On November 22, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer reported the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia (AML) (Press release, TC Biopharm, NOV 22, 2022, View Source [SID1234624358]).
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Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow — the spongy tissue inside bones where blood cells are made.
The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP’s step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
"The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune, for patients with AML and for TC BioPharm’s emerging pipeline of ‘off-the-shelf’ gamma-delta T cell therapies," said Bryan Kobel, CEO of TC BioPharm. "This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7×10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023."
TC BioPharm’s Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes (MDS), conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients.