Zinger Key Points
- The first Cohort B patient in Phase 2B trial for TCB008 in AML has completed full dosing and is expected to receive a fifth dose.
- Preliminary data from the trial show no drug-related adverse events after cumulative infusions of TCB008, containing up to a billion cells.
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On Monday, TC BioPharm (Holdings) PLC TCBP announced the first Cohort B patient in the ACHIEVE Phase 2B UK trial of TCB008 in Acute Myeloid Leukemia has completed the full dosing regimen.
The ACHIEVE trial is an open-label Phase 2 study evaluating the efficacy and safety of TCB008.
The trial is focused on assessing TCB008’s effectiveness and tolerability in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML) with refractory or relapsed conditions.
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Cohort B recruits patients who have achieved remission following previous treatment yet continue to have a detectable or minimal residual disease (MRD).
Recruitment into Cohort B was initiated during the fourth quarter of 2024, ahead of the company’s anticipated schedule.
The first Cohort B patient received their dose in October 2024.
The initial Cohort B patient has completed the dosing regimen, received all four planned doses of TCB008, and is expected to receive an additional fifth dose.
Enrolment of a second Cohort B patient has also been initiated.
The trial’s safety objectives and endpoints evaluate patient responses to TCB008, including grading of adverse events experienced and the incidence and severity of cytokine release syndrome and neurotoxicity.
A review of preliminary data shows no drug-related adverse events following cumulative infusions of TCB008, containing up to a billion cells.
“We expect to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year,” said < Bryan Kobel, TC BioPharm’s CEO.
In December, TC BioPharm announced it advanced negotiations with both of its previously aforementioned acquisition candidates.
Earlier, TCBP announced the execution of non-binding letters of intent as part of its M&A strategy to expand its therapeutic platform. The company continues to pursue its expansion strategy via acquisition, specifically in new indications and new cell therapy modalities.
Price Action: TCBP stock closed at $0.20 on Friday.
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