30 August

Project PB001 – completion of the first pilot preclinical study

Pure Biologics has completed its first pilot preclinical study for the development of a completely novel immuno-therapy for the treatment of colorectal cancer. According to the hypothesis, the PB001 project aims to develop a bispecific antibody that simultaneously engages TIM-3 on tumor-infiltrating lymphocytes and a yet undisclosed tumor-antigen on cancer cells. The primary aim of the study in mice with implanted human immune system was to assess safety and the secondary aim was to monitor for early signs of drug-induced immune-responses targeted against engrafted tumors.

“No symptoms of acute toxicity or major histopathological changes were observed during repeated dosing of a model PB001 test compound, with doses up to 250 mg/kg over 48 days in normal mice. Also in tumor-challenged mice, the tested compound appeared safe at the highest dose for 28 days. Therefore, we concluded that simultaneous targeting of TIM-3 and the undisclosed tumor antigen appears safe. Analyses of biomarkers in blood indicated that the model test compound activates the immune system, but we’ve got to further investigate that in broader studies to better understand the mechanistic aspects.” – says dr. Pieter Spee, Chief Scientific Officer at Pure Biologics.

“In conclusion, the results of this pilot study support further development of PB001 for the treatment of solid tumors. Based on these results, the Company will intensify its focus on the development and preclinical testing of selected PB001 lead compounds in the upcoming year. Also, the experience gained is valuable, as it will positively impact the upcoming preclinical studies in our other immune-oncology projects, the PB003 and PB004.” – summarises dr. Filip Jelen, Chief Executive Officer of the company.

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