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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.