FDA clears T-cell receptor natural killer cell therapy for sarcoma


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

NY-ESO-1 TCR/IL-15 NK is being developed by Syena, an oncology-focused product launched by Replay and MD Anderson based on the scientific findings 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.

Read more about Syena’s creation and purpose here.

This first-class engineered cell therapy comprises cord blood-derived natural killer cells that express the affinity-enhanced T-cell receptor (TCR) targeted against the cancer-associated antigen NY-ESO-1, which is highly immunogenic and expressed on a wide variety of cancer cell types. . NY-ESO-1’s ability to elicit humoral and cellular immune responses, together with its limited tissue expression, makes it an attractive target for cancer immunotherapy.

A 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. This will be given after lymphodepletion with a standard dose of fludarabine/cyclophosphamide (Flu/Cy). Approximately 44 patients will be enrolled in this study, expected to start in Q3 2023.

“Syena leverages the scalability and allogeneic nature of engineered cord blood-derived NK cells to democratize cell therapy for cancer treatment. The recent IND FDA approval of the first human TCR-NK protocol is an important milestone for Syena,” said Adrian Woolfson, chief executive, president, and co-founder of Replay.

“Syena is now one step closer to bringing a first-in-class, engineered ‘off-the-shelf’ TCR-NK therapy to patients with solid tumors.”

Lachlan MacKinnon, CEO and co-founder of Replay, added: “After IND FDA approval, Syena became the first Replay product company to enter the clinic. Being able to get fast IND FDA clearance for our class one TCR-NK program is a testament to the caliber of our team and the quality of our science, and continues to validate our business model.”

McKinnon is featured on the latest episode of the Beyond Biotech podcast.

“Synovial and myxoid/spherical cell liposarcomas express NY-ESO-1 at high levels and in high cell frequencies, making them excellent tumor types for establishing a proof-of-concept platform for TCR-NK,” said Rezvani.

“I am pleased with the team’s progress and look forward to starting the phase 1/1b study later this year.”


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