Roche and GE enter partnership to develop integrated digital diagnostics platform to improve oncology and critical care treatment

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Roche has announced a strategic, long-term partnership with GE Healthcare in order to jointly develop and co-market digital clinical decision support solutions. The partnership will initially focus on products that accelerate and improve individualised treatment options for cancer and critical care patients.

The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration and analysis of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.

For example, oncology care teams with multiple specialists will have a comprehensive data dashboard to review, collaborate and align on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, genomic and sequencing data, helping physicians to identify, or even predict severe complications before they strike.

“This unique partnership will deliver innovative solutions and insights in clinical decision-making. Our goal is to support clinicians and other relevant stakeholders for the benefit of patients by providing the right decision support at the right time and through comprehensive digital offerings,” said Roland Diggelmann, CEO Roche Diagnostics.

Roche Diagnostics is the global leader in in-vitro diagnostics, and GE Healthcare is a worldwide leader in medical imaging equipment. “This is the first time that two major players in healthcare have combined digital, in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said Kieran Murphy, President & CEO of GE Healthcare.

Pre-diabetes discovery marks step towards precision medicine

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Researchers from the University of Sydney’s Charles Perkins Centre have identified three specific molecules that accurately indicate insulin resistance, or pre-diabetes – a major predictor of metabolic syndrome, the collection of medical conditions that include abdominal obesity, high blood pressure and high blood sugar levels.

The finding, from a study undertaken in mice, could make earlier detection of pre-diabetes in humans much easier for doctors and allow for more personalised and effective treatments for patients in the future.

Researchers combined the high-tech mathematical approach of machine learning with omics technology that examines the various types of molecules that make up the cells of an organism to successfully identify specific molecules in mice. That information was used to classify the mice according to what kind of food they eat, their genetic origin and their whole-body insulin sensitivity.

Published in the Journal of Biological Chemistry, the research was conducted with the Garvan Institute of Medical Research, Duke University (USA) and the University of Melbourne.

 

Technology key to uncovering factors that contribute to pre-diabetes

Co-lead author Dr Jacqueline Stöckli, a research fellow with the University’s Charles Perkins Centre and School of Life and Environmental Sciences, said the study suggested there are likely multiple factors that contribute to pre-diabetes and this is why more traditional approaches have failed to identify similar highly predictive signatures or indicators of disease.

“Our study identified a three molecule signature that was able to diagnose insulin resistance or pre-diabetes, a condition that is often associated with diabetes, obesity and high blood pressure,” she said.

“But we know the story is much more complicated; strikingly, each of the three molecules on their own was considerably less predictive of pre-diabetes than when combined.

“The next step is to further exploit these technologies to uncover the full suite of pathways and factors that contribute to pre-diabetes – which will include genetic, environmental and possibly epigenetic influences – at a population level.”

 

Customised treatments for pre-diabetes patients step closer

The study represented a segue into precision medicine for humans, said senior author Professor David James, Leonard P. Ullmann Chair of Metabolic Systems Biology at the Charles Perkins Centre.

Precision medicine classifies individuals according to their susceptibility or response to a particular disease, and tailors healthcare treatments and practices accordingly.

“Once we can identify the molecules and other factors that contribute to pre-diabetes, we can customise treatments to suit patients’ specific make up and needs,” Professor James said.

“This study demonstrates the power of combining technologies to solve some of the world’s biggest problems,” he added.

“The burden of the ‘lifestyle diseases’ the Charles Perkins Centre is dedicated to easing – which include obesity, diabetes and cardiovascular disease – stubbornly remain at high levels globally; we need to innovate in order to tackle these conditions effectively.”

Using Social Media Big Data to Combat Prescription Drug Crisis

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Researchers at Dartmouth, Stanford University, and IBM Research, conducted a critical review of existing literature to determine whether social media big data can be used to understand communication and behavioral patterns related to prescription drug abuse. Their study found that with proper research methods and attention to privacy and ethical issues, social media big data can reveal important information concerning drug abuse, such as user-reported side effects, drug cravings, emotional states, and risky behaviors.

Their work, “Scaling Up Prescription Drug Abuse and Addiction Research Through Social Media Big Data,” is reported in the Journal of Medical Internet Research.

Prescription drug addiction is a well-known nationwide problem. Many people who are unable to get help for their addiction seek out peer support groups on Facebook or other social media platforms to share stories about their experiences and also provide social peer-based support.

Lead author, Sunny Jung Kim, PhD, an e-health communication scholar in the departments of biomedical data science and psychiatry at Dartmouth’s Geisel School of Medicine, says that because we are prolific consumers of social media, which is not limited to geography—globally, people spend more than two hours every day on social media platforms generating vast amounts of big data about our personal communications and activities—we can use these platforms to enhance public health communication strategies to help people on a large scale.

