Darren Davis
Company Background
ApoCell, Inc., was founded in 2004 by Darren W. Davis to commercialize biomarker technologies that monitor the effectiveness of cancer drugs by measuring biomarker expression patterns in tumor biopsy specimens. ApoCell provides molecular analytical services supporting clinical trials for pharmaceutical/biotechnology companies, government, and academia. The company mission is to be in the forefront of scientific and technological developments for providing highly effective molecular diagnostic services and products to significantly improve the treatment and outcomes for people afflicted with cancer and other chronic diseases. ApoCell scientists have investigated and developed laboratory techniques that provide highly accurate mechanistic, predictive, and prognostic cancer information.
ApoCell has seen continued growth in revenue from its service business since its inception. In 2011, ApoCell made the Inc. Magazine’s 500/5000 list with more than a 400 percent growth rate over the past three years and ranked the 13th fastest growing company in Houston, Texas. ApoCell has 41 employees and continues to hire additional staff to support the continued growth of its service and product development businesses.
Technology Overview
The ApoStream™ system uses dielectrophoresis field-flow fractionation (DEP-FFF) technology to capture rare circulating tumor cells (CTCs) from blood. Growing evidence suggests that capture of CTCs from a blood sample may allow reliable early detection and molecular characterization of cancer for diagnosis or relapse and provide a minimally invasive method to guide and monitor the efficacy of cancer therapy. CTCs represent a potential alternative to tumor biopsy as a real-time ‘liquid biopsy’ and have been shown to be a prognostic indicator of survival.
The ApoStream™ point-of-care (POC) is currently in the alpha prototype stage and will be launched as a Research Use Only Device (RUO) in the fall of 2012. ApoCell anticipates the final POC device will become a foundational platform for several next-generation diagnostics based on molecular profiling of CTCs for tailoring patient-specific therapy.
Market Potential
A report by BCC Research indicates that the total global annual market for next-generation cancer diagnostics was $776 million in 2010, and is growing at a compound annual growth rate (CAGR) of 47 percent, to reach a forecast market size of $5.3 billion in 2015. Current clinical applications of CTCs have been shown to predict overall survival in breast, prostate, and colorectal cancer.
Competitive Advantage
The ApoStream™ rare cell capture technology is an improved approach from current marketed technology, in that it is the first device that enables antibody-free capture of viable cancer cells from a wide range of human cancers, including non-epithelial cancers or cancers with low or negative epithelial expression. The captured cells are not modified (no labeling or fixing) thereby enabling the cancer cells to be cultured and allowing RNA/DNA and protein analysis for complete cell characterization.
ApoStream’s ability to capture viable, unlabeled CTCs from cancer patients will contribute to significant improvement for diagnosis, prognosis, and discovery of biomarkers associated with cancer progression and treatment, thereby advancing the clinical application of personalized medicine.
Financial Overview
Currently, ApoCell has funded the majority of its operations from its pharmaceutical and clinical trial services business.
In 2009, a private equity investment of $5 million was raised for the development/commercialization of the ApoStream technology, and to expand the capabilities of the services business.
In January of 2010, ApoCell was awarded a $2.9 million contract from the NCI/SAIC for development and delivery of 12 alpha research use only (RUO) prototypes along with several pre-clinical diagnostic applications. Subsequently, a SBIR Phase I grant for $200,000 was awarded to begin conversion of the RUO device into a clinical POC device.
ApoCell is currently looking for $10 to $15 million to further implement the technology into the ApoCell research services business and to fund the next development and commercialization stage of the ApoStream POC device.
Intellectual Property
ApoCell has an exclusive license from the University of Texas MD Anderson Cancer Center to commercialize the ApoStream technology. There are five patent families and 22 patents included in the license agreement. In addition, the company continues to file its own intellectual property (IP) and has several agreements with major pharma/biotech companies that permit ApoCell additional diagnostic rights.
Commercialization Strategy
ApoCell plans to establish strategic partnerships with companies that can provide appropriate distribution channels for each stage of the device. Discussions are ongoing with several larger companies to target the RUO and clinical in vitro diagnostics (IVD) markets.
ApoStream will be rolled out in the following three phases during its development:
- Research Only Device (RUO) – Academic, pharma/biotech research environment, and fee-for-service work
- Clinical Sample Device (IUO) – Internal services, diagnostics development, and analytical instruments markets
- In Vitro Diagnostic Device (IVD) – For use as a clinical instrument providing diagnostic assays
Pipeline Products
The ability to capture viable CTCs from various cancer types will allow researchers to culture these rare cells to advance scientific knowledge, including discovery of novel drug targets on these metastatic cells. Further, capturing adequate numbers of CTCs will allow for RNA/DNA molecular characterization and protein expression analysis.
Management Team
Darren W. Davis, Ph.D., President and CEO/CSO, is a world-recognized cancer researcher who has published 40 scientific articles and edited the book Antiangiogenic Cancer Therapy.
David K. Hasegawa, M.S., is Vice President of Product Development.
Kenna Anderes, Ph.D., is Vice President of Scientific Affairs.
Glen A. Ferguson, MBA, is Vice President of Molecular Biomarkers.
Jim M. Walther, MBA, is Vice President of ApoStream Business Development and Strategic Partnerships.
Natalie Gassen, C.P.A., is Chief Financial Officer.
Vlada Melnikova, M.D., Ph.D., is Director of Molecular Biology.
