Business
PRTC's Gallop: Positive Initial Topline AML Data
PureTech Health's founded entity, Gallop Oncology, announced positive initial topline data from its Phase 1b trial of LYT-200 for relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, demonstrating favorable tolerability and strong efficacy. The combination cohort showed an initial median overall survival of 13.2 months at the proposed Phase 2 dose, significantly exceeding the expected survival of less than 2.5 months in this patient population, with final overall survival data anticipated in the first half of 2026. Responses were observed across various high-risk mutations, suggesting broad applicability for LYT-200, which has received Fast Track and Orphan Drug designations from the FDA. Disclaimer*
About this update from Puretech Health Plc
[{"type":"text","content":"\n\n5 December 2025\nPureTech Health plc\n \nPureTech's Founded Entity Gallop Oncology Announces Positive Initial Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome\n \nLYT-200 demonstrated favorable tolerability and strong efficacy in a heavily pretreated population, both in combination with standard of care and as a monotherapy, supporting advancement toward a potentially registrational Phase 2 trial\n \nInitial median overall survival of 13.2 months observed in the combination cohort at the proposed Phase 2 dose, exceeding expected late-line relapsed/refractory setting survival of <2.5 months; overall survival data at this dose continue to mature with final results expected in 1H 2026\n \nResponses observed in patients with high-risk mutations, suggesting potential broad applicability\n \nFurther details to be shared at the 67th American Society of Hematology (ASH) Annual Meeting\n \nPureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, notes that its Founded Entity, Gallop Oncology, today announced initial topline results from the Phase 1b clinical trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The data demonstrated a favorable tolerability profile and strong efficacy, supporting the advancement of LYT-200 into a potentially registrational Phase 2 trial in AML. Additional details will be shared at the 67th American Society of Hematology (ASH) Annual Meeting on December 6th, 2025.\n \n\"Patients with relapsed/refractory AML or high-risk MDS face extremely limited treatment options, and overall survival at this stage is typically less than 2.5 months. With LYT-200, we have demonstrated durable responses, enabled a substantially meaningful proportion of patients to proceed to transplant, and shown initial median overall survival data of 13.2 months at the proposed Phase 2 dose - all alongside a very favorable safety profile. Together, these findings represent a potential step change in the treatment of AML,\" said Luba Gr...