EDINBURGH, Scotland, Oct. 30,
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 provides an
update to its shareholders and highlighted the Company's
operational achievements thus far in 2024.
"The Company has made tremendous strides during the current year
and bolstered its standing as a leading clinical-stage
biopharmaceutical company," said Bryan
Kobel, CEO of TC BioPharm. "The ACHIEVE UK trial has
progressed with alacrity since we received MHRA acceptance of the
increased dosing regimen; 8 patients have been dosed to date,
including 2 patients that have received their 4th and
final dose, all patients are in Cohort A bringing the total
patients dosed to xx. We recently announced a new site opening,
Guy's and St. Thomas Hospital which is one of the leading oncology
clinics in the UK, this is expansion is related to increased scope
and interest in the trial. Another site has opened since this
announcement, and we are working towards opening two more sites in
Q1 2025. Additionally, our compassionate use program has received
physician attention in the UK and US, informing us of TCB008's
potentially broad use case in patients suffering in various forms
of cancer."
In addition to its existing therapeutic platform, TC BioPharm
has signed two separate non-binding LOIs for acquisitions in cell
therapy modalities outside the core of TCB008, announced its
intention to begin proof of concept for preclinical trials for the
treatment of Mpox with a leading infectious disease expert in the
UK, and formed a strategic partnership with a leading University
for AI initiative in the potentially multi-billion dollar field of
donor screening for allogeneic cell therapies. In Q1 2024, cash
burn was reduced by 50%, and TCBP aligned R&D efforts towards
commercial applications. The benefits of these measures are now
evident in Q4 2024, including Dr. Lauren
Bor's team expects to implement manufacturing process
improvements months ahead of the announced 24-month schedule.
Directly correlated to our achievements of our strategic
initiatives and milestone successes, the Company added
approximately $8 million in capital
to the balance sheet in August in a non-brokered transaction with
an investor group."
First Half 2024 Highlights
- Announced that the MHRA has officially accepted its proposed
amendment to the Company's clinical trial authorization (CTA).
- The amendment allows for an increase in dosing size of TCB008
(unmodified expanded gamma delta T cell Lymphocytes), up to 230
million gamma delta T-cells per dose.
- Completed the dosing of 5 new patients in the ACHIEVE Phase
2b trial ongoing in the UK.
- To date, the trial has successfully dosed 8 patients with their
first and second doses, of a possible 4 doses at the higher dose
level.
- TCBP Announced the Launch of the Compassionate Use Program for
TCB008.
- TC BioPharm Announced Execution of Two Non-Binding Letter of
Intent for Acquisition, Targeting Innovative CAR-T Therapies and NK
Platform Technologies.
- Developed a streamlined and scaled-up manufacturing process
- increases treatment capacity from 52 patient treatments per
year to more than 1,000
- Cost reduction of 85% per patient treatment.
Second Half 2024 Highlights
- Announced new site opening of Guys and St. Thomas Hospital in
the ACHIEVE UK Trial;
- Guys and St. Thomas is a London-based leading oncology clinic and cell
therapy clinical team.
- This new site was opened in September
2024, facilitating the expedited progression of the ACHIEVE
clinical trial timelines.
- TCBP intends to begin Proof of Concept preclinical studies for
its lead therapeutic TCB008, for the treatment of Mpox;
- Research studies are being planned in collaboration with Dr.
Carlos Maluquer de Motes, a Reader and Principal Investigator at
the University of Surrey, who
works closely with a leading center of excellence in research of
viral diseases, the Pirbright Institute.
- TC BioPharm is partnering with Dr. Wei
Wu of Carnegie Mellon University
to create an artificial intelligence solution to optimize the donor
screening and matching process.
- Potentially multi-billion-dollar market of screening
capabilities for all allogeneic cell therapy companies utilizing
donor material
- Successfully raised $8.0 Million
in capital during the Third Quarter 2024.
Kobel concluded, "TCBP's objectives for 2024 were ambitious, yet
our team has executed plans to achieve and exceed the requirements
of each milestone by a significant margin. We expect to continue
executing our strategic initiatives and operational plans for 2025,
including driving Cohort B to a data readout, amending our Phase
1b FDA trial to a shortened timeline,
and executing our acquisition strategy to expand our cell therapy
offerings at TCB. The Company will continue this trend through the
remainder of 2024 and beyond as we approach the collation of
clinical data in H1 2025 for Cohort A."
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 statements
regarding the Company's intent or ability to affect any budget
savings or execute 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 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 treating 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