Pharma Focus Europe

TC BioPharm Partners with Excellos as CDMO to Meet Expanding US Clinical Trial Demands

Thursday, October 26, 2023

TC BioPharm (Holdings) PLC (NASDAQ: TCBP) has revealed its partnership with Excellos, a Contract Development & Manufacturing Organization (CDMO) based in San Diego, California. Excellos, which originated from the San Diego Blood Bank, was selected after a rigorous evaluation process. The choice was primarily based on their ability to navigate the complex regulatory challenges associated with sourcing donor materials for allogeneic cell therapies between the UK and the US. TCBP also considered its expansion of clinical trials in the US beyond Acute Myeloid Leukemia (AML) in 2024, either as an independent sponsor or in collaboration with partners or investigator-sponsored trials.

Excellos, emphasizing their shared entrepreneurial spirit and commitment to advancing global cell therapies. This decision is expected to enhance TCBP's ability to progress on multiple clinical fronts, improve production planning efficiency, and maintain manufacturing autonomy for the final product. The TCBP team looks forward to ongoing clinical and platform expansions in 2024, with expectations of achieving multiple milestones for investors in the next 12 months.

Under this partnership, Excellos will provide TC BioPharm with allogeneic cell banks, serving as an intermediate step connecting donor blood with the final product. TCBP will then utilize these allogeneic cell banks to manufacture the final product doses, freeze them, and ship them to various US locations for storage.

Excellos, expressed enthusiasm for collaborating with TCBP to facilitate novel cell therapies for various cancer indications. He highlighted their shared vision of starting with well-characterized cells to create compliant cell banks adhering to current Good Manufacturing Practices (cGMP) standards. This approach is expected to enhance the success of clinical trials and optimize the final product. The partnership is considered commercially significant for therapeutic companies seeking comprehensive support, from collecting and analyzing starting materials to producing commercial products. Excellos has recently launched a validated commercial cell manufacturing facility in San Diego, California.

The production of allogeneic cell banks by Excellos is poised to significantly enhance access to donors compliant with FDA standards, expand the existing platform, and streamline the delivery of TCB008 clinical trials. The expansion of this platform will also support proof-of-concept initiatives for anti-fungal and CAR-T therapies, both expected in the first and second half of 2024, respectively.

Excellos accelerates cell and gene therapies by improving the quality, diversity, and variance of donor samples. They provide end-to-end cell therapy services, ranging from customized collection to cGMP production of the final product. Their proprietary Excellos 360 technology enables in-depth characterization of cells, ensuring better alignment with patient needs in therapeutic development.



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