- First Cohort B patient received 4 doses (approx. 819 million
Gamma Delta T-cells)
- Cohort B recruitment continues at multiple clinical sites
across the United Kingdom
EDINBURGH, Scotland, Feb. 10,
2025 /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 the first Cohort B patient in the ACHIEVE Phase
2B UK clinical trial, evaluating
TCB008 in Acute Myeloid Leukemia, has completed the full dosing
regiment.
The ACHIEVE trial is an open-label Phase II study dedicated to
evaluating the efficacy and safety of TCB008. This trial is focused
on assessing the treatment's effectiveness and tolerability on
patients suffering from acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS/AML) with challenging cases such as
refractory or relapsed conditions. Cohort B recruits patients who
have achieved remission following previous treatment yet continue
to have a detectable or minimal residual disease (MRD).
Recruitment into Cohort B was initiated during the fourth
quarter of 2024, ahead of the Company's anticipated schedule. The
first Cohort B patient received their dose in October 2024. The initial Cohort B patient has
completed the dosing regiment, receiving all four planned doses of
TCB008, and is expected to receive an additional fifth dose.
Enrolment of a second Cohort B patient has also been initiated.
The safety objectives and endpoints of ACHIEVE evaluate patient
responses to TCB008, including; grading of adverse events
experienced and the incidence and severity of cytokine release
syndrome and neurotoxicity. In a review of preliminary data, there
are no drug-related adverse events following cumulative infusions
of TCB008, containing up to a billion cells. These data continue to
support the positive safety profile of TCB008 and the ACHIEVE UK
study safety objectives and endpoints.
"The ACHIEVE study progressed at an incredible rate in 2024,"
stated Alison Bracchi, EVP of
Clinical Operations. "Thanks to the hard work and dedication of
both the TC BioPharm team and Clinical sites, we've reached a
significant study milestone in under six months. We're seeing a
fantastic safety profile from our initial data review and exciting
efficacy signals that indicate cellular recovery and a reduction of
inflammation in AML patients. The TC BioPharm team and I are
inspired by the progress to date and look forward to sharing
further updates on Cohort B."
"The progression of ACHIEVE, with dosing underway in the second
cohort, is a key milestone in the clinical development of our gamma
delta therapy candidate TCB008. We believe it has potential
to serve as an efficacious treatment for AML patients, whom still
have significant unmet needs," said Bryan Kobel, CEO of TC
BioPharm. "The therapy has been well-tolerated with no unexpected
events or toxicities observed and promising efficacy results
observed in some patients, with additional data being collected and
analyzed. Cohort B is an extremely compelling patient population
for TCB008 for many reasons, including patients having a more
intact immune system to amplify the impact of TCB008 and the lack
of true treatment options for these patients who are unfortunately
on a path to relapse. We expect to complete enrolment in the second
cohort in the first half of 2025, with data readout anticipated
later this year."
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company
focused on discovering, developing, and commercializing gamma-delta
T-cell therapies for cancer treatment 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 the treatment of acute
myeloid leukemia using the Company's proprietary allogeneic CryoTC
technology to provide frozen product to clinics worldwide.
Forward-Looking Statements for TC BioPharm
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.
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SOURCE TC BioPharm
