INDIANAPOLIS, Ind.—After collaborating for two years on thedevelopment of diagnostic tools that predict how patients may react to cancertreatments, researchers at Eli Lilly & Co. and scientists at GE GlobalResearch have taken the wraps off a significant achievement in their work—thecreation of a tissue-based, biomarker technology that for the first time cansimultaneously map more than 25 proteins in tumors at the sub-cellular level.
According to the companies, who discussed the breakthroughas well as their plans to extend their collaboration Oct. 21 during a newsconference at GE's Healthymagination Showcase in New York, the technologybirthed by their partnership is an important step in the development ofpersonalized and more effective treatments.
The technology addresses a key limitation of currentpathology methods. Currently, a diagnosis of cancer and the decision of which therapyto prescribe are based on the histology of the tumor and, in some cases, theexpression of just one or two biomarkers inside the patient's tumor. The newmolecular pathology technology developed in GE's Biosciences laboratories givesresearchers a "visual map" of the tissue sample, allowing them to see a cancercell's comprehensive biomarker signaling pathway, and the interplay ofsignaling networks inside the tumor.
By unlocking this crucial information that has until nowbeen hidden from doctors, and enabling researchers to map a tumor's complexbiomarker network, scientists involved in drug discovery and the clinicians whomake treatment decisions will be better equipped to identify the most effectivecancer therapies for patients, while avoiding those that are not aseffective—saving time, money and providing a better patient experience, saysDr. Jeremy Graff, a senior research advisor at Lilly.
"We have used the pathology technology that is currentlyavailable for almost 100 years now," Graff says. "With current technology, youlook through a microscope onto a slide and see a section of tissue and see onlyone biomarker at a time. But looking at one biomarker at a time isn't gettingthe job done. Understanding one marker is not nearly enough when you're tryingto understand a patient's tumor and all of the complexity within that tumor. Bygetting that type of granular detail, we can better understand what is going onin each person's tumor, and that is how we plan to match the patient to theright drug."
Ensuring that patients get the specific therapies they needcould dramatically impact efficacy and survival rates, Graff adds.
"Sometimes with cancer, we over-treat patients, or we treatpatients in the early stages of the disease who may not need a particulartreatment at all," he says. "If we apply what we learn from the patients'tissues at the time of diagnosis, we can say whether or not we believe thedisease requires aggressive therapy. If the patient has malignant tissue, we'llalso be able to tell whether or not it will stay malignant."
For Lilly, the mapping technology has applicability andbenefits beyond pre-clinical research. By using the advanced molecularpathology imaging tools developed in this collaboration, companies like Lillycan use the complex molecular signatures within patient tumors to designclinical research programs to study if these biomarkers can predict whichpatients are most likely to respond to a particular targeted therapy. Selectingthe proper patients early, using these advanced technologies, could reduce thepatient population sizes necessary for conducting clinical trials and willsubstantially shorten clinical development timelines. In turn, these changesshould also lead to a reduction in the cost of drug development, Graff says.
"The technology will allow us to hone in on the group mostlikely to respond to a treatment, so we anticipate seeing enhanced results inclinical trials," he says. "Ideally, this will speed up clinical trials becausewe won't have to accrue as many patients and invest as much time and funds inoverall development. This would drive down costs precipitously."
GE believes that the technology made possible by itscollaboration with Lilly may give doctors the most powerful tools available attheir disposal, says Fiona Ginty, a project leader for molecular pathology atGE's research center in Niskayuna, N.Y. GE researchers with specialties inbiology, bioinformatics, optics, fluidics, chemistry and mechanical engineeringhave built a prototype system capable of staining, washing and re-stainingtissue samples for study under a digital microscope. The system combines imageanalysis of cancerous cells and structures with GE's patented visualizationtools to provide a color map of protein concentrations within the sample.
"We have leveraged the expertise at our research center thatwe previously applied to aviation and other types of technological applicationsat GE and brought it to bear on a biology problem requiring computationalskills," Ginty says. "We kept this technology internal to GE while we weredeveloping it over the last few years, and the partnership with Lilly was agreat opportunity to give us feedback on what is relevant from a drug discoverystandpoint. Working with the samples Lilly has provided, we also developed thebioinformatics tools to quantify and interpret the data."
Ultimately, GE hopes that its technology, advanced as aresult of this collaboration, may lead to the ability to identify the stemcells within a tumor that researchers believe control cancer, Ginty says.
"There are many examples today where this kind of approachis being used to predict patients' response to drugs, as well as a shift togenomic analysis, which requires the destruction of a sample," she says. "Ourapproach is the same, but we are keeping the tissue intact as well as theinformation within that tissue related to patient outcome. By doing so, we maybe able to discover more innovative, targeted therapies for the treatment ofpatients with cancer."
To date, the new technology has been tested successfully oncolon and prostate cancer tissue samples and is believed to be applicable toall types of cancer. Lilly and GE have extended their research agreement toinclude the study of four Lilly oncology molecules that are currently in thecompany's development pipeline. While the technology is expected to help in theanalysis of all cancers, the two companies will perform specific investigationsin breast, ovarian, lung and possibly gastric cancers. The companies have notdisclosed the financial aspects of their 50-50 venture.
GE launches $250 million Healthymagination Fund
New equity investment fund to invest in high-potentialhealthcare technology companies
FAIRFIELD, Conn.—GE also announced in late October theformation of the GE Healthymagination Fund, a new equity fund that will makeinvestments in highly promising healthcare technology companies. The fund willinvest in companies globally that have innovative diagnostic, IT and lifesciences technologies aligned with the strategic objectives of GE'sHealthymagination initiative. The fund will also support healthcare companiesdeveloping innovative and unique business models and services.
The formation of the fund is part of GE's $6 billionHealthymagination initiative, a global commitment to deliver better healthcareto more people at lower cost. The fund will target three broad areas forinvestment: broad-based diagnostics, including imaging, home health, patientmonitoring, molecular diagnostics, pathology, novel imaging agents and othertechnologies for disease diagnosis; healthcare information technology,including electronic medical records, clinical information systems, healthcareinformation exchanges and value-added data services; and life sciences,including tools for research and development in biopharmaceuticals and stemcells, and technologies for manufacturing of biopharmaceuticals and vaccines.
The fund will draw on capabilities from across GEHealthcare, GE Capital and GE Global Research, and will have a globalfootprint.
