FDA Grants Fast Track Designation to LYT-200 for AML

LYT-200 has received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML), according to a press release from PureTech, the developer of the drug.

This designation is expected to streamline the development and accelerate the assessment of LYT-200, a first-in-class anti-galectin-9 monoclonal antibody.¹ LYT-200 previously received Orphan Drug designation in March 2024.

A phase 1 trial of LYT-200 monotherapy and in combination with venetoclax and hypomethylating agents for patients with AML and high-risk myelodysplastic syndromes was presented at the 66th American Society of Hematology Annual Meeting & Exposition by Amir Fathi, MD, of Massachusetts General Hospital.

Clinical benefit with LYT-200 was observed in 100% of patients in the single-agent cohort and 88% of patients in the combination cohort. No dose-limiting toxicities were observed at doses ranging from 2 mg/kg to 16 mg/kg in the single-agent cohort and from 4 mg/kg to 12 mg/kg in the combination cohort.²

“LYT-200 is an intriguing novel agent, targeting galectin 9, and in this way harnessing the power of the immune system in attacking malignancy,” Dr. Fathi told Blood Cancers Today. “Based on early results from clinical study, it appears that there is some promising activity in patients with myeloid malignancies. This should be studied further and rigorously to identify the patients who may benefit.”

A second phase 1/2 trial is evaluating the drug in advanced and metastatic solid tumors.

References

1. PureTech receives FDA Fast Track designation for LYT-200 in acute myeloid leukemia (AML). BusinessWire. January 9, 2025. Accessed January 9, 2024.https://www.businesswire.com/news/home/20250109191836/en/PureTech-Receives-FDA-Fast-Track-Designation-for-LYT-200-in-Acute-Myeloid-Leukemia-AML
2. Fathi AT, Filipovic A, Maher K, et al. A phase I dose escalation and expansion trial of Lyt-200 (a first-in-class anti-galectin-9 antibody) alone and in combination with venetoclax/HMA in relapsed/refractory AML/MDS. Abstract #1499. Presented at the 66th American Society of Hematology Annual Meeting & Exposition; December 7-10, 2024; San Diego, California.