PureTech Health plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (head and neck cancers). LYT-200 is an antibody against galectin-9, a potent cancer driver, and is the most advanced clinical program against this target. It is being evaluated in two ongoing clinical trials: a Phase 1/2 adaptive design trial in advanced/metastatic solid tumors, including head and neck cancers.

In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. LYT-200 has demonstrated a favorable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene?s tislelizumab, and shown disease control and suggestions of initial anti-tumor activity. Phase 1b clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in hematological malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome.

LYT-200 has demonstrated a favorable safety and tolerability profile as well as early signals of potential clinical activity.