Myeloid Therapeutics Announces FDA Fast Track Designation for MT-101 for the Treatment of CD5+ Relapsed/Refractory PTCL
MT-101 is the First mRNA-Engineered CAR Monocyte Therapy to be Dosed in Humans
Excerpt from the Press Release:
CAMBRIDGE, Mass., Oct. 27, 2022 /PRNewswire/ — Myeloid Therapeutics, Inc. (“Myeloid”), a clinical-stage mRNA-immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MT-101 in patients with refractory or relapsed CD5+ peripheral T cell lymphoma (PTCL). MT-101 is the first mRNA engineered CAR monocyte derived from the Company’s proprietary ATAK™ platform delivered with a vein-to-vein time of only 8 days. MT-101 targets CD5, a surface receptor present on greater than 75% of PTCL. The ATAK™ CAR is proprietary to Myeloid and manufactured using the company’s patented process. MT-101 has been specifically designed to harness the ability of myeloid cells to penetrate into tumors and promote broad anti-tumor activity.
“We are pleased that MT-101 has received Fast Track designation from the FDA,” said Michele Gerber, MD, MPH, Chief Medical Officer of Myeloid. “The designation speaks to the serious nature of CD5+ relapsed/refractory PTCL, an aggressive form of non-Hodgkin lymphoma, and the potential MT-101 has to transform the treatment paradigm of this disease. IMAGINE, a Phase 1/2 trial assessing safety, tolerability, and efficacy of MT-101 in this indication is open for enrollment and the initial data is very encouraging.”
“MT-101 is the first mRNA engineered monocyte cell product to receive Fast Track designation from the FDA, representing a tremendous milestone for Myeloid and the broader field of cell therapy,” said Daniel Getts, PhD, CEO of Myeloid. “We continue to demonstrate our ability to manufacture scalable and cost-effective cell therapy products and deliver them expeditiously to the clinic. We remain optimistic on the future of MT-101 and its ability to provide PTCL patients with improved outcomes.”
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