FDA Grants Fast Track to PureTech's LYT-200 for AML

PureTech Health plc, a clinical-stage biotherapeutics company, has announced that its investigational drug LYT-200 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation is intended to expedite the development and review of drugs aimed at serious conditions with unmet needs. LYT-200 is a pioneering anti-galectin-9 monoclonal antibody, and its enhanced regulatory status underscores PureTech's commitment to addressing critical medical challenges faced by AML patients.

Luba Greenwood, Entrepreneur-in-Residence at PureTech, highlighted the significance of the FDA's Fast Track designation as a testament to LYT-200's potential impact on AML treatment. This milestone follows previously received recognitions, including Orphan Drug designation for AML and a separate Fast Track designation for head and neck cancers. These acknowledgments from the FDA reflect the promising therapeutic approach of LYT-200, which targets galectin-9, a protein known to facilitate cancer growth and suppress immune responses.

LYT-200 demonstrates its therapeutic potential by directly inducing cancer cell death through apoptosis and DNA damage, as well as by reactivating crucial immune system components. It is currently the most advanced clinical program targeting galectin-9 and is undergoing evaluation in two active clinical trials. The first is a Phase 1/2 trial focusing on LYT-200 as a standalone treatment and in combination with venetoclax and hypomethylating agents for hematological malignancies, including AML and high-risk myelodysplastic syndrome (MDS). The trials have shown encouraging safety and tolerability, along with early indications of clinical activity.

The second trial is a Phase 1/2 study investigating LYT-200 in patients with advanced solid tumors, including head and neck cancers. This trial explores LYT-200 both as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. So far, LYT-200 has displayed a favorable safety profile across all study groups, with initial signs of disease control and anti-tumor activity.

In addition to its Fast Track designation for AML, LYT-200 has been granted Orphan Drug designation for the same condition. It also received Fast Track status for treatment of recurrent or metastatic head and neck cancers in combination with anti-PD1 therapy. These designations highlight the innovative potential of LYT-200 in treating cancers with traditionally poor survival outcomes.

LYT-200 is a fully human IgG4 monoclonal antibody that targets galectin-9, an oncogenic and immunosuppressive protein. Its development is based on extensive preclinical data showcasing its efficacy in treating various cancers, both as a standalone therapy and in conjunction with other treatments. LYT-200 has been shown to outperform anti-PD-1 therapies in some solid tumor models and works synergistically with anti-PD-1 in activating T cells. The drug is currently being evaluated in adaptive design trials for its potential use in treating AML/MDS and head and neck cancers.

PureTech Health is a biotherapeutics company focused on developing novel medicines for severe diseases. The company's extensive pipeline includes numerous therapeutic candidates, with several in advanced stages of clinical trials. PureTech leverages its robust research and development capabilities, alongside partnerships with leading scientists and clinicians, to advance its mission of transforming patient care for those facing critical health challenges.