Publication of ONM-100 Phase 1
Southlake, TX. – June 26, 2020 – OncoNano Medicine, Inc. announced today the publication of Phase 1clinical trial data in Nature Communications featuring OncoNano’s intraoperative tumor imaging productcandidate, ONM-100. The study evaluated safety, pharmacokinetics and feasibility of ONM-100 inimage-guided surgery, occult tumor detection and visualization of tumor margins in four differentcancer types. Following tumor resection, ONM-100 detected residual tumor positive margins in 9 of 9patients in whom histology confirmed tumor positive margins, and also detected occult lesions in anadditional 5 patients whose tumors were undetected by standard of care. The research paper, Exploitingmetabolic acidosis in solid cancers using a tumor-agnostic pH-activatable nanoprobe for fluorescenceguided surgery, will appear in the June 26 issue of Nature Communications.
Surgical resection remains a cornerstone treatment strategy for solid tumors today and incompletetumor removal can be predictive of cancer recurrence and metastasis. Despite imaging advances, thereare no approved imaging options to provide real-time feedback to surgeons that specifically targettumor masses but are agnostic to cancer type. ONM-100, a pH-sensitive micelle conjugated to afluorescent tag, targets the relatively acidic pH of the tumor microenvironment – a universal biomarkerof solid tumors – to precisely label tumor masses. ONM-100 is intravenously administered prior tosurgery and visualized during surgery using existing surgical fluorescent imaging equipment. Exploitingthis universal biomarker of solid tumors confers the potential for ONM-100 to be used in various cancertypes, irrespective of tissue of origin.
“We are extremely pleased to have this critical work published in Nature Communications,” commentedGooitzen Michell van Dam, MD, PhD, CEO of TRACER BV and professor at the University Medical Centerof Groningen, Netherlands. As Principal Investigator and corresponding author of the manuscript hestates, “ONM-100 was able to detect tumor positive resection margins and several cancerous lesionsthat standard of care procedures missed in diverse types of solid cancers. We eagerly anticipate seeingONM-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 thisacceptance in Nature Communications,” commented Ravi Srinivasan, PhD, Cofounder and CEO ofOncoNano. “ONM-100 has the potential to substantially simplify and enhance the effectiveness oftumor resection surgeries, and given its possible tumor-agnostic applications, it may be used in broadpatient populations in the future. We look forward to this same pH-sensitive micelle technology beingutilized 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 uniquecancer indications, including breast, ovarian, prostate and colorectal cancers. Learn more about this trialat www.clinicaltrials.gov.
About ONM-100
ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform toencapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidicpH of the tumor microenvironment – to intraoperatively image tumors. ONM-100 micelles remaininactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelledissociation and fluorescent tag expression, making tumors visible during surgery with standard surgicalimaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded forclinical 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 diagnoseand treat cancer with high specificity. Our product candidates are designed to help patients across thecontinuum of cancer care and include solid tumor therapeutics, agents for real-time image-guidedsurgery and a platform of product candidates that activate and guide the body’s immune system totarget cancer. Learn more at OncoNano.com.
Contact
Lauren Arnold
MacDougall
larnold@macbiocom.com
781-235-3060
