PJSC “pharmsynthez” and the American biopharmaceutical company Xenetic Biosciences Inc. entered into an agreement to conduct clinical stages of technology development XCART as a means of dealing with b-cell malignancies. Under the agreement, the “farmsintez” will act as the main research organization, which coordinates the activities of project participants during the whole period of cooperation. Expected start of clinical trials in 2021.
Member of an international research group was composed of the largest research institutes Russia and USA and Institute of Bioorganic chemistry. Shemyakin and Ovchinnikov (IBCH RAS) and Institute of SCRIPPS (Scripps Research, San Diego, CA).
The initial stage of clinical trials involves a preliminary evaluation and refinement of the process of recognition of target cells, screening, and baseline use XCART in a real clinical setting. At this stage, will be carried out recruitment of patients primarily with malignant B-cell lymphomas, to obtain samples of the tumor, determining the molecular-genetic profile of the tumor of each patient and customize the interface with XCART based on the identified features. Plan the clinical phase I studies can also be expanded to include the development of production processes for autologous (self) T-cells from these patients.