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Replay and MD Anderson Receive FDA Clearance for First-in-Class T-Cell Receptor Natural Killer (TCR-NK) Cell Therapy Targeting Multiple Myeloma

Tuesday, July 25, 2023

Replay, a company focused on genome writing and the reprogramming of biology through large DNA synthesis, along with The University of Texas MD Anderson Cancer Center, has received clearance from the U.S. Food & Drug Administration (FDA) to proceed with their Investigational New Drug (IND) application for NY-ESO-1 TCR/IL-15 NK. This innovative T-Cell Receptor Natural Killer (TCR-NK) cell therapy is designed for patients with relapsed or refractory multiple myeloma. MD Anderson is acting as the IND sponsor for the research.

NY-ESO-1 TCR/IL-15 NK is being developed by Syena, an oncology-focused product company created by Replay and MD Anderson based on the scientific discoveries of Dr. Katy Rezvani, Professor of Stem Cell Transplantation & Cellular Therapy at MD Anderson. Syena has an exclusive licensing agreement for MD Anderson's TCR-NK platform.

Earlier in June 2023, the FDA also granted IND clearance for a study involving patients with synovial sarcoma and myxoid/round cell liposarcoma, showcasing the progress of this program in treating various malignancies.

Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay, expressed excitement over the swift FDA clearance for the engineered TCR-NK cell technology in hematological malignancies, following the approval of the solid tumor study in sarcoma. He emphasized the broad potential of this innovative TCR-NK cell therapy.

Lachlan MacKinnon, CEO and Co-Founder of Replay, highlighted the significance of conducting clinical studies in both solid tumors and hematological malignancies, showing the promise of Syena's 'off-the-shelf' engineered TCR-NK platform in addressing various unmet clinical needs.

Dr. Katy Rezvani emphasized the importance of the clinical study, as NY-ESO-1 is highly expressed in certain multiple myeloma patients and associated with a poor prognosis. The study is expected to commence later this year, providing valuable insights into the potential of the TCR-NK platform in treating hematological malignancies.



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