TC BioPharm has completed subject dosing in Cohort A of the Phase IIb ACHIEVE trial of TCB008 in the UK, focusing on individuals with relapsed or refractory acute myeloid leukaemia (AML).
The data so far indicates a positive safety profile and efficacy response, with no drug-related adverse events reported and some subjects achieving stable disease after several infusions of the therapy.
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ACHIEVE was designed to evaluate the therapy’s efficacy and safety in treating AML and myelodysplastic syndromes (MDS).
Cohort A comprised subjects who had no remaining treatment options, either due to ineligibility or having exhausted all other therapies without achieving or maintaining remission.
In July last year, recruitment for this cohort was re-initiated with increased therapy doses, reaching up to one billion gamma delta T-cells.
The heightened interest from investigators and subjects has accelerated recruitment, leading to the early closure of enrolment for the cohort. Recruitment for Cohort B is ongoing.
TC BioPharm CEO Bryan Kobel said: “We’re seeing the expedited delivery of data, six months after study re-initiation, signalling a positive safety and efficacy profile for TCB008.
“This data will shape our approach to clinical development as we continue to investigate how stable disease can be sustained, both to prevent relapse and to progress patients to additional treatment options in conjunction with TCB008.”
A clinical-stage biopharmaceutical company, TC BioPharm is focused on developing gamma-delta T-cell therapies for cancer.
These immune cells combine features of both innate and adaptive immunity and can distinguish between healthy and diseased tissue. The company is pioneering the use of these therapies in Phase II and pivotal oncology trials.
In November 2022, the first three subjects were dosed in the company’s Phase IIb trial of OmnImmune, an allogeneic unmodified cell therapy for AML.
