Study to provide safety data on allogeneic use of GDTs prior to
subsequent use of CAR-modified variants
GLASGOW, Scotland–(BUSINESS WIRE)–TC BioPharm (TCB), a developer of allogeneic CAR-T immuno-oncology
products, and leaders in Gamma Delta T (GDT) cell therapies, today
announced it has initiated a Phase I clinical study of TCB002, an
allogeneic cell therapy consisting of activated and expanded gamma delta
T cells. 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.
Patient recruitment commenced January 2019 following regulatory approval
late 2018. Dose escalation is in progress, with completion of treatment
imminent for the first patient cohort. The clinical trial is registered
with identifier NCT03790072.
Developed by TC BioPharm, TCB002 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.
The study in Prague is designed to provide safety data on allogeneic use
of GDTs prior to subsequent use of CAR-modified variants later in the
year. GDTs are an obvious vehicle for allogeneic cell therapies as they
do not elicit ‘graft versus host’ rejection. TCB is developing its
proprietary GDT CAR-T (Chimeric Antigen Receptor T Cell) platform in a
stepwise manner, evolving the clinical development program from
autologous to allogeneic to CAR-modified products.
The first human trial of TCB002 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. The development of this allogeneic product
has been supported by a €4m grant from the European Union’s Horizon 2020
research and innovation program.
Angela Scott, Chief Operating Officer, TC BioPharm, said: “Treatment
of the first patients with TCB002 represents the culmination of a
concerted collective effort from our in-house product development,
quality, manufacturing, regulatory and clinical teams, as well as the
expert physicians at ÚHKT. We are now focused on successful completion
of this trial and the progression of our CAR-T products to treat further
patient groups with unmet clinical needs, as part of our strategic plan
of delivering allogeneic CAR-T medicines as mainstream cancer therapies.”
Prof. Petr Cetkovský, Director, ÚHKT, added: “Collaborating
with TC BioPharm on clinical evaluation of Advanced Therapy Medicinal
Products allows us to offer experimental options to patients with acute
clinical need, and builds upon our position of expertise with pioneers
of cellular immuno-oncology products.”
This project has received funding from the European Union’s Horizon 2020
Research and Innovation program.
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