EDINBURGH, Scotland, Dec. 20,
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 3
patients have now completed the full-dose regimen in the ACHIEVE
Phase 2b trial in the UK with no drug-related Adverse
Events seen in any of the restart patients.
The ACHIEVE UK clinical trial is an open-label, phase II study
designed to evaluate the efficacy and effectiveness of TCB008 in
patients with AML or MDS/AML, with either refractory or relapsed
disease.
To date, 10 patients have received their first dose, 9 patients
have received their second dose, 4 patients have received their
third dose, and 3 patients have received their fourth and final
dose. 9 out of 10 patients recruited to date are in Cohort A,
representing relapsed/refractory patients who have been unable to
attain remission. One patient has been enrolled into Cohort B,
representing patients who have attained remission following prior
treatment yet continue to have a detectable residual disease. The
patient enrolled in Cohort B received their fourth and final dose
in November 2024. Initially, 14
patients are planned to be recruited into Cohort A and Cohort B
and, following confirmation of study endpoints, a further 10
patients will be recruited into each cohort, giving a total of 48
patients.
The preliminary safety data shows that the 5mL dose of TCB008 is
well tolerated, with no drug-related Adverse Events. These data
outputs remain aligned with TCB008's safety profile, in support of
the ACHIEVE study safety objectives and endpoints.
"Recruitment into the ACHIEVE trial has been an overwhelming
success in 2024," said Alison
Bracchi, Executive Vice President of Clinical Operations.
"Currently, more than half of the patients in the initial stage of
Cohort A have been recruited into the ACHIEVE study. We're also
thrilled to observe the progression of Cohort B. This expedited
rate of recruitment has been accomplished in less than 5 months due
to the hard work and dedication of both the ACHIEVE Clinical sites
and the entire TCBP team. The TCBP team and I look forward to
continued success with recruitment and preliminary data from the
ACHIEVE study in 2025."
"As we progress with Cohort B, there is the potential for an
expedited review given these patients' stage and disease
expression," said Bryan Kobel, CEO
of TC BioPharm. "We believe minimal residual disease represents a
high opportunity for TCB008 to be extremely impactful. We could see
a response indicating high responsiveness in fewer than the
currently proposed cohort size. At this trial stage, we are still
collating data, due to the regulatory framework, we cannot yet
comment on efficacy specifically, but we are encouraged to see
patients completing the dosing regimen successfully and without any
safety issues. Our immediate clinical focus will be high
recruitment on Cohort B in 2025 and completing the Cohort A patient
set for data review. We appreciate the hard work of the King's
College Hospital and our fantastic investigator group including Dr.
Victoria Potter, and Dr. Emma
Nicholson. The recruitment has been exceptional and we look
forward to continuing our work with them in 2025."
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
