Taking a long, hard look at HER
July 2012
by Jeffrey Bouley  |  Email the author


CHALFONT ST. GILES, England—With an eye toward beginning clinical trials later this year, GE Healthcare signed an agreement in early June with Solna, Sweden-based Affibody AB to collaborate on the development of a HER2-targeted PET imaging agent. Future clinical trials would investigate the confirmation of HER2 status in patients with breast cancer recurrence to determine if HER2 status changes over time, monitor therapy of patients with metastatic breast cancer receiving anti- HER2 treatments and help resolve indeterminate HER2 tests.  
According to the two companies, these studies, if positive, could ultimately pave the way for better targeting of anti-HER2 therapies to those patients most likely to benefit from them. Although the focus of the collaboration announcement was on breast cancer, the companies also made passing mention of addressing gastric cancer as well with their work, as there is often a HER2 component with that oncologic disease as well.  
"The partnership brings together the best of several distinct offerings—GE Healthcare's market expertise in the global PET market, industrialization and commercialization and Affibody's expertise in generating high-affinity binders and initial clinical data," said Marivi Mendizabal, head of research for GE Healthcare, Medical Diagnostics, in the official statement about the deal. "We expect a productive collaboration with leading academics and the pharma industry to help this research reach its full potential."  
Noting that he was pleased to build on his company's existing collaborative relationship with GE Healthcare "from the preclinical to the clinical setting," David Bejker, CEO of Affibody, added that "Our clinical data, the first of which was presented at the 34th San Antonio Breast Cancer Symposium last December, is the result of collaborative research with leading academics and has led us to believe that a HER2-targeted PET imaging agent may benefit many cancer patients. "  
While happy to highlight this latest collaboration, GE Healthcare is also quick to note that its commitment to cancer spans beyond its own products and services and well beyond this deal, too. In fact, the company built on its more than five decades of work in oncology in September 2011 when it announced through its Healthymagination program a "commitment to take cancer research, diagnostics and treatment to the next level." As part of that boost in oncology work, GE committed to accelerate cancer innovation by investing $1 billion in cancer technology research and development as well as improve care for 10 million cancer patients around the world by 2020.  
Along with that announcement, GE and several partners launched a $100 million open-innovation cancer challenge, an open call to action seeking ideas to accelerate early detection and enable more personalized treatment for breast cancer specifically. GE and its venture capital partners are looking to fund breakthrough ideas that help healthcare professionals better understand triple-negative cancer pathways, as well as the molecular similarities between breast cancer and other solid tumors.  
In other recent breast cancer news besides the Affibody collaboration, GE Healthcare announced the five winners of the first stage of the Healthymagination Cancer Challenge in April, part of that open innovation challenge, with each of the winning entries awarded $100,000. Notably, two of the winning entries related to personalized therapy for triple-negative breast cancer.  
Also in May, GE Healthcare celebrated the first U.S. commercial installation of SenoBright at Pink Lotus Breast Center in Beverly Hills, Calif., a technology said to offer clinicians a new tool to help detect and diagnose breast cancer rapidly and accurately, even in the densest part of the breast.  
For Affibody, the GE Healthcare collaboration represents the first major HER2 news it has touted on its website since December 2011, when it announced the first-in-human whole-body HER2-receptor mapping using Affibody molecular imaging with ABY-025, a study indicating "that ABY-025 can be used safely in humans with similar excellent whole body HER2-receptor molecular imaging capabilities as noted with a previous generation Affibody molecule."  
The GE Healthcare announcement is also the first major collaborative news Affibody has highlighted since a December 2011 deal with Nuclisome AB to develop cancer therapeutics and a February deal this year with Creative Antibiotics AB to develop targeted antibiotics.  

GE Healthcare licenses lung cancer biomarker from Insight Genetics  
ALISO VIEJO, Calif.—Clarient Diagnostic Services Inc., a GE Healthcare company, has licensed intellectual property from Insight Genetics, granting Clarient rights to develop a genetic test covering the ALK (anaplastic lymphoma kinase) biomarker, a promising target for several classes of cancer drugs.  
Clarient will develop and evaluate the performance characteristics of a quantitative PCR-based test that detects increased transcription of the ALK gene. Rearrangements involving the ALK gene are implicated in non-small cell lung cancer (NSCLC) and other cancers. Several therapeutics compounds, known as ALK inhibitors, are in clinical trials, and one, Xalkori, has been approved by the U.S. Food and Drug Administration. Since only patients with ALK fusions are likely to respond to ALK inhibitors, accurate diagnostic screening is essential before prescribing ALK-targeted drugs.  
In addition to the proven role it plays in select lung cancers, ALK has been found to have a pathogenic role in many cancers including diffuse large B-cell lymphoma, inflammatory myofibroblastic tumor, esophageal squamous cell carcinoma, colorectal cancer and breast cancer. It is estimated that more than 250,000 new cancer diagnoses in the U.S. each year can be linked to ALK mutations and fusions.  
"The National Comprehensive Cancer Network guidelines now suggest ALK testing as a standard measure for all non-small cell lung cancer patients due to the development of therapies targeting ALK inhibition," said Dr. Kenneth J. Bloom, chief medical officer of Clarient. "Our agreement with Insight Genetics is another example of our mission of translating biomarker discovery to aid the development of new therapeutics and to assist physicians in determining the eligibility of their patients to receive the most appropriate therapy."  
Code: E071223

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