“Harnessing social media platforms and data can provide insight into important novel discoveries of collective public health risk behavior, a better understanding of peoples’ struggles with addiction, and their process of recovery,” Kim says. “I started this project because there were few studies about why people use social networking sites to share unsolicited, highly personal information about their drug use, nor about the psychological effects or consequences of this type of user-generated communication.”

Co-author Jeffrey Hancock, PhD, a professor in the department of communication and the director of computational social science at Stanford University, says, “Given the importance of this problem for the U.S. population, it’s imperative that we understand how social media is playing a role and how it can be part of the solution.”

Based on their findings, the researchers designed an evidence-based, multi-level framework to inform future social media-based substance use prevention and recovery intervention programs.

“Our review and typology suggests that social media big data and platforms can be a tremendous resource for monitoring and intervening on behalf of people with drug addiction and abuse problems,” Kim says.

Russian biotechnology company BIOCAD prepares to enters the European market

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The largest Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines. So far, there are seven molecules in the European portfolio of BIOCAD. This are innovative and biosimilar products, which could be used in treatment of melanoma, breast, stomach, kidney and lung cancer, rheumatoid arthritis, psoriasis and multiple sclerosis.

“The presence of Russian innovative medicines on the European market depends on the speed of approval process in the EMA (European Medicines Agency) which correlate with readiness to provide sufficient documents from manufacturer. BIOCAD is the only pharmaceutical company in Russia, which is ready to provide dossiers for its medicines according to ICH CTD format in the shortest possible time, “says Dmitry Morozov, general director of BIOCAD biotechnological company. In addition, the advantage of BIOCAD is its own production plant, which the company builds in Finland, in the city of Turku.

Currently, the Russian pharmaceutical company BIOCAD has not only biosimilars and generics in its pipeline, but also original molecules for the treatment of oncological and autoimmune diseases. The company invests in clinical trials of all this products. The last preparations are underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is planed to be signed in Frankfurt at CphI exhibition.

“As for the EU countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” says Dmitry Morozov. In addition, in 2021, the generics of oncology drugs – docetaxel, paclitaxel, pemetrexed and irinotecan – will also enter the European countries.

BIOCAD is interested in licensing innovative products from small companies on mutually favorable terms for the Russian market. During the visit to Frankfurt, Russian experts will discuss with their Swiss colleagues the prospects of collaboration on a drug against hard-to-treat chronic viral infections based on a molecule obtained in the laboratories of the Swiss company. In addition, the company plans to sign a preliminary agreement on the licensing of an immune-oncology molecule with a pharmaceutical company from Germany. This drug will be used in combination therapy of some cancers along with the original BIOCAD medicine.

Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio

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Novartis has announced, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® , a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” said Bruno Strigini, CEO, Novartis Oncology. “With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.”

Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.

In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT® and SomaKit TOC(TM)). AAA had sales of EUR 109 million in 2016.

Merck Set to Join Forces with Project Data Sphere to Pioneer Global Big Data Alliance

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Merck has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck KGaA, Darmstadt, Germany’s, Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.

“The ultimate goal of our alliance with Project Data Sphere is to unleash the power of big data to bring value to cancer patients,” said Belén Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. “Merck KGaA, Darmstadt, Germany, is deeply committed to investing in initiatives that push the boundaries of cancer research, that we hope will accelerate the discovery, development and delivery of innovative treatments to all who need it.”

The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

“Big data is changing the face of healthcare as we know it, and advances in our ability to collect data, share and analyze it has already led to ground-breaking work,” said Dr Martin J. Murphy, CEO of Project Data Sphere LLC. “The joint force of Merck KGaA, Darmstadt, Germany, and Project Data Sphere will aim to connect and empower a truly global oncology community with these big data and analytical capabilities. We are excited about the Global Oncology Big Data Alliance initiative and the continuing engagement of a diverse community focused on finding solutions for cancer patients.”

Investment in the initiative builds on Merck KGaA, Darmstadt, Germany’s, commitment to rewarding innovation and creative thinking that could further advance the field of medicine, and begins a new chapter for global oncology innovation. Since 2014, the company has awarded a total of €4 million to further research in oncology through the Grant for Oncology Innovation award, which has engaged over 1,000 investigators worldwide, generated 12 winning research proposals from leading academic institutions, and generated seven high impact manuscripts.

OncoQR ML’s Vaccine Platform closes the Final Gap in the Immunological Attack against Cancer

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OncoQR ML GmbH has announced that even a single therapeutic vaccine based on its proprietary S-TIR™ platform technology, is able to induce the killing of tumor target expressing cells by simultaneously activating all possible immunological pathways (humoral and cellular).

Scientific Breakthrough

By showing this, the Austrian Biotech is the first company* to succeed in controlling all the relevant immune checkpoints that prevent the immune system from attacking and defeating cancer.

Whereas current passive checkpoint specