TCB-008 Phase IIb Trial Progress

The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy and safety of TCB 008. This trial is focused on assessing the treatment's effectiveness and tolerability on patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML) with challenging cases such as refractory or relapsed conditions. 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 regiment, receiving all four planned doses of TCB 008, and is expected to receive an additional fifth dose. Enrolment of a second Cohort B patient has also been initiated.

The safety objectives and endpoints of ACHIEVE evaluate patient responses to TCB 008, including; grading of adverse events experienced and the incidence and severity of cytokine release syndrome and neurotoxicity. In a review of preliminary data, there are no drug-related adverse events following cumulative infusions of TCB008, containing up to a billion cells. These data continue to support the positive safety profile of TCB 008 and the ACHIEVE UK study safety objectives and endpoints.

"The ACHIEVE study progressed at an incredible rate in 2024," stated Alison Bracchi, EVP of Clinical Operations. "Thanks to the hard work and dedication of both the TC BioPharm team and Clinical sites, we've reached a significant study milestone in under six months. We're seeing a fantastic safety profile from our initial data review and exciting efficacy signals that indicate cellular recovery and a reduction of inflammation in AML patients. The TC BioPharm team and I are inspired by the progress to date and look forward to sharing further updates on Cohort B."

"The progression of ACHIEVE, with dosing underway in the second cohort, is a key milestone in the clinical development of our gamma delta therapy candidate TCB 008.  We believe it has potential to serve as an efficacious treatment for AML patients, whom still have significant unmet needs," said Bryan Kobel, CEO of TC BioPharm. "The therapy has been well-tolerated with no unexpected events or toxicities observed and promising efficacy results observed in some patients, with additional data being collected and analyzed. Cohort B is an extremely compelling patient population for TCB 008 for many reasons, including patients having a more intact immune system to amplify the impact of TCB 008 and the lack of true treatment options for these patients who are unfortunately on a path to relapse. We expect to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year."