Publication data suggests ONM-100 was safe and provides preliminary feasibility data for use in resection surgery in 4 diverse tumor types
SOUTHLAKE, Texas–(BUSINESS WIRE)–OncoNano Medicine, Inc. announced today the publication of Phase 1 clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging product candidate, ONM-100. The study evaluated safety, pharmacokinetics and feasibility of ONM-100 in image-guided surgery, occult tumor detection and visualization of tumor margins in four different cancer types. Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9 patients in whom histology confirmed tumor positive margins, and also detected occult lesions in an additional 5 patients whose tumors were undetected by standard of care. The research paper, Exploiting metabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescence-guided surgery, will appear in the June 26 issue of Nature Communications.
Surgical resection remains a cornerstone treatment strategy for solid tumors today and incomplete tumor removal can be predictive of cancer recurrence and metastasis. Despite imaging advances, there are no approved imaging options to provide real-time feedback to surgeons that specifically target tumor masses but are agnostic to cancer type. ONM-100, a pH-sensitive micelle conjugated to a fluorescent tag, targets the relatively acidic pH of the tumor microenvironment – a universal biomarker of solid tumors – to precisely label tumor masses. ONM-100 is intravenously administered prior to surgery and visualized during surgery using existing surgical fluorescent imaging equipment. Exploiting this universal biomarker of solid tumors confers the potential for ONM-100 to be used in various cancer types, irrespective of tissue of origin.
“We are extremely pleased to have this critical work published in Nature Communications,” commented Gooitzen Michell van Dam, MD, PhD, CEO of TRACER BV and professor at the University Medical Center of Groningen, Netherlands. As Principal Investigator and corresponding author of the manuscript he states, “ONM-100 was able to detect tumor positive resection margins and several cancerous lesions that standard of care procedures missed in diverse types of solid cancers. We eagerly anticipate seeing ONM-100’s potential further explored in Phase 2 clinical trials.”
“We are delighted to see the scientific community’s validation of ONM-100 that is demonstrated by this acceptance in Nature Communications,” commented Ravi Srinivasan, PhD, Cofounder and CEO of OncoNano. “ONM-100 has the potential to substantially simplify and enhance the effectiveness of tumor resection surgeries, and given its possible tumor-agnostic applications, it may be used in broad patient populations in the future. We look forward to this same pH-sensitive micelle technology being utilized for other oncology applications, such as tumor-specific therapeutic delivery.”
ONM-100 is currently being evaluated in Phase 2 clinical trials in the United States in several unique cancer indications, including breast, ovarian, prostate and colorectal cancers. Learn more about this trial at www.clinicaltrials.gov.
ONM-100 is OncoNano’s lead product candidate that utilizes the 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 expression, making 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.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer. Learn more at OncoNano.com.