Pressure BioSciences expands license deal with Target Discovery

Pressure BioSciences (OTCQB:PBIO) said Monday it has signed expanded technology license and supply agreements with Target Discovery Inc, giving Target the right to use its patented Pressure Cycling Technology (PCT) platform for a planned entry into the clinical diagnostics testing market.

Life science company Pressure BioSciences' patented PCT platform uses rapid and repeating cycles of hydrostatic pressure at controlled temperatures to extract cell components in the preparation of a biological sample, such as DNA, and proteins from humans, animals and plants, for further study.

The applications of the company's PCT-based products are endless - from the key $2 billion target market of mass spectrometry, an analytical technique used to determine the characteristics of molecules, to biomarker discovery, forensics and counter-bioterrorism, among other uses.

Target's planned commercial diagnostic services will initially target "critical, unmet needs" in treatment selection guidance for ovarian cancer, the parties said.

Until now, Pressure BioSciences' PCT platform has been available on a “research-use-only” basis.

In 2010, the companies announced a collaboration to combine Pressure BioSciences' PCT platform with Target's proprietary reagents, to allow for the extraction of membrane protein biomarkers from human tissue.

These biomarkers are typically difficult to extract from tissue in a form suitable for diagnostic testing.

The companies said, however, that they believe their "unique" ability to rapidly extract and recover the commercially useable protein biomarkers from cell membranes positions them to "exploit this critical class of membrane proteins as diagnostic biomarkers". 

“Membrane proteins play key biological roles in cancer, in drug resistance, and in viral infections, yet until now scientists have been virtually unable to use this important class of biomarkers for diagnostic and prognostic testing,” said Target's chief scientific officer, Dr. Luke V. Schneider.

CEO of Target, Jeffrey N. Peterson, added: “We are very pleased with the progress and outcomes achieved in our on-going multi-year collaboration with PBI.

"We believe that the PCT Platform, in combination with TDI’s proprietary reagents, provides reliable access to this important class of protein biomarkers for life sciences R&D.

"We further believe that variations measured in these protein isoforms are expected to translate into important commercial applications, and desperately needed breakthroughs in improved patient care and health-economic outcomes."

Indeed, the first area of application is in ovarian cancer, where more than 22,000 women are diagnosed each year in the US. The companies said over two thirds of these new patients could be helped "dramatically" by the introduction of "reliable treatment selection guidance diagnostic information."

The non-exclusive, worldwide, royalty-bearing license is for the in vitro diagnostic services testing for the detection of proteins that may be regarded as biomarkers of ovarian and other cancers.

The license agreement includes a minimum royalty that is replaced by an annual royalty once Target achieves a specified minimum level of diagnostic testing sales.

It also includes a right of first negotiation and right of first refusal for an exclusive license to sell biomarker and/or diagnostic assay products, including instruments, software, kits and consumables, in a specified field of use.

The license continues for the life of Pressure BioSciences PCT patents.

Under the supply agreement, Pressure BioSciences will make available to Target the PCT instruments and consumables at "most favored nation" pricing, it said.

"The innovative scientific team at TDI has vaulted important anticipated applications for PCT forward into near-term realities," said CEO of Pressure BioSciences, Richard T. Schumacher.

"The power and impact of TDI’s isoform-focused technologies and their promise in opening a new era in personalized medicine diagnostics for cancer treatment is dramatic and inspiring.

"We are excited that PBI’s patented PCT Platform will provide the sample-processing foundation upon which many of TDI’s next generation clinical laboratory testing services will be based, and we look forward to supporting our colleagues at TDI with our continued collaboration, and by fulfilling their expected PCT Platform instrument and consumables needs," he concluded.

Palo Alto, California-based Target Discovery is a privately held company developing the clinical diagnostics. The company focuses on creating protein isoform diagnostics to better guide therapeutic choices and lower overall treatment costs for cancer and other diseases.

Pressure BioSciences is focused on the development and sale of PCT-enhanced sample preparation systems (instruments and consumables) for mass spectrometry, biomarker discovery, bio-therapeutics characterization, vaccine development, soil and plant biology, forensics, histology, and counter-bioterror applications.

Earlier this month, the company said that Ironridge BioPharma would buy $500,000 in shares of Series E convertible preferred stock of the company, immediately boosting its balance sheet.

Since Pressure BioSciences began commercial operations in the middle of 2007, it has come a long way, releasing a number of PCT-based products geared towards the $6 billion sample preparation market, including three pressure-generating instruments named Barocyclers, a patent-pending sample homogenization device (The Shredder SG3), five types of single-use processing containers and six different, application-specific reagent kits.

Already, the company has installed around 200 of its PCT Barocycler instruments plus required consumables in laboratories. The sample preparation system has been proven to be safer, more accurate, reproducible, and much faster than current cell extraction methods - with up to 48 samples able to be processed from a wide variety of cells and tissues within minutes.