Intezyne, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, has partnered with Exosome Diagnostics, a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics, to design and validate an assay for use in Intezyne's upcoming phase 1/2 clinical trials of IT-139, a novel Cancer Resistance Pathway (CRP) inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies.

"In order to optimize further clinical development of our novel CRP inhibitor, IT-139, we need a biomarker to stratify patients into potential responders and non-responders," said E. Russell McAllister, CEO. "After evaluating a number of potential partners and technologies, we selected Exosome to design and validate a GRP78 assay using their proprietary exosomal RNA platform technology."

"We are excited to leverage our patented ExoLution isolation kit, a cGMP-grade exosome RNA isolation platform, that provides increased sensitivity to develop a companion diagnostic for IT-139," stated John Boyce, president and CEO for Exosome Diagnostics. "Exploiting a novel mechanism of action, Intezyne's IT-139 has demonstrated remarkable potential to mitigate pan-cancer drug resistance. We are thrilled to utilize our leading expertise in the liquid biopsy field, potentially enabling such a promising therapeutic breakthrough."

Intezyne's IT-139 is a novel CRP inhibitor for the treatment of pancreatic, gastric and other cancers in combination with existing anti-cancer therapies. IT-139 successfully completed a Phase 1 monotherapy study and was granted an Orphan Drug Designation (ODD) in pancreatic cancer. Additional ODDs are expected in the next 18 months. Intezyne is currently manufacturing IT-139 and expects to initiate one or more combination phase 1/2 studies by early 2019.