- 5 New patients dosed, bringing total to 6 patients dosed in
ACHIEVE at higher dose level
- 5 Patients received second dose
- 2 Patients received third dose
EDINBURGH, Scotland, Sept. 3,
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 announces
dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK.
Currently, the trial has successfully dosed 6 patients with
their first of 4 possible doses at the higher dose level. Each 5mL
dose contains up to 230 million gamma delta T cells, and a patient
is expected to receive up to an approximate 1 billion gamma delta T
cells over four doses. Five patients have received their second
dose, with 2 of these patients having also received their third
dose. This correlates with TCBP's step-wise approach to
process improvements, as implemented in Q4 2023, and further steps
taken to amend the trial protocol in the first quarter of
2024. New patients will continue to be identified, screened,
and enrolled into the study.
"TCBP is excited to announce our rapid progression in the
ACHIEVE Phase 2b trial with very
strong enrolment in the second part of the trial using the higher
dose," stated, Bryan Kobel, CEO of
TC BioPharm. "TCB008 is potentially a game-changing
monotherapy for blood cancers, and the strong recruitment and
patient retention rates are testament to clinician/physician
interest in TCB008 as a monotherapy in leukemia. We're proud of the
milestones accomplished to date, having rapidly dosed 6 patients
with an additional 10 patients lined up. It is encouraging to see
re-dosing of several patients, which we believe reflects positively
on the steps the organization took in 2023 and early 2024. TCBP
remains poised to execute on our clinical trial plans in 2024 and
into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded
manufacturing capabilities to enhance our operational capabilities
and our economic efficiencies."
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.
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.
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SOURCE TC BioPharm