CareDx, Inc. has announced a strategic partnership with TC BioPharm to support the ACHIEVE clinical trial by performing pharmacokinetic analysis using its AlloCell solution. This collaboration aims to enhance the monitoring of TCB008, an allogeneic gamma-delta T-cell therapy, in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
The ACHIEVE trial is an adaptive, open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008. CareDx's AlloCell test, a solution for pharmacokinetic monitoring of allogeneic immune and stem cell therapies, will be used to evaluate the expansion and persistence of TCB008 in patients enrolled in the trial. The data obtained is expected to provide insights into the duration and effect of TCB008 gamma-delta T-cells in reconstituting the immune system of AML patients.
AlloCell's Role in Monitoring TCB008
AlloCell has been utilized in ten prior cell therapy clinical trials and is currently being used in four active clinical trials, including ACHIEVE. The test will play a crucial role in evaluating the expansion and persistence of TCB008, offering a deeper understanding of how the therapy impacts the immune system of patients with AML.
Executive Perspectives
Marica Grskovic, PhD, CareDx Chief Strategy Officer, stated, "This partnership builds upon our growth strategy to expand into hematology oncology with pharmacokinetic and monitoring assays for patients undergoing cell therapy. We are thrilled to continue to progress the science of allogeneic cell therapy for patients battling acute myeloid leukemia."
Alison Bracchi, Executive Vice President of Clinical Operations at TC BioPharm, added, "Our partnership with CareDx is a significant milestone. The collaboration is pivotal to the development and optimization of TCB008 as a therapy for acute myeloid leukemia and other blood cancers."
About TCB008 and the ACHIEVE Trial
TCB008 is an allogeneic gamma-delta T cell therapy being developed by TC BioPharm for the treatment of AML and other blood cancers. The ACHIEVE trial is designed to assess the therapy's ability to induce remission and improve outcomes in patients with these conditions. The trial's adaptive design allows for adjustments based on interim data, potentially optimizing the treatment strategy.
Significance of the Partnership
The collaboration between CareDx and TC BioPharm represents a significant step forward in the development of allogeneic cell therapies for AML. By leveraging CareDx's AlloCell technology, the ACHIEVE trial aims to gain a more comprehensive understanding of TCB008's pharmacokinetic properties and its impact on the immune system, potentially leading to more effective treatment strategies for patients with AML and other blood cancers.
