PureTech's LYT-200 Receives FDA Fast Track Designation For Treatment Of Head & Neck Cancers

(RTTNews) - PureTech Health plc (PRTC) announced on Thursday that it received FDA's Fast Track designation for LYT-200 in combination with anti-PD1 therapy for treating recurrent or metastatic head and neck cancers.

The LYT-200 is an antibody targeting galectin-9 and it is currently under assessment in two ongoing clinical trials.

The Phase 1/2 adaptive study assessed LYT-200 as a standalone treatment and combined with tislelizumab, an anti-PD-1 antibody from BeiGene, showing a positive safety record across all groups.

The Phase 1b study evaluated LYT-200 as a standalone treatment and combined with venetoclax and hypomethylating agents in hematological malignancies such as AML and high-risk myelodysplastic syndrome. This trial has also displayed a favorable safety and tolerability record and early signs of potential clinical effectiveness.

Additionally, LYT-200 has previously received orphan drug designation from the FDA for AML treatment.