CanScan

An excerpt from previous interviews from the leading cancer researchers on the therapeutic potential of circulating tumor cells (CTCs).

“Everybody understands how important research on these cell is; first and foremost, for patients, but also for other reasons, such as health economics. If doctors can use CTCs to tell patients that a drug is not going to work ahead of time, then you’ve spared the patients toxicity and allowed them to move on to something else.”

– Dr. Howard Scher (Memorial Sloan-Kettering Cancer Center)

“The future of targeted therapies in cancer is completely dependent on a patient’s genetic profile, and you also need to be able to do serial monitoring of patients over time.  When a patient stops responding to therapy, you need to know why and the principal mechanism of resistance.”

– Dr. Daniel Haber (MGH)

“We’re trying to find out which genes are being expressed in the CTCs and whether they might help us choose a therapy.”

– Dr. Stephanie Jeffery (Stanford)

“What’s most exciting about the technology is reaching a point where we can ask some questions, and trials are actually being done in multiple diseases. The most important question being: How will testing CTCs help us make medical decisions?”

– Dr. Howard Scher (Memorial Sloan-Kettering Cancer Center)

In the simplest terms, Circulating tumor cells, or CTCs are rare cells that have separated from tumors and are found circulating in a cancer patient’s blood.  Recent research by Dr. Massimo Cristofanilli (Fox Chase Cancer Center, Philadelphia) has shown that as little as five CTCs per 7.5 mL of blood can predict poorer overall survival compared to those that have fewer.  So what exactly are these cells, and how can they predict overall survival?

First reported in 1869 by the Australian physician, Thomas Ashworth, he observed and characterized a group of cells circulating in the blood of a patient with metastatic cancer. They appeared to resemble cells making up the primary tumor, but were found circulating in various parts of the patient’s body. Based on this initial observation, he postulated that these rare cells may be the initial ‘seeds’ that lead to the propagation of cancer at distant sites, occurring far away from where the original tumor may reside – the central component of metastasis.

Currently there is one FDA approved device to isolate and enumerate CTCs, CellSearch by Veridex (Johnson & Johnson Company), and the company has gained notoriety for their joint ventures, most recently in a $30 million deal with Massachusetts General Hospital to advance their technology. However, their approach is limited in its detection ability, largely due to their use of antibodies that target only adenocarcinomas. In other words, if CTCs do not express these markers, these cells would go undetected, and cancers would go undiagnosed.

CanScan’s core technology does not require the use of antibodies, but it is focused on the central paradigm of metastasis – in that CTCs are programmed to invade, attach and rapidly divide to promote cancer progression. In the next 10 weeks, CanScan will provide a comprehensive overview of its technology and will offer proof-of-concept prototypes before officially launching in late 2012.

I spoke briefly with an RN (Rollie Rockett) who manages a variety of patients, including cancer patients. He was excited about the idea for the business and supported the model of an outsourced service. Currently, lab samples for the hospital are sent across the state to be tested, with results returning for many tests within the first 6-24 hours. He wasn’t familiar with pathologists methodologies or how long it takes to diagnose cancer. An obvious but important insight from the discussion is that the nurse has limited visibility into the cancer diagnostic process nor has decision-making ability for what tests to run and where to send them. Nurses seem to not be within the target customer group.

Rollie did think there was value in a less invasive means to diagnosing cancer (e.g., blood sample vs. tissue sample of gland) and monitoring progression. He thought it might save time and money, in addition to creating a lighter burden on the patient.

Rollie had planned to link me up with one of his colleagues that is a nurse focused in care for cancer patients who might be able to provide greater insight into the process of diagnosing and managing a metastatic cancer patient.

A couple of key questions around the value proposition generated from but not answered by the interview are:

• Is it a good assumption that following cancer treatment, there is living and dead cells floating in the blood and that having info about living cells only would be valuable?
• Is there value in having information about cancer growth rates? Would growth rates in vitro be different than growth rates in vivo? If so, is it still valuable?
• Is it unpleasant to take tumor samples from patients? How invasive are current methods and would a blood-based CTC count / characterization add value and be less invasive for the patient?

Dr. Lutz (MD, PhD) is a Professor and director of molecular pathology at the University of Kentucky. He has over 30 years of experience in medicine, and is currently interested in studying the role of the immune system in targeting and attacking cancerous cells in the human body. Dr. Lutz was kind enough to provide us with an interview on the subject of medical methods to diagnose and monitor the progression of cancer.

Q. Can you briefly describe the function of a cancer pathologist?

A. Pathologists receive biological tumor samples from oncologists/surgeons and we provide an assessment of the tumor type and grade.  We do not deal directly with the patients, but we deal directly with their tumor.

