Southlake, TX – January 4, 2023 – OncoNano Medicine, Inc. today announced that its lead clinical development candidate, pegsitacianine, a pH-sensitive fluorescent nanoprobe for image-guided cancer surgery, has received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) as an adjunct for the visualization of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.
“We are thrilled to receive breakthrough therapy designation, which underscores the potential of pegsitacianine to alter the paradigm of surgical imaging in oncology,” said Kartik Krishnan, Chief Medical Officer of OncoNano. “Providing real-time feedback, pegsitacianine demonstrates the capacity to identify tumors that may otherwise go undetected.”
The FDA’s Breakthrough Therapy Designation is designed to expedite development and regulatory review of medicines that aim to address a serious or life-threatening condition with showing preliminary clinical evidence demonstrating substantial improvement over existing treatments on one or more clinically significant endpoints. A Breakthrough Therapy Designation provides more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.
Based on the results of an ongoing Phase 2 clinical trial evaluating the safety and efficacy of pegsitacianine following standard of care cytoreductive surgery, pegsitacianine enabled surgeons to detect additional cancerous tissue at a clinically significant rate of >50%. It is estimated that each year in the United States more than 17,000 patients undergo cytoreductive surgery due to metastasis from many different tumor types, including appendiceal, colorectal or ovarian cancer.
Pegsitacianine is an intraoperative fluorescence imaging agent for the detection of cancerous tissue in patients undergoing removal of their solid tumor. Relying on an ultra pH-sensitive activation mechanism of OncoNano’s ON-BOARDTM platform, pegsitacianine exists in a fluorescently dark (“Off”) state at physiological pH but transitions rapidly to a fluorescently “On” state in the presence of the elevated acidic tumor microenvironment. Pegsitacianine’s unique mechanism of action provides it with the potential to function as a tumor-agnostic imaging agent compatible with most clinical cameras designed for ICG imaging across a variety of solid tumor types.
About OncoNano Medicine
OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions 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 immune-oncology therapeutics that activate and guide the body’s immune system to target cancer.
OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at www.OncoNano.com.