TC Biopharm (Holdings) PLC announced that it has received MHRA and Research Ethics Committee approvals to initiate gamma-delta T cell therapy clinical trials of OmnImmune® for the treatment of Acute Myeloid Leukemia (AML).
OmnImmune® an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells has already received orphan drug designation for the treatment of patients suffering from the blood and bone marrow cancer. Phase 2/3 trials will begin enrollment in the first half of 2022 in the UK with expansion into the US following shortly thereafter.
“We are extremely pleased to receive MHRA and Research Ethics approvals, which marks the final step in our protocol submission and commencing through the clinical trial process of our proprietary AML therapy,” said Bryan Kobel, CEO of TC BioPharm. “On the heels of announcing our Orphan Drug Dsignation from the FDA, we have now further demonstrated our ability to run parallel processes for clinical trials in both the US and UK/EU. The positive results demonstrated by OmnImmune® in Phase 1b/2a clinical trials are encouraging and bolsters our belief in its potential as an effective therapy for Acute Myeloid Leukemia.”