On June 7th, 2022, Pure Biologics commenced its first pilot preclinical study in the PB004 project developing a potential drug for the treatment of solid tumors and leukemia.
PB004 is a novel therapeutical concept that stimulates tumor-infiltrating Natural Killer (NK) cells and macrophages to kill cancer cells that express the tumor-associated antigen (TAA) ROR-1. The primary aim of the study is to generate data that can help to predict the half-life of PB004 in cancer patients.
The pharmacokinetic profile of antibodies and serum albumin is determined by the neonatal Fc receptor (FcRn) expressed on cells lining blood-vessels. For this reason, pharmacokinetics of PB004 will be studied in B6.Cg- Tg(FCGRT) 32Dcr Albem12Mvw Fcgrttm1Dcr Prkdcscid/J or Tg32 AlbKO SCID mice strain bearing the human FcRn (so called humanized mice). The study will be performed by Jackson Laboratory (Bar Harbor, Maine (USA)).
This study is a first step in preclinical development of PB004 and is a major milestone in the development of PB004. The results of the study will help to determine the dosing of the drug in cancer patients and will therefore be an important parameter for the design of PB004 clinical development – says Dr. Pieter Spee, Chief Scientific Officer at Pure Biologics.