Many cell therapies rely on autologous cells isolated from the patient, multiplied in the lab and then infused back into the same patient. Despite the significant achievements achieved using this approach, there are important challenges that prohibit the universal implementation of this strategy.
GDT cells: an attractive anti-cancer effector cell population
As an alternative immunotherapy strategy, the EU-funded OmnImmune project proposed to use allogeneic GDT cells. “GDT cells possess endogenous mechanisms that allow them to recognise cells undergoing stress or having a dysregulated metabolism, endowing them with an inherent capacity to target cancer cells,” explains project coordinator and Director of Research at TC Biopharm Owain Millington. GDT cells represent a promising alternative as they are naturally cytotoxic and recognise many types of cancer cells. Upon target recognition they activate a wider immune response and become highly efficient killer cells. Because they act in a major histocompatibility complex-unrestricted manner, they are suitable for allogeneic therapies. Importantly, they can be expanded in sufficient numbers to facilitate administration to many patients, thus reducing the overall cost.
Putting GDT cells to the test
TC BioPharm generated allogeneic GDT cell banks from healthy donors, expanded and activated them in large numbers before purifying for infusion into patients. The donors were selected based on criteria designed to ensure that the cells are potent killers of cancer cells and can be a more effective and consistent treatment compared to the patient’s own cells. Results demonstrated the capacity of these cells to destroy acute myeloid leukaemia (AML) cancer cells in an allogeneic capacity and have urged TC BioPharm to rapidly progress towards the clinical evaluation of the GDT allogeneic therapy. A Phase I clinical study (NCT03790072) for the treatment of AML patients is currently being conducted at the Institute of Hematology and Blood Transfusion in Prague, Czech Republic with additional clinical sites planned for opening in the United Kingdom in 2020. It is a dose-escalating study in patients with relapsed or refractory AML that are ineligible or non-consenting to a stem cell transplant. Future prospects “The OmnImmune grant has enabled a fundamental shift in TC BioPharm’s commercial ambitions and strategy, which is now focused exclusively on a pipeline of allogeneic products,” emphasises Millington. Results and infrastructure developed under this grant, have been pivotal to the rapid progress of the company’s preclinical programmes. Similarly, the direct collaboration with clinical centres in Europe on evaluation of Advanced Therapy Medicinal Products enabled TC BioPharm to offer an experimental protocol to patients with unmet clinical need. Following the successful conclusion of the GDT Phase I clinical trial, OmnImmune partners intend to launch a Phase III trial for AML treatment. This will determine the marketing of GDT allogeneic cells as a treatment for AML, either by investment-led growth of TC BioPharm or through one of the company’s commercial partners. Not only does OmnImmune represent an important commercial milestone for TC Biopharm, but the availability of clinical-grade allogeneic GDT cell banks paves the way for a more cost-effective anti-cancer therapy available to a larger population of cancer patients. Implementation of this allogeneic medicine is expected to reduce the economic burden for healthcare systems and improve the lives of cancer patients.
OmnImmune, cancer, gamma delta T (GDT) cells, allogeneic, AML, clinical trial