MD Anderson and Replay announce FDA clearance of IND application for first-in-class TCR NK cell therapy for multiple myeloma

Phase I study of NY-ESO-1 TCR/IL-15 NK for relapsed or refractory multiple myeloma, first TCR NK clinical study in hematological malignancies, anticipated to commence Q3 2023

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, a first-in-class engineered T cell receptor natural killer (TCR NK) cell therapy for relapsed or refractory multiple myeloma. 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.

A study in patients with synovial sarcoma and myxoid/round cell liposarcoma received IND clearance from the FDA in June 2023.

"This IND clearance of Syena’s engineered TCR NK cell technology in hematological malignancies swiftly follows the FDA’s clearance of our solid tumor study in sarcoma, signalling the rapid advancement of our TCR NK program into the clinic and the breadth of our engineered TCR NK cell therapy’s potential,” said Adrian Woolfson, executive chairman, president and co-founder of Replay.

“With clinical studies in two indications, spanning solid tumors and hematological malignancies, we are excited for the potential of Syena's first-in-class 'off-the-shelf' engineered TCR NK platform to address multiple unmet clinical needs,” said Lachlan MacKinnon, chief executive officer and co-founder of Replay.

“NY-ESO-1 is highly expressed in certain patients with multiple myeloma and associated with a poor prognosis, so this clinical study will be key to further understanding the potential of our TCR NK platform in hematological malignancies,” Rezvani said. “I look forward to the study beginning later this year.”


MD Anderson has an institutional conflict of interest with Replay and Syena, and MD Anderson will implement an Institutional Conflict of Interest Management and Monitoring Plan to manage these relationships.