_tx_379376_3]** 
- Responses were durable, with **three patients achieving complete response for over a year** and five patients showing clinical benefit for over six months, despite being heavily pretreated, including prior CAR T-cell therapy and bispecifics.  **[1094038_tx_379376_2]** 
- The company plans to proceed with a dose expansion phase for **DLBCL CAR relapse and bispecific relapse patients**, which will form the basis for a future pivotal study, with the goal of seeking accelerated approval.  **[1094038_tx_379376_2]** **[1094038_tx_379376_7]** **[1094038_tx_379376_9]**

Marker Therapeutics Provides Positive Phase 1 Clinical Update for MT-601 in Relapsed Lymphoma

Marker Therapeutics (MRKR)