On September 19, 2022, Pure Biologics made an important next step in its PB003 drug development project. In collaboration with Jackson Labs (Bar Harbour, MN, USA) a first animal study has been initiated to test the unique therapeutic concept of PB003 for cancer treatment.
The aim of the study is to test the design of the PB003 therapeutic molecule for pharmacokinetics (PK) and tolerability.
The study will determine the half-life of the PB003 model compound in blood, as well as safety aspects, when given in two different doses. The study results will yield important information for estimating stability and safety profile of highly innovative PB003 molecule format in cancer patients.
The importance of the study is commented on by Dr. Monika Litwin, Project Manager of PB003
“The half-life of antibodies, including therapeutic antibodies, in the human bloodstream is determined by the neonatal Fc receptor (FcRn) present on blood vessel cells. The pharmacokinetics of the model molecule will be tested in genetically modified mice expressing human FcRn., which will allow us to estimate the half-life of the construct we are working on in the human body, and thus better prepare for the next stages of the project – a clinical trial. “
dr Pieter Spee, Chief Scientific officer and Vice President of the Board at Pure Biologics S.A. adds:
“This study brings PB003 to the in vivo phase, which is a very important step in drug development. The study results will provide the PB003 development team with important information on how to design the optimal dosing regimen for cancer treatment, that yields maximum anti-tumor efficacy: a dosing that is therapeutically efficacious in cancer patinets yet safe.“
PB003 is one of the company’s key projects and aims to develop a dual-action therapeutic antibody that 1) eliminates regulatory immuno–suppressive T lymphocytes (Treg) in the tumor microenvironment and 2) stimulates cytotoxic NK and T immune cells to kill cancer cells directly.
The PB003 therapeutic concept has been designed with very clear improvements over therapeutic concepts that have recently been tested successfully in early clinical development. As such, the PB003 is a very promising drug concept with a very strong competitive edge for commercialization in the cancer market.