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About Us

Anytime someone is diagnosed with cancer, many decisions have to be made regarding development of an optimal personalized treatment plan. Development of an optimal treatment plan requires accurate information regarding the diagnosis, prognosis and predicted responsiveness of a specific tumor – in other words accurate staging of the tumor. This information comes from several sources such as a physician's judgment based upon the physical signs and symptoms of a patient, traditional laboratory testing, and newer molecular testing.

Accurate information is required because all treatment plans (such as surgery, radiation, drug-therapy, surveillance, and even watching and waiting) have benefits and risks that the physician and patient need to weigh. These considerations help to determine an optimal treatment plan for that patient with that tumor at that time. Some cancers exhibit very little variation from patient to patient in terms of prognosis and predictive responsiveness. This means that the diagnosis, prognosis and predictive responsiveness achieved by traditional laboratory tests may be entirely appropriate to design an optimal treatment plan for a specific patient. Many cancers, however, exhibit a large variation in prognosis and predictive responsiveness from patient to patient. Often accurate information cannot be obtained through traditional laboratory testing alone – these cancers require the use of newer molecular tests to enable development of an optimal personalized treatment plan. Many common cancers have such molecular testing options available.

Unfortunately, development of molecular testing for rare cancers lags behind the advances made in common cancers. Sometimes testing has been developed in a given cancer institution and may be available only to patients treated at that institution.

At Castle Biosciences, we focus on addressing this gap. We work with leading cancer institutions to in-license proprietary technologies and complete development and validation. The ultimate goal is to make these proven tests available to all individuals afflicted with a rare cancer.

Licensing Opportunities

We are constantly responding to inquiries from leading cancer institutions regarding their technologies that may be appropriate for the patient afflicted with a rare cancer.

We use the following template when evaluating license opportunities:

Tests in development focus on cutaneous melanoma, esophageal cancer, and BAP1 testing.
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In Development

Development efforts for: DecisionDx-EC

The proprietary DecisionDx-EC test was discovered at The University of Texas M. D. Anderson Cancer Center for the purpose of predicting pathologic response to preoperative chemoradiation therapy in esophageal cancer (EC). The objective of the DecisionDx-EC test is to predict which patients may have a complete pathologic response to preoperative chemoradiation and which patients may be resistant to this regimen. This helps in the design of an optimal personalized treatment regimen.

The DecisionDx-EC test has completed assay development and clinical development. The verification study (n=60) demonstrated high sensitivity and specificity for detection of both the complete pathologic response group and the non-responsive group. The final validation study (n=167) was the focus of an NIH-sponsored grant and was completed in late 2010. Some of this data was presented at the American Society of Clinical Oncology (ASCO) in June, 2011.

We are currently completing the final steps of validation and anticipate having the DecisionDx-EC test available for clinical use in the next three months.

Preliminary data suggests that this assay may have application in other non-esophageal cancers.

Development efforts for: DecisionDx-Melanoma

The proprietary DecisionDx-Melanoma test was discovered at Castle Biosciences for the purpose of predicting distant metastatic risk in patients diagnosed with American Joint Committee on Cancer (AJCC) stage I, II or III cutaneous melanoma. Patients with stage I melanoma have thin tumors, generally less than 1 mm and have a low risk (7 to 14% risk of metastasis at 10 years). Stage II and III melanomas are thicker than stage I melanomas. Patients with stage II melanoma have a sentinel node evaluation that was negative for the presence of melanoma cells. Stage II patients have a higher average risk of metastasis than stage I patients but lower than stage III patients. Stage III patients have a sentinel node evaluation that was positive for the presence of melanoma cells. There is significant overlap in the range of metastatic risk between patients with stage II and stage III. However, today patients with stage I or II melanoma are managed primarily by the dermatologist for local recurrence and development of additional primary melanomas. Patients with stage III melanoma generally receive removal of regional lymph nodes and are offered adjuvant interferon treatment.

To summarize, there are a significant number of patients with stage I or II melanoma who will develop metastatic disease. These patients are treated as group of ‘low risk’ patients despite that individual patients are at ‘high risk’.

Castle Biosciences embarked on a series of collaborative studies beginning in mid-2011 for the purpose of developing a molecular test that would improve identification of stage I and II melanomas that are at high risk of metastasizing. Preliminary data was presented at the American Society of Clinical Oncology in June 2012 (link). While clinical validation has not been completed, this data and subsequent analyses with additional datasets show the DecisionDx-Melanoma test to be accurate in identifying patients with stage I and II melanomas that are at high risk for distant metastasis. Furthermore, these analyses show the test to be superior to AJCC staging and other clinical and pathologic factors such as Breslow’s thickness.

