On May 31, 2023 OncoNano Medicine, Inc. reported that it will present positive final results from its Phase 2 study of pegsitacianine, a pH-sensitive fluorescent nanoprobe for enhanced intra-operative visualization of cancer, in a podium presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2023 (Press release, OncoNano Medicine, MAY 31, 2023, View Source [SID1234632279]). Results of the study show that acidic pH is a viable marker and can be used for tumor targeting by the company’s ON-BOARD micelle platform.

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Pegsitacianine has been studied in more than 135 patients across multiple tumor types, including peritoneal metastatic, breast, head and neck, colorectal, esophageal, ovarian and prostate cancers. Results show that pegsitacianine is able to localize different tumor types regardless of their histology or anatomic location. The ON-BOARD platform, therefore, is able to target solid tumors, deploying its payload specifically within the acidic tumor microenvironment (TME).

"We are encouraged by this data as it demonstrates the potential of pegsitacianine to augment the visualization of cancer during an operation, which has the potential to be a significant advance in real-time surgical imaging," said Kartik Krishnan, M.D., Ph.D., Chief Medical Officer of OncoNano Medicine. "We look forward to taking pegsitacianine to the next levels of development and continue our mission to diagnose and treat cancer with high specificity."

The results of this Phase 2 study reveal that pegsitacianine was well tolerated and that 20 of 40 evaluable patients (50%) had pathology-confirmed disease resected, that was not resected in the planned standard of care surgery, under pegsitacianine guidance. Approximately 25% of patients experienced a pegsitacianine-related adverse event, which was a transient, selfresolving, non-anaphylactic infusion-related reaction.

"We were highly encouraged with the results observed in this Phase 2 trial and look forward to validating these findings in the upcoming Phase 3 trial," said Patrick Wagner, M.D., lead author and Director of Complex General Surgical Oncology, Allegheny Health Network Cancer Institute. "The results demonstrate that acidic pH is a viable tumor agnostic marker and highlight pegsitacianine’s ability to target different tumor types regardless of their genotype or anatomic location."

"This Phase 2 data brings new hope to both clinicians and patients," said Charles M. Balch, M.D., former EVP and Chief Executive Officer of ASCO (Free ASCO Whitepaper) and present Chair of the Scientific Advisory Board at OncoNano Medicine. "Having demonstrated the capacity to identify tumors that were previously not clinically visible to surgeons, pegsitacianine has the potential to improve the accuracy of staging and surgical outcomes, while reducing operating time for several types of abdominal cancers. Newer versions in the pipeline have great potential to expand therapeutic targets and enable new combinations of drugs previously hindered by toxicity."

Presentation Overview:

TITLE: Detection of peritoneal metastases during cytoreductive surgery using pegsitacianine, a pH sensitive imaging agent: Final results from a phase 2 study
PRESENTER: Patrick Wagner, MD, Director of Complex General Surgical Oncology, Allegheny Health Network Cancer Institute
DATE: June 5, 2023