The biological samples can be obtained from the patient’s bone marrow, peripheral blood, and tumor biopsies.  We employ various cell and antibody-dependent staining methods to look for known cancer markers.  

Q. How satisfied are you with the current treatment options for cancer patients?

A. The truth is, we have very few effective methods to treat invasive cancers .  

Q. How satisfied are you with the current capabilities in diagnosing cancer?

A.  Not satisfied at all. There is currently no effective means to diagnose the cancer at an early stage.  If there was such a device, the prognosis and survival rates for cancer patients would be a lot higher.  

Q. What is your opinion on using circulating tumor cells (CTCs) as a diagnostic and prognostic tool for cancer?

A. I personally do not look for CTCs in our blood samples, but the idea of looking at CTCs is not a new idea.  There are some concerns with the current enumeration methods with respect to their accuracy and biological significance in merely counting the number of these cells circulating in the blood. We’re not quite sure what this tells us.

Q. Would you consider adopting the current medical devices available to detect and enumerate CTCs?

A. In short, No. The current detection methods can be performed in any well-equipped pathology lab, the only advantage these devices would offer is speed, but again, that maybe at the expense of accuracy.

Q. What would it take for you to adopt CTC-based approaches?

A. The product or service would need to have a unique set of biomarkers to detect and characterize CTCs.  

—Interview Conducted by Dr. Nelson Chan.

Our first week was full of highs and lows.

On the high side, we spent some time discussing the vision for the company and what we thought would be possible to accomplish. We truly believe we have the opportunity to develop diagnostic tool that can significantly improve oncologists ability to effectively manage a patient’s cancer, resulting in dramatic improvements in cancer patient outcomes! We’re all excited to be working on this project together and have the opportunity to do so in the framework of the Lean Launchpad class offered by Steve Blank. The teaching team and mentors that are supporting the class read like a who’s-who of the silicon valley start-up and venture financing community. It doesn’t get much better than this.

On the lows, our team has encountered its first major challenge as a team. Arun, our computer science expert and experienced business professional/EWMBA student, will need to leave the team indefinitely to attend to family matters. It will be difficult to fill Arun’s role on the team, and we will miss him. On a personal note, I (Brian) found out I would be unable to receive credit for the course due to course requirements that currently limit enrollment for full-time MBA students. We’ll be pushing on regardless.

Over the course of the first week, we’ve had some really productive working sessions on initial steps in team formation. We were able to further fill-out a primary and secondary business model canvas and flush out some ideas for follow-on products/services. We also submitted an application to the Haas Business Plan competition and will be moving forward on that front in parallel with objectives for the Lean Launchpad class.

Interviews have commenced and we’re in the process of absorbing customer (?) feedback. Still establishing who the customer actually is and attempting to crystallize the value proposition to each. Its been challenging!

CanScan has been founded by student and scientists from the Lawrence Berkeley National Laboratory (LBL) and UC Berkeley’s Haas School of Business. Our team is comprised by individuals from different backgrounds and different skill sets:

James L.: James is a scientist at LBL and developed the idea for the technology/service. He is the mastermind behind team/company’s formation in the first place and will be leading the on-going development of the technology. James was most recently a post-doctural research associate at Harvard Medical School where he developed the idea of starting a diagnostics company based on the property that cancer cells rapidly divide.

Nelson C.: Nelson is a postdoctoral researcher at LBL and works closely together with James in his research at LBL. With seven years experience in biochemical cancer research, Nelson provides invaluable expertise in cancer biology with respect to biochemical assay development and toxicology analysis mediating cancer cell death. Nelson brings deep scientific insights and will be co-leading development of the technology with James.

Arun S.: Arun is a EWMBA at UC Berkeley’s Haas School of Business and has an expertise in computer science. Arun was to lead the development of the software-side of the technology, manage the team’s IT needs (i.e., he created this blog!), and lend his insight as an experienced businessman and MBA student. Unfortunately, Arun may be leaving the team indefinitely to attend to some family issues. We wish he and his family the best and a speedy return to the team if possible. In the meantime, we are seeking an individual with computer science expertise (preferable either an MBA or an individual with healthcare/biotech/pharma experience).

Brian F.: Brian is a full time MBA student at UC Berkeley’s Haas School of Business who brings a breadth of experience in the life science industry and depth in diagnostic in particular. His background includes management consulting and private equity, as well as a strong knowledge and network within the venture capital community. He’ll be supporting the team’s business-oriented needs.

Looking forward to working together as a team and growing together!