Our broad platform technology allows us to design specific therapies to treat a broad range of cancers and infectious diseases with "off the shelf” allogeneic gamma delta T cell (GDT) products. Unlike other CAR-T platforms, destruction of target cells is controlled by the innate endogenous kill-switch, augmented by power of synthetic transgenes for more effective targeting and armoring. Tolerance of off-tumor target expression allows for targeting of tumor-associated antigens previously considered impossible.
Our stepwise approach to clinical development has enabled TC BioPharm to take a logical, safer and more agile approach to our clinical trials. By starting with an autologous, unmodified gamma delta product, we were able to establish safety prior to entering the clinic in 2018 with our unmodified allogeneic product. Now, our focus is on clinical development and refinement of products based on the ideal GDT vehicle with a proprietary genetic CAR-T arsenal to fight a range of cancers.
TCB002 is an unmodified allogeneic gamma delta T cell product, being initially used for the treatment of Acute Myeloid Leukaemia (AML). This product is currently undergoing a phase 1 clinical trial as part of a dose escalation and safety study, in partnership with ÚKHT, Institute of Hematology and Blood Transfusion, Prague.
AML is a cancer characterized by infiltration of the bone marrow, blood, and other tissues by proliferative, clonal, poorly differentiated cells of the hematopoietic system.
TCB003 is an allogeneic CAR-T product using engineered GDTs from healthy donors and specifically targets CD19, which is highly expressed on a number of B cell malignancies. These malignancies, such as acute lymphoblastic Leukaemia (ALL) or diffuse large B cell lymphoma (DLBCL) arise when B cells replicate uncontrollably within the bone marrow, before progressing to the blood and circulatory system. Using the safety check of the gamma delta TCR, we have produced an allogeneic CAR-T product with significantly improved therapeutic index.
TCB004 is a gamma delta CAR-T product for the treatment of AML redirected against an undisclosed target antigen. The co-stim CAR structure on TCB004 prevents toxicity against healthy cells and is ideally suited for targeting AML where finding a target ubiquitously and exclusively presented on diseased cells has so far proved impossible.
AML is a cancer characterized by infiltration of the bone marrow, blood, and other tissues by proliferative, clonal, poorly differentiated cells of the hematopoietic system and is predicted to affect 22,000 people per year in the US.
TCB005 is an allogeneic CAR-T product which targets B7-H3 (also known as CD276). B7-H3 expression has been detected in a wide range of solid tumors including lung, breast, colorectal, liver and skin cancers. It has also been observed on tumor vasculature and stroma, has been hypothesized to be an immune checkpoint and to be expressed on cancer stem cells, making it promising target for the treatment of metastatic disease.
The broad B7-H3 expression means there is a scope to help a large number of patients across many cancer types.
TCB006 is an allogeneic CAR-T product targeting B7-H4 for the treatment of cancers arising from solid tumors. B7-H4 antigen is overexpressed in breast cancers, especially triple negative breast cancer, and ovarian cancers, both diseases with acute clinical needs. There are 270,000 new cases of breast cancer and 23,000 new cases of ovarian cancer per year in the US. It is also implicated in cancers associated with infection by Epstein-Barr Virus (EBV). Previous efforts to target B7-H4 expression have been limited by off-tumor toxicity which makes it an ideal candidate for GDTs with a Co-stim CAR. Additionally, B7-H4 is a potential cancer stem cell marker in esophageal squamous cell carcinoma – this may permit targeting of the tumor initiating compartment.
TCB007 is an unmodified allogeneic gamma delta T cell product, being used for the treatment of COVID-19. This product is at the CTA application stage and is expected to enter phase 1 trials in summer 2020.