TC BioPharm Announces Streamlined Efficiencies and Reduces Overhead with Selection of Single Global CRO for Clinical Trials

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TC BioPharm has selected Fortrea as its Contract Research Organization (CRO) for global trials, including ACHIEVE and ACHIEVE2. The trials will be managed by Fortrea, creating a vertically integrated clinical trial program that aims to increase operational efficiencies and improve data management. TC BioPharm expects to generate cash savings by consolidating CRO services under a single entity.

• Creates economic leverage with vertical integration of database and management

EDINBURGH, Scotland, Nov. 2, 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, announced today that it has selected of Fortrea (FTRE) as the Company's Contract Research Organization (CRO) for global trials, including ACHIEVE and ACHIEVE2.

The trials, in the UK and US respectively, will be managed by Fortrea on an ongoing basis, creating a vertically integrated clinical trial program which allows for increased operational efficiencies, resulting in better data management and review as well as value creation. TC BioPharm expects to generate cash savings through the creation of these efficiencies by consolidating CRO services under a single entity.

"Fortrea is a leading global CRO who we believe brings a wealth of knowledge and experience that is expected to increase the likelihood of success in both ACHIEVE and ACHIEVE2," said CEO Bryan Kobel. "By consolidating these trials under a single CRO we have established a unified database for the trial management, removed potential miscommunication issues, and eliminated an onerous cost structure, which we believe will create cost savings. We appreciate Fortrea taking on these exciting trials with us and look forward to data read outs in 2024."

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

FAQ

Who has TC BioPharm selected as its Contract Research Organization (CRO) for global trials?

TC BioPharm has selected Fortrea as its CRO for global trials.

Which trials will be managed by Fortrea?

Fortrea will manage the ACHIEVE and ACHIEVE2 trials.

What is the goal of creating a vertically integrated clinical trial program?

The goal is to increase operational efficiencies and improve data management.

How does TC BioPharm expect to generate cash savings?

TC BioPharm expects to generate cash savings by consolidating CRO services under a single entity.

When can we expect data read outs from the trials?

Data read outs from the trials are expected in 2024.