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Vortex Biosciences Announces Initiation of Clinical Research Studies with UCLA in Non-Small Cell Lung Cancer Patients

London, UK - May 24th 2017 - NetScientific plc (AIM:NSCI), the transatlantic healthcare IP commercialisation Group, announces that its portfolio company, Vortex Biosciences ("Vortex"), yesterday announced that it has initiated two clinical research studies with UCLA in patients with Non-Small Cell Lung Cancer (NSCLC). These studies will provide proof of principle that well understood biomarkers currently utilised in tumor biopsies to support treatment decisions can be similarly utilized in circulating tumour cells (CTCs).

Commenting on the news, François R. Martelet, Chief Executive Officer of NetScientific and Chairman of Vortex Biosciences, said: "Vortex's mission is to be the world-leader in CTC technology, enabling physicians to make accurate, real-time decisions when diagnosing, treating and monitoring patients with cancer. These two proof of principle clinical research studies, In collaboration with UCLA, are a vital step in clinically validating and thus commercialising the Company's first product, the VTX-1 system. Vortex is currently working with researchers and clinicians in the US to build on the positive data already seen, to accelerate commercialisation in the future."

The full text of the announcement is below:

Vortex Biosciences Initiates Clinical Research Studies with UCLA in Non-Small Cell Lung Cancer Patients

Clinical Research Studies Intended to Identify Utility of Characterizing Circulating Tumor Cells for Key Companion Diagnostics

MENLO PARK, CA, May 23, 2017 - Vortex Biosciences, provider of circulating tumor cell (CTC) capture systems, today announced that they have initiated 2 clinical research studies with UCLA in Non-Small Cell Lung Cancer (NSCLC) patients. These studies are intended to provide proof of principle that well understood biomarkers currently utilized in tumor biopsies to support treatment decisions can be similarly utilized in CTCs.

Clinicians continue to rely on invasive tissue biopsies as a means to assess a patient's disease and prescribe appropriate treatment regimens. Not only is this risky and expensive, it limits the understanding of disease. Cancer is known to be heterogeneous, with multiple cell populations. With cells extracted from a single location in a single tumor, tissue biopsies do not provide a complete understanding of the patient's disease. Furthermore, as a patient undergoes treatment, the opportunity to monitor cancer status and adjust treatment is not available. Collecting tumor cells from circulation results in a more representative sample that can be collected frequently allowing for ongoing monitoring of the disease. Shifting the sample type from tumor biopsies to CTCs for companion diagnostics offers a real opportunity for improved care. These clinical research studies are intended to be a first step in establishing liquid biopsies as a better approach towards determining the right treatment path.

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapies, based on the evaluation of EGFR mutations, have shown dramatic clinical benefits. Detection of EGFR mutations in liquid biopsies can both support initial diagnosis when a tissue biopsy is not available and support ongoing monitoring to detect drug resistance and determine a need for a change in therapy as early as possible. Several studies have shown that detecting EGFR mutations in both the ctDNA and CTCs from the same patient blood sample can improve the probability of detecting treatable mutations. This first 60 patient study is intended to determine if actionable EGFR mutations can be identified in CTCs isolated and collected using the Vortex Biosciences' VTX-1 Liquid Biopsy System from NSCLC patient samples. Concordance of actionable EGFR mutations between matched CTCs, ctDNA and tumor biopsy samples will be analyzed.

PD-L1 expression on tumor cells in lung cancer biopsies has been identified as a biomarker that can be used to stratify patient populations for immunotherapy. Utilizing circulating tumor cells in a liquid biopsy will allow for a low cost, low risk approach towards patient stratification. Furthermore, it would allow for ongoing monitoring of PD-L1 tumor cell expression throughout treatment, allowing for treatment to be modified as needed. The second 100 NSCLC patient study is intended to demonstrate that (i) the circulating tumor cells isolated using the VTX-1 Liquid Biopsy System are compatible with PD-L1 immunostaining, and (ii) an appropriate threshold for expression can be identified for CTCs that can allow for the identification of the same NSCLC patient population that is identified by the current PD-L1 expression test using tissue biopsies.

"Our mission is to be the innovation leader in CTC capture technology delivering diagnostic tests that improve therapeutic decisions and save lives," explained Vortex CEO Gene Walther. "We are excited to be taking this first important step towards the clinical market with UCLA Hospital."

"Tissue biopsies are dangerous, costly and the time to schedule, complete and analyze the biopsy sample simply takes too long." Said Dr. Jonathan Goldman, Director of Clinical Trials, UCLA Health. " Characterizing biomarkers on CTCs changes the way I can diagnose and treat patients leading to better outcomes."

CTCs are relatively scarce, with concentrations as low as 1-10 CTCs/mL of whole blood, against a background of millions of white blood cells and billions of red blood cells. Not having an easy to use system that can efficiently collect intact CTCs, ready for analysis has slowed adoption for clinical applications. The VTX-1 Liquid Biopsy System changes this.

The fully automated, easy to use VTX-1 Liquid Biopsy System from Vortex represents the next step in CTC isolation. Inside the VTX-1 chip, unlabeled CTCs in whole blood are selectively trapped in microscale vortices while smaller, less deformable red and white blood cells pass through. Afterwards, CTCs can be flushed and collected into a variety of containers for downstream analysis. With a cancer cell recovery of 65-75%, best in class CTC purity, CTCs collected unbiased by their molecular characteristics, intact, viable, and ready for downstream analysis, the VTX-1 offers the best CTC samples available today.

About Vortex Biosciences

Vortex Biosciences is a cancer research and diagnostics company that integrates cancer biology, microfluidic engineering and informatics to develop tools for isolating and characterizing circulating tumor cells. The Vortex VTX-1 instrument harvests intact circulating tumor cells from whole blood samples for use in downstream research and clinical applications such as patient stratification in clinical trials, monitoring disease progression and drug treatment effectiveness. With a mission to enable noninvasive diagnosis of cancer and real-time monitoring throughout a patient's treatment, Vortex is at the forefront of accelerating cancer research and improving patient outcomes. Vortex is a core subsidiary of NetScientific plc, a transatlantic healthcare technology group with an investment strategy focused on sourcing, funding and commercializing technologies that significantly improve the health and well-being of people with chronic diseases. For more information, visit www.vortexbiosciences.com.

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About NetScientific

NetScientific is a transatlantic healthcare technology group with an investment strategy focused on sourcing, funding and commercialising technologies that significantly improve the health and well-being of people with chronic diseases. For more information, please visit the website at www.netscientific.net