TC BioPharm (TCB), a developer of Gamma Delta T (GDT) cell therapies, completed formulation of its first allogeneic GDT cell banks. The GDT cell banks provide TC BioPharm with core technology to develop a deep portfolio of next-generation cell therapy products directed against a wide variety of different cancer types, both hematological and solid tumors.
OmnImmune® comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. The donors are 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. GDT cells are a subset of lymphocytes which have both innate and adaptive immune properties and represent an emerging therapeutic option for cancer and other diseases. Use of allogeneic GDT cells from healthy donor cell banks paves the way for development of superior drug products through screening and selection of the highest quality starting material, facilitating preparation of consistent batches capable of treating many patients.
Benefitting from H2020 support, TCB has been rapidly progressing its clinical evaluation of allogeneic therapies.
TCB initiated a Phase I clinical study of OmnImmune®. The trial, for treatment of patients suffering from Acute Myeloid Leukemia (AML), is being conducted at the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czech Republic with additional clinical sites planned for opening in the UK in 2020. Patient recruitment commenced January 2019 following regulatory approval late 2018. Dose escalation is in progress. The clinical trial is registered with identifier NCT03790072.
The first human trial of OmnImmune® is an ICH GCP compliant, open-label single arm study expected to enroll 9 patients, with three escalating doses of the drug product. Cancer patients in the study are suffering from relapsed or refractory AML and are ineligible or non-consenting to a stem cell transplant. The product is manufactured at TCB’s GMP-compliant manufacturing site in the UK using cells sourced from healthy allogeneic donors.
