Nano-Cap TC BioPharm Completes Initial Cohort B Patient Dosing in Mid-Stage Leukemia Trial, Data Readout Expected by End of 2025

TC BioPharm (Holdings) PLC (TCBP), a clinical-stage biotechnology company specializing in allogeneic gamma-delta T cell therapies for cancer, has reached a significant milestone in its mid-stage leukemia trial. The company announced the completion of the initial Cohort B patient dosing in the ACHIEVE Phase 2B UK trial of TCB008 in Acute Myeloid Leukemia (AML). This achievement marks a crucial step in the trial's progress and sets the stage for an anticipated data readout by the end of 2025.

The ACHIEVE trial is an open-label Phase 2 study designed to evaluate the efficacy and safety of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease. The trial consists of two cohorts: Cohort A, representing relapsed/refractory patients who have been unable to attain remission, and Cohort B, representing patients who have attained remission following prior treatment yet continue to have a detectable residual disease (MRD).

The completion of the initial Cohort B patient dosing is a testament to TC BioPharm's ability to successfully execute its clinical trials and move through different cohorts. This milestone is particularly notable as it was achieved ahead of the company's previously anticipated schedule, indicating that the trial is progressing faster than initially expected.



As the trial progresses with Cohort B, there is the potential for an expedited review given these patients' stage and disease expression. This could lead to a response indicating high responsiveness in fewer than the currently proposed cohort size, further accelerating the timeline for the trial's completion. TC BioPharm expects to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year.

Investors should focus on several key data points and metrics when evaluating the upcoming data readout for the ACHIEVE trial. These include efficacy metrics such as Complete Remission (CR) rate, Overall Response Rate (ORR), Duration of Response (DoR), and Event-Free Survival (EFS). Safety metrics, such as Adverse Events (AEs), Cytokine Release Syndrome (CRS), and Neurotoxicity, will also be crucial in assessing the potential of TCB008 as a treatment for AML and MDS/AML.

The progress of the ACHIEVE trial positively influences the company's valuation and investment potential as a nano-cap stock. The completion of the initial Cohort B patient dosing is a significant clinical milestone that demonstrates TC BioPharm's ability to successfully execute its clinical trials. The anticipation of upcoming data can drive investor interest and potentially increase the stock's valuation. Moreover, the potential for an expedited review and faster market access could further enhance the company's valuation and investment potential.

In conclusion, TC BioPharm's completion of the initial Cohort B patient dosing in the ACHIEVE trial is a significant achievement that sets the stage for an anticipated data readout by the end of 2025. Investors should focus on key data points and metrics when evaluating the upcoming results, as they will provide valuable insights into the potential of TCB008 as a treatment for AML and MDS/AML. The progress of the trial also positively influences the company's valuation and investment potential as a nano-cap stock.