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Company Background

BioMarker Strategies was founded in 2006 by Dr. Douglas Clark, a Professor of Pathology at Johns Hopkins, to improve the treatment of cancer by developing first-in-class, live-tumor-cell-based predictive tests to guide targeted drug therapy selection. Today the company is based at the Johns Hopkins Science + Technology Park and employs 10 people. BioMarker Strategies has successfully developed the SnapPath™ testing platform, and is engaged in pre-clinical and clinical studies with two major academic medical centers. 

Technology Overview

The SnapPath biomarker testing system is an automated live-tumor-cell processing platform that enables next-generation, ex vivo biomarker tests to guide targeted drug therapy selection. A small portion of a patient’s live tumor (from a biopsy or surgical excision) is placed into a disposable cartridge and inserted into the SnapPath instrument. The SnapPath uses onboard robotics and fluid handling systems to expose a patient’s live tumor cells to drugs and/or growth factors to evoke a phosphoprotein-based Functional Signaling Profile (FSP) of the signal transduction network that is not possible using static biomarkers from dead, fixed tissue. These FSPs generated by the SnapPath device can be utilized by oncologists to guide targeted therapy for cancer patients. To date, the company completed proof-of-mechanism studies with human melanoma samples using a prototype device, produced and verified several SnapPath alpha units, and placed two of alpha units at academic medical centers for clinical research studies.

Market Potential 

With approximately 1.5 million solid tumor cancer patients in the U.S., the total addressable market for live-tissue testing exceeds $5 billion, assuming value-based reimbursement. Within this population, the initial target markets include: 

• Melanoma (BRAF V600E)
• Lung carcinoma (EGFR wt)
• Colorectal carcinoma (KRAS wt)
• Breast (Triple Negative) 
• Renal cell carcinoma 

Competitive Advantage 

Most current molecular profiling strategies rely on the analysis of static DNA or protein-based biomarkers, but this tells little about the actual functioning of the complex signal transduction network within tumor cells. By interrogating living solid tumor cells from cancer patients using the SnapPath testing platform, the resultant predictive tests will contain novel information content — such as pathway bypass mechanisms and feedback loops — that will enable oncologists to select better targeted therapies, including drug combinations, for their patients. 

Financial Overview 

To date, BioMarker Strategies has obtained the following funding:

• $9 million from private investors 
• $2.3 million SBIR Fast Track Phase I/II contract for SnapPath instrumentation development
• $200,000 Phase I SBIR contract for companion diagnostic development 
• Additional funding from the Federal Therapeutic Discovery Tax Credit Program, MD TEDCO, and Johnson & Johnson

BioMarker Strategies is currently seeking investors for an initial institutional investment round of $7 million to achieve the early-stage commercialization goals outlined below.

Intellectual Property 

BioMarker Strategies is using a combination of patent filings, trade secrets, and trademarks to protect its proprietary interest in the SnapPath testing system. To date, the company has filed three patent applications that focus on the platform, the process of ex vivo stimulation, and the resultant ex vivo test content. 

Commercialization Strategy 

The company’s long-term commercialization strategy is focused on developing SnapPath-deployed predictive tests to guide therapy for solid-tumor cancer patients in the U.S., Europe, and Asia. BioMarker Strategies will use the following steps to bring its products to market: 

• Early-stage commercialization
• Place first-generation SnapPath units at comprehensive cancer centers 
• Achieve 510(k) approval for the platform
• Expand academic and pharma collaborations 

Later-stage commercialization 

• Increase SnapPath placements at additional cancer centers
• Expand sales and marketing infrastructure
• Validate and clinically qualify tests
• Establish Clinical Laboratory Improvement Amendments (CLIA) lab and launch Laboratory Developed Tests (LDTs)
• Transition LDTs to pre-market approval (PMA) 

Pipeline Products 

BioMarker Strategies’ proof-of-concept studies have focused on characterizing resistance to BRAF inhibitors in advanced melanoma. This will be followed by the development and launch of tests to guide targeted drug use in larger markets such as non-small-cell lung, colorectal, breast, and renal cell carcinomas. Given the ability to test specific drugs in the device, SnapPath also has the potential to become a platform to improve early drug development, provide more effective clinical trial design through patient stratification, and enable companion diagnostics. To this end, the company was awarded a SBIR grant in September 2011, to support the development of a pathway-based companion diagnostic test to use in conjunction with the SnapPath platform. 

Management Team 

Douglas Clark, M.D., Chief Medical Officer/Acting CEO, is an entrepreneur and a Professor of Pathology at The Johns Hopkins Medical Institutions, who brings over 20 years of experience in diagnostic pathology, laboratory management, and biomarker discovery. 

Scott Allocco, co-founder, brings 15 years of business development, pharmaceutical drug management, and public-sector reimbursement experience to the company, having most recently served as the Vice President of State Government Affairs and Business Development for Coventry Health Care. 

Adam Schayowitz Ph.D., MB A, Senior Director of Operations and Business Development, brings nearly a decade of experience in tumor cell biology with a focus in targeted cancer therapeutics, preclinical, and early clinical drug development, and leads the company’s strategic partnerships and collaborations with external collaborators.

Board of Directors: Glenn Miller, Ph.D., Chairman, VP/Head of Personalized Medicine at AstraZeneca; Dr. Samuel Broder, former Director of the National Cancer Institute; Dr. Paul Beresford, VP of Business Development at Biodesix and former VP of Translational Diagnostics at Ventana Medical Systems; Skip Klein, Managing Member at Gauss Capital Advisory and founder of the T. Rowe Price Health Sciences Fund; and Christy Wyskiel, former Managing Director at Maverick Capital and Life Sciences Equity Analyst at T. Rowe Price.