FDA gives LYT-200 fast track status as potential AML treatment
Therapy in clinical trial in pretreated adults with relapsed or refractory disease
The U.S. Food and Drug Administration (FDA) has granted fast track designation to Puretech Health’s LYT-200, an investigative treatment for acute myeloid leukemia (AML), a type of blood cancer.
This FDA status aims to speed developmental work on therapies for serious diseases with a need for new medications, with a goal of more quickly moving them through clinical trials and into a possible regulatory approval review.
“Fast Track designation from the FDA reinforces our belief in the potential for LYT-200 to address the urgent needs of AML patients,” Luba Greenwood, entrepreneur-in-residence at Puretech, said in a company press release.
Phase 1/2 clinical trial of LYT-200 is underway in AML and MDS patients
LYT-200 is a monoclonal antibody designed to target galectin-9, a protein that works to spur the growth of cancer cells while also helping cancer cells avoid being targeted by the immune system. By blocking galectin-9, the therapy aims to directly kill cancer cells, as well as to help the immune system be more effective in destroying them.
“By targeting galectin-9, a key driver of cancer proliferation and immune suppression, LYT-200 represents a novel and promising approach for patients in need, and we look forward to the continued development of this program,” Greenwood said.
Puretech is running a Phase 1/2 clinical trial (NCT05829226) testing LYT-200 on its own and in combination with standard cancer treatments in people with AML and another blood cancer. Early results indicated that more than half of patients given LYT-200 experienced a treatment response, showing with at least stable disease. The therapy also was reported to have a favorable safety profile at the various doses tested as a monotherapy (dose range: 2 mg/kg to 16 mg/kg) and in combination with standard therapy (dose range: 4 mg/kg to 12 mg/kg).
The trial may be recruiting eligible adults at nine sites in the U.S. The study is open to people with AML or high-risk myelodysplastic syndrome (MDS) whose disease has relapsed or failed to respond following at least one prior line of treatment.
“Relapsed/refractory acute myeloid leukemia is one of the most dire cancer diagnoses, with 50% of patients non-responsive to or relapsing after initial treatment,” Greenwood said in the December release of initial trial findings. “We are encouraged to see that LYT-200 achieved responses as well as long-term disease stabilization in heavily pre-treated patients, and we look forward to progressing LYT-200 as a critical therapeutic option with the potential to treat most AML patients.”
Puretech also is developing LYT-200 as a treatment for head and neck cancers. The FDA previously granted the therapy fast track status for that indication, and it has named LYT-200 an orphan drug for the treatment of AML. Orphan drug status is designed to provide extra incentives to companies that are investing in new treatments for rare diseases.
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