OncoNano to Present Poster on First-in-Human Study of pH-Activated Platform for Detection of Solid Tumors During Surgery at 2019 ASCO Annual Meeting

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:

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
intra-operative imaging based on its pH-sensitive micelle technology.
www.onconanomed.com

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