EDINBURGH, Scotland, Nov. 27,
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, announced today that the FDA
provides clearance on the Company's investigational new drug (IND)
application for a Phase 1B study in
relapse/refractory Acute Myeloid Leukemia (AML).
The Phase 1B study, dubbed
ACHIEVE2, will be a 9 patient, dose escalating study measuring for
safety and dose optimization. The Open-label, multi-center study
conducted in 2 parts (dose escalation followed by dose expansion)
will evaluate safety, persistence/expansion, and preliminary
efficacy of single and multiple IV doses of TCB008 in patients with
AML or MDS/AML. Patients may be reinfused with TCB008 up to 3 times
following initial infusion as deemed appropriate by the
investigator or designee should protocol specified criteria be
met.
"The acceptance of the TCB-008 IND is a significant milestone
for TC BioPharm and reflects execution of our strategic plan which
we announced to shareholders in April. TC BioPharm will
continue to work towards its primary goal of establishing a better
method of treatment for the millions of people around the world
suffering blood and bone marrow cancer as we establish TCB008 the
standard of care for these patients, with higher quality of life
and extended remission of these devastating diseases," said
Bryan Kobel, Chief Executive Officer
of TC BioPharm.
Additionally, the Company will be continuing the UK ACHIEVE
trial in AML, expecting to submit amendments to the protocol before
year-end to align the dosing and other criteria with the ACHIEVE2
trial of TCBP's lead product.
Mr. Kobel continued, "TCB-008 has shown promising results
previously as a therapeutic in late stage AML patients and we
believe the safety profile and mechanism of action combine to make
the asset a therapeutic for a number of blood related cancers, as
well as an ideal combination treatment in oncology indications. As
we look to 2024, we see copious milestones and inflection points,
both in our US trial as well as our ongoing ACHIEVE trial and our
platform expansion. Since announcing our refocused strategy this
year, TC BioPharm has continued to execute and deliver key
milestones. We expect to continue to execute in 2024 and appreciate
shareholders believing in our vision. Our team will maintain its
focus on expanding our platform and generating strong clinical data
as the leader in the gamma delta space, and we expect shareholder
value will improve accordingly."
About TCB008 (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.
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