OncoNano Announces Dosing of Patients in Phase 1 Clinical Trial with ONM-100, an Intraoperative Imaging Agent that Targets Tumor Acidosis for the Detection of Solid Tumors

OncoNano
Medicine, Inc. today announced the initiation of its Phase 1
clinical trial evaluating ONM-100 as an injectable imaging agent to
detect tumors and metastatic lymph nodes in solid cancers during
surgery. The Phase 1 trial is being conducted at Tracer Center of
Expertise, University Medical Center Groningen (UMCG) in Groningen, The
Netherlands.

Surgery remains a main pillar for the treatment of most solid tumors
today, including breast cancer, head and neck squamous cell carcinoma
(HNSCC), esophageal cancer and colorectal cancer, with postoperative
margin status being one of the most important prognostic factors to
determine the chance for recurrent disease or tumor metastasis. Despite
the growing options in imaging modalities, techniques such as CT, MRI or
ultrasound used for intra-operative navigation do not provide feedback
in real-time during surgery and surgeons must rely upon pre-operative
imaging data with tactile and visual information during surgery.

Since cancers are known to be more acidic than healthy tissue,
OncoNano’s SHINe study is evaluating ONM-100, which targets the acidic
pH environment within tumors to provide surgeons with a method to assess
lymph nodes and tumor margins in real-time during surgery. ONM-100
features a digital on-off response to pH changes – switching on in the
tumor’s acidic environment and remaining off in blood circulation and
normal cells. By accurately distinguishing cancer cells from healthy
tissues during surgery, ONM-100 has the potential to eliminate the
“guesswork” often associated with the removal of tumors.

“While it is established that pH is a strong biomarker that can be used
to distinguish cancer cells from healthy tissue, it has not been fully
explored until now as a way to image, diagnose or treat tumors with
therapeutic agents,” said Ravi Srinivasan, Ph.D., founder, President and
Chief Executive Officer of OncoNano Medicine. “The initiation of our
Phase 1 trial for tumor and lymph node detection is a tremendous
milestone toward addressing the unmet need of enhanced visualization of
tumors during surgery and sets the stage for us to reach our ultimate
goal of improving patients’ lives.”

The SHINe study is an open-label, single center clinical trial to
evaluate the safety , pharmacokinetics (PK) and imaging feasibility of
ONM-100 in patients with solid cancers that require surgical excision.
The study contains two parts – dose escalation and dose expansion. Phase
1a will be performed in a dose-escalating design to determine the range
of optimal doses of ONM-100 that are safe and provide adequate contrast
to noise ratio in detecting tumors in cancer patients undergoing surgery
with breast cancer and HNSCC. The dose expansion will occur in Phase 1b
to further characterize safety, PK and imaging at the dose selected from
phase 1a.

“We are extremely pleased to be part of this clinical study that has the
future potential to bring about important changes in optical imaging of
cancer,” said Dr. G.M. Van Dam, professor of surgery and principal
investigator at UMCG and CEO of TRACER EUROPE BV. “Being able to
accurately visualize and differentiate healthy tissue from cancer cells
during surgery is critical and despite tremendous advances in cancer
diagnostics and treatment, there is still an unmet need in getting
real-time information during surgery on whether you were able to remove
all the diseased tissue.”

About OncoNano MedicineOncoNano 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. Our lead program, ONM-100, targets tumor acidosis to accurately
differentiate cancer from healthy tissue for use in surgery. www.onconanomed.com

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