Cortalix BV acquires patents and know-how from BiOrion on its single domain antibody platform and fibrogenesis biomarker radiopharmaceuticals.
With these patents and know-how, Cortalix can continue to work on 2 active clinical programs around PET imaging of fibrogenesis, the active stage of organ fibrosis. The company recently completed a first clinical PET imaging study in humans following a basket design clinical trial in patients suffering from organ fibrosis. It was found that especially patients with a history of conditions associated with cardiac fibrosis showed a clear uptake of 68-Gallium-BOT5035 in typical heart regions within 60 minutes after administration, while this was not the case in patients without a history of heart disease. A follow-up phase 2 study will soon start in heart failure patients with conserved ejection fraction (HFpEF). A third phase 2 PET-imaging study is expected to start in Q1 2024 in patients suffering from idiopathic pulmonary fibrosis (IPF) in collaboration with a consortium of US major pharmaceutical companies.
In addition, Cortalix will soon start testing a 2nd generation fibrogenesis PET imaging diagnostic in patients with early-stage NASH/liver fibrosis, in collaboration with a consortium of US pharmaceutical companies and an imaging CRO.
Cortalix is a Dutch biopharmaceutical drug discovery and services company involved in developing targeted radiopharmaceuticals for myofibroblasts-associated diseases, such as hepatic fibrosis, renal fibrosis, cardiac fibrosis, idiopathic pulmonary fibrosis and fibrosis-associated cancers such as colorectal cancer and pancreatic cancer.
Cortalix’s platform and drug development engine is based on proprietary fibrogenesis-receptor-binding (camelid-derived) single domain antibodies. In addition to targeting to PDGFRB, the company is using its single domain antibody discovery engine, to extend development towards novel tracers for other myofibroblasts membrane receptors such as for PDGFRA, EGFR, IGF-1/2R and FAP. Similar to PDGFRB, these receptors are over-expressed on key pathogenic cells, although differently per fibrosis type. For more information about Cortalix: www.cortalix.com
Herman Steen, PhD
CEO Cortalix BV