- Positive safety data, allowing for exploration of higher TCB008
doses
- 4 UK-based clinical sites recruiting patients, with a further 2
sites expected in H1 2025
EDINBURGH, Scotland, Dec. 4, 2024
/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 and other indications, today announced an update on the
progression of the ACHIEVE UK Trial.
As of this week, over half of the Cohort A patients in Stage One
of the ACHIEVE study have received TCB008. These patients have an
unmet clinical need, as they have been unable to attain remission
with the existing Standard of Care, other treatments, or tolerate
further chemotherapy. Data evaluated at this milestone demonstrate
positive safety signals for the 5mL dose of TCB008, as no Serious
Adverse Events have been attributed to the TCB008 drug product. The
Company intends to use this data to justify further increases in
the TCB008 dose, from 230 million Gamma Delta T-Cells up to 819
million Gamma Delta T-Cells, to identify the optimal dose for
Cohort A patients.
Cohort B patients with residual disease after initially
achieving remission with existing available treatment continue to
be actively recruited into the ACHIEVE study at the current TCB008
dose of 230 million Gamma Delta T-Cells. These patients will be
recruited at 1 of the 4 active clinical trial sites. Each site,
including Guy's and St. Thomas, is led by a Principal Investigator,
who are experienced hematologists who oversee the use of TCB008 as
an experimental acute myeloid leukemia treatment. Two more sites
will be onboarded in the first half of 2025 for 6 recruiting sites
in the United Kingdom.
"Medicinal products cannot be effective if they are not safe,
and it's clear from these initial data that TCB008 is safe for our
patients," said Alison Bracchi,
Executive Vice President of Clinical Operations. "Our priority now,
for Cohort A, is to find the optimal biologically effective dose
for patients that have exhausted all other treatments to drive a
long term response. We look forward to completing the recruitment
of Cohort B patients, and are planning to evaluate these data in
the first half of 2025."
The increased TCB008 dose will be implemented concurrently to
the scaled-up manufacturing process, developed by Dr. Lauren Bor's team, in 2025.
"The operational teams at TC BioPharm are incredibly
resourceful," said Callum Fiske,
Head of Operations. "Cross-functional collaboration is ongoing to
deliver improvements to the manufacturing process as soon as
possible, enabling increased yields that will expedite TCB008
delivery from cleanroom to clinic, and drive economic efficiencies
to the commercial cost, in 2025."
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this Current Report on Form 8-K
that do not relate to matters of historical fact should be
considered forward-looking statements, including without limitation
statements regarding the Company's intent or ability to affect any
budget savings or execute on any M&A or capital raising
strategy. These statements are based on management's current
assumptions and are neither promises nor guarantees, but involve
known and unknown risks, uncertainties and other important factors
that may cause the Company's actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. For other important factors that could
cause actual results to differ materially from the forward-looking
statements in this Current Report on Form 8-K, please see the risks
and uncertainties identified under the heading "Risk Factors" in
our Annual Report on Form 10-K for the year ended December 31, 2023, and our other reports filed
with the SEC, all of which is available on the Company's Investor
Relations website at www.tcbiopharm.com and on the SEC website at
www.sec.gov. All forward-looking statements reflect the Company's
beliefs and assumptions only as of the date of this Current Report
on Form 8-K. The Company undertakes no obligation to update
forward-looking statements to reflect future events or
circumstances.
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 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 in treatment of acute myeloid
leukemia using the Company's proprietary allogeneic CryoTC
technology to provide frozen product to clinics worldwide.
Contact:
Chris Camarra
EVP Communications
c.camarra@tcbiopharm.com
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SOURCE TC BioPharm