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.
TC BioPharm (PRNewsfoto/TC BioPharm)
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.
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