1 out of 7
Up to 50% have severe side effects
Up to 40% have recurrence
Prostate cancer is the most frequently diagnosed cancer among men in the United States. Nearly 91% of prostate cancers first detected in men are estimated to be clinically localized, qualifying these patients as potential candidates for radical prostatectomy. Surgery, however, often incurs major side effects, including incontinence and impotence and often prostatectomies fail to achieve a surgical cure. Innovations such as minimally invasive and robotic surgery simplified and improved the procedure, yet the clinical need is still unmet. Evolving therapy guidelines delay surgeries until the disease progresses, complicating surgical procedures. When surgery fails to cure the disease, radiation and chemotherapy are prescribed adding to side effects of the procedure. Today, this occurs in over 50% of cases.
Exo-413 is designed as a dual-purpose agent, that both fluoresces cancerous tissue to facilitate curative surgery and also ablates remaining malignant cells beyond the edge of the tumor. It is an injectable to be administered before surgery and dovetails with current surgical workflow.
Exo-413 is highly selective for the PSMA receptor, which is almost exclusively overexpressed on prostate cancer cells, and is rapidly taken up. This eliminates off-target binding and precisely defines tumor tissues for surgery.
EXO-413 fluoresces in response to excitation by light, highlighting the tumor and enabling image guided surgery. Suitable light sources are standard on many intraoperative imaging systems already on the market.
Subsequent to tumor resection, the surgeon will irradiate the intraoperative field with higher intensity light, activating remaining probe and producing reactive oxygen species that lead to cell death of any remaining cancer cells.
Image Guided Surgery
Image guided surgery (“IGS”) can potentially improve outcomes by guiding surgeons to the area of interest using radiopharmaceuticals or imaging agents. As an optical fluorescence agent, Exo-413 could provide real-time guidance to surgeons on the exact margins of the tumor. Since the agent exquisitely binds to tumor-specific biomarkers, it can minimize cutting healthy tissue and associated complications. Photodynamic therapy (“PDT”) uses focused energy to a sensitizing agent to ablate tissue. Its use in cancer is growing. Activating Exo-413 after surgery can destroy nearby migrating tumor cells, potentially minimizing cancer recurrence.
Exotome’s technology, Exo-413 is licensed from Case Western Reserve University and was developed in the laboratory of Professor James P. Basilion.
The technology is comprised of two proprietary innovations: a ligand and a theranostic optical imaging agent.
Results from multiple in-vivo preclinical studies reveal that all mice whose tumors were resected under normal surgical conditions (“white light surgery”) had tumor recurrence and expired within 40 days. Mice whose tumors were resected under image-guided surgery had tumor recurrence and expired within 60 days.
Conversely, mice who had both resection and photodynamic therapy stayed cancer free and survived for the duration of the trials, three months or longer.
Advisory BoardProf. ben Feringa
Molecular imaging – Nobel Laureate Chemistry 2016 Prof. Michael Bouvet
Surgical oncology, UCSD, MD Anderson Cancer Center Prof. Eben Rosenthal MD, PhD
Surgery/Radiology, Stanford Cancer Center
AxelaRx is a US-based accelerator dedicated to accelerating next-generation therapeutics by applying molecular imaging techniques, micro-dose based technology and industry expertise.
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Exotome has operations in Cleveland, Ohio and San Diego, California.