ONM-100 was able to detect occult disease which was otherwise missed by standard surgery and pathology
No ONM-100 related serious adverse events observed for all 30 patients enrolled in trial
SOUTHLAKE, TX. – May 23, 2019 – OncoNano Medicine, Inc. announced today that data from its first-in-human study of ONM-100, an intravenously administered imaging agent, was well tolerated and enables fluorescent visualization of tumor positive margins and occult disease in solid tumors during surgery. The full results will be presented in a poster at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 31 to June 4, 2019.
Low pH is a well-known indicator of diseased tissue and ONM-100 has the potential to act as a broadly indicated tumor agnostic imaging agent. ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which enables surgeons to visualize the tumor during surgery using existing near infrared surgical cameras. OncoNano recently concluded a Phase 1 clinical trial for ONM-100 at the University Medical Center Groningen (UMCG) in The Netherlands with principal investigator Professor Go van Dam. The OncoNano micelle platform is also being used to develop therapeutics, including T-cell activating agents that target lymph nodes and dendritic cells, as well as immunomodulation of the tumor micro-environment.
“pH is a simple and robust biomarker to distinguish cancer cells from healthy ones, but until now, there has not been a way to accurately visualize tumors broadly using tumor acidity in real-time during surgery and incomplete tumor resection can result in cancer recurrence and metastasis. We are thrilled with the results of our Phase 1 study which clearly demonstrated that surgeons were able to detect tumor margins and occult disease which was otherwise missed by standard of care surgery and pathology, and we look forward to expanding our trial later this year,” said Ravi Srinivasan, Ph.D, founder, President and Chief Executive Officer of OncoNano.
Poster Presentation Details and Study Results:
TITLE: Image-guided surgery for tumor agnostic detection of solid tumors using the pH-activated micellar imaging agent ONM-100
POSTER: Poster Board: #60; Abstract 3068
DATE /TIME: Saturday, June 1, 2019; 8:00 am – 11:00 am CT
The trial found that no ONM-100 related serious adverse events were observed and the agent was well tolerated in all 30 patients with histopathologically confirmed breast cancer, head and neck squamous cell carcinoma, colorectal cancer and esophageal cancer who were enrolled in the study. This first-in-human data demonstrate the feasibility for potential use of ONM-100 for image guided surgery, margin assessment and detection of occult disease. Tumors in four patients with breast cancer or head and neck squamous cell carcinoma that went unnoticed during surgery were detected on the margin or wound bed using ONM-100 fluorescence imaging. Additionally, two breast tumor lesions that were missed by conventional pre-operative imaging and pathological assessment were detected with ONM-100.
About OncoNano Medicine
OncoNano Medicine is developing a new class of pH-activated compounds that digitalize and exploit the variability of pH in disease. pH variability is a proven, simple and effective identifier of diseased tissue providing a foundation for the development of a broad range of highly targeted therapeutics and imaging agents. OncoNano is the first company to advance product candidates using pH as a biomarker for cancer immunotherapy, therapeutic use and intraoperative imaging based on its pH-sensitive micelle technology.