Peter S. Lu, M.D.
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.
