NEW YORK – Replay subsidiary Syena on Monday said it has treated the first multiple myeloma patient in a Phase I/II clinical trial of its engineered T-cell receptor natural killer (TCR-NK) cell therapy, NY-ESO-1 TCR/IL-15 NK.
In the trial, Syena is studying the safety and preliminary efficacy of the off-the-shelf cell therapy in up to 44 patients with relapsed or refractory multiple myeloma whose cancers express NY-ESO-1 according to immunohistochemistry testing and are HLA-A*02:01 positive according to HLA typing.
The treatment, which involves cord blood-derived natural killer cells engineered to express a T-cell receptor targeting the NY-ESO-1 antigen, is administered following lymphodepleting chemotherapy.
In February 2023, Replay and MD Anderson Cancer Center jointly launched Syena, a company focused on off-the-shelf cancer cell therapies. Under the terms of the collaboration, Syena has an exclusive license to use MD Anderson's TCR-NK technology platform to develop treatments, and NY-ESO-1 TCR/IL-15 NK is Syena's first therapeutic product to enter clinical studies.
"NY-ESO-1 is highly expressed in poor-prognosis multiple myeloma, making this a suitable indication for demonstrating proof of concept for Syena's TCR-NK technology platform," Adrian Woolfson, the executive chairman, president, and cofounder of Replay, said in a statement.