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Company Background

Oncoscope, founded in June 2006 by Dr. Adam Wax, employs optical imaging technologies developed at Duke University. Oncoscope has been supported by grants from NCI, NIH, the National Science Foundation, and the Wallace H. Coulter Foundation. The company resides in Durham, N.C., maintains eight full-time employees, and manages close relationships with Duke University and regional service providers.

Technology Overview

Oncoscope develops diagnostic devices that use proprietary a/LCI optical technology to locate abnormal epithelial tissue, where 85 percent of all cancers begin. These devices are fast, accurate, non-invasive, and allow real-time examination of large tissue areas in vivo. They detect early pre-cancerous dysplasia, a breakthrough over existing diagnostic methods, and have demonstrated 100 percent sensitivity in human studies to date. These devices leverage the biological premise that the primary early marker of cancer examined by pathologists is enlarged cell nuclei. The system examines scattered light to determine average cell nuclei size using a technology called angle-resolved low coherence interferometry (a/LCI). Oncoscope’s first product targets the rapid in vivo identification of pre-cancerous tissue in the esophagus during standard esophageal endoscopy. The device consists of a base unit, a probe compatible with current esophageal endoscopes, and a disposable single-use probe cover. The company has collected clinical pilot data from over 200 patients and is presently preparing for its pivotal trial for FDA approval.

Market Potential

More than 12 million invasive biopsy procedures costing $25 billion are performed annually in the U.S. to detect cancerous epithelial tissue. Many cancers cannot be reliably detected at early stages with current techniques. For example, early detection in esophageal cancer could significantly improve the abysmal nearly 95 percent mortality rate. The esophagus is of particular concern given an estimated 43 million adults with Gastro-Esophageal Reflux Disease, 10 percent of which develop Barrett’s Esophagus leading to an estimated 16,000 cases of esophageal cancer and 15,000 deaths annually. Oncoscope’s device targets 1.6 million annual esophageal endoscopy procedures, each averaging 35 randomly selected biopsies. Oncoscope’s first product addresses this market by: (1) improving accuracy in the early detection of dysplasia, (2) eliminating unnecessary biopsies, (3) decreasing procedure time and cost, and (4) combining diagnosis with immediate treatment. 

Competitive Advantage

Of the many different cancer detection technologies in use or in development, none employ a/LCI or other proprietary technologies used by Oncoscope. Only two of the many devices attempting to detect epithelial cancer can see early stage growth. Of these, only Oncoscope examines deep tissue layers where cancer begins, works in real time, is non-invasive, does not require patient pre-treatment with a contrast agent, and does not require a pathologist to interpret the data.

Financial Overview

Oncoscope has been funded by SBIR grants and $5.1 million in equity financing. The company is looking to raise a $10.0 million series B to support U.S. and EU regulatory approval, product validation, manufacturing development, clinical trial support for regulatory filings, and commercial product launch.

Intellectual Property

Oncoscope has three issued patents and has developed six patent families directed to devices and methods for various optical systems. The first two cover key innovations for determining cell nuclei size in multiple tissue layers from a single data collection event using scattered light. Broad patent claims have been recently issued by the USPTO for the core technology involved in determining cell nuclear size.

Commercialization Strategy

Oncoscope will focus on marketing a product and the procedure in which the product is employed with a small, dedicated, and focused sales force. A key objective is to expand to both the earlier stage of lower risk patient monitoring and later-stage treatment. Physician customers are interested in assessing Oncoscope’s a/LCI device to improve detection and treatment in all stages of cancer. The company plans to capture as much of these investigations as possible in a number of clinical studies aimed at expanding the clinical range of use for Oncoscope’s a/LCI. On the therapeutic end of the clinical spectrum, studies will be pursued to evaluate the utility of “see-treat” methods and for post-ablation margin analysis. Thus, the initial marketing will entail an active parallel development program to capture the array of clinical use concept testing that will inevitably occur once physicians have access to a powerful new tool that provides critical insight on the condition of tissue.

Pipeline Products

Oncoscope’s device is applicable to screening for a wide spectrum of cancers with little adaptation. The company is exploring product development opportunities in colon IBD, cervix, and gastric cancers. Additionally, Oncoscope is developing product enhancements for wide area and trans-nasal scanning to further improve screening paradigms.

Management Team

Perry A. Genova, Ph.D., CEO, is a serial entrepreneur, who has held Global VP positions with GSK, KOS. He has more than 25 years developing medical devices and drug products.

Adam Wax, Ph.D., CTO, is Professor of biomedical engineering at Duke. He is a recognized biophotonics expert.

Micki Lew, Director Regulatory Affairs has significant domestic and foreign experience in clinical operations.

Company 

Qualiber, Inc. is a nanomedicine company with the mission to deliver innovative treatments for cancer and other life threatening diseases.  Utilizing nanotechnology it is creating medicines that have superior efficacy and safety profile. In addition, Qualiber is partnering with pharmaceutical/biotechnology companies to address delivery challenges of partner’s treatments.

The company has secured funding from the National Cancer Institute, UNC-CH, the North Carolina Biotechnology Center and pharmaceutical company partners.  The company is seeking $500K first tranche of $5M Series A funding to progress lead cancer product, NanoGTP™ (Nanomedicine delivering Gemcitabine Tri-Phosphate) towards human clinical trials.

1st Product: NanoGTP™, demonstrated superior efficacy & safety in animal models of human cancer 

Cancer (especially pancreatic and lung cancer) is a continuing leading cause of death and suffering in the US and the World. Though there are chemotherapeutic drugs on the market, most have limited effectiveness and cause serious side effects/toxicities. Qualiber is developing its first product NanoGTP for pancreatic and lung cancers. NanoGTP substantively improves the delivery of existing anticancer drug, gemcitabine, and enhances the potential for greater clinical benefit and expanded use.  In preclinical animal models of human cancer NanoGTP has demonstrated superior efficacy and safety than gemcitabine.  Company expects to complete scale-up manufacturing and preclinical toxicology studies by end-2013 followed by Investigational New Drug (IND) application filing to the FDA in 2014. The market for pancreatic cancer treatments is estimated to be $1.2Billion in 2015 and for lung cancer to be $9.5Billion in 2018.

Founders and Management Team

·        Dr. Anil K. Goyal, President & CEO. Over 20 years of leadership experience at venture-backed and public biotechnology companies. Managed and led exits: Optherion’s diagnostics division sale and Serenex >$300M sale to Pfizer.

·        Dr. Leaf Huang, CSO and Co-founder.  Distinguished Professor and Chair, Division of Molecular Pharmaceutics, UNC-Chapel Hill. More than 30 years research experience and world-renowned in development of liposome based drug and gene-delivery systems. Co-founder of four other companies.