TC BioPharm (Holdings) PLC (“TC BioPharm” or the “Company”) (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, today announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of TCB-008 in the treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008, an allogeneic unmodified gamma delta t-cell, is the Company’s lead product and is currently in Phase 2b trials in the U.K. for the treatment of AML.).
The IND application leverages pioneering research on the use of Gamma Deltas in the treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008 has been designated Orphan Drug Status in the treatment arena of AML previously.
“Filing of the IND for TCB-008 is the next step in the clinical development of TCB-008 and aligns with our strategic refocus announced in Q2 of this year to target our clinical strategy to US trials in the future.” said Bryan Kobel, Chief Executive Officer of TC BioPharm. “The IND application leverages supporting clinical study data from ongoing studies in patients with Acute Myeloid Leukemia and is also a reflection of substantial pre-clinical IND enabling work done over the course of the last 6 months by the TCB team. I would like to thank our entire team, who worked tirelessly to complete the Company’s first ever US FDA trial filing. We look forward to working closely with the FDA to garner acceptance of our IND over the coming 30 days and advancing our lead candidate through clinical phases of development.”
The FDA will review the application and determine the acceptability of the data before TC BioPharm begins its first clinical trial for TCB-008 It is possible that the FDA will require additional information.