TC BioPharm is a biotechnology company that develops allogeneic gamma-delta T cell therapies. “Chimeric antigen receptor CAR T cell therapy has emerged as one of the major breakthroughs in cancer immunotherapy in the last decade.” Significant results have shown that CAR T cell therapy is one of the more promising treatments for treating cancer. Up until now, most CAR T clinical trials have used autologous T cells (cells taken from the patient that will later be injected as modified cells). Recently, allogeneic (“off-the-shelf”) CAR T cells are offering promising results without the difficult side effects that come with the autologous T cells.

In March 2022, BioPharm announced “positive interim data its Phase 1a/2b human study evaluating safety and tolerability of TCB-002, OmnImmune®, the Company's allogeneic, unmodified gamma delta t-cell product, a novel therapeutic targeting the potential treatment of relapsed/refractory AML. “ This study carefully tracked 7 patients with advanced AML. Three received a low dose of OmnImmune® and 4 received OmnImmune® at a higher dose of cells.

• Low-dose: one patient acheived MLFS (morphologic leukemia-free state).
• Low-dose: one patient achieved stable disease.
• Low-dose: one patient lost achievable data due to pneumonia unrelated to treatment.

“In the higher dose sample, 50% of patients achieved complete responses, one patient had progressive disease and one patient exhibited significantly reduced cancer blast count at day fourteen (prior to the study being cut short due to Covid 19).”

OmnImmune® is an allogeneic, unmodified cell therapy that is used for patients who are suffering from relapsed/refractory AML. OmnImmune® is: 

• Comprised of gamma delta T cells (GDT) that come from healthy donors.
• Expanded and activated, then purified and injected back into the patient. 
• Donor cells that are a frozen and then thawed product.
• GDT cells occur naturally in the immune system and can distinguish between healthy and diseased tissue.

"We are extremely pleased to receive such positive data from our phase 1b/2a study demonstrating OmnImmune® as safe and tolerable among patients with advanced AML," said Bryan Kobel, Chief Executive Officer of TC BioPharm. "These results underline OnmImmune's potential in becoming a viable AML treatment. We look forward to reporting additional phase 2/3 clinical data during the first half of 2022."

The clinical data provided by this trial testing showed good safety and tolerability for the patients. No graft versus host disease, immune cell-associated neurotoxicity syndrome or cytokine release syndrome were reported. Three patients were redosed with allogeneic material and no toxicities occurred. Previously, patients with unresponsive AML had few treatment options. OmnImmune® now offers hope for a more direct and responsive treatment.