- Increases dose level in line with Cohort 2 in IND
- Changes from "in patient" to "out patient"
procedure
EDINBURGH, Scotland, Feb. 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 the MHRA has officially accepted its proposed amendment to the
Company's clinical trial authorisation (CTA). The amendment allows
for an increase in dosing size of TCB008 (unmodified expanded gamma
delta T cell Lymphocytes) to 12x10^7-23x10^7 gamma delta
t-cells.
Additionally the amendment allows for patients to be treated as
"out patients", easing the burden on patients and lessening the
burden on clinical sites as patients will not need to be monitored
overnight after the first five patients are dosed. The ACHIEVE
trial is a Phase 2b trial in Acute
Myeloid Leukemia testing efficacy for TCBPs lead product
TCB-008 (Omnimmune).
Medical and Healthcare Products Regulatory Agency (MHRA) is the
UK regulatory authority, a government agency, for medicines and
medical devices. The MHRA is responsible for the regulation of
medicines and medical devices and equipment used in healthcare and
the investigation of harmful incidents.
Bryan Kobel, Chief Executive
Officer of TC BioPharm stated, "Management is pleased to receive
amendment clearance from the MHRA, this is yet another example of
the team executing on plans we have laid out for the investment
community. The changes to the protocol will substantially impact
both the timing of data in the ACHIEVE trial as well as impacting
the proposed FDA trial. Shifting to an out patient procedure means
patients in the trial are not forced to spend a night in the
hospital, increasing their quality of life in a difficult time, and
also allows hospitals to not need to hold a bed for a patient in a
time when beds are scarce in the NHS. We believe, after
feedback from the clinical sites, that this was a material rate
limiting concern in enrolment and are happy we can now provide them
relief. Increasing the dose size, in accordance and discussion with
our investigators, can increase the positive impact in patients
with no safety concerns, furthering our stance that TCB-008 should
be used in a myriad of settings at high doses. This step also
aligns the dosing levels with the IND, where our second cohort
would be receiving this dose, and gives us a window to approach the
FDA with data at this level to potentially go immediately to dose
level two in our US Phase 1b in
relapse/refractory AML."
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