The company is performing the independent clinical validation studies and believes that it is on track to completing the initial studies in the first half of 2013.

Development efforts for BAP1

The role of BAP1 in metastasis in uveal melanoma was recently discovered by Drs. Harbour and Bowcock at Washington University (link). Castle Biosciences exclusively licensed the use of BAP1 in uveal melanoma and cutaneous melanoma from Washington University and is completing development of the technology as a tool for identifying patients who may be responsive to certain treatments as well as inherited risk for risk of uveal melanoma, cutaneous melanoma, mesothelioma and other cancers (so called germ line testing). Castle compared BAP1 testing as a predictor of metastasis in uveal melanoma to their DecisionDx-UM test. The analysis confirmed that the DecisionDx-UM test is superior to BAP1 testing for predicting the risk of metastasis in uveal melanoma. The company also plans to investigate the role of BAP1 in metastasis of other cancers.

Development efforts for: DecisionDx-Mesothelioma

A prognostic test in patients undergoing standard of care surgical resection and differential diagnostic (for mesothelioma vs other thoracic neoplasms) test were discovered, developed, and validated for use in mesothelioma by inventors at Brigham and Women’s Hospital. Castle Biosciences exclusively licensed the intellectual property and technology rights related to these tests from Brigham and Women’s Hospital.

The DecisionDx-Mesothelioma test is technically robust and has been evaluated in a prospective clinical study, achieving level of evidence ”1A” as defined by the National Comprehensive Cancer Network (Febbo, 2011). Level 1A is the highest level of evidence for tumor biomarkers.

As background, mesothelioma disease creates diagnostic and prognostic challenges. Standard of care includes surgical resection with or without adjuvant therapy which is a complex procedure involving significant recovery time. Unfortunately, only some patients experience significant benefit from standard of care interventions. When used alone, or in conjunction with other simple clinical parameters, the DecisionDx-Mesothelioma test can help identify those patients who will most likely benefit from aggressive surgery, as well as assist with further treatment planning.

The company is completing validation and the test should be available in early 2013.

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Our Team

Derek Maetzold, President and CEO

Derek is founder, President, CEO, and Board member of Castle Biosciences, Inc. He has been a leader in biopharmaceuticals for 24 years, working in increasing leadership roles at Encysive Pharmaceuticals, Schering Corporation (now Merck), Integrated Communications, Amylin Pharmaceuticals and Sandoz (now Novartis). Derek started in field sales, completed assignments in marketing, new product development, business development, commercialization strategy and completed his tenure prior to Castle Biosciences at Encysive as Officer and Vice President, Marketing and Sales. Derek attended George Mason University, where he received a BS in Biology before completing additional coursework at the University of Calgary Health Sciences Center and the MBA program at University of California-Riverside.

Toby Juvenal, Vice President, US Sales and Marketing

Toby is the Vice President, US Sales and Marketing at Castle Biosciences, Inc. He has over 20 years of sales, sales management, and managed care experience in the pharmaceutical, biotechnology and diagnostics industries. He has held multiple management positions at decode Genetics, Encysive Pharmaceuticals and Genzyme Pharmaceuticals after beginning his pharmaceutical career at Stuart (now AstraZeneca). Toby attended the University of Florida where he received a BS in Marketing.

Kristen Oelschlager, RN, Executive Director, Operations

Kristen is the Executive Director of Operations at Castle Biosciences. Kristen brings over 15 years experience in the field of nearing, clinical services, management and leadership including the start-up and growth management of a multi-location hospital and outpatient based clinical research department. Kristen joins Castle with a strong history of process management under strict QA/QC/SOP. Kristen attended Purdue University, where she completed her core nursing requirements, prior to receiving her Associate of Science, Nursing from the Indiana Vocational Technical College. She recently completed a program as a Legal Nurse Consultant and has held certification as a Clinical Research Coordinator. Kristen has been a speaker for Actelion Pharmaceuticals, Eli Lilly, and Encysive Pharmaceuticals and is a published author.

Robert W. Cook, PhD, Manager, Scientific Relations

Bob joined Castle as Manager of Scientific Relations. Bob brings over fifteen years of experience and training in academic and industrial science. Bob has an extensive background in molecular biology and genetics. He received his B.S. Degree in Biology from Temple University in Philadelphia, and his Ph.D. degree from Northwestern University for his studies of the structural characteristics of protein hormones important for regulating the reproductive system. Bob comes to Castle following a postdoctoral fellowship at Baylor College of Medicine that was focused on the genetic regulation of rare ovarian granulosa cell tumors. Prior to pursuing his doctoral degree, Bob spent five years (1995-2000) at Gen-Probe, Incorporated as a member of their Product Transfer Department and in the Research and Development Department, designing diagnostic assays using Gen-Probe's patented nucleic acid amplification technology.

