PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers - Seite 2

Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need. The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting galectin-9 for the potential treatment of locally advanced/metastatic solid tumors that have poor survival rates, including head and neck cancers. It is also in development for the treatment of hematological malignancies, such as acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Galectin-9 is a potent oncogenic driver and immunosuppressor, and in AML it has been described to work via engagement with cytotoxic CD8 T cells and natural killer cells.

A wide variety of preclinical data underscores the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. These data demonstrate high expression of galectin-9 across various blood cancers and solid tumor types and show that galectin-9 levels correlate with poor survival in several cancers.

LYT-200 has demonstrated direct cytotoxic, anti-leukemic effects through multiple mechanisms, as well as synergy with standard of care chemotherapy and venetoclax in preclinical models. Consistent with its hub-and-spoke model, PureTech intends to advance LYT-200 via its Founded Entity Gallop Oncology.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 28 therapeutics and therapeutic candidates, including two that have received both U.S. FDA clearance and European marketing authorization and a third (KarXT) that has been filed for FDA approval. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.