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13 Apr 2024
Admin
News Article

PureTech’s LYT-200 Gets Approval for Head and Neck Cancers

US FDA grants fast track designation to PureTech’s LYT-200 in head and neck cancers

Overview

PureTech Health plc, a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for LYT-200 in combination with anti-PD1 therapy for the treatment of recurrent/metastatic head and neck squamous cell carcinomas (head and neck cancers).

Words from Trial Investigator

"In the US, there are approximately 66,000 people diagnosed with head and neck cancers each year, and the prognosis for metastatic disease is unfavourable, with a median survival rate of about ten months," said Eric Sherman, M.D., Memorial Sloan Kettering Cancer Center and an investigator in PureTech's phase 1/2 clinical trial.
"There is an important need to explore promising new mechanisms and targets such as galectin-9 to bring therapeutic innovation to this patient population."

LYT-200 is an antibody against galectin-9, a potent cancer driver, and is the most advanced clinical programme against this target.

It is being evaluated in two ongoing clinical trials:

1. A phase 1/2 adaptive design trial in advanced/metastatic solid tumours, including head and neck cancers.

In this trial, LYT-200 is being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene.
LYT-200 has demonstrated a favourable safety profile in all cohorts, including the monotherapy and combination arms with BeiGene's tislelizumab, and shown disease control and suggestions of initial anti-tumour activity.

2. A phase 1b clinical trial evaluating LYT-200 as a monotherapy and in combination with venetoclax and hypomethylating agents in haematological malignancies, including acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome.

LYT-200 has demonstrated a favourable safety and tolerability profile as well as early signals of potential clinical activity.

Words from PureTech

"By granting Fast Track designation to LYT-200 for head and neck cancers, the FDA continues to highlight areas of critical need within oncology as well as the potential for LYT-200,"" said Aleksandra Filipovic, M.D., Ph.D., head of oncology at PureTech.
"As galectin-9's role in suppressing immune-mediated activity has been well-validated, it represents an important area of clinical research, especially in aggressive cancers with increased mortality."

About FTD

Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need. The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML.

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting galectin-9 for the potential treatment of locally advanced/metastatic solid tumours that have poor survival rates, including head and neck cancers.
It is also in development for the treatment of haematological malignancies, such as acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS).
Galectin-9 is a potent oncogenic driver and immunosuppressor, and in AML it has been described to work via engagement with cytotoxic CD8 T cells and natural killer cells.

A wide variety of preclinical data underscores the importance of galectin-9 as a target and suggests a potential opportunity for biomarker development. These data demonstrate high expression of galectin-9 across various blood cancers and solid tumour types and show that galectin-9 levels correlate with poor survival in several cancers.

LYT-200 Effects

LYT-200 has demonstrated direct cytotoxic, anti-leukemic effects through multiple mechanisms, as well as synergy with standard of care chemotherapy and venetoclax in preclinical models.
Consistent with its hub-and-spoke model, PureTech intends to advance LYT-200 via its Founded Entity Gallop Oncology.
About PureTech
PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases.
The company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities.