MESA, Ariz. -- Oct. 20, 2010 -- In an industry that faces increasing challenges in delivering new drugs to patients, Predictive Biomarker Sciences (PBS-Bio) today announced three new contracts aimed at bringing new medicines to the marketplace.
PBS-Bio said it is helping more companies develop therapies against a variety of cancers. Most new cancer drugs fail in late-stage studies, and it can take as much as $1 billion and more than a decade to bring the drugs to market.
To jump-start drug development, PBS-Bio's analysis helps pharmaceutical companies better understand how their drugs work, and identifies biomarkers that can help predict which patients will respond to treatment.
PBS-Bio's three new pharmaceutical collaborators are:
- ENDECE, a Mequon, Wis., company that discovered and is developing a family of anti-cancer compounds, including their lead compound NDC-1308, which target molecular "bioswitches" that control metabolic pathways impacting cancer cell growth.
- Revalesio Corporation, a Tacoma, Wash., group developing novel therapeutic candidates containing "charged-stabilized nanostructures" to prevent inflammatory mediated diseases without inhibiting normal cellular functions.
- Unibioscreen, a Brussels, Belgium, firm that is developing a promising anti-cancer drug called UNBS1450 -- currently in European clinical trials.
These three small pharmaceutical companies are in addition to four collaborations in progress between PBS-Bio and four large pharma groups, said Dr. Edward Smith, co-founder and CEO of PBS-Bio, which is a privately held, Mesa-based for-profit corporation.
"We feel that we have reached critical momentum for the growth of PBS-Bio," said Dr. Smith. "The pharmaceutical industry is failing in their efforts to bring new cancer drugs to patients with only two drugs approved in 2009, and only two so far this year. The problems are empty pipelines, and outdated methods of drug discovery and development. Pharmaceutical companies are now seeing the value of the PBS-Bio dynamic technology to help bring more new cancer drugs to market faster and cheaper."
In each case, connections to PBS-Bio were made through scientific networks involving the Translational Genomics Research Institute (TGen), a Phoenix-based biomedical research facility.
And in each case, PBS-Bio is providing drug companies with unique real-time looks at how new therapeutics actually work over time within cellular pathways -- the so-called mechanisms of action.
Rather than focusing on a single target or mutation, ENDECE's approach is to identify key molecular switches that prevent tumors from growing out of control.
"We previously identified a primary mechanism of action for how NDC-1308 kills tumor cells. However, the PBS-Bio technology will validate that mechanism and enable us to observe, in real time, the temporal order of changes for components of the pathways that control cancer cell growth," said James Yarger, President and CEO of ENDECE. "In addition, we may obtain data showing the impact, both positive and negative, of NDC-1308 on other cellular pathways. With current technology, we have not been able to identify the temporal order of events."
By working with PBS-Bio, Yarger said, his company also hopes to determine which cancer patients might be the best candidates for the drug and gain an understanding of what current cancer drugs, if any, would be appropriate candidates for combination drug therapies.
"Our bodies fight cancer cells every day, and in general our bodies do it very, very well. However, the appearance of cancerous tumors signifies uncontrolled cancer cell growth and proliferation. When the body's control over some of these pathways are lost, the cancer cells can grow out of control," Yarger said. "ENDECE's focus is on novel therapies that enhance the body's natural control over cancer cell growth."
Although initially focused on lung and pancreatic cancer, Yarger said, "Our data supports the notion that NDC-1308 may control the growth of many kinds of aggressively growing cancers. We hope to further verify this data with PBS-Bio's technology."
Revalesio is targeting inflammation associated with various inflammatory mediated diseases, including cancer, through the creation of charged-stabilized nanostructures, or CSNs.
CSNs are aqueous based nano-bubble cores surrounded by an ionic scaffolding stabilized with free energy. CSNs interact with cells, specifically naïve immune cells, altering the surface of the cell membrane and preventing unwanted downstream cellular activity that causes inflammation.
"We're developing a new technology that has novel anti-inflammatory effects applicable to a broad range of diseases," said Dr. Richard Watson, Director of Revalesio's Clinical Science. This technology is under development for the treatment of asthma, cardiovascular disease, multiple sclerosis, Parkinson's disease, Alzheimer's disease, and other inflammatory mediated diseases.
"The charged-stabilized nanostructure is a platform from which we can create a variety of products as combination therapies or standalone therapeutics," Dr. Watson said. "Working with PBS-Bio, we want to see how our technology alters cell-survival in a number of different cancer lines, specifically looking at the connection of specific signaling pathways to inflammatory processes and proliferation signaling in oncology."
At hospitals in Belgium and the Netherlands, Unibioscreen has begun phase 1 clinical trials -- first in human tests -- with a drug called UNBS1450.
The drug is a hemi-synthetic derivative of a compound identified by Unibioscreen in the root bark of an African plant called Calotropis procera. Pre-clinical tests have shown that UNBS1450 is very effective against various tumor types.
Unibioscreen CEO Christiane Verhaegen said the company wants to further decipher the mechanism of action of this novel drug candidate, in parallel with the ongoing clinical Phase I trial, to optimize the dose and schedule for the further development stages.
"This is a unique compound, that has shown to be very potent in pre-clinical tests. It is crucial for us to do the biomarker work with PBS-Bio, as this work helps us to get a more in-depth understanding of the mechanism and to define the most effective patient treatment," Verhaegen said.
About ENDECE LLC
ENDECE is a privately held, drug development company focused on first-in-class therapeutics for cancer. ENDECE's core business relies on the in-house rational design of new chemical entities that control molecular "switches" which impact cancer cell growth. The company plans to take its lead candidate into the clinic in 2011. ENDECE has filed multiple composition-of-matter and use patents on its compounds. ENDECE is privately held and has raised over $13 million dollars from private investors. Please visit: www.endece.com.
James Yarger, Ph.D.
Chief Executive Officer and President
1001 West Glen Oaks Lane
Mequon, WI 53092
Revalesio Corporation is a biomedical development company dedicated to restoring hope and transforming lives. Founded in 2000 and based in Tacoma, Washington, the company is advancing an entirely new class of therapeutics that disrupts inflammatory pathways and protects cellular function. With leading research partners from around the world, Revalesio is targeting neuro-inflammatory, respiratory, cardiovascular and other inflammatory mediated diseases. For more information about Revalesio, visit www.revalesio.com.
Unibioscreen is a private Belgian specialist oncology company focused on innovative "first-in-class" oncology therapeutics. Unibioscreen has successfully discovered, patented and developed a drug candidate currently in clinical trials in cancer patients. Unibioscreen built its competitive edge on exploiting through hemi-synthesis the structure activity relationship (SAR) of natural product chemistry and through development and use of unique technologies and demanding orthotopic models of cancer. For more information, visit: www.unibioscreen.com.
Christiane Verhaegen, CEO
+32 476 98 10 78
Predictive Biomarker Sciences Inc. (PBS-Bio) is a privately held corporation based in Mesa, Arizona, and founded in 2006 with funding from private investors, mostly based in Arizona. It is owned in part by the non-profit, Phoenix-based Translational Genomics Research Institute (TGen). The PBS-Bio/TGen collaborative team includes: Dr. Michael Bittner, a biologist, Co-Director of TGen's Computational Biology Division, and Principal Investigator at TGen for the PBS-Bio technology; Dr. Edward Dougherty, an electrical engineer and the other Co-Director of TGen's Computational Biology Division; and Dr. Edward Smith, a medical doctor, an adjunct faculty member of TGen, and co-founder and CEO of PBS-Bio. The three began their collaborations while working under TGen President and Research Director Dr. Jeffrey Trent when Dr. Trent was the Scientific Director of the National Human Genomics Research Institute in Bethesda, Md. Their professional relationships continued after TGen was founded in Phoenix in 2002. For more information, please visit: pbs-bio.com.
Dr. Edward Smith, M.D.
President and CEO