On October 7, 2020 OncoNano Medicine, Inc. reported positive results from its ongoing Phase 2a study of ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors (Press release, OncoNano Medicine, OCT 7, 2020, View Source [SID1234568201]). The data, presented today at the World Molecular Imaging Congress (WMIC) Virtual 2020, demonstrate successful imaging of various solid tumors.
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"As low pH is a hallmark of all solid tumors, our novel imaging agent ONM-100 has the potential to become a useful tool for successful tumor resection surgeries," said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. "These data indicate that ONM-100 was well-tolerated and was able to visualize various solid tumor types. We are encouraged by these findings and are excited to continue developing ONM-100 to address this persistent and challenging unmet need in detection of cancer."
OncoNano is currently enrolling patients in the Phase 2a trial to further evaluate the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile of ONM-100. More information can be found at ClinicalTrials.gov
Presentation Overview
TITLE: Image Guided Robotic Prostatectomy Using the pH-Activated Micellar Imaging Agent ONM-100 – A Phase 2 Study of Tumor and Camera Agnostic Detection of Solid Cancers
PRESENTER: Aditya Bagrodia, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center
Results announced today are based on 16 patients with various cancers (4 breast, 5 head and neck, 6 prostate and 1 ovarian), all of whom received a single intravenous dose of ONM-100 the same day as, or previous to the day of surgery. The findings indicate that ONM-100:
Is well tolerated at doses 3X higher than doses administered in Phase 1
Detects pathologically confirmed tumor regions through the prostatic capsule, indicating imaging feasibility during robotic prostatectomy
Demonstrates ability to provide fluorescence signals even within a few hours after dosing, which combined with a half-life > 55 hours enables a wide imaging window
Can feasibly image breast, head and neck, prostate, and ovarian cancers.
About ONM-100
ONM-100 is OncoNano’s lead product candidate under development. ONM-100 utilizes a proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM‑100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag activation. This has the potential to make tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas (CPRIT).