The University of Texas MD Anderson Cancer Center and Replay announced this week that its 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 has received a “safe to proceed” clearance from the US Food & Drug Administration (FDA).
The drug is being developed by oncology company Syena, which was launched by Replay and MD Anderson earlier this year based upon the work of MD Anderson researcher Katy Rezvani, a professor of Stem Cell Transplantation and Cellular Therapy.
NY-ESO-1 TCR/IL-15 NK is a first-in-class engineered cell therapy comprising NK cells derived from cord blood that express an affinity-enhanced TCR targeted against the NY-ESO-1 cancer-associated antigen, which is known to be highly immunogenic. The ability of the candidate cell therapy to elicit elicit humoral and cellular immune responses, along with its restricted tissue expression, establishes it as a compelling target for cancer immunotherapy. Syena has exclusive rights to the MD Anderson TCR NK platform.
“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.
The Phase I/Ib study will asses the safety and efficacy of NY-ESO-1 TCR/IL-15 NK in approximately 44 patients with synovial sarcoma and myxoid/round cell liposarcoma. Administration will occur following lymphodepletion with standard doses of fludarabine/cyclophosphamide, with the trial set to begin in the third quarter of 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.”
Lachlan MacKinnon, CEO and co-founder of Replay noted that Syena is the first Replay company to advance a potential product into the clinical and that the development demonstrates the quality of the science behind the TCR NK candidate, as well as the company’s business model.
