TC Biopharm

TC BioPharm is a clinical-stage biopharmaceutical company that develops allogeneic gamma-delta T-cell (GDT) therapies for cancer and infectious diseases. The company was co-founded in February 2014 by Dr. Michael Leek and Angela Scott. Dr. Leek has 30 years of experience in regenerative medicine, taking multiple cell-based products to clinical trials. Scott has over 37 years of experience in cell therapy production and was part of the team that cloned 'Dolly the Sheep'. Their shared interest in the therapeutic potential of GDT cells led to the formation of the company.

TC BioPharm is publicly traded and became the first Scottish biotech listed on the Nasdaq. The company's core business revolves around its proprietary allogeneic gamma-delta T-cell platform. This involves sourcing GDT cells from healthy donors, expanding them into large quantities, and creating "off-the-shelf" therapies that can be banked and frozen for later use. This allogeneic approach avoids graft-versus-host disease, a common complication in cell therapies, and allows for a more consistent and cost-effective manufacturing process compared to autologous therapies that use a patient's own cells. The business model focuses on an integrated approach, controlling critical elements of drug development from preclinical research in its own facilities to managing its own clinical trials.

The company's lead product candidate is OmnImmune®, an unmodified allogeneic GDT cell therapy. It is currently in Phase 2b clinical trials, known as the ACHIEVE trial, for the treatment of relapsed or refractory Acute Myeloid Leukemia (AML). The therapy has shown a promising safety profile in trials, with no significant drug-related adverse events reported. TC BioPharm is also developing Chimeric Antigen Receptor (CAR) T-cell therapies, which genetically modify GDT cells to enhance their ability to target specific cancers, including a focus on ovarian cancer. The company has received orphan drug status from the FDA for its treatment method for AML.

Keywords: allogeneic cell therapy, gamma-delta T-cells, CAR-T, cancer treatment, immunotherapy, Acute Myeloid Leukemia, clinical-stage biopharmaceutical, off-the-shelf therapy, OmnImmune, oncology, infectious diseases, cell-based products, regenerative medicine, clinical trials, GMP manufacturing, drug development, biotechnology, hematological cancers, solid tumors, therapeutic platform