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BOSTON - PureTech Health’s (NASDAQ:PRTC, LSE:PRTC) founded entity Gallop Oncology will present new data from its ongoing Phase 1b trial of LYT-200 in relapsed/refractory acute myeloid leukemia at the American Society of Hematology Annual Meeting on December 6.
The first-in-class anti-galectin-9 monoclonal antibody has demonstrated clinical activity in heavily pretreated patients who had previously failed standard therapies, according to the company’s press release statement.
Data from the trial shows that when used as a monotherapy, LYT-200 resulted in one marrow complete response and three partial responses among 31 participants. In the combination arm with venetoclax and hypomethylating agents, 12 complete responses were observed among 39 participants receiving weekly doses of 7.5mg/kg or higher.
The company highlighted that complete responses were achieved across diverse tumor subtypes, including patients with KRAS, NRAS, HRAS, and JAK2 mutations who were previously fully refractory to standard of care.
Standard treatments in this advanced relapsed/refractory population typically achieve complete response rates of 6-12%, while LYT-200 demonstrated a greater than 30% complete response rate in the combination cohort as of the data cutoff.
The drug was well-tolerated across all dose levels with no dose-limiting toxicities or serious adverse events related to LYT-200. The most common adverse events were described as mild and transient.
PureTech expects to report topline efficacy data in the fourth quarter of 2025, with survival data anticipated in the first half of 2026. The company plans to engage with regulatory authorities to advance LYT-200 into a Phase 2 trial.
LYT-200 has received Fast Track and Orphan Drug designations from the FDA for the treatment of acute myeloid leukemia.
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