TC BioPharm Expands Patient Dosing in ACHIEVE Clinical Trial
TC BioPharm's Progress in Patient Dosing
TC BioPharm (Holdings) PLC (NASDAQ: TCBP) has reached an important milestone by announcing that it has dosed 5 new patients in its ACHIEVE Phase 2b trial. This brings the total number of patients dosed to six, all of whom are receiving higher dose levels. The ongoing trial reflects TC BioPharm's commitment to developing effective allogeneic gamma-delta T cell therapies for cancer.
Details of the ACHIEVE Phase 2b Trial
The ACHIEVE clinical trial is critical in evaluating the safety and efficacy of TCB008, particularly in patients suffering from acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that either have relapsed or are refractory. Currently, the trial is structured to allow patients the possibility of receiving four doses, with each 5mL dosage containing approximately 230 million gamma-delta T cells. It is anticipated that patients will receive a total of about 1 billion gamma-delta T cells throughout the study.
Patient Progress and Dosing Regimen
Among the participants, five patients have successfully received their second dose, and two have advanced to their third dose. This achievement underscores the efficacy of the treatment and reflects the company's strategic improvements made in the dosing protocol during 2023 and early 2024.
CEO's Perspective on Trial Advancements
“We are thrilled to report our rapid advancements in the ACHIEVE Phase 2b trial, particularly regarding the high enrolment rates for the second part of the study using the higher dose,” commented Bryan Kobel, CEO of TC BioPharm. He notes that TCB008 has the potential to be a transformative therapy for blood cancers, demonstrating substantial recruitment and patient retention. This is a clear indication of the interest from medical professionals in utilizing TCB008 as a standalone treatment for leukemia.
Looking Ahead
With six patients already dosed and an additional ten prepared for enrolment, TC BioPharm is confident in their pathway forward. The company plans to continue refining its clinical trial strategies in 2024 and beyond, which include the expansion of the ACHIEVE trials and enhancements to its manufacturing capabilities. These advancements aim to bolster operational efficiency and support the ongoing commitment to innovative cancer therapies.
Commitment to Innovative Cancer Treatments
TC BioPharm is pioneering the development of gamma-delta T cell therapies, being among the first to conduct pivotal clinical studies in oncology. This innovative approach focuses on targeting cancers through naturally occurring immune cells, which have shown promise in differentiating between healthy and diseased tissues.
Clinical Trials and Future Directions
The company is actively conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line, including a pivotal Phase 2b/3 trial targeting acute myeloid leukemia. Utilizing proprietary CryoTC technology, TC BioPharm aims to deliver effective treatments anywhere in the world.
About TC BioPharm
As a clinical-stage biopharmaceutical entity, TC BioPharm focuses fundamentally on exploring and advancing gamma-delta T cell therapies. The company holds significant expertise in the field, housing robust human efficacy data. With these therapies, TC BioPharm is working towards enhancing cancer treatment modalities and providing novel therapeutic options.
Frequently Asked Questions
What is the ACHIEVE trial?
The ACHIEVE trial is a Phase 2b clinical study designed to assess TCB008's efficacy in treating blood cancers, particularly AML and MDS.
How many patients have been dosed in the trial so far?
Currently, six patients have been dosed in the trial, with hopes to expand enrollment further.
What is TCB008?
TCB008 is an innovative therapy developed by TC BioPharm utilizing gamma-delta T cells to target cancerous cells.
What are gamma-delta T cells?
Gamma-delta T cells are unique immune cells that combine features of both innate and adaptive immune responses, allowing them to differentiate between healthy and diseased tissues.
What future projects is TC BioPharm planning?
TC BioPharm is focused on expanding its clinical trials, including the ACHIEVE and ACHIEVE2 trials, while also enhancing its manufacturing capabilities to support its treatments.
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