March 1, 2005 (Vol. 25, No. 5)

Bricks and Mortar Concretize Area’s Commitment fo the Life Sciences

Phoenix, Arizona recently marked three development milestones in its burgeoning biotech initiative, opening the way for more growth in a city that boasts the unusual combination of a high standard and low cost of living.

In December, the $69 million Biodesign Institute opened its doors at Arizona State University (ASU) in nearby Tempe, the first building of four planned at ASU for bioscience research.

In January, the Translational Genomics Research Institute (TGEN) moved into new headquarters in downtown Phoenix to an area designated to become the Phoenix Bioscience Center. The 15-acre site will serve as a centrally located bioscience and medical research campus. Immediately adjacent is the new Biotechnology Accelerator space, where in February Ribomed Biotechnologies (Phoenix) became the first company to move in.

The Biodesign Institute and TGEN are the cornerstones of a 20-year, $1 billion initiative of local and state funding giving priority to building Arizona bioscience research and commercialization.

Phoenix, the fifth largest city in the U.S. and the most rapidly growing urban area in the nation, recruited Jeffrey Trent, former founding director of the National Human Genome Research Institute at the NIH to head TGEN, and Michelle Hanna, Ph.D., formerly an associate professor of chemistry at the University of Oklahoma and currently the CEO of Ribomed, back to the area.

With historically strong defense, aerospace, and micro-electronics industries, Phoenix’ biomedical research has been limited until recently. Now it is set to expand exponentially as part of Arizona’s biotech roadmap, with a medical school planned to open next fall in conjunction with the University of Arizona (Tucson).

Phoenix Focuses on Strengths

Phoenix is emphasizing existing strengths of neurology, oncology, and bioengineering in the future biotech development. ASU’s Technopolis initiative is helping life science academics commercialize their technologies by offering a series of in-depth coaching programs to help refine business strategy and identify funding for early-stage product development.

Phoenix also aims to draw to the area out-of-state pharmaceutical and biotech business as the cost of running a bioscience business in the area is reportedly competitive when compared with markets of similar size.

The locale also offers researchers access to the area’s diverse ethnic populations such as the Salt River Pima-Maricopa Indian community, which plans a biomedical research campus in the area; a large senior population; a statewide Alzheimer’s research consortium; and an expanding network of healthcare institutions, including the Mayo Clinic in Scottsdale, the Sun Health Research Institute, and Banner Healthcare.

Recently, the Mayo Clinic in Scottsdale received a $10.8 million, five-year grant from the National Cancer Institute (NCI) for brain cancer research. TGEN and Affymetrix (Santa Clara, CA) were granted $2 million from the National Alliance for Autism Research for genetic studies. Phoenix’ Southwest Autism Research & Resource Center is contributing funds to the project as well.

Biodesign Institute

The $69 million, 17,000-square foot Biodesign Institute will house 285 researchers and eight of the Institute’s initial 10 centers. “This building is a symbol of the university’s goal, founded in 1980, to grow up,’ and be more competitive in the research area,” said ASU president Michael Crow.

Biodesign Institute director George Poste observed that the building’s design reflects its intended function: open glass atrium and flexible-space design geared to foster collaborative, multidisciplinary biological research.

The Institute is taking a systems approach to biological, nanoscale, cognitive, and sustainable research. A second building of equal size, now under construction, will open next autumn.

The Institute’s 10 research centers, which include Centers for Protein and Peptide Pharmaceuticals, Applied NanoBioscience, Infectious Diseases and Vaccinology, Environmental Biotechnology, and Neural Interface Design will engage in basic research geared toward real-world applications.

Neuroscientific Models

Co-directors of the Center for Rehabilitation Neuroscience and Rehabilitation Engineering, James Abbas, Ph.D., and Ranu Jung, Ph.D., have spun off two biotech companies, CustomKynetics (Versailles, KY) and Advensys (Phoenix) respectively, that will commercialize technology for treating neurological and movement disorders.

“Advensys is using computational neuroscientific models of the spinal motor pattern generator for understanding neuromotor control as well as to develop biomedical fixed-pattern and adaptive controllers.

“Ultimately, the goal is to develop bio-mimetic and bio-hybrid living hardware systems for motor control that bypass thinking, and coordinate with other parts of the body at a subconscious level,” Dr. Jung explained.

Advensys is working to gain a better understanding of nervous system reorganization subsequent to neurotrauma in order to develop improved neural interface devices for rehabilitation and therapy.

“We are utilizing locomotor retraining therapies using treadmill walking for functional neuromuscular stimulation to tap into spinal plasticity after neurotrauma,” Dr. Jung added.

Research to Clinic

Founded in 2002, TGEN focuses on cancer, neurological disorders, and diabetes.

It has spun out three companies to move research rapidly into the clinic: the Center for Translational Drug Development (TD2) provides consultations for the initiation of clinical trials and services to evaluate the safety and efficacy of preclinical compounds using animal models and genomic analyses; the for-profit Molecular Profiling Institute (MPI) develops personalized medicine tests for cancer; and Nanobiomics, which is developing genomics-based tests.

MPI’s first molecular profile program, TargetNow, is available for cancer patients for whom all standard therapies have failed to identify at least one good drug target. The goal is to find therapeutic options that have not been considered. “We are also in the process of establishing relationships to test patients at the beginning of treatment,” Richard Love, TGEN’s COO, remarked.

In January, MPI introduced MammaPrint in the U.S., a 70-gene microarray gene profiling assay that provides prognostic information for women with primary invasive breast cancer, age 55 and younger, with lymph node-negative disease and with either positive or negative estrogen-receptor status, said president and CEO Robert Penny, M.D., Ph.D.

Developed by Agendia (Amsterdam) with the Netherlands Cancer Institute, MammaPrint outperformed all currently used standard diagnostic criteria in predicting future development of distant metastases and overall survival, according to a large study announced in December at the “San Antonio Breast Cancer Conference”.

“MammaPrint is also useful for patients considered to be at low risk for metastatic disease by the classical diagnostic tests, and for those where conventional diagnostic tests produce ambiguous results,” said Rene Bernards, Agendia’s CSO.

Results of the test enable physicians to more precisely tailor treatment to patients. Large-scale prospective trials of the test are being conducted in 10,000 patients by the Netherlands Cancer Institute, which helped develop the test.

Inflammatory Disorders

Cynexus (Chandler, AZ) is a recent ASU spin-off focusing on inflammatory disorders. Led by Steve Massia, Ph.D., CTO and associate professor of bioengineering, Chad Kennedy, Ph.D., president and CEO, and Steve Bade, COO, Cynexus’ technology disrupts white blood cell adhesion to inflamed tissue.

“Our technology shuts off abnormal local leukocyte adhesion to inflamed tissue without targeting the entire immune system, and without the side-effects of typical anti-inflammatory drugs,” said Dr. Massia.

While the technology can be applied to cardiovascular disease, autoimmune disease, and allergies, septic shock, reperfusion injury, and transplant rejection, Cynexus decided to focus first on ophthalmologic, topical applications for chronic dry eye (keratoconjunctivitis sicca), a market of over 30 million in the U.S.

“Our next, actually concurrent application focuses on inflammation and bacterial responses to contact lenses, and then for treating allergic conjunctivitis and post-surgical eye inflammation,” said Dr. Kennedy.

Abortive Transcription

Ribomed Biotechnologies is a translational genomics company developing rapid, specific tests for drug screening and early disease detection and causative agent characterization.

Founded in 1999 by Dr. Hanna, Ribomed’s platform signal generation process, Abscription (abortive transcription), allows for rapid, isothermal detection and characterization of RNA, DNA, and proteins.

Abscription is the basis of the RiboMaker Detection System, used for the detection of methylated DNA in silenced genes, pathogenic organisms, and disease-associated changes in RNA and protein expression levels without PCR or gel electrophoresis.

Ribomed was initially founded to pursue treatments of cancer. It recently submitted an SBIR Phase II grant to NCI and is collaborating with a country in Southeast Asia to develop kits for early diagnosis of gastric and liver cancer using the abscription process.

Recently, however, Ribomed’s technologies have been recognized by the U.S. government for utility in homeland security applications.

“We are working on our fourth DARPA contract now, and also have a Phase I SBIR grant funded by NIH to develop a rapid blood test to use in developing new vaccines against infectious agents,” said Dr. Hanna.

In July 2004, it received a $1 million contract to develop and produce a continuous monitoring system of outdoor urban areas, and in January 2004, Ribomed received over $3 million from DARPA to apply the RiboMaker Detection System to a handheld sensor to rapidly detect germs used in biowarfare.

The Proteomic Cowboy

A recent visitor to Intrinsic Bioprobe (IBI; Tempe) described founder, president, and CEO Randall Nelson, Ph.D., as the “proteome cowboy” for his colorful shirts, cowboy boots, and informal manner, but he could just as easily be dubbed the “proteome pioneer.”

Dr. Nelson started IBI in 1996, but developed the first MALDI-TOF, which he sold to Applied Biosystems 15 years ago, before the word “proteomics” was coined. IBI may be one of the only profitable proteomics companies.

Dr. Nelson created tools and techniques for high throughput protein screening and characterization, using a specialized form of mass spectrometry to produce information about protein mass and structure. This MASSAY system includes Bioreactive Mass Spectrometer Probes for rapid, accurate characterization, and immunoassay to selectively isolate proteins from complex biological matrices.

The matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS) system produces qualitative information about differences between a protein sample and its normal or modified state, as well as quantitative information on the protein’s abundance. Other analysis techniques may not distinguish between wild-type and variant proteins.

“IBI is primarily a service company whose technologies provide high content biomarker discovery, validation, and analysis to clients in the pharma, biotech, and diagnostic industries,” said Michael Robinson, director of business development. “IBI offers products to our partners if they want to bring our technologies in-house for routine screening and analysis.”

In-house research projects center around cardiovascular, neurodegenerative disorders, cancer, and biodefense. It is also working to increase throughput and automating data analysis.

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