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Highlights
- PureTech unveils favorable Phase 1b data for LYT-200 in relapsed/refractory AML and MDS.
- LYT-200 shows clinical benefit, safety, and sustained disease management in heavily pre-treated patients.
- Positive results highlight LYT-200’s potential as a new treatment option for AML and MDS patients.
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a clinical-stage biotherapeutics company focused on developing transformative therapies for patients with devastating diseases, has presented data from the dose escalation phase of its ongoing Phase 1b trial of LYT-200 at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego, California. LYT-200 is a first-in-class anti-galectin-9 monoclonal antibody currently being evaluated as both a monotherapy and in combination with venetoclax and hypomethylating agents (HMA) for patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Galectin-9, the target of LYT-200, is a glycan-binding protein that is significantly upregulated in AML and MDS. It plays a pivotal role in disease development, immune modulation, and drug resistance. By targeting this protein, LYT-200 aims to address the unmet needs of patients with these aggressive hematologic cancers, especially those whose diseases are resistant to existing treatments.
Initial data from the trial show a favorable safety profile across all dose levels, with no dose-limiting toxicities reported. Additionally, there is early evidence of clinical responses, hematological improvement, and sustained disease control in heavily pre-treated patients. LYT-200 is being tested in two arms of the study: as a monotherapy and in combination with standard-of-care therapies (venetoclax and HMA).
The monotherapy arm of the study included 22 evaluable patients, all of whom were heavily pre-treated and had relapsed/refractory AML/MDS. These patients had previously been treated with multiple lines of therapy, including standard of care, and included those with complex genetic mutations such as KRAS, NRAS, and BRAF. Remarkably, 59% of patients achieved stable disease or better, with two partial responses. The mean duration of treatment in this group was over two months, which is significantly higher than the typical survival time of 1.7 months for patients refractory to venetoclax/HMA.
Luba Greenwood, J.D., Entrepreneur-in-Residence at PureTech, commented on the findings, saying, "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, and a median survival time of less than six months. We are encouraged to see that LYT-200 has not only achieved responses but also demonstrated long-term disease stabilization in these heavily pre-treated patients. We are optimistic about LYT-200’s potential to become a critical therapeutic option for AML patients."
The positive data from this early-phase trial represent a significant step forward in the development of LYT-200 as a treatment for relapsed/refractory AML and MDS, offering hope for patients with limited therapeutic options. PureTech Health is committed to progressing LYT-200 through further clinical trials and expanding its potential in treating a broad spectrum of AML patients.
The ongoing Phase 1b trial is designed to assess the safety, tolerability, and efficacy of LYT-200, with future studies aimed at confirming these encouraging early results and further exploring its role in combination therapies. As the trial continues, PureTech Health remains focused on its mission to bring innovative therapies to market that have the potential to change the lives of patients with serious, life-threatening diseases.
