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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.

MyeloRx is developing proprietary prodrugs and derivatives of the natural product triptolide. This agent has demonstrated clinical efficacy in acute leukemias. The company is currently funded by an NCI Fast Track SBIR contract enabling the development of its lead product, MRx102. MRx102 has demonstrated efficacy in a variety of preclinical models of AML; this work, performed in collaboration with Dr. Michael Andreeff of the M.D. Anderson Cancer Center, was recently published in Leukemia.  It has also shown a high degree of safety in rodent toxicology models. 

 Based on its novel mechanism of action, the inhibition of XPB, it is expected to enhance the effects of radiation in solid tumors. Preclinical data support this hypothesis.

 The compound is currently undergoing additional toxicology studies in rodents as well as toxicology studies in dogs. Is has patent coverage in the U.S., E.U., Japan and China.

The principals have extensive pharmaceutical experience at both large (Pfizer, Wyeth, DuPont) and small (Cetus, Cygnus and Pharmagenesis) pharmaceutical/biotechnology organizations. 

Company Background

Nortis is dedicated to developing a new generation of in vitro systems that are based on small segments of tissues and organs grown from human-derived cells in disposable, chip-like devices. Such human “body-on-a-chip” systems represent urgently awaited alternatives to laboratory animals and are expected to become the gold standard for the testing of drugs, vaccines, toxic compounds, cosmetics, and warfare countermeasures.

The Nortis project started in 2005 as a division within VisionGate, a bio-imaging company. In 2011, Nortis, Inc., was officially spun-off and subsequently moved into its new facilities at a biotech incubator on the University of Washington campus. As of January 2012, the Nortis team consists of 10 full- and part-time employees and consultants.

Technology Overview

Nortis is developing products that will overcome a crucial bottleneck in the development of therapeutic drugs and vaccines. Due to the lack of reliable in vitro assays, drug development depends heavily on animal testing for predicting efficacy, safety, and pharmacokinetics in humans. This is problematic for several reasons. Testing in animals is expensive and fraught with ethical concerns. Most importantly, the results obtained with animals often don’t translate to humans. 

Nortis has pioneered proprietary techniques for the in vitro creation of human tissues and organs in disposable chip-like devices. These organ microenvironments are designed as disposable modules, to be used as single assays or integrated in fluidic circuits that connect several different organ modules in various configurations as needed for the testing of drug/vaccine efficacy, toxicity, and pharmacokinetics. Nortis established proof-of-principle for their technology through a completed SBIR Phase I grant. Nortis anticipates their first products to enter the market within two to three years.

Market Potential 

Market analysis for the first two Nortis assays, a model of the blood-brain-barrier assay and an angiogenesis assay, were prepared by Foresight Science & Technology, a leading technology commercialization and transfer firm. The combined yearly revenue potential for the two assays was predicted to exceed $400 million. The market potential of the other tissue/organ assays has not yet been evaluated, but is expected to have the same magnitude.

Competitive Advantage

Nortis’ tissue and organ models differ significantly from other body-on-a-chip approaches. The competitive advantage of Nortis’ technology arises from the integration of living vasculature, which can be directly perfused to mimic blood flow. This unique feature allows for the study of vascular growth and function in real time, reducing the need for expensive and laborious animal testing. Vasculature is a structural and functional key element of almost every tissue. Thus, Nortis’ assays are poised to produce test results that better replicate in vivo conditions and predict clinical outcome. Notably, the Nortis system is ideally suited for administering test compounds either through the vessel lumen or through the surrounding microenvironment. This is especially important for the testing of drugs, toxins, and vaccines. Nortis’ assays are modular and can be set up in flexible configurations with anticipated widespread adoption in various research areas, including high-throughput drug screening.

Financial Overview

The development of Nortis’s first commercial assays were supported by three NCI SBIR Phase I grants. The company aims to raise an additional $1 million in private investment this year to support R&D efforts until SBIR Phase II grants are secured in 2013. 

Intellectual Property

Nortis owns two issued U.S. patents, and two U.S. applications that were filed on this technology to cover additional features and techniques. International patent applications in important global markets are currently undergoing the examination process. Nortis is the sole owner of all related IP. 

Commercialization Strategy

Nortis plans to introduce the first assays and basic perfusion platforms into the scientific research market during the second half of 2014 — ideally by partnering with a company with established sales structures in this area. Nortis anticipates that the success in the scientific research market will translate to adoption in the area of commercial drug development. 

Pipeline Products

The first line of products will include a blood-brain-barrier assay, an angiogenesis assay, a metastasis assay, as well as a perfusion platform in which the assay modules can be inserted. 

Management Team

Thomas Neumann, M.D., is President and CEO of Nortis. His career path includes clinical work, academic appointments, and leadership positions in industry, where he has gained extensive experience in directing multidisciplinary teams. He and Dr. Nelson are the founders of Nortis.

Alan Nelson, Ph.D., Chairman, held multiple prestigious academic positions. He is a dynamic serial entrepreneur. His first biomedical company, Neopath, won landmark FDA approval in 1995, had an initial public offering (IPO) in 1996 and was sold to Becton Dickinson in 2000. 

Company Background

NovoMedix LLC specializes in the development of small molecule inhibitors of multiple biological pathways that are critical drivers of disease and are relatively inactive in normal tissues and housekeeping processes, with an initial focus on cancer. NovoMedix targets underserved markets with unmet clinical needs, including triple negative breast cancer (TNBC), high risk B-cell acute lymphoblastic leukemia (B-ALL), and melanoma.

Technology Overview 

NovoMedix has developed two new classes of small molecule translation initiation inhibitors with unique mechanisms of action as targeted therapies for high risk TNBC (estrogen and progesterone receptor, and HER2/neu-negative breast cancer). Lead compounds are currently in the preclinical stage and have been tested in an animal model of TNBC in which they significantly reduced tumor growth (better than paclitaxel) with no apparent toxicity. These novel compounds are promising clinical candidates and represent first-in-class small molecule therapeutics aimed at reducing recurrence and increasing survival rates for TNBC. Since these drug candidates are small molecules, they will be less expensive and easier to administer than biologics and should fit easily within the current treatment regimen.

Market Potential 

Breast, prostate, and colorectal cancer account for more than half of cancer patients in the United States. One in eight women in the U.S. will develop breast cancer during her lifetime. Although the overall survival rate for early stage breast cancer is high, triple negative breast cancers are particularly aggressive and are more likely to recur than other subtypes, resulting in a significantly increased risk of death. Currently, no targeted therapies exist for TNBC. Since more than 60 percent of triple negative breast tumors overexpress eIF4E (a critical factor in translation initiation), and high levels of eIF4E are correlated with recurrence and death, inhibitors of protein translation initiation should prove to be a viable targeted therapy for TNBC with high eIF4E.

Competitive Advantage

NovoMedix’s most advanced drug candidates for the treatment of TNBC represent two new classes of translation initiation inhibitors with unique mechanisms of action. Besides the anti-viral drug, ribavirin, there are no viable drug-like inhibitors of translation initiation have been reported to date. More importantly, there are virtually no novel therapies in clinical trials for TNBC. Most ongoing trials for TNBC are on various combinations of existing chemotherapy drugs. Recent data suggests that at least one of these “first-in-class” compounds has the potential to enter into a Phase I clinical trial for TNBC.

Financial Overview 

NovoMedix LLC was established as a partnership in 2001 and converted to an LLC in 2010 in anticipation of angel or VC funding and/or corporate partnerships. NovoMedix is currently privately owned and has no venture capital investment. NovoMedix has raised $1.75 million in equity, government grant, and tax credit revenue. SBIR funding has allowed the company to increase its value without dilution. NovoMedix is seeking a strategic investment of $5 million to complete preclinical studies and file an IND for TNBC within 24 months. NovoMedix would then partner with a larger pharmaceutical company for clinical development and commercialization of a novel therapy for TNBC.

Intellectual Property 

NovoMedix has filed a composition of matter patent application (PCT/US2011/039377) for the NM043 series of compounds for the treatment, prevention, and/or amelioration of various disorders, including cancer. In addition, NovoMedix is in the process of filing provisional patents on several other lead series.

Commercialization Strategy 

NovoMedix’s commercialization strategy is to design and execute an IND-enabling nonclinical safety program to support a Phase I clinical trial in patients with advanced metastatic disease and enter into partnerships with pharmaceutical companies for the clinical development and ultimate commercialization of novel small molecule drugs. NovoMedix plans to license its compounds in exchange for licensing fees, milestone payments, and royalties.

Pipeline Products 

The NovoMedix pipeline contains several novel compounds in various stages of development. Most relevant to this project are follow-up studies that are planned to determine the efficacy of previously identified lead compounds for the treatment of metastatic breast cancer. In addition, several different novel lead compounds are currently under development for the treatment of high risk pediatric B-ALL. These compounds have demonstrated in vitro safety and efficacy and preliminary safety in animals. In vivo studies in mouse models of high risk B-ALL are the subject of a recently submitted Phase I SBIR proposal.

Management Team 

Cathy Swindlehurst, Ph.D., Founder and CEO, has 22 years of experience in biotechnology. Former V.P. at PanCel, MagneSensors, and NovaDx.

Leah Fung, Ph.D., Founder and Exec. Director, Drug Discovery, has 20 years of experience in medicinal chemistry. Management positions at Structural Genomics, Structural Bioinformatics, and Celgene.

Sabine Ottilie, Ph.D., Director, Molecular Oncology, has 20 years of molecular oncology research experience in academia and biotechnology.

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.