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FDA Gives Fast Track Designation to LYT-200 in Advanced Head and Neck Cancers

LYT-200 is currently being investigated for those with solid tumors and hematologic malignancies. The FDA has granted fast track designation to LYT-200 plus a PD-1 inhibitor as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma, according to a press release from PureTech Health, the developer of LYT-200.

The acceptance was based on the results of a phase 1/2 trial (NCT04666688) assessing LYT-200 monotherapy or with chemotherapy and tislelizumab-jsgr (Tevimbra) for patients with locally advanced or metastatic solid tumors.2 Of note, safety was favorable in all cohorts including the monotherapy and combination ones, and patients had disease control with a suggestion of antitumor activity.

"In the United States, there are approximately 66,000 people diagnosed with head and neck cancers each year, and the prognosis for metastatic disease is unfavorable, with a median survival rate of about 10 months," said Eric Sherman, MD, a head and neck oncologist from Memorial Sloan Kettering Cancer Center and an investigator on the trial. "There is an important need to explore promising new mechanisms and targets such as galectin-9 to bring therapeutic innovation to this patient population."

LYT-200 is a human IgG4 monoclonal antibody designed to target galectin-9 for those with locally advanced or metastatic solid tumors. Those with this disease often have poor survival rates. This treatment is also being evaluated for those with hematologic malignancies, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). To date, LYT-200 is the most potent clinical program against galectin-9.

Investigators have found that LYT-200 has previously shown direct cytotoxic and anti-leukemic events through multiple mechanisms and has shown a cohesiveness with standard chemotherapy and venetoclax (Venclexta).

Currently, a phase 1b trial (NCT05829226) is underway assessing LYT-200 monotherapy and LYT-200 plus venetoclax and a hypomethylating agent for patients with AML and MDS. The most recent data have shown favorable safety and tolerability as well as potential clinical activity.

April 15, 2024

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