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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.

Company Background

Arbor Vita Corporation (AVC) was founded in 1998, based on technology initiated at Howard Hughes Medical Institute (HHMI) at Stanford University. AVC focuses on the development of novel diagnostics and therapeutics using the proprietary PDZ platform to improve health care worldwide. AVC was the first to obtain FDA clearance for a rapid test for H5N1 Avian Flu in 2009, and it is now moving into commercialization of the HPV E6 Test. AVC also maintains a program to develop a treatment for HPV-induced cancers. Currently the company has 30 employees and several consultants. 

Technology Overview

PDZ protein domains play important regulatory roles in the cell. The AVC PDZ proteome platform combines informatics and chemistry to identify and validate important biological targets for development. Using its PDZ proteomic technology, AVC has developed one diagnostic product (H5N1 rapid test) 510(k) cleared by the FDA, a suite of diagnostics for HPV malignancy (one of which just completed a successful clinical trial), and a companion therapeutic for HPV cancer currently in pre-clinical development. The HPV E6 oncoprotein test platform addresses HPV neoplasia like cervical cancer, anal cancer, and oral cancers. In the clinical trial conducted by PATH (Seattle) and CICAMS (Chinese Academy of Medical Sciences, Beijing) the AVC E6 test achieved analytical sensitivity of less than 1,000 transformed cells, 99 percent specificity, and a positive predictive value (PPV) of 33 percent in a general screening population. In contrast current screening technologies (like Pap and HPV DNA/RNA) achieved lower specificity and a 5 percent PPV. The AVC HPV E6 rapid test that completed the clinical trial is suited for use in near point-of-care settings in developing countries and also physician’s offices.

Market Potential 

The current cervical cancer screening market is more than $1 billion in the U.S. Current screening technologies lack specificity which leads to over treatment and more testing. The AVC E6 test addresses this concern with a test that is 99 percent specific. In addition, the improved analytical sensitivity permits earlier detection of cervical cancer (and potentially anal and head-and-neck cancers) that is crucial for survival and to decrease morbidity associated with surviving cancer. AVC plans to commercialize the HPV E6 Test within the next two years.

Competitive Advantage 

Current cervical cancer screening (Pap and HPV DNA/RNA tests) suffers from low specificity, best captured by the term PPV. The 5 percent PPV typically seen in screening technologies means only 5 percent of the positives have disease and 95 percent do not. Low PPV leads to more testing, higher cost and greater morbidity. The HPV E6 Test achieves a 33 percent PPV for high-grade disease in the same general screening population. The improved PPV means better screening efficiencies, lower costs, and better outcomes for the patient.

Financial Overview 

The HPV E6 oncoprotein detection platform is supported by SBIR grants and private investments. To accelerate the commercialization of this new technology, AVC will require an infusion of $10 to $20 million in new investments.

Intellectual Property 

Most IP associated with the technology was developed by AVC and is patent protected in the U.S., Europe, and Asia. Ancillary patents to enable commercialization of this product have been licensed.

Commercialization Strategy 

AVC’s HPV E6 oncoprotein detection platform can be used in point-of-care settings, high-throughput reference labs, and as augmentation to traditional pathology lab assays. The initial focus will be non-U.S. countries, with an emerging middle class, that have not invested in the health care infrastructure that exists in the U.S. and Europe. This approach favors new technologies able to bypass current practices to provide improved care at a lower cost. AVC also plans to introduce its technology in the U.S. initially through specialty labs, and then to established medical communities.

Pipeline Products 

AVS’s initial focus is to commercialize the HPV E6 Test, followed by adapting the E6 platform to fit various environments. AVC also has a drug in pre-clinical development to address HPV-related cancer treatment and prevention.

Management Team 

Peter Lu, M.D., Founder and CEO, trained at Caltech, Stanford, and University of Washington with a background in medicine, molecular biology, and oncology.

Johannes Schweizer, Ph.D., VP of Research and Development, trained at Institute Pasteur and Stanford with a background in genetics, molecular biology.

Olga Petrauskene, Ph.D., Director of Commercialization, formerly at ABI.

Charles Trimble, Chairman, founded Trimble Navigation and is a successful entrepreneur who has brought new technology into practical use, such as GPS. 

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.

Company Background

Metabolomx is commercializing a non-invasive, rapid, and inexpensive breath test for cancer with the potential to revolutionize cancer diagnosis. 

Technology Overview

Metabolomx has developed technology enabling the identification of lung cancer from its metabolomic fingerprint in exhaled breath, currently in a second round of efficacy trials at Cleveland Clinic and other distinguished clinical centers. At the heart of the system is a high dimensional array of diversely reactive chemical indicators that change color upon interaction with volatile species or mixtures.

Using the first generation of the Metabolomx sensor a recent Cleveland Clinic study (Mazzone et al., 2012, Journal of Thoracic Oncology) reported 85 percent specificity and sensitivity for lung cancer detection, comparable to a CT scan, the present gold standard. In the first quarter of 2012, the Cleveland Clinic and National Jewish Health Center in Denver (led by Dr. Jim Jett, Editor-in-Chief of JTO) began testing a Metabolomx sensor over 100 times more sensitive than the version used in the Journal study. The Mayo Clinic, led by Dr. David Midthun, is scheduled to begin testing in the second quarter of this year. Metabolomx’s technology will be in the clinic at the country’s three top-ranked lung care centers (U.S. News and World Report), reflecting the promise of this new paradigm for lung cancer assessment.

Market Potential 

First indication: A companion diagnostic to CT scan 

Metabolomx’s first FDA indication will be as a diagnostic adjunct to an inconclusive CT scan. Results from the 53,000 patient National Lung Screening Trial (NSLT) indicate that a CT scan screening of high-risk patients extends life expectancy over 20 percent (NEJM, June 2011). The study has already prompted a powerful shift toward widespread use of CT, with Wellpoint recently announcing it will cover CT screening of the enormous at-risk population (more than 55 years of age, more than 30 pack years) identified in the study. However, CT generates a large number of false positives (the NLST found 27% of the high-risk group had a positive CT). Millions of people who have a positive CT are faced with the difficult decision of whether to monitor with follow-up CT or submit to an invasive and expensive biopsy, magnifying the need for a diagnostic adjunct to inconclusive CT. The estimated market size of this first indication is 10 million units per year in the U.S., with revenue of $1 billion.

Pre-screen of high-risk population to triage who should receive CT 

The financial costs of CT, risks involved with radiation exposure, and the enormous size of the at-risk population defined in the NLST calls for a non-invasive, inexpensive initial test to better triage who should be screened by CT. Metabolomx expects to gather data on more than 1,000 patients to confirm that the breath test is a candidate pre-CT screen of the high-risk population. The estimated market size to pre-screen the high-risk population is 25 million units per year in U.S., with revenue of $2 billion.

Monitor efficacy of chemotherapy

Metabolomx is gathering data to confirm that the breath signature declines when chemotherapy is effective in curtailing tumor growth. The estimated potential market to monitor treatment is 15 million units per year in the U.S., with revenue of $1.5 billion.

Correlation between metabolomic breath fingerprint and effective treatment

Metabolomx is compiling an unmatched database allowing the post-hoc assessment of whether there is a predictive correlation between the metabolomic breath fingerprint and the efficacy of a particular treatment. With each treatment often tailored to intervene in a particular metabolic pathway, Metabolomx predicts that the metabolomic fingerprint in exhaled breath will allow individualized selection of treatment.

Competitive Advantage 

The technology is a five minute, inexpensive (less than $100), non-invasive test for lung cancer and other cancers, based on the VOC profile present in the bloodstream and picked up in exhaled breath. Each cancer has its own “smell,” and canines have been documented more than a 95 percent accurate in detection across stages, signaling the extraordinary promise of this new paradigm. 

Financial Overview 

Metabolomx has received several government development contracts, including a NCI Phase I/Phase II Fastrack award of $1.135 million. The company seeks a $5 million Series A round to reach clinical quantification of the level of accuracy of the second generation lung cancer detection system (building on the 85 percent accuracy of the first generation system) and submission to the FDA. Financial information on Metabolomx is available to interested parties under NDA.

Intellectual Property 

The company holds exclusive, worldwide rights to an estate of fundamental enabling technology, including both the sensor itself and application IP. Additional private information is available to interested parties under NDA.

Commercialization Strategy 

The Metabolomx breath analysis instrument will be sold or leased to the same hospitals and testing centers that use CT. The bulk of the company revenue is from the disposable sensor arrays and the balance from equipment and support. The company’s first FDA indication will be as a diagnostic adjunct to indeterminate CT scan. 

Pipeline Products 

The first product is a breath test for lung cancer, but tests for other cancers will follow.

Management Team 

Paul Rhodes, Ph.D., CEO leads a diverse group of technology companies, which have received $13 million in DARPA contracts to develop next-generation sensory systems. 

Ray Martino, COO, who, during a 20-year career at Symbol Technologies was General Manager of its mobile business ($500 million in division sales) and then CTO of Symbol prior to its acquisition by Motorola for $3.9 billion in 2007. 

Sung Lim, Ph.D., Chief Scientist, is a co-inventor of the company’s proprietary nanoporous pigment array optical sensing technology, along with Metabolomx’ co-founder, University of Illinois Professor Ken Suslick.

A Clinical Advisory Board has been formed, and includes deep practical expertise in FDA approval processes.

Molecular Express, Inc., a wholly owned subsidiary of Molecular GPS Technologies has an exclusive license to a virus electrode technology, "Viratrode™", from the University of California, Irvine to pursue commercialization opportunities in pharmaceutical and biotechnology applications. 

The Viratrode™ is an exciting new platform technology capable of monitoring biological environments at the molecular level.  By coupling the desirable features of biological systems with nanomaterials, hybrid technologies such as Viratrodes™ will lead to a whole new generation of extremely sensitive detection devices that would be highly competitive in todays global market.

The Viratrodes™ technology possesses several advantages including high specificity and sensitivity for a target analyte in an easy-to-use format that provides results within a short period of time.  These attractive features will revolutionize many areas of science and technology since the technical capabilities of the Viratrodes™ could be used not only as a diagnostic, but as a real-time analytical tool to accelerate the pace of research and development throughout the world.

Oranoxis has a strong R&D team and we are enthusiastic in applying biomedical sciences. We actively pursue quick and accurate solutions for detections of small and big molecules in human body and environment, to help disease diagnosis, drug monitoring, personalized drug monitoring for efficient and safe dosing. We work hard to serve medical professionals, law enforcement, environment protection and personal care.