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LYT-200 continues to demonstrate strong evidence of clinical activity, survival benefit and a highly favorable safety profile in heavily pretreated relapsed/refractory AML patients, both as a monotherapy and in combination with standard of care
Compelling responses achieved in population with diverse tumor molecular subtypes
Data continue to mature and will be presented during ASH 2025; topline efficacy readout and overall survival data expected in Q4 2025 and 1H 2026, respectively
PureTech 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, today announced that new data from its ongoing Phase 1b clinical trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in relapsed/refractory acute myeloid leukemia (AML) will be shared on December 6th, 2025, during the 67th Annual American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, by its Founded Entity Gallop Oncology. The accepted abstract reflects data as of July 8, 2025, and additional analyses based on a later data cut-off are expected to be presented during the ASH meeting.
The ongoing, open-label, dose-ranging trial is evaluating LYT-200 both as a monotherapy and in combination with the standard-of-care (SOC) regimen of venetoclax (VEN) and hypomethylating agents (HMA) in a very vulnerable population. All participants in the trial have previously been treated with SOC (median prior lines of treatment: 3; range: 1-7), and their disease had either returned or failed to respond.
The data submitted to ASH reflect efficacy and safety findings for 31 participants in the monotherapy arm and 39 participants in the combination arm who received LYT-200 weekly at doses ≥7.5mg/kg. As a monotherapy, treatment with LYT-200 resulted in 1 marrow complete response (CR) and 3 partial responses (PRs). Notably, one PR in the monotherapy arm was maintained for 24 months as of the data cut off in an individual whose disease previously progressed following five prior rounds of treatment with SOC. When administered in combination with VEN/HMA, LYT-200 treatment resulted in 12 CRs, 1 PR, and 1 morphological leukemia-free state (MLFS). Importantly, CRs were achieved in this cohort across a diverse range of tumor subtypes, including KRAS, NRAS, HRAS, and JAK2 mutations, in patients who were previously fully refractory to SOC.
When evaluating patients with AML, a CR is the primary goal of treatment and means that no leukemia cells are detectable in the blood, fewer than 5% blasts remain in the bone marrow, and blood counts have returned to normal. Achieving a CR is generally associated with improved outcomes, including longer overall survival. A PR reflects a significant reduction in leukemia burden, with at least a 50% decrease in blasts, while an MLFS indicates that there are no leukemia cells visible and fewer than 5% blasts in the marrow, though blood counts have not yet recovered. While SOC in this advanced relapsed/refractory population typically achieves CR rates of 6–12% and median overall survival is less than 2.5 months,1 LYT-200 has demonstrated a >30% CR rate in the combination cohort as of the data cut off, underscoring its potential to serve as a meaningful new treatment option.
Across all dose levels and treatment arms, LYT-200 was well tolerated. No dose-limiting toxicities were reported, and there were no LYT-200-related serious adverse events, discontinuations, or deaths. The most common adverse events potentially related to LYT-200 were mild and transient.
PureTech intends to share further matured data at ASH, including updated efficacy across dose levels, as well as survival and pharmacokinetic/pharmacodynamic data. Topline efficacy data are expected in the fourth quarter of 2025, with topline survival data anticipated in the first half of 2026. PureTech intends to engage with regulatory authorities to advance LYT-200 into a Phase 2 trial.
Posted In: PRTC
