Replay, a genome writing company, and The University of Texas MD Anderson Cancer Center (MD Anderson), have announced that the U.S. 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.\n\n\n\nNY-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, professor of stem cell transplantation and cellular therapy at MD Anderson. Syena has an exclusive licensing agreement for MD Anderson’s TCR-NK platform. \n\n\n\nRead more about the creation of Syena and its goals here.\n\n\n\nThis 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.\n\n\n\nThe phase 1/1b 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.\n\n\n\n"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. \n\n\n\n"Syena is now one step closer to bringing its first-in-class, ‘off-the-shelf’ engineered TCR-NK therapy to patients with solid tumors."\n\n\n\nLachlan MacKinnon, CEO and co-founder of Replay, added: "Following the FDA IND acceptance, Syena is Replay’s first product company to enter the clinic. 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."\n\n\n\nMcKinnon featured on a recent episode of the Beyond Biotech podcast.\n\n\n\n"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. \n\n\n\n"I am delighted with the team's progress and look forward to initiating the phase 1/1b study later this year."