Exosome Diagnostics is partnering with Intezyne to design and validate a companion diagnostic for the drug developer’s upcoming Phase I/II clinical trials of its cancer treatment IT-139, Intezyne said today.
Exosome Diagnostics plans to apply its proprietary exosomal RNA platform technology toward development with Intezyne of an assay measuring the impact of IT-139 on levels of the glucose-regulated protein GRP78. IT-139 is a novel Cancer Resistance Pathway (CRP) inhibitor designed to inhibit stress reduction of the GRP78 cancer resistance pathway.
Exosome Diagnostics plans to use its ExoLution isolation kit, a cGMP-grade exosome RNA isolation platform toward the planned companion diagnostic for IT-139, a treatment candidate for pancreatic, gastric and BRAF-mutated cancers (including BRAF-mutated melanoma, lung cancer and thyroid cancer) in combination with existing anti-cancer therapies.
IT-139 has successfully completed a Phase I monotherapy study, and is set to launch one or more combination Phase I/II studies by early 2019, Intezyne said.
“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,” Intezyne CEO E. Russell McAllister said in a statement. “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.”
IT-139 has been granted the FDA’s Orphan Drug Designation in pancreatic cancer, with the company expecting orphan drug designations in additional indications over the next 18 months.
IT-139 is one of Intezyne’s two clinical-stage candidates. The other is IT-141, a Phase I nanoparticle formulation of SN-38, the active metabolite of irinotecan, a chemotherapy treatment marketed as Camptosar® by Pfizer. IT-141 uses Intezyne's proprietary nanoparticle technology (IVECT) to deliver SN-38, an topoisomerase-1 (TOP-1) inhibitor, directly to tumors.
Founded in 2004, Intezyne is headquartered at the University of South Florida (USF) Tampa Bay Technology Incubator. In October 2017, Intezyne closed an oversubscribed $10M Series A Preferred round
Exosome Diagnostics is a developer of biofluid-based tests for cancer and other diseases, and is headquartered in Waltham, MA. In July 2017, the company raised $30 million in an oversubscribed Series C financing, saying it planned to use the proceeds to support rapid commercial expansion of its ExoDx Prostate(IntelliScore) and other oncology tests—as well as apply its proprietary technologies toward developing tests for areas that include neurodegenerative diseases, transplant rejection monitoring, and cardiology.