Drugs / LYT-200

Trials 2

202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05829226 Dec 2022 → Dec 2025 acute myeloid leukemia, myelodysplastic syndrome PureTech Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04666688 Dec 2020 → Dec 2024 colorectal cancer, head and neck cancer, malignant pancreatic neoplasm, metastatic malignant neoplasm +1 PureTech Completed No outcome recorded

News releases announcing trial results or a regulatory action · 11

DateIssuerRelease
2026-09-21 PureTech Regulatory PureTech Announces Successful End-of-Phase 1 Meeting with U.S . Food and Drug Administration (FDA) and Receipt of Fast Track Designation for LYT-200 in Relapsed/Refractory (R/R) High-Risk Myelodysplastic Syndromes (HR-MDS) puretechhealth.com ↗
PureTech Announces Successful End-of-Phase 1 Meeting with U.S . Food and Drug Administration (FDA) and Receipt of Fast Track Designation for LYT-200 in Relapsed/Refractory (R/R) High-Risk Myelodysplastic Syndromes (HR-MDS)
2026-04-22 PureTech Results PureTech Reports Positive Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory (R/R) High-Risk (HR) Myelodysplastic Syndrome (MDS) and R/R Acute Myeloid Leukemia (AML) puretechhealth.com ↗
PureTech Reports Positive Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory (R/R) High-Risk (HR) Myelodysplastic Syndrome (MDS) and R/R Acute Myeloid Leukemia (AML)
2025-12-05 PureTech Results PureTech’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 puretechhealth.com ↗
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.
2025-11-03 PureTech Results PureTech’s Founded Entity Gallop Oncology to Present New Data from Ongoing Phase 1b Trial of LYT-200 in Relapsed/Refractory Acute Myeloid Leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting puretechhealth.com ↗
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
2025-01-09 PureTech Regulatory PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML) puretechhealth.com ↗
PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
2024-12-09 PureTech Results PureTech Presents Data for LYT-200 (anti-galectin-9 monoclonal antibody) for Relapsed/Refractory AML/MDS at the 2024 ASH Annual Meeting puretechhealth.com ↗
LYT-200 demonstrates clinical benefit as a single agent, with two partial responses and 59% of evaluable patients achieving stable disease or better
2024-04-11 PureTech Regulatory PureTech Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers puretechhealth.com ↗
2024-03-13 PureTech Regulatory PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia puretechhealth.com ↗
2023-12-07 PureTech Results PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress 2023 puretechhealth.com ↗
Three out of four patients treated so far with head and neck cancers experienced disease control, with one complete response and one partial response observed in the first subset of patients
2022-12-12 PureTech Results PureTech Presents Data for LYT-200 Targeting Galectin-9 in Preclinical Leukemia Cancer Models at the 64th American Society of Hematology (ASH) Annual Meeting puretechhealth.com ↗
Data support the role of galectin-9 in multiple types of leukemia and the ability of anti-galectin-9 antibodies to provide effective anti-tumor activity in these cancers
2021-11-11 PureTech Regulatory PureTech Receives Orphan Drug Designation for Wholly Owned Candidate LYT-200 for the Treatment of Pancreatic Cancer puretechhealth.com ↗
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (" PureTech " or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its wholly owned clinical therapeutic candidate, LYT-200, for the treatment of pancreatic cancer.

All press releases naming this drug 15 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as LYT-200 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05829226 ↗
1

NCT04666688 ↗

Modality Monoclonal antibody “monoclonal antibody (mAb), targeting galectin-9 protein” NCT04666688 ↗
Route Intravenous “administered via IV infusion over 60 minutes every week” NCT05829226 ↗