The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PureTech Health's LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (AML). This designation is intended to accelerate the development and review of drugs that address serious conditions with unmet medical needs.
Clinical Significance of LYT-200 in AML Treatment
AML is a rapidly progressing cancer of the blood and bone marrow, characterized by the overproduction of immature white blood cells. Despite advances in treatment, a significant portion of patients do not respond to initial therapy or relapse, resulting in poor overall survival rates. The Fast Track designation underscores the potential of LYT-200 to address this critical unmet need.
Luba Greenwood, Entrepreneur-in-Residence at PureTech, stated, "Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients." This milestone builds upon previous FDA recognition, including Orphan Drug designation for AML and Fast Track designation for head and neck cancers.
Mechanism of Action and Ongoing Clinical Trials
LYT-200 exerts its therapeutic effects by targeting galectin-9, a protein linked to cancer proliferation and immune suppression. The antibody induces cancer cell death through apoptosis and DNA damage while reactivating key components of the immune system. LYT-200 is currently being evaluated in two ongoing Phase 1/2 clinical trials.
One trial is evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including AML and high-risk myelodysplastic syndrome (MDS). Data presented at the American Society of Hematology (ASH) Annual Meeting in 2024 showed a favorable safety and tolerability profile, along with early signals of clinical activity as a single agent and in combination.
The other Phase 1/2 trial is investigating LYT-200 in advanced/metastatic solid tumors, including head and neck cancers, both as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. Initial results have demonstrated a favorable safety profile and indications of anti-tumor activity.
Galectin-9 as a Therapeutic Target
Galectin-9 is a key driver of cancer proliferation and immune suppression, making it an attractive target for novel cancer therapies. Preclinical data suggest that high expression of galectin-9 correlates with shorter time to disease relapse and poor survival in several cancers. LYT-200 has demonstrated single-agent efficacy in preclinical models and synergizes with anti-PD-1 antibodies in activating T cells.
With the FDA's Fast Track designation, LYT-200 is poised to potentially offer a new therapeutic option for AML patients, addressing a critical unmet need in this challenging disease.
