Genetic Engineering & Biotechnology News

MAY1 2015

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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10 | MAY 1, 2015 | | Genetic Engineering & Biotechnology News Gail Dutton Laser ablation electrospray ionization (LAE- SI ® ) provides direct molecular imaging of all types of tissues within minutes, without touching the sample. This mass spectrometry technology promises to be disruptive, while integrating easily into current laboratory and bioinformatics workfows. "We are all used to antibody and radiola- beling," Stephen Turner, chairman and CEO of Protea Biosciences Group, tells GEN. "But LAESI needs no labeling and no sample preparation. You just look for the molecules of interest." LAESI mass specrometry imaging was de- veloped at George Washington University by Akos Vertes, Ph.D., and exclusively licensed to Protea Biosciences. It simultaneously iden- tifes hundreds to thousands of endogenous or exogenous molecules per analysis—in- cluding proteins, peptides, lipids, and metab- olites—with micron resolution. Within one hour, a full proteomic, metabolomic, and lipidomic profle of a specifc area of tissue can be performed. Basically, the LAESI technology combines laser ablation from a mid-range infrared la- ser with a secondary electrospray ionization (ESI) process. The laser's energy is absorbed by water molecules in the sample tissue, cre- ating a stream of gas-phase particles. The stream, rising above the tissue sample, en- counters an ESI plume, and sample particles from the stream become ionized. Once ion- ized, the molecules are swept into a mass spectrometer for analysis. "There's no need for sample preparation," Turner emphasizes. Because the sample need not be handled, analysis is convenient, fast, and free of bias. The results are screened against large mo- lecular databases, and molecular maps can be created using the company's ProteaPlot soft- ware showing the two- and three-dimensional distribution of molecules within the sample. At the molecular level, LAESI can distin- guish between tumors and nontumors, "even though the histology might appear similar," Turner says. Applications This fully automated platform can be used to analyze fresh and frozen tissues, formalin- fxed paraffn-embedded (FFPE) tissue, living cells, biofuids, and even rehydrated blood. "One of our customers has used it to analyze contact lenses," Turner remarks. Citing a time study of drug migration in a mouse digestive track, with imaging at 10, 30, and 60 minutes, Turner points out that such studies were impossible using mass spectrom- etry before LAESI. "You had to 'grind and fnd'—do extractions and then do HPLC," he explains. "Then you could not image the data." With LAESI, however, imaging can be done multiple times on the same subject, and early enough in trials to allow compounds to be reformulated if necessary. The frst applications are in pharmaceu- tical research and cancer diagnostics. Col- laborations are underway for lung, colon, skin, and breast diagnoses. "We are devel- oping collaborations to further pharmaceu- tical research and to develop a new class of products for cancer," Turner notes. LAESI also is being used for the molecular profl- Protea Biosciences Is Commercializing an Ambient Ionization Mass Spec Technique Direct-from-Tissue Bioanalytics CORPORATE PROFILE Protea scientists Holly Henderson and Callee Walsh, Ph.D., analyze data collected on the LAESI DP-1000 system. The LAESI DP-1000 has a translation stage that can ac t as a temperature - controlled autosampler. Samples loaded into the LAESI DP-1000 require vir tually no preparation, and they can be quickly analyzed under ambient conditions. > Novartis to Pay Juno $12.25M+ to Settle CAR Patent Lawsuits Novartis will pay Juno Therapeutics more than $12.25 mil- lion to settle a nearly three-year legal wrangle over ownership of patents covering the technology for chimeric antigen re- ceptors (CARs) used in cancer immunotherapies. The settle- ment resolves a dispute that began in 2012 and expanded as Novartis licensed CAR T-cell technology from the University of Pennsylvania (Penn), while Juno licensed a CAR technology from St. Jude Children's Research Hospital. The competing technologies are both designed to fght cancer by using a pa- tient's own immune system. In addition to the $12.25 million initial payment, Novartis agreed to give Juno future milestone payments and "mid- single digit" royalties from U.S. net sales of product candidates based on the patents at issue—as well as a "low double-digit" percentage of royalties Novartis pays to Penn for global net sales for those product candidates. As for the settlement, Juno said it will share payments received from Novartis with St. Jude as called for under their license agreement. All parties agreed to dismiss legal claims in the case. > BIND, Pfzer Extend Two-Year Accurins Collaboration BIND Therapeutics and Pfzer have extended their two- year-old collaboration to develop and commercialize a new class of highly selective targeted and programmable thera- peutics called Accurins™ to optimize the therapeutic poten- tial of two oncology drugs in Pfzer's pipeline. The up-to-$210 million collaboration was launched in April 2013, with an un- specifed preclinical development milestone achieved for the frst program in December, BIND said. As a result, BIND collected a $1 million milestone payment from Pfzer in February. That milestone payment is part of a to- tal $89.5 million BIND could receive in payments tied to devel- opment and regulatory events under the Pfzer partnership, BIND said in its Form 10-K annual report fled March 11 with the U.S. Securities and Exchange Commission. BIND also stands to gain up to $110 million tied to com- mercial milestones, plus royalties in the low-single- to high- single-digit percentages on potential future sales of each Accurin commercialized, if any. BIND received a $4 million up-front payment from Pfzer when the deal was launched. Pfzer still has until September of this year to exercise its op- tion to acquire the exclusive license for the frst Accurin pro- gram. The companies agreed to extend the timeline for the second program through March 2016 in order to complete preclinical research. > Daiichi Sankyo's U.S. Subsidiary Merges with Asubio Pharma Daiichi Sankyo's U.S. subsidiary said it will merge with its U.S.-based sister company Asubio Pharmaceuticals, whose parent is also a subsidiary of the Japanese pharma giant. Asubio's drug development projects will be integrated into the broader Daiichi Sankyo global development organization, led by Mahmoud Ghazzi, M.D., Ph.D., Daiichi Sankyo said.Dai- ichi Sankyo will manage analysis and dissemination of data from Asubio's ongoing clinical trial of the Phase II compound SUN13837 in patients with acute spinal cord injury. The trial, designated ASBI 603ASCENT, has completed enrollment, ac- cording to the company. > Mylan Offers $28.9B for Perrigo Mylan said it wants to buy Perrigo for $28.9 billion cash and stock, creating a combined giant with a diverse mix of brand- ed, generic, over-the-counter drugs, and nutritional products. Mylan made its unsolicited proposal in a letter to Joseph C. Papa, Perrigo's president, CEO, and chairman. "This proposal is the culmination of a number of prior discussions between Mylan and Perrigo about the compel- ling strategic and fnancial logic of this combination," Mylan's executive chairman Robert J. Coury said in a statement. "This combination would result in meaningful immediate and long- term value creation, and our proposal is designed to deliver that value to shareholders and other stakeholders of both companies." Coury asserted that the Mylan-Perrigo combination— which generated about $15.3 billion in 2014 pro forma sales— could generate "signifcant and meaningful synergies" or cost- cutting by both companies should a deal be completed. n News INDUSTRY WATCH

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