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Company Background

Omniox is a biotechnology company commercializing a breakthrough oxygen delivery technology called H-NOX for a broad range of peripheral hypoxia diseases including cancer, acute cardiovascular ischemia, wounds, and trauma. The H-NOX technology directly overcomes key reasons for the failure of prior efforts in this area. The technology was originally developed in the laboratory of Michael Marletta, currently President and CEO of The Scripps Research Institute. Omniox currently employs seven full-time scientists and has laboratory operations in Mission Bay, San Francisco, and Sunnyvale, Calif. 

Technology Overview

Omniox is a preclinical/IND-stage company initially focused on developing an H-NOX product that sensitizes hypoxic tumors to radiation and chemotherapy. Preclinical data with the lead H-NOX candidate demonstrate substantial re-oxygenation of hypoxic tumors. When combined with radiation, there is a significant delay in tumor growth and enhanced survival in relevant mouse models of human cancer including glioblastoma, with a promising safety profile.

The University of California, San Francisco Neuro-Oncology Clinical Site Committee has approved H-NOX for parallel Phase IB clinical trials in recurrent and newly diagnosed glioblastoma. A real-time pharmacodynamic biomarker for hypoxia has been validated in the clinic and will be used to identify appropriate patients and measure the biological effects of H-NOX in reducing tumor hypoxia. 

Market Potential

Radiation therapy is the most common non-surgical treatment for cancer patients (more than chemotherapy and targeted therapies combined). Needham & Company estimates that an oxygen-delivery therapy to improve chemo-radiation would command $4,000 to $20,000 per round of chemo-radiation treatment and may represent a market of $3 to $5 billion per year. The competitive, regulatory, clinical, and reimbursement landscapes for this indication are compelling.

Competitive Advantage 

Omniox’s H-NOX oxygen carriers are designed to penetrate deep into the tumor tissue, beyond the reach of red blood cells. This approach is a major improvement over prior clinical efforts relying on manipulating red blood cells: this only succeeded in hyper-oxygenating normoxic tissues with minimal effects on hypoxic tumors. H-NOX is an entirely new approach to re-oxygenating hypoxic tumors to enhance chemo/radiosensitiation.

Financial Overview 

Omniox has secured more than $4 million in NIH SBIR funding since 2009. We are actively seeking equity financing to match the NCI Phase IIB $3 million Bridge Award to advance a lead candidate through Phase IB clinical trials. This clinical milestone will create a significant value inflection for investors joining at this stage of development.

Omniox has received firm commitments for $1 million from high net worth investors, and is seeking a minimum of $2 million in additional investments to match the NCI Bridge award. 

Intellectual Property 

In 2006, UC Berkeley filed broad patent claims to protect the core technologies, and Omniox continues to file for further protection of specific applications. Omniox holds an exclusive option to negotiate (with capped financials) for an exclusive worldwide license for all therapeutic and industrial uses of these technologies. The company has retained the law firm of Morrison & Foerster to oversee IP matters and the firm of Latham & Watkins for corporate affairs. More details on the current status of national filing phases of the core patents are available upon further request.

Commercialization Strategy 

Omniox expects to partner with or be acquired by a pharmaceutical company to successfully commercialize H-NOX for peripheral oxygen delivery. All major pharmaceutical companies are currently conducting clinical trials with chemotherapeutics or targeted therapies in combination with radiation, with the goal of enhancing the efficacy of radiation. 

The lead H-NOX product will be best utilized by medical oncologists who oversee patient treatment plans as part of a team of oncology professionals, including a radiation oncologist. More than 90 percent of radiation oncologists practice within two blocks of medical oncology clinics, therefore, radiosensitizers can be infused at the medical oncology office prior to transport of the patient for radiation treatment.

Pipeline Products 

H-NOX oxygen carriers have the potential to reduce tissue loss during myocardial infarctions and stroke, as well as in acute and chronic wound settings, a range of transplant surgeries, and ultimately may function as part of a resuscitation fluid in emergent situations. There is tremendous life cycle potential for H-NOX proteins beyond their utility in oncology.

Management Team 

Omniox is led by CEO and co-founder Stephen Cary, formerly in Research and Development/Market Strategy at Genentech. 

The Chair of the Scientific Advisory Board is co-founder, Michael Marletta, currently President/CEO of The Scripps Research Institute, member of the SAB of HHMI, and member of NAS and IOM. He has extensive experience in advising pharmaceutical companies in drug development. 

The business co-founder is Ajit Shah, who has a combined 24 years of experience as an entrepreneur, operating executive, and venture capitalist. He is active in Silicon Valley as an outstanding scientific and strategic advisor to start-ups. 

The IND Core Team is made up of experienced drug development veterans from Genentech, Quintiles, and Baxter Healthcare. 

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.

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.

Orphagen focuses on orphan nuclear receptors for which pharmacological data is limited or non-existent and industry competition is minimal. Orphagen’s strengths lie in the validation of novel drug-like small molecule ligands in receptor assays and subsequent clarification of therapeutic utility in target cells and animal models. This "first-to-ligand" strategy attracts industry partners earlier in the drug development cycle than is possible in a more crowded area. By taking this approach, Orphagen signed a discovery and development partnership in autoimmune disease in 2008 with a mid-sized Japanese pharmaceutical company.

Orphagen Pharmaceuticals has been funded through partnership revenues and more than $5.5 million in external grant funding.

Orphagen's project pipeline:

1. Castration-resistant prostate cancer, Cushing's syndrome and adrenocortical cancer based on antagonists to steroidogenic factor-1 (SF-1).
2. Retinitis pigmentosa (novel target in retina) and the dry form of age-related macular degeneration
3. Mood disorders (novel target in CNS) based on modulation of circadian rhythm

TECHNOLOGY

Nuclear receptors are ligand-mediated transcription factors. As a drug class they have been very successful, but 23 of 48 remain unexplored (orphans).

Orphagen has performed the first small molecule validation for several of these orphan nuclear receptors and continues discovery on new targets.

Orphagen chooses targets based on key criteria:

1. Restricted expression (not ubiquitous)
2. Link between tissue distribution and knockout phenotype
3. Plausible therapeutic hypothesis
4. Evidence for ligand-binding pocket