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. Syena is now one step closer to bringing its first-in-class, 'off-the-shelf' engineered TCR-NK therapy to patients with solid tumors."

Adrian Woolfson, executive chairman, president and co-founder of Replay

"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," said Rezvani. "I am delighted with the team's progress and look forward to initiating the Phase I/Ib study later this year."