OncoNano Medicine is a Southlake, Texas–based medical company that exploits pH as a biomarker to diagnose and treat cancer. Its product portfolio includes 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. The company is developing pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors. It also is advancing an internal therapeutic development program, ONM-501, a novel immune-therapeutic formulated with its core delivery technology. OncoNano intends to use the funds to support Phase 3 clinical trials in the U.S. and Europe for pegsitacianine and to accelerate advancement of ONM-501. The company is led by CEO Martin Driscoll. OncoNano Medicine develops products that exploit pH as a biomarker to diagnose and treat cancer, centered on a proprietary pH-activated micelle platform. Its lead candidate, pegsitacianine, is a fluorescent nanoprobe under study as a real-time intraoperative imaging agent for solid tumor resection and is in Phase 2 trials. The company is also advancing ONM-501, a next-generation dual-activation STING agonist immuno-therapeutic, toward first-in-human studies. Proceeds from the recent financing will support initiation of pivotal Phase 3 trials of pegsitacianine in the U.S. and Europe and help accelerate ONM-501 through IND submission and Phase 1a/1b trials. OncoNano says the Series B funds combined with support from the Cancer Prevention & Research Institute of Texas will provide resources to operate for several years and advance pegsitacianine toward commercialization. The company is based in Southlake, Texas. OncoNano’s lead product, ONM-100, uses a pH-sensitive micelle platform that activates a fluorescent tag in the acidic tumor microenvironment to enable intraoperative imaging of solid tumors. ONM-100 is in Phase 2 clinical trials and has received FDA Fast Track designation. During trials the company found ONM-100 can also image and stage metastatic disease, and the company plans to expand its application to identify metastatic deposits in the peritoneum, lymph nodes and pleural surfaces. OncoNano also advances ONM-500, a candidate that leverages the same micelle technology to deliver antigens and activate innate immunity for HPV-associated cancers. The company has received multiple CPRIT awards to support development of these programs. OncoNano is based in Southlake, Texas. OncoNano Medicine is developing a platform of pH-sensitive micelles that detect diseased tissue and enable targeted imaging and therapeutic applications. Its lead product, ONM-100, is an intravenously administered intraoperative imaging agent that detects tumors and metastatic lymph nodes. The company completed a Phase 1 trial of ONM-100 that reported a 100% imaging response in patients and has an IND accepted by the FDA; ONM-100 is entering a Phase 2 clinical trial and a separate application received Fast Track designation. OncoNano is applying the same micelle platform to therapeutic candidates, including a T-cell activator that targets lymph nodes and dendritic cells, and exploring cancer vaccine applications. Proceeds from the recent financing are intended to fund the imaging clinical trials and support expansion into therapeutic programs. OncoNano Medicine develops a new class of pH-activated compounds that digitalize and exploit pH variability to detect and treat diseased tissue. Its lead program, ONM-100, is an injectable imaging agent designed to target acidic pH within tumors to help surgeons distinguish cancer from healthy tissue in real time during surgery. ONM-100 is intended to fit seamlessly with current surgical practices for intraoperative assessment, cancer staging, and post-surgery evaluation of lymph nodes and tumor margins. The company announced a $11.7 million Series A financing to support continued clinical development of the platform and to expand applications across therapeutics and imaging agents. This Series A supplements a prior $6 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The platform’s technology was invented at the University of Texas Southwestern Medical Center, and the inventors remain engaged on the company’s scientific advisory board. OncoNano also appointed five established industry leaders to its board to support its clinical and commercial progress.

Total raised

$114M

Funding rounds

5

Latest round

Series B

Latest activity

Oct 2021