- No adverse events related to TCB008 have occurred
- Evidence of stable disease following TCB008 infusion
EDINBURGH, Scotland, Feb. 13,
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
that it has concluded dosing of Cohort A patients in the ACHIEVE
Phase 2B UK clinical trial.
The available data show a favorable safety and efficacy response
in Cohort A patients, patients with relapse or refractory AML. No
patients have experienced any drug-related adverse event, and
preliminary efficacy data demonstrate a number of patients
attaining stable disease following multiple infusions of
TCB008.
"We're thrilled to be sharing these preliminary results," stated
Alison Bracchi, EVP of Clinical
Operations. "These early data points pave the way for future
clinical studies, as we consider how the therapeutic effect of
TCB008 can be prolonged or enhanced to reverse the disease state in
these incredibly sick patient populations. We have additional data
review to complete, which will further define our next steps with
TCB008, including as a potential bridge to transplant or other
combination efforts."
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 in
patients suffering from acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS/AML). Cohort A targeted patients who
were ineligible for, or had exhausted all, available therapies, as
they were unable to achieve remission or had subsequently relapsed
following remission.
Cohort A recruitment was re-initiated in July 2024 using higher doses of TCB008 that
contained a cumulative dose of up to a billion Gamma Delta T-Cells.
Investigator and patient interest in the ACHIEVE trial has allowed
the Company to expedite recruitment; as such, enrolment into Cohort
A has concluded. Recruitment into Cohort B continues.
"This early safety and efficacy data, obtained in patients with
significant unmet clinical need, reiterates our confidence in our
lead candidate, TCB008," said Bryan
Kobel, CEO of TC BioPharm. "We're seeing the expedited
delivery of data, six months after study re-initiation, signalling
a positive safety and efficacy profile for TCB008. This data will
shape our approach to clinical development as we continue to
investigate how stable disease can be sustained, both to prevent
relapse and to progress patients to additional treatment options in
conjunction wth TCB008."
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
