Periodic Reporting for period 2 - OmnImmune (Manufacturing and testing of an allogeneic gamma delta T cell therapy for the treatment of cancer) Okres sprawozdawczy: 2018-10-01 do 2019-09-30 Podsumowanie kontekstu i ogólnych celów projektu The overall project objective was to accelerate the development of the Gamma Delta T (GDT) cell therapy OmnImmune®. The aim was to manufacture, test and characterise a cell bank of allogeneic GDT cells and conduct phase I dose-escalation clinical trial to determine safety of allogeneic GDT cell treatment. The expected outcome was a validated, clinical grade allogeneic GDT cell bank and established safety profile of OmnImmune®. The project was supported by funding from the European Union’s Horizon 2020 (H2020) Research and Innovation program via a €4million grant, the largest such EU award to any UK company for development of a healthcare therapeutic product. Prace wykonane od początku projektu do końca okresu sprawozdawczego oraz najważniejsze dotychczasowe rezultaty TC BioPharm (TCB), a developer of Gamma Delta T (GDT) cell therapies, completed formulation of its first allogeneic GDT cell banks. The GDT cell banks provide TC BioPharm with core technology to develop a deep portfolio of next-generation cell therapy products directed against a wide variety of different cancer types, both hematological and solid tumors. OmnImmune® comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. The donors are selected based on criteria designed to ensure that the cells are potent killers of cancer cells, and can be a more effective and consistent treatment compared to the patient’s own cells. GDT cells are a subset of lymphocytes which have both innate and adaptive immune properties and represent an emerging therapeutic option for cancer and other diseases. Use of allogeneic GDT cells from healthy donor cell banks paves the way for development of superior drug products through screening and selection of the highest quality starting material, facilitating preparation of consistent batches capable of treating many patients.Benefitting from H2020 support, TCB has been rapidly progressing its clinical evaluation of allogeneic therapies. TCB initiated a Phase I clinical study of OmnImmune®. The trial, for treatment of patients suffering from Acute Myeloid Leukemia (AML), is being conducted at the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, Czech Republic with additional clinical sites planned for opening in the UK in 2020. Patient recruitment commenced January 2019 following regulatory approval late 2018. Dose escalation is in progress. The clinical trial is registered with identifier NCT03790072.The first human trial of OmnImmune® is an ICH GCP compliant, open-label single arm study expected to enroll 9 patients, with three escalating doses of the drug product. Cancer patients in the study are suffering from relapsed or refractory AML and are ineligible or non-consenting to a stem cell transplant. The product is manufactured at TCB’s GMP-compliant manufacturing site in the UK using cells sourced from healthy allogeneic donors. Innowacyjność oraz oczekiwany potencjalny wpływ (w tym dotychczasowe znaczenie społeczno-gospodarcze i szersze implikacje społeczne projektu) The realization of this project is the product of our unwavering commitment to translating potential of Gamma Delta T cells to benefit patients. Collaborating with clinical centres in Europe on clinical evaluation of Advanced Therapy Medicinal Products (ATMP) allows us to offer experimental options to patients with acute clinical need, and builds upon our position of expertise with pioneers of cellular immuno-oncology products. Treatment of the first patients with OmnImmune® represents the culmination of a concerted collective effort from our in-house product development, quality, manufacturing, regulatory and clinical teams, as well as the expert physicians at the clinical centre. We are now focused on successful completion of this trial and the progression of our gamma delta T cells products to treat further patient groups with unmet clinical needs, as part of our strategic plan of delivering allogeneic cell medicines as mainstream cancer therapies. Availability of clinical-grade allogeneic Gamma Delta T cell banks is an important commercial milestone for TC BioPharm. This allows us to transition our therapeutic approach from expensive and complex personalized therapy using patient’s own cells (autologous), to a more cost-effective ‘pharmaceuticalized’ approach.” Using allogeneic material from healthy donors offers several advantages over conventional autologous therapies. Additionally, a larger population of cancer patients can be treated with a single reproducible product, ‘campaign-manufactured’ in bulk to keep costs lower, consequently increasing accessibility and reducing financial burden for healthcare systems. Allogeneic T Cell Immunotherapy Clinical Team TCB alphabeta depletion TC BioPharm Logo OmnImmune Main Concept and target applications
