- No TCB008-related Adverse Events seen in any of the re-start
patients
- 6 Patients received second dose, 3 Patients received third
dose, 1 Patient received fourth dose
EDINBURGH, Scotland,
Sept. 12, 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 the first patient has completed
the full dose regimen in the ACHIEVE Phase 2b trial ongoing in the UK with no drug related
Adverse Events seen in any of the re start patients. As previously
stated, patients are eligible to receive up to 4 total doses of TCB
under the ACHIEVE protocol. Based on the amended dosing, this
patient received approximately one billion cells in the TCB008
dosing regimen.
One patient in Cohort A has successfully completed the full
dosing regimen having received all 4 doses. Preliminary safety data
indicate the 5mL dose of TCB008 is well tolerated, with no
TCB008-related Adverse Events. These data outputs are indicative of
TCB008's safety profile, in support of the ACHIEVE study safety
objectives and endpoints. New patients will continue to be
identified, screened, and enrolled into the study.
It's expected that a further three patients will have received
their 4th and final dose by the end of September. 14
patients in Cohort A are initially expected to receive TCB008 and,
pending confirmation of primary endpoints, a further 10 patients
will be recruited into the cohort for a total of 24 patients.
"We are extremely pleased to announce that the full dosing
regimen is completed by the first patient to receive the increased
dose of TCB008 under the ACHIEVE trial. Including the fully-dosed
first patient in the ACHIEVE Phase 2b
trial, we have observed no drug related Adverse Events in any of
the restart patients," said Bryan Kobel, Chief Executive
Officer of TC BioPharm. "This initial feedback speaks to the safety
and tolerability of TCBP's drug. An additional three patients will
receive their 4th and final dose by the end of
September. While we are able to see safety and tolerability in the
immediate aftermath of dosing for ACHIEVE to update investors, the
measurement for efficacy and the release of that data will be after
completion of the cohort and the data clean per regulatory mandate.
We are seeing strong recruitment and enrollment at our active sites
and expect to be able to announce a full data set in the first half
of 2025 inclusive of primary and secondary endpoints"
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