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Board of Directors

Dan Bradbury, Board Member

Mr. Bradbury is a Life Sciences Executive with over 30 years of experience creating and implementing strategies that transform businesses, bring novel medicines to market and maximize shareholder value. He is the Managing Member of BioBrit, LLC, a Life Sciences Consulting and Investment Firm.

Mr. Bradbury is the former President, Chief Executive Officer and Director of Amylin Pharmaceuticals, a biopharmaceutical company based in San Diego, CA, focused on metabolic diseases. During his 18-year tenure at Amylin, the company launched three first-in-class medicines, including the first once-a-week therapy to treat diabetes and was listed on the Nasdaq 100. He served as Amylin’s Chief Executive Officer from March 2007 until its acquisition by Bristol-Myers Squibb Company for $7 billion in August 2012. Before joining Amylin, Mr. Bradbury worked in marketing and sales roles for ten years at SmithKline Beecham Pharmaceuticals. He also serves on the board of directors of Corcept Therapeutics (CORT), Geron Corporation (GERN), Illumina, Inc. (ILMN) and Castle Biosciences, Inc., the board of trustees of the Keck Graduate Institute, the Investor Growth Capital Advisory Board, and the BioMed Ventures Advisory Committee.

Mr. Bradbury currently serves on the University of California San Diego’s Rady School of Management's Advisory Council, the RAND Health Board of Advisors and the University of Miami's Innovation Corporate Advisory Council. He received a Bachelor of Pharmacy from Nottingham University and a Diploma in Management Studies from Harrow and Ealing Colleges of Higher Education in the United Kingdom.

Joe C. Cook, Jr, Board Member

Mr. Cook is a principal and co-founder of Mountain Group Capital. Mr. Cook is a founder and Past-Chairman of the Board of Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) a biotechnology company in Cambridge, MA where he continues to serve as a director. Also, Mr. Cook serves as a director of Corcept Therapeutics, Inc. (NASDAQ: CORT) a biopharmaceutical company in Palo Alto, CA. Mr. Cook served as Chairman of Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) from 1998 to 2009 and was Chief Executive Officer from 1998 to 2003. In 2009, Mr. Cook received the Pinnacle Award for Life Science Leadership from the Rady School of Management at the University of California at San Diego.

Mr. Cook retired as a Group Vice-President, Global Operations, of Eli Lilly and Company in 1993 after more than 28 years of service. During his career at Lilly he served in various senior executive positions including: manufacturing, engineering, finance, sales and marketing and general management. Mr. Cook took a leave of absence from Eli Lilly and Co. in 1976 and was employed by the US International Trade Commission in Washington, DC as a part of the President’s Executive Exchange Program.

Mr. Cook serves as Chairman of the Board of Mercy Ministries International, Inc. with headquarters in Nashville, TN. He is also a past Chair and current member of the University of Tennessee College of Engineering Advisory Board. In 1999, Mr. Cook received the Nathan W. Dougherty Award from the University of Tennessee for distinguished service in the engineering profession. Mr. Cook also serves on the national board of the American Diabetes Association and is Chairman of the board of Life Science Tennessee. Mr. Cook also serves as Chairman of Diabetes Care Group and on the boards of Castle Biosciences and Clinical Products. He was a co-founder and serves on the boards of Device Innovation Group and Diagnovus.

Mr. Cook graduated from the University of Tennessee in 1965 where he received a BS in Engineering with High Honors and was a UT Torchbearer.

Derek Maetzold, President, CEO, and Board Member

Mr. Maetzold is the founder, President, CEO, and Board member of Castle Biosciences, Inc.

He has been a leader in biopharmaceuticals for 28 years, working in leadership roles in both biotechnology and traditional pharmaceutical companies. Prior to founding Castle Biosciences, Mr. Maetzold was an Officer and Vice President, Marketing and Sales at Encysive Pharmaceuticals, a publicly traded company that was acquired by Pfizer. Prior to Encysive, Mr. Maetzold worked in business development and new product development at Schering Corporation (now Merck). Previous experience included positions at Integrated Communications, Amylin Pharmaceuticals (now BMS) and Sandoz (now Novartis). Derek started in field sales at Sandoz, eventually working into leadership positions in both U.S. and international marketing.

Mr. Maetzold attended George Mason University, where he received a BS in Biology before completing additional coursework at the University of Calgary Health Sciences Center and the MBA program at University of California-Riverside.

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Institutional Investors:

Mountain Group Capital and Affiliates

Longfellow Venture Partners I

State of Texas Emerging Technology Fund

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Scientific Advisory Board

We are completing development of several new technologies. We will be structuring our Scientific Advisory Board to meet the needs of these new technologies and making announcements shortly.

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