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SimBioSys Gains FDA Approval for Spatial Omics Platform in Breast Cancer, Seeks Financing

NEW YORK – Spatial biophysics company SimBioSys announced on Thursday that it secured 510(k) clearance from the US Food and Drug Administration to market TumorSight Viz, a software application for creating 3D spatial visualizations of breast tumors.

This is the first FDA clearance for an application that runs on SimBioSys' TumorSight precision medicine platform, which is designed to help clinicians and medical researchers establish optimal dosing and timing of medications, assess cancer risk, determine the need for and develop plans for surgeries, and evaluate breast cancer-related biomarkers, among other things.

Tushar Pandey, CEO of the Chicago-based company, said that these components address many of the key aspects patients are seeking from precision medicine: a precise diagnosis, the need for surgery, treatment dosage and timing, and disease risk.

"What we're trying to do with this treatment planning platform," he added, "is cover that patient journey end to end."

TumorSight Viz, the first clinical application to become available on this platform, generates 3D breast cancer images from standard-of-care medical imaging (DCE MRI) and uses artificial intelligence (AI) to quantify key metrics needed for treatment planning. The platform automatically segments the tumor and surrounding tissue to display features such as tumor volume, the tumor-to-breast volume ratio, and tumor distance to key anatomical breast structures.

Pandey said that although several studies supported the 510(k) submission, these have not yet been published, but are "coming up soon."

SimBioSys is developing the TumorSight platform for use in clinical settings beyond breast cancer care and for research use. TumorSight Marker, for instance, is designed to identify spatial biomarkers that can help determine immune-oncology (IO) drug response.

In a study published last year in Frontiers in Artificial Intelligence, SimBioSys researchers linked PD-1/PD-L1 gene expression levels to biophysical features derived from DCE-MRIs. From this, the company established what it called the TumorIO biomarker of IO response. Integrative modeling based on virtual tumors was then used to train and develop a corresponding TumorIO Score.

Other companies also see the value of using spatial biology to improve precision medicine. Castle Biosciences' TissueCypher platform, for instance, analyzes both biomarkers and tissue morphology of Barrett's esophagus, a disorder that raises one's risk for developing esophageal cancer.

Paris-based biotech Owkin is also investing heavily in spatial biology. Last year, the company launched the Multi Omic Spatial Atlas in Cancer (MOSAIC) project with the aim of building the world's largest spatial omics database to advance cancer biomarker and drug discovery.

Beyond TumorSight's clinical applications, SimBioSys also offers its technology for research use through its PhenoScope platform. The company last month announced a partnership with UT Southwestern to improve its PhenoScope tumor visualization and analysis platform by drawing on transcriptomic data and bioinformatics expertise at the university. PhenoScope combines genomic, cellular, microscopic tissue environment, and other biological data with clinical outcomes to construct spatially resolved tumor models.

As part of that effort, Pandey said that SimBioSys is building what he hopes will be the world's "largest virtual server bank" of digitized, spatially resolved tumors. Such "digital twins" he said, could be used to test treatments, run virtual clinical trials, and find biomarker signatures. Pandey estimates that the company's databases currently have between 15,000 and 16,000 virtualized 3D tumors.

"And we're expanding that constantly," he said.

Pharma customers, Pandey said, are already using PhenoScope for precision dosing and biomarker development studies, although he could not yet disclose who those customers are. Pandey said that precision drug dosing will likely be a popular use of PhenoScope going forward. "Every drug company is focused on how they [can] get more precise with the dose" of their agents, he said.

Despite such uses, Pandey said that PhenoScope, which the company initially developed with a $2 million Small Business Innovation Research grant from the National Institutes of Health, is primarily a research tool.

"[It's] a foundational discovery platform that's going to accelerate drug development and [enable] a deeper understanding of cancer," he said.

SimBioSys expects to begin developing TumorSight in indications beyond breast cancer over this year and is planning several clinical studies to that effect.

The company, which raised $15 million in a Series A financing round in 2021, also plans to initiate a Series B round in the near future.

"It'll be a large series B that would allow us to commercialize both the clinical and research technologies, and run some of the trials that will kick off in January," Pandey said.

The company also expects to announce more collaborations early this year, Pandey said.