- Excellos to provide scale up solution for final
manufacturing in TCBP facility
EDINBURGH, Scotland, Oct. 25,
2023 /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, today announced it has
selected Excellos, a San
Diego based Contract Development & Manufacturing
Organization (CDMO) spun out of San Diego Blood Bank, for its
expanding US clinical trial efforts.
Excellos was chosen after an extensive review process due
to their ability to navigate the complex regulatory impediments
between the UK and US which relate to the sourcing of donor
material for allogeneic cell therapies. TCBP's clinical trial plans
in the US were also impactful in the decision to engage a CDMO. The
Company intends to expand the clinical trial efforts beyond AML in
2024 with additional IND filings, either as an independent sponsor
or in conjunction with partners or investigator sponsored
trials.
"We feel that Excellos is an ideal partner for TCBP,
sharing our entrepreneurial spirit and belief in a collaborative
effort to advance cell therapies globally," commented CEO
Bryan Kobel. "We believe this step
materially strengthens our ability to deliver on multiple clinical
fronts and creates economic efficiencies within our production
planning, while also maintaining our manufacturing autonomy for the
final product. Our team is looking forward to the continued
clinical and platform expansions in 2024, and anticipate multiple
milestone achievements in the next 12 months for
investors."
Excellos will provide TC BioPharm with allogeneic cell
banks, a "middle-step" that bridges donor blood with the finished
product. TC BioPharm will then utilize the allogeneic cell banks to
manufacture the final product doses, freeze and ship to the US for
storage at the various sites.
"Excellos is excited to partner with TCBP to enable novel
cell therapies for a number of cancer indications," said
David Wellis, Ph.D., CEO of
Excellos. "We share the vision of starting with deeply
characterized cells to create cGMP compliant cell banks, which
ultimately may enhance clinical trial success and optimized final
product. Excellos believes this type of partnership is
commercially significant for therapeutic companies looking for
end-to-end support from collection and analysis of starting
material through commercial product, and it supports our recent
launch of our validated commercial cell manufacturing facility in
San Diego, California."
The production of the allogeneic cell banks by Excellos
will significantly increase access to FDA compliant donors,
expanding the current platform and streamlining delivery of TCB008
clinical trials. Expansion of this platform will support the
anti-fungal and CAR-T proof of concept, both expected in 2024,
first half and second half respectively.
About Excellos, Inc.
Excellos accelerates cell and gene therapies by improving
the quality, breadth, and variance of donor samples, and providing
end-to-end cell therapy services: from customized collection to
cGMP production of final product. Excellos' proprietary
Excellos 360 technology provides deep characterization of cells to
better match patient with therapeutic development needs.
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 uses
an allogeneic approach in both unmodified and CAR modified
gamma-delta T cells to effectively identify, target and eradicate
both liquid and solid tumors in cancer.
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.
TC BioPharm also maintains a robust pipeline for future indications
in solid tumors as well as a significant IP/patent portfolio in the
use of CARs with gamma-delta T cells and owns our manufacturing
facility to maintain cost and product quality controls.
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SOURCE TC BioPharm