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Archive - Feb 6, 2017

Exosome Diagnostics Enters Agreement with Merck KGaA, Darmstadt, Germany

On February 6, 2017, Exosome Diagnostics, Inc., announced that it has entered into an agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to help further the company’s drug development efforts in oncology and other therapeutic areas, utilizing the full breadth of Exosome Diagnostics’ proprietary technology platforms. The platforms span across both nucleic acid and protein, including Shahky™, Exosome Diagnostics’ exosomal protein capture and quantitative analysis instrument. This agreement represents the first publicly announced partnership that grants access to Exosome Diagnostics’ recently unveiled point-of-care protein detection instrument. The instrument, Shahky, which has the ability to generate a high signal above the noise by selectively targeting disease-specific exosomes and removing background that is non-relevant to the disease in question, was tested and its performance validated in a leading Boston Hospital in early January of 2017. The instrument’s capabilities will make it a powerful technology for discovering, assessing, and validating clinical biomarkers, on a system that has been developed, and overseen by Exosome’s Regulatory Department, with design control and engineering practices that are in accordance with FDA and other applicable regulations. “We are excited to bring first-of-its-kind technologies, such as Shahky, to our partners. The Shahky instrument represents a disruptive technology for drug development and ultimately the clinic,” stated Mario Morken, Head of Business Development for Exosome Diagnostics.

“Landmark” Gene Therapy Work Significantly Restores Hearing in Genetically Deaf Mice

In the summer of 2015, a team at Boston Children's Hospital and Harvard Medical School reported restoring rudimentary hearing in genetically deaf mice using gene therapy. Now the Boston Children's research team reports restoring a much higher level of hearing -- down to 25 decibels, the equivalent of a whisper -- using an improved gene therapy vector developed at Massachusetts Eye and Ear. The new vector and the mouse studies are described in two back-to-back papers in Nature Biotechnology (published online on February 6, 2017). The first article is titled “A Synthetic AAV Vector Enables Safe and Efficient Gene Transfer to the Mammalian Inner Ear,” and the second is titled “Gene Therapy Restores Auditory and Vestibular Function in a Mouse Model of Usher Syndrome Type 1c.” While previous vectors have only been able to penetrate the cochlea's inner hair cells, the first Nature Biotechnology study showed that a new synthetic vector, Anc80, safely transferred genes to the hard-to-reach outer hair cells when introduced into the cochlea. This study's three Harvard Medical School senior investigators were Jeffrey R. Holt Ph.D., of Boston Children's Hospital; Konstantina Stankovic, M.D., Ph.D., of Massachusetts Eye and Ear and Luk H. Vandenberghe, Ph.D., who led Anc80's development in 2015 at Massachusetts Eye and Ear's Grousbeck Gene Therapy Center. "We have shown that Anc80 works remarkably well in terms of infecting cells of interest in the inner ear," says Stankovic, M.D., an otologic surgeon at Massachusetts Eye and Ear and Associate Professor of Otolaryngology at Harvard Medical School.