Taking a long, hard look at HER

GE Healthcare and Affibody team up on HER2-specific PET imaging agent for breast and gastric cancer

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CHALFONT ST. GILES, England—With an eye toward beginningclinical trials later this year, GE Healthcare signed an agreement in earlyJune with Solna, Sweden-based Affibody AB to collaborate on the development ofa HER2-targeted PET imaging agent.
Future clinical trials would investigate the confirmation ofHER2 status in patients with breast cancer recurrence to determine if HER2status changes over time, monitor therapy of patients with metastatic breastcancer receiving anti-HER2 treatments and help resolve indeterminate HER2tests.
According to the two companies, these studies, if positive,could ultimately pave the way for better targeting of anti-HER2 therapies tothose patients most likely to benefit from them. Although the focus of thecollaboration announcement was on breast cancer, the companies also made passingmention of addressing gastric cancer as well with their work, as there is oftena HER2 component with that oncologic disease as well.
"The partnership brings together the best of severaldistinct offerings—GE Healthcare's market expertise in the global PET market,industrialization and commercialization and Affibody's expertise in generatinghigh-affinity binders and initial clinical data," said Marivi Mendizabal, headof research for GE Healthcare, Medical Diagnostics, in the official statementabout the deal. "We expect a productive collaboration with leading academicsand the pharma industry to help this research reach its full potential."
Noting that he was pleased to build on his company'sexisting collaborative relationship with GE Healthcare "from the preclinical tothe clinical setting," David Bejker, CEO of Affibody, added that "Our clinicaldata, the first of which was presented at the 34th San Antonio Breast CancerSymposium last December, is the result of collaborative research with leadingacademics and has led us to believe that a HER2-targeted PET imaging agent maybenefit many cancer patients."
While happy to highlight this latest collaboration, GEHealthcare is also quick to note that its commitment to cancer spans beyond itsown products and services and well beyond this deal, too. In fact, the companybuilt on its more than five decades of work in oncology in September 2011 whenit announced through its Healthymagination program a "commitment to take cancerresearch, diagnostics and treatment to the next level." As part of that boostin oncology work, GE committed to accelerate cancer innovation by investing $1billion in cancer technology research and development as well as improve carefor 10 million cancer patients around the world by 2020.
Along with that announcement, GE and several partnerslaunched a $100 million open-innovation cancer challenge, an open call toaction seeking ideas to accelerate early detection and enable more personalizedtreatment for breast cancer specifically. GE and its venture capital partnersare looking to fund breakthrough ideas that help healthcare professionalsbetter understand triple-negative cancer pathways, as well as the molecularsimilarities between breast cancer and other solid tumors.
In other recent breast cancer news besides the Affibodycollaboration, GE Healthcare announced the five winners of the first stage ofthe Healthymagination Cancer Challenge in April, part of that open innovationchallenge, with each of the winning entries awarded $100,000. Notably, two ofthe winning entries related to personalized therapy for triple-negative breastcancer.
Also in May, GE Healthcare celebrated the first U.S.commercial installation of SenoBright at Pink Lotus Breast Center in BeverlyHills, Calif., a technology said to offer clinicians a new tool to help detectand diagnose breast cancer rapidly and accurately, even in the densest part ofthe breast.
For Affibody, the GE Healthcare collaboration represents thefirst major HER2 news it has touted on its website since December 2011, when itannounced the first-in-human whole-body HER2-receptor mapping using Affibodymolecular imaging with ABY-025, a study indicating "that ABY-025 can be usedsafely in humans with similar excellent whole body HER2-receptor molecularimaging capabilities as noted with a previous generation Affibody molecule."
The GE Healthcare announcement is also the first majorcollaborative news Affibody has highlighted since a December 2011 deal withNuclisome AB to develop cancer therapeutics and a February deal this year withCreative Antibiotics AB to develop targeted antibiotics.

GE Healthcarelicenses lung cancer biomarker from Insight Genetics
ALISO VIEJO, Calif.—Clarient Diagnostic Services Inc., a GEHealthcare company, has licensed intellectual property from Insight Genetics,granting Clarient rights to develop a genetic test covering the ALK (anaplasticlymphoma kinase) biomarker, a promising target for several classes of cancerdrugs.
Clarient will develop and evaluate the performancecharacteristics of a quantitative PCR-based test that detects increasedtranscription of the ALK gene. Rearrangements involving the ALK gene areimplicated in non-small cell lung cancer (NSCLC) and other cancers. Severaltherapeutics compounds, known as ALK inhibitors, are in clinical trials, andone, Xalkori, has been approved by the U.S. Food and Drug Administration. Sinceonly patients with ALK fusions are likely to respond to ALK inhibitors, accuratediagnostic screening is essential before prescribing ALK-targeted drugs.
In addition to the proven role it plays in select lungcancers, ALK has been found to have a pathogenic role in many cancers includingdiffuse large B-cell lymphoma, inflammatory myofibroblastic tumor, esophagealsquamous cell carcinoma, colorectal cancer and breast cancer. It is estimatedthat more than 250,000 new cancer diagnoses in the U.S. each year can be linkedto ALK mutations and fusions.
"The National Comprehensive Cancer Network guidelines nowsuggest ALK testing as a standard measure for all non-small cell lung cancerpatients due to the development of therapies targeting ALK inhibition," saidDr. Kenneth J. Bloom, chief medical officer of Clarient. "Our agreement with InsightGenetics is another example of our mission of translating biomarker discoveryto aid the development of new therapeutics and to assist physicians indetermining the eligibility of their patients to receive the most appropriatetherapy."

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