TC BioPharm Reports Progress on ACHIEVE Clinical Trial with Promising Safety Data for Cancer Treatment

TC BioPharm's Quarterly Progress Report on the ACHIEVE Trial

TC BioPharm (Holdings) PLC, a biotechnology firm focused on allogeneic gamma-delta T cell therapies, has provided an important update regarding its ongoing clinical trial known as the ACHIEVE study, based in the UK. This trial is particularly significant as it aims to address the unmet clinical needs of patients suffering from cancers such as acute myeloid leukemia (AML) who haven't experienced remission through conventional treatments.

As of the latest reporting, it has been confirmed that more than half of the participants in Cohort A's first stage have already received treatment with TCB008. These individuals have not been successful in achieving remission with existing standard care approaches, or they are unable to handle further chemotherapy. The initial data gathered from this phase demonstrates encouraging safety signals, particularly at the 5mL dose of TCB008, with no serious adverse events linked to the drug reported thus far. The company is poised to leverage these promising findings to explore increasing the TCB008 dose from an initial 230 million gamma-delta T-cells up to a significant 819 million, in order to determine the optimal dosage that may lead to durable treatment responses for Cohort A patients.

Moreover, the recruitment for Cohort B, which includes patients with residual disease that had initially achieved remission with prior treatments, continues at the established TCB008 dosage of 230 million gamma-delta T-cells. This segment of the trial is being actively monitored at one of the four currently operational clinical sites, all supervised by seasoned hematologists, including renowned institutions like Guy's and St. Thomas' Hospitals. In addition, TC BioPharm anticipates launching two additional recruitment sites in the first half of 2025, which will ultimately elevate the total to six participating sites across the UK.

Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm, emphasized the value of safety in medicinal products, noting, “It’s clear from these initial data that TCB008 is safe for our patients.” She indicated that the immediate goal for Cohort A is to identify the most effective biologically active dose, especially for patients who have been left with no other options, aiming ultimately for a long-term positive health response. In anticipation of this strategic direction, TC BioPharm aspires to successfully complete the recruitment of Cohort B participants during early 2025, with the expectation of further evaluating the trial data soon afterward.

To enable this dose escalation, the company will also be ramping up its manufacturing processes, a project led by Dr. Lauren Bor’s team within TC BioPharm. Callum Fiske, Head of Operations, commended the cross-functional teams working tirelessly to improve manufacturing efficiency. This collaborative effort is projected to yield higher outputs, accelerating the transport of TCB008 from production facilities to clinical settings, which should in turn enhance economic efficiencies for the eventual commercial pricing.

These developments mark significant milestones for TC BioPharm as both the ACHIEVE Trial progresses and the operational capabilities of the company are expanded. The future of gamma-delta T-cell therapy appears promising, as TC BioPharm continues to lead pioneering clinical studies aiming for breakthroughs in cancer treatment.

In conclusion, as TC BioPharm moves forward with its ambitious plans, stakeholders can expect to witness the unfolding of crucial insights that will not only impact the company's portfolio but may significantly reshape therapeutic strategies in the fight against malignancies such as acute myeloid leukemia.

For those interested in exploring the cutting-edge advances in cancer treatment, TC BioPharm remains at the forefront with its innovative therapies and clinical efforts.