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Flagship’s computational Tissue Analysis (cTA™) tools support Summit’s DMD drug development

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Flagship develops cTA™ tools and duplex IHC assays for muscle biopsy evaluation in support of disease-modifying therapies for Duchenne muscular dystrophy

Granada, Spain – October 18th, 2016 – Data and findings featuring Flagship’s computational Tissue Analysis (cTA™) in the development of biomarker analysis tools to support Duchenne muscular dystrophy (DMD) drug development were presented by Summit Therapeutics at the 21st International Congress of the World Muscle Society including details of Flagship Biosciences’ role in the research. Flagship and Summit have collaborated to develop a biomarker analysis process using Flagship’s cTA™ methodologies, accelerating precise muscle fiber biomarker quantification across entire muscle sections. Summit aims to treat DMD by modulating utrophin, a structural protein expressed in developing and regenerating muscle fibers. The biomarker analysis is being optimized for clinical trial evaluation of Summit’s lead utrophin modulator candidate, ezutromid.

In a press release on Oct. 6th, Summit’s Chief Medical Officer, Dr Ralf Rosskamp, highlighted the importance of Flagship’s tools, saying “The development of new, fully automated biomarker tools capable of evaluating the disease status of muscle biopsies will play an important role in clinical trials, including our ongoing PhaseOut DMD trial.”

The poster presented at the WMS Conference detailed three duplex, IHC assays and cTA™ solutions that enable quantification of utrophin, beta-dystroglycan, and developmental myosin heavy chain in whole-slide images to robustly assess muscle health in DMD, BMD (Becker muscular dystrophy), and control skeletal muscle biopsies. The research also demonstrated that Flagship’s cTA™ approach can measure biomarker expression and muscle fiber morphometrics in all muscle fibers in a biopsy, resulting in robust datasets formed by quantifying thousands of fibers per sample. The approach can aid pathologists in evaluating the disease status of skeletal muscle biopsies and the efficacy of novel neuromuscular therapeutics.

“Flagship is proud to be a part of this promising research into treatments for muscular dystrophy. We look forward to further development of our tools to support Summit’s efforts. With our combined expertise and advanced image analysis capabilities, we anticipate successful biomarker quantification and evaluations for this crucial trial,” said Dr David Young, Flagship Chief Executive Officer.

Read Summit’s press release here:
http://g923gvc6go14zuzz1vaotb19.wpengine.netdna-cdn.com/wp-content/uploads/2016/10/2016_RNS_41-WMS-2016-Presentations-FINAL.pdf

See the full scientific poster:
http://g923gvc6go14zuzz1vaotb19.wpengine.netdna-cdn.com/wp-content/uploads/2016/10/Summit_WMS_Congress_Poster_FINAL.pdf

About Flagship Biosciences
Flagship Biosciences advances precision medicine by quantifying and simplifying complex pathology through proprietary tissue analysis technology and trusted scientific collaboration. Flagship’s focus is providing meaningful data and interpretation, using tissue image analysis solutions to enhance sound decision-making. The company accomplishes this by fostering collaborative partnerships with clients that allow for a comprehensive understanding of the biological endpoints being investigated.

Forward Looking Statement disclaimer
Any statements in this press release about Flagship’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of product candidates, the utility of tools developed to evaluate product candidates, the therapeutic potential of product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Flagship’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent Flagship’s views only as of the date of this release and should not be relied upon as representing Flagship’s views as of any subsequent date. Flagship specifically disclaims any obligation to update any forward-looking statements included in this press release.

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