MD Anderson and Replay announce FDA clearance of IND application for first-in-class TCR NK cell therapy for sarcoma

First-in-human Phase I study of NY-ESO-1 TCR/IL-15 NK for advanced synovial sarcoma and myxoid/round cell liposarcoma anticipated to commence Q3 2023

The University of Texas MD Anderson Cancer Center and Replay today announced that the Food & Drug Administration (FDA) has issued a ‘safe to proceed’ for the Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK, an engineered T cell receptor natural killer (TCR NK) cell therapy for advanced synovial sarcoma and myxoid/round cell liposarcoma. MD Anderson is the IND sponsor.

NY-ESO-1 TCR/IL-15 NK is being developed by Syena, an oncology-focused product company launched by Replay and MD Anderson based upon the scientific discoveries of Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson. Syena has an exclusive licensing agreement for MD Anderson’s TCR NK platform. This first-in-class engineered cell therapy is comprised of cord blood-derived natural killer cells that express an affinity-enhanced T cell receptor (TCR) targeted against the NY-ESO-1 cancer-associated antigen, which is highly immunogenic and expressed on numerous cancer cell types. The ability of NY-ESO-1 to elicit humoral and cellular immune responses, along with its restricted tissue expression, establishes it as a compelling target for cancer immunotherapy.

The Phase I/Ib study will assess the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in patients with synovial sarcoma and myxoid/round cell liposarcoma. It will be administered following lymphodepletion with standard doses of fludarabine/cyclophosphamide (Flu/Cy). Approximately 44 patients will be enrolled into the study, anticipated to commence in Q3 2023.

"Syena is leveraging the scalability and allogeneic nature of engineered cord blood-derived NK cells to democratize cell therapy for cancer treatment. The recent FDA IND clearance of the first-in-human TCR NK protocol is a significant milestone for Syena," said Adrian Woolfson, executive chairman, president and co-founder of Replay. “Syena is now one step closer to bringing its first-in-class, ‘off-the-shelf’ engineered TCR NK therapy to patients with solid tumors.”

“Following the FDA IND acceptance, Syena is Replay’s first product company to enter the clinic,” said Lachlan MacKinnon, chief executive officer and co-founder of Replay. “The ability to secure rapid FDA IND clearance for our first-in-class TCR NK program is a testament to the caliber of our team and quality of our science, and continues to validate our business model.”

“Synovial and myxoid/round cell liposarcomas express NY-ESO-1 at high levels and in a high frequency of cells, making them excellent tumor types for establishing proof of concept for the TCR NK platform,” Rezvani said. “I am delighted with the team's progress and look forward to initiating the Phase I/Ib study later this year.”


MD Anderson has an institutional conflict of interest with Replay and Syena, and MD Anderson will implement an Institutional Conflict of Interest Management and Monitoring Plan to manage these relationships.