Introducing LS301
A novel fluorescing molecule that specifically binds to and illuminates cancer tissue.
How It Works
Integro’s optical imaging agent, LS301, consists of a small peptide and a dye that emits near-infrared light (NIR). LS301’s small peptide binds to the activated form of its target protein in cancer cells, aggregating the NIR emitting dye within diseased tissues and cancer-positive lymph nodes. The small molecular size enables LS301 to reach cancer cells and its target protein quickly. With consistent, selective, and fast-acting accumulation in diseased tissues, LS301’s dosing schedule can be flexible. This reduces the impact that incorporating LS301 into patient care has on operating room workflow.
Various commercially available devices can detect LS301’s cancer specific fluorescent signal, as well as Integro’s proprietary CancerVision™ Goggles. The surgeon can see LS301’s fluorescence signal while operating using existing imaging equipment currently in the operating room or Integro’s wearable CancerVision Goggles. The surgeon can be confident that all cancerous tumors and lymph nodes have been successfully removed when they no longer see any illuminated tissue.
This video showcases the intraoperative imaging of our tumor-targeting LS301 technology during a lung cancer surgery. The patient received LS301 the day before the procedure, enabling the surgeon to use a near-infrared endoscope to detect and precisely remove the tumor.
Designed to Identify Cancer Cells
LS301 is a stable molecule that directly targets cancer cells. It selectively binds to an activated protein that is uniquely expressed by cancer cells and is not found in the same form in healthy tissues. Paired with NIR light, which can penetrate human tissue, LS301 illuminates cancer cells with high specificity. LS301 offers significant opportunity for improved cancer imaging and more successful surgical intervention.
Enhanced Detection
The target protein transforms to its activated state when cancer cells are multiplying and in the process of spreading to healthy tissues. LS301 provides the potential to locate tumors, metastases, or cancer-positive lymph nodes that would otherwise have gone undetected. Due to its high sensitivity and specificity, LS301 enables more accurate identification of cancerous tissue during surgery.
Broad Indications
Unlike on normal cells, the activated protein that LS301 targets is found on the surface of cancer cells. It is a critical and unique protein in cancer cells making it an ideal target for detecting diverse types of solid tumors and some blood cancers. Real-time imaging of LS301 facilitates improved tumor margin assessment, surgical cavity assessment for residual tumor tissue, and visualization of sentinel and secondary cancer-positive lymph nodes.
Data Insights
Pairing LS301 with imaging devices, such as Integro’s CancerVision™ Goggles, offers the opportunity to store and aggregate deidentified pre-, intra-, and post-operative imaging data. This data set offers the potential to develop algorithms for advanced clinical decision support, predicting cancer spread, and personalizing patient treatment, further improving cancer surgery outcomes.
Imaging Tools Designed for Surgeons
Integro developed the CancerVision™ Goggles to support NIR fluorescence image-guided surgery without disrupting normal surgical workflow.
This wearable imaging system allows surgeons to visualize the LS301 fluorescence images overlaid onto natural color images of tissues in the surgeon’s field of view via a head-mounted, mixed reality display. Surgeons can use the CancerVision Goggles intraoperatively to visualize cancerous tissues, including tumors and lymph nodes. Tumor resection surgery guided by LS301 and the CancerVision Goggles could allow surgeons to identify even microscopic tumors and assess surgical margins in real-time, leading to more thorough tumor removal and improved surgical outcomes.
AI Powered Solutions
Optimizing the Cancer Clinical Trials with Real Time AI Powered Solutions
Integro and OmniScience accelerate clinical trials on fluorescent imaging agent to bring unparalleled precision in cancer surgery and improve patient outcomes
Challenge
Surgical resection is the primary treatment for solid tumors, with the goal of safely removing as much cancer as possible. However, surgeons must rely on visual inspection, tactile cues, and intraoperative pathology, which can be time-consuming and may limit real-time precision in distinguishing healthy from cancerous tissue. Residual cancerous tissue left behind after surgery is a strong predictor of cancer recurrence and patient survival. In many cancer types, 20%-30% of patients undergo repeat surgery, increasing morbidity, impacting cosmetic outcomes, and raising medical costs. Validating surgical innovations through traditional clinical trials is slow and costly, delaying access to new technologies that could improve patient outcomes.
Solution
Integro is transforming cancer surgery through its ongoing partnership with OmniScience, a leader in AI applications for clinical trials. In this collaboration, clinical data scientists are building AI-powered computer vision workflows that allow deep tissue analysis at gross and microscopic scales and fluorescence characterization of a multitude of tissue types. By leveraging advanced analytics and AI throughout their clinical trials, Integro is working to improve the precise detection of cancer intraoperatively, by combining Integro’s proprietary LS301 fluorescent imaging agent with AI-powered insights, Integro is enabling:
Identify patterns and trends through algorithms that enhance the detection of cancer with greater accuracy during surgery
Deliver data-driven clinical decision support by unifying imaging data to optimize cancer trial insights with traceable pathways
Streamline data and analysis processes to unlock new efficiencies and simplify workflows
Enable intraoperative pathology assessment through computer vision that helps identify cancer
With Integro’s proprietary LS301 fluorescence imaging agent and the support of OmniScience’s AI expertise, surgeons will be able to see, analyze, and act with confidence - leading to more successful cancer surgeries and improved outcomes.
Pipeline
LS301’s leading indications are for intraoperative use in breast cancer and lung cancer surgeries. As part of Integro’s product pipeline, the company is also exploring the utility of LS301 in other solid tumor cancer types.
*The Phase 1/2 breast cancer clinical trial led by Washington University School of Medicine and sponsored by Kingdom Capital (Integro Theranostics) used the CancerVision™ Goggles for imaging LS301.
In addition to intraoperative indications, LS301 may also have noninvasive cancer imaging applications for screening, preoperative tumor localization, and histopathology.
Clinical Trials
Title: Fluorescence imaging agent in breast cancer surgery.
Enrollment Status: Enrolling
This dose escalation clinical study is designed to assess the safety and fluorescence signal of LS301-IT in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB), and/or Stage I-II primary invasive carcinoma of the breast (whether or not undergoing SLNB). Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data. Various imaging technologies will be used to assess the fluorescence signal intensity in breast cancer patients.
Title: Fluorescence imaging agent for lung cancer resection
Enrollment Status: Enrolling
This dose escalation clinical study is designed to assess the safety and fluorescence signal of LS301-IT in patients undergoing surgical thoracoscopy and VATS (Video-Assisted Thoracoscopic Surgery) or RATS (Robotic Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study. Various imaging technologies will be used to assess the fluorescence signal intensity in lung cancer.
Publications
Non-invasive monitoring of arthritis treatment response via targeting of tyrosine-phosphorylated annexin A2 in chondrocytes Arthritis Research and Therapy.
Bio-inspired imager improves sensitivity in near-infrared fluorescence image-guided surgery Optica.
Optical See-Through Cancer Vision Goggles Enable Direct Patient Visualization and Real-Time Fluorescence-Guided Oncologic Surgery Annals of Surgical Oncology.
Binocular Goggle Augmented Imaging and Navigation System provides real-time fluorescence image guidance for tumor resection and sentinel lymph node mapping Scientific Reports.
Hands-free, wireless goggles for near-infrared fluorescence and real-time image-guided surgery Surgery.