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

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 ATAKtm 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 ATAKtm 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."

Fast Track designation is designed to facilitate development and expedite the review of therapies with the potential to treat serious or life-threatening conditions and fill an unmet medical need. Investigational products that receive Fast Track designation may benefit from early and frequent communication with the FDA and are eligible for rolling submission and review of the marketing application. Additionally, this designation provides potential pathways for accelerated regulatory approval.

IMAGINE is a Phase 1/2, multicenter, open-label, first-in-human, multiple ascending dose study 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.

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, 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.

Myeloid Therapeutics is a clinical stage mRNA-immunotherapy company harnessing the power of myeloid cell biology to engineer new therapeutic alternatives for patients with cancer and autoimmune diseases. Integrating the fields of RNA biology, immunology, and medicine, the Company's proprietary platform provides clinical solutions that match therapeutic modalities to disease conditions, including use of autologous cell therapies, in vivo cell programming using mRNA, RNA-based gene-editing using RetroTtm and multi-targeted biologics. Myeloid is advancing a broad portfolio of clinical and preclinical candidates designed to enable full immune system responses. Myeloid has entered into strategic partnerships with Prime Medicine and Acuitas and is supported by well-known biotechnology investors. Myeloid is headquartered in Boston, MA.

For more information, please visit https://www.myeloidtx.com/.

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SOURCE Myeloid