Myeloid Therapeutics Doses First Patient with MT-101 in the IMAGINE Phase 1/2 Clinical Study, Marking the First-ever Dosing of an mRNA Engineered CAR Monocyte to Humans

- Myeloid dosed MT-101 in a patient with refractory PTCL within 18 months, illustrating the potential of mRNA therapies to help patients sooner and to accelerate Myeloid's portfolio-

- Myeloid achieved an unprecedented, reduced vein-to-vein time of eight days with this patient dosing-

- MT-101 represents a new class of non-T cell CAR's being tested in the clinic for their ability to modify the tumor microenvironment and stimulate a robust anti-tumor immune response-

CAMBRIDGE, Mass., May 11, 2022 /PRNewswire/ -- Myeloid Therapeutics, Inc. ("Myeloid", or the "Company"), a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases, today announced the first patient dosed in the IMAGINE Study, a Phase 1/2 clinical study of MT-101, in patients with refractory or relapsed peripheral T cell lymphoma (PTCL), an aggressive form of non-Hodgkin lymphoma. MT-101 is the first mRNA engineered CAR monocyte (CAR-M) derived from the Company's proprietary ATAK™ platform. MT-101 targets CD5, a surface receptor present in many T cell malignancies. The ATAK™ CAR is proprietary to the company and specifically designed to promote broad anti-tumor activity. At Day 28, the primary endpoint for safety and tolerability, the patient had no dose limiting toxicities, no cytokine release syndrome (CRS), and no immune effector cell-associated neurotoxicity syndrome (ICANS).    

"We are pleased to announce the initiation of dosing in the IMAGINE clinical trial, which represents a major milestone in our efforts to provide treatment with CD5 ATAK cells for patients with relapsed or refractory PTCL," said Michele Gerber, MD, MPH, Chief Medical Officer of Myeloid. "Currently, we are continuing through the dose-escalation cohorts of IMAGINE, which is designed to assess the safety and tolerability, optimal dose regimen, tumor penetration and preliminary efficacy of MT-101 in patients with PTCL. Following conclusion of Phase 1, we expect to expand quickly into the Phase 2 portion of this study, which we designed to support registration of MT-101."

"MT-101, Myeloid's leading mRNA-engineered monocyte, was advanced from conception and preclinical proof of concept to our first dose in human in just eighteen months. Importantly, this is the first instance of an engineered monocyte cell product delivered to a patient with a significantly reduced vein-to-vein time of just eight days," said Daniel Getts, PhD, CEO of Myeloid. "Overall, this achievement highlights Myeloid's ability to produce scalable cell therapy products in an efficient manner, and we are optimistic about the impact this program can provide to PTCL patients and their families going forward."

About the IMAGINE Study

IMAGINE is a Phase 1/2, multicenter, open-label, dose-escalation and dose cohort expansion clinical trial evaluating MT-101 in patients with refractory or relapsed PTCL. The dose-escalation portion of this Phase 1 study, with and without conditioning therapy, is open and enrolling patients. Once Myeloid establishes the recommended Phase 2 dose, a Phase 2 trial will be initiated to support  registration in this patient population.

Please visit www.clinicaltrials.gov (NCT05138458) for additional information.

About the ATAK™ Immunotherapy Platform

Myeloid's proprietary ATAK platform is designed to harness the innate abilities of myeloid cells.  When applied to a therapeutic candidate, the immunotherapy recognizes cancer cells, alters the tumor microenvironment, produces anti-tumor cytokines, promotes anti-tumor adaptive immunity, and ultimately, kills cancer. The natural immune surveillance and trafficking ability of myeloid cells makes them particularly advantaged for finding cancers metastases, an especially relevant consideration for many advanced-stage patients. Myeloid's initial products are based on ATAK CAR monocytes (CAR-M), which are myeloid cells with innate immune receptor-inspired CARs to recognize and kill cancer. In addition, Myeloid developed a proprietary, streamlined manufacturing process for its ATAK cell therapy candidates, with a rapid, single-day cell process. This process provides significant advantages to the patient and contract development and manufacturing organizations (CDMO) over allogenic approaches. 

About Myeloid Therapeutics

Myeloid Therapeutics is a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases. Integrating the fields of RNA, immunology and medicine, the Company's proprietary platform provides clinical solutions by matching therapeutic modalities to disease conditions, including use of  autologous cell therapies, in vivo cell programming using mRNA, RNA-based gene-editing using RetroT™ and multi-targeted biologics. For more information, visit https://www.myeloidtx.com/.

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SOURCE Myeloid Therapeutics, Inc.