TC BioPharm Selects Excellos as CDMO in Anticipation of Expanded US Clinical Trial Requirements
- 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
Released October 25, 2023