The PB004 project presents a novel therapeutic concept for the treatment of solid tumors and leukemia, in which a bispecific drug molecule stimulates tumor infiltrating NK cells (natural killer cells) to destroy tumor cells that have a tumor-related antigen on their surface – the ROR-1 protein.
Pure Biologics has signed a research agreement with The Jackson Laboratory, a leading US animal research services company operating worldwide, to launch the first in vivo preclinical pilot study in the PB004 project.
The main goal of the pharmacokinetic study in collaboration with The Jackson Laboratory is to generate data that can help predict the half-life of the PB004 molecule in cancer patients. The circulating half-life of antibodies (including therapeutic antibodies) and human serum albumin in the bloodstream is determined by the neonatal Fc receptor (FcRn) on the cells lining the blood vessels. For this reason, the pharmacokinetics of PB004 will be invstigated in genetically engineered mice bearing human FcRn and lacking the murine albumin counterpart.
Pure Biologics’ management expects the study to begin in early May, 2022, and will last approximately two months.
“In vivo research is a key milestone in the preclinical development of PB004. The results of the experiment will have a major impact on drug dosing in patient dosing and will be an important parameter for designing the clinical development of PB004” – says Dr. Peter Spee, Chief Scientific Officer at Pure Biologics.