- Filing is supported by strong clinical data and IND enabling
pre-clinical data associated withTCB-008 in treatment of Acute
Myeloid Leukemia
EDINBURGH, Scotland , Oct. 23,
2023 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC
BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage
biotechnology company developing platform allogeneic gamma-delta T
cell therapies for cancer, today announced submission of an
Investigational New Drug (IND) application to the U.S. Food
and Drug Administration (FDA) for the use of TCB-008 in the
treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008, an
allogeneic unmodified gamma delta t-cell, is the Company's lead
product and is currently in Phase 2b
trials in the U.K. for the treatment of AML.).
The IND application leverages pioneering research on the use of
Gamma Deltas in the treatment of relapse/refractory Acute Myeloid
Leukemia. TCB-008 has been designated Orphan Drug Status in the
treatment arena of AML previously.
"Filing of the IND for TCB-008 is the next step in the clinical
development of TCB-008 and aligns with our strategic refocus
announced in Q2 of this year to target our clinical strategy to US
trials in the future." said Bryan
Kobel, Chief Executive Officer of TC BioPharm. "The IND
application leverages supporting clinical study data
from ongoing studies in patients with Acute Myeloid Leukemia and is
also a reflection of substantial pre-clinical IND enabling work
done over the course of the last 6 months by the TCB team. I
would like to thank our entire team, who worked tirelessly to
complete the Company's first ever US FDA trial filing. We
look forward to working closely with the FDA to garner acceptance
of our IND over the coming 30 days and advancing our lead candidate
through clinical phases of development."
The FDA will review the application and determine the
acceptability of the data before TC BioPharm begins its first
clinical trial for TCB-008 It is possible that the FDA will require
additional information.
About OmnImmune®
OmnImmune® an allogeneic unmodified cell therapy consisting
of activated and expanded gamma delta T cells. The trial, for
treatment of patients suffering from relapse/refractory Acute
Myeloid Leukemia (AML). The therapeutic comprises GDT cells
sourced from healthy donors, expanded and activated in large
numbers before being purified and formulated for infusion into
patients. OmnImmune® is a frozen and thawed product, now
"banked" from donor derived cells. Phase 2/3 trials will begin
enrollment in the first quarter of 2022 in the UK with expansion
into the US in 2022.
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
gamma-delta T cell therapies for the treatment of cancer with human
efficacy data in acute myeloid leukemia. Gamma-delta T cells are
naturally occurring immune cells that embody properties of both the
innate and adaptive immune systems and can intrinsically
differentiate between healthy and diseased tissue. TC BioPharm uses
an allogeneic approach in both unmodified and CAR modified
gamma-delta T cells to effectively identify, target and eradicate
both liquid and solid tumors in cancer.
TC BioPharm is the leader in developing gamma-delta T cell
therapies, and the first company to conduct phase II/pivotal
clinical studies in oncology. The Company is conducting two
investigator-initiated clinical trials for its unmodified
gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of
acute myeloid leukemia using the Company's proprietary allogeneic
CryoTC technology to provide frozen product to clinics worldwide.
TC BioPharm also maintains a robust pipeline for future indications
in solid tumors as well as a significant IP/patent portfolio in the
use of CARs with gamma-delta T cells and owns our manufacturing
facility to maintain cost and product quality controls.
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SOURCE TC BioPharm