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.

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.

Pipeline

LS301’s leading indication is for intraoperative use in breast cancer. As part of Integro’s product pipeline, the company is also exploring the utility of LS301 in other cancer types with a focus on gynecological cancers. This includes potential applications in ovarian, endometrial, and cervical cancers.

 

*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

Breast cancer Phase 1/2 dose escalating clinical trial 

Washington University, Sponsored by Kingdom Capital (Integro Theranostics)

 

Title: Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

Enrollment Status: Completed Phase 1a


This dose escalating clinical trial is designed to define the optimal imaging dose of LS301 and evaluate LS301’s safety and efficacy in patients undergoing partial mastectomy and sentinel lymph node biopsy for breast cancer. The imaging tool used for visualizing LS301 in this clinical trial is Integro’s CancerVision Goggles.

Publications