- No Significant Safety Concerns Observed in Safety
Cohort
- Management expects to expand ACHIEVE trial in Q1
EDINBURGH, Scotland, Nov. 14,
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, announces today that the Company has
successfully completed its Safety Cohort and received positive
review from the Data Safety Monitoring Board (DSMB).
The DSMB review was held after completion of enrollment of the
initial cohort of the ACHIEVE trial and examined the safety data
from all patients enrolled to ensure of no dose limiting toxicities
or drug related serious adverse events. TC BioPharm's trial
involves administering TCB008, dubbed OmnImmune® in the UK, to
treat Acute Myeloid Leukemia in a large swathe of patient
population. Management now intends to move the ACHIEVE Trial
forward with enrollment and will continue dosing patients
for the phase 2B clinical trial
beginning in 2024, with an additional 14 patients to be dosed prior
to an interim look at data. TC BioPharm expects to propose
amendments to the existing protocol of ACHIEVE to better align
ACHIEVE and ACHIEVE 2 protocols in dosing and other areas in an
effort to generate a more heterogeneous data set across trials.
"This positive safety review marks an important milestone in the
development of our allogeneic gamma delta platform, building on the
strong safety profile that we previously established for our novel
therapeutic," said Bryan Kobel,
Chief Executive Officer of TC BioPharm. "We expect the trial
to enroll well in 2024, as we believe there is a high degree of
interest in our therapeutic and a growing recognition of the role
gamma deltas play in the fight against cancer. We will begin
redosing in ACHIEVE based on the compelling existing therapeutic
profile. While the process has been relatively slow getting to this
point in ACHIEVE, we believe those headwinds to have subsided and
been addressed by our team and we look forward to a more rapid open
enrollment throughout 2024 now that the safety portion of the trial
is complete."
The global market for acute myeloid leukemia is anticipated
to reach $3.2 billion by 2029,
growing at a CAGR of 9.1% over the forecast period, driven by
introduction of high-priced products, and a strong pipeline of
upcoming candidates.
About OmnImmune®
OmnImmune® an allogeneic unmodified cell therapy consisting
of donor derived, 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.
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