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FDA Approves Groundbreaking Cell Therapy Trial for Sarcoma Treatment - Cord Blood

Cord Blood

and Stem Cell Banking

FDA Approves Groundbreaking Cell Therapy Trial for Sarcoma Treatment

A doctor looking at her notes

The University of Texas MD Anderson Cancer Center and a company called Replay have received a green light from the Food & Drug Administration (FDA) to start a Phase I clinical trial for a new type of cancer treatment. This treatment is called NY-ESO-1 TCR/IL-15 NK, and it’s a type of cell therapy designed to fight advanced synovial sarcoma and myxoid/round cell liposarcoma, two types of cancer.

This new therapy is being developed by Syena, a company focused on cancer treatments, which was created by Replay and MD Anderson. The therapy is based on the scientific work of Katy Rezvani, a professor at MD Anderson.

It uses cells from cord blood (the blood from a baby’s umbilical cord after birth) that have been engineered to express a specific type of receptor (a protein that can bind to other specific molecules). This receptor is designed to target a cancer-associated antigen called NY-ESO-1. An antigen is a substance that triggers an immune response, and in this case, the NY-ESO-1 antigen is found on many types of cancer cells.

The Phase I study will test the safety and effectiveness of this new therapy in patients with synovial sarcoma and myxoid/round cell liposarcoma. The therapy will be given after the patients have undergone lymphodepletion, a process that reduces the number of certain types of immune cells in the body. This is done using standard doses of two drugs, fludarabine and cyclophosphamide. The study is expected to start in the third quarter of 2023 and will involve about 44 patients.

Syena is using this new therapy to make cell therapy for cancer treatment more accessible. The recent FDA approval is a big step forward for Syena, bringing them closer to offering this new type of therapy to patients with solid tumors.

In summary, this is a significant development in the field of cancer treatment, with the potential to offer a new, effective therapy for patients with certain types of cancer. The upcoming clinical trial will provide important information about the safety and effectiveness of this new approach.