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Clinica Medtech Ventures: Clearbridge BioMedics

This article was originally published in Clinica

Executive Summary

Specialty area(s): Circulating tumor cell capture technology

Based in: Singapore

Founded in: 2010

No. of employees: 20

Total investment received to date: Undisclosed

Investors: Clearbridge BSA, SPRING Seeds Capital, Vertex Venture Holding, BioVeda Capital

When Johnson & Johnson’s CellSearch became the first circulating tumor cell (CTC) capture system to be cleared by the US FDA in January 2004, it marked a major milestone in the field of liquid biopsies, which allow cancer diagnosis and monitoring with just a blood sample rather than a tumor biopsy.

However, the adoption of liquid biopsies in clinics did not take off as quickly as expected, not least because of the limitations of the antibody-based approach of CellSearch and other CTC systems that are currently being developed.

“CellSearch uses antibodies to pull out CTCs from the sample. But over the years, we’ve come to understand that cancer evolves over time and there are many processes involved in metastases,” So when you take a specific antibody-based approach to pull out these cells, when the cancer changes or when the targeted cell surface antigens are no longer expressed, the cancer cells are still there but you are no longer able to pull them out. As a result, this is going to limit the ability of the physician to use this test continually, either to monitor treatment effectiveness or pick up relapse.”

That is the view of Andrew Wu, general manager of Clearbridge BioMedics, a Singapore company which launched its own CTC capture system, the ClearCell FX, at last year’s ASCO Annual meeting in Chicago, Illinois.

Clearbridge’s system works in conjunction with its proprietary microfluidic biochip, the CTChip FR1, which employs a label-free technique known as “inertial focusing” to separate the CTCs from other blood components. “Because of the way we designed the channels in our microfluidic chip, and the way cells naturally behave within the microfluidic flows, you can focus these cells into different streams based on their inertial characteristics, such as size and mass. So the larger CTCs are focused on one end of the stream and the other white blood cells and blood components focused on the other end,” said Dr Wu.

While there are other CTC systems that also use a label-free approach, what really differentiates ClearCell FX from these technologies is the quality of the cells. The use of inertial focusing allows the CTC retrieval process to be “very gentle” – similar to the circulatory environment in the peripheral vascular system – which means the collected CTCs remain intact and viable for use in downstream molecular analyses, cell culture and other applications.

“Some other label-free methods pass the cells through a filter. And because of the pressure differentials, it’s like having the cells squeezed through a sieve,” said Dr Wu. Additionally, in other CTC systems, the cells often remain within the chip throughout the whole processing time, which is usually over an hour. Whereas with the ClearCell FX, the cells go in and come out of the CTChip and are collected in under an hour, he told Clinica, adding that the system has “shown consistently high CTC capture”.

“When we designed the system, we took a very practical approach. We spent a lot of time talking to various pathologists and to our clinical partners at the Singapore General Hospital. We visited many pathology labs in the US, Europe, to understand their infrastructure. How do they handle cells? How does a cytologist handle cells and tissue compared with a pathologist? And this process we designed with the ClearCell FX fits into the whole pathology process – it is straightforward, automated and ready for use in the path lab.”

The ClearCell FX was CE marked last year for research use and Clearbridge has already begun selling the system to academic medical centers that conduct clinical research in cancer, with a strong focus on translational work, as well as offering clinical care. The company is also collaborating with these and other cancer centers around the world to build sufficient data to back the use of ClearCell FX as part of a full cancer diagnostic assay.

Among Clearbridge’s clinical partners is the National Cancer Center in Japan and the company will also be announcing this year partnerships with centers in the US and Europe.

“We are working with our partners not just to capture CTCs but understanding the CTCs and how it ties back to the patient so it can be used clinically. These centers are not just trying to advance the understanding of cancer but also to improve the way that it is managed. Most of the interest in our technology has been in that space and it fits very well,” Dr Wu told Clinica. “Liquid biopsy and CTCs is still a very new area and there is a lot of work that needs to be done. It is in these organizations and this kind of setting, where they have a strong understanding of cancer biology and of cancer care, that you have the best chance of success of translating a technology, translating a biomarker into clinical use, so that’s where we’ve been focusing our partnerships around.”

The company’s initial clinical focus will be on major cancers in the region: “We are an Asian company so we want to concentrate on the market where there is the biggest demand here. Lung cancer is one of the most prevalent cancers in Asia with the highest mortality rates.”

When asked about potential timelines as to when ClearCell FX might be approved for clinical use, Dr Wu said it depends on the jurisdiction where they are seeking approval. “The key is for us to be able to build up the body of evidence over the next few years, publish the clinical utility of our assay with our partners and seek regulatory approval in different countries. It’s not a short journey but we don’t believe in short-term gains.”

In the meantime, the company will continue to offer its system to research customers, in Singapore and beyond. It will use distributors outside its home market and will be looking for partners in the EU, the US and rest of Asia. “We are keen to work with people who have a strong presence and a strong network of partners among healthcare institutions.”

Andrew Wu, general manager.

Tel: +65 6873 0668. Email: Andrew.Wu@clearbridgebiomedics.com

Clearbridge BioMedics Pte Ltd. 81 Science Park Drive, The Chadwick #02-03, Singapore Science Park 1, Singapore 118257.

www.clearbridgebiomedics.com

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