- 5 patients treated in "safety cohort" showed no drug related
Serious Adverse Events
- Restart of trial after amendment approved by MHRA to
increase dose level
EDINBURGH, Scotland, July 22,
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
that on July 16, the sixth patient in
ACHIEVE (UK) was treated. This is the first patient treated
with a higher dose of TCB-008 post the amendment approved by the
MHRA on Feb 22, 2024.
The ACHIEVE UK clinical trial is an open-label, phase II study
designed to evaluate the efficacy and effectiveness of TCB-008 in
patients with AML or MDS/AML, with either refractory or relapsed
disease. ACHIEVE is comprised of two cohorts representing separate
disease states. The protocol allows for either cohort to be
advanced as an independent Phase III Pivotal Trial upon completion
of the cohort, presuming the primary efficacy endpoints is met.
Cohort A represents relapsed/refractory patients who have been
unable to attain remission and are in palliative care as they are
unable to tolerate further chemotherapy. Initially, 5 patients were
treated at the lower dose. Up to 14 patients may be recruited into
this cohort at the higher dose. Pending confirmation of the primary
endpoints, a further 10 patients may be recruited into Cohort A for
a total of 24 patients.
Cohort B represents patients who have attained remission
following prior treatment, however, continue to have a detectable
residual disease. Up to 14 patients may be recruited into this
cohort at the higher dose. Pending confirmation of the primary
endpoints, a further 10 patients may be recruited into Cohort B for
a total of 24 patients.
Interim data review is not reliant on the completion of either
Cohort, and consequently the Company is not required to complete
investigation of both Cohorts prior to advancing to a Pivotal Phase
3 study in one or both Cohorts simultaneously.
Enrolled patients will be treated with an increased dose of
TCB-008, containing up to 230,000,000 cells per dose compared to
the previous dose of 35,000,000. The increased dose is commensurate
with the proposed medium dose cohort in the Company's FDA trial in
AML. Eligible patients will receive up to three additional
infusions of TCB008, starting 14 days after the previous infusion
and administered every subsequent 14 days, representing a total of
4 doses of TCB-008 or approximately 1,000,000,000 cells.
Details of the ACHIEVE Study can be found at
https://www.clinicaltrials.gov/study/NCT05358808
"The dosing and restart of ACHIEVE represents an important
milestone in our progress towards Phase 2b efficacy data in AML with an interim data
announcement in the next six to nine months, as well as proof in
our ability to successfully navigate potentially arduous regulatory
and clinical trial environments in both ACHIEVE and ACHIEVE2," said
Bryan Kobel, CEO of TC BioPharm. "In
addition to dosing our 6th patient and restarting
ACHIEVE, we've screened and enrolled additional patients into the
trial and expect to dose up to 10 more in 2024 and expect to open
at least one additional clinical trial site in Q3. These
efforts, combined with additional refinement of TCB-008 over the
last 6 months, escalating the dose size in the ACHIEVE trial and
existing data, have us poised for inflection points in 2024 and
confidence in our ability to continue to execute on our clinical
trial plans. Based on the substantial clinical safety and efficacy
data to date and encouraging tolerability information generated in
the five-patient safety cohort of ACHIEVE, we are excited to
realize the potential of TCB-008 as a mono-therapy and continue to
pursue partners for combination therapies."
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 for OmnImmune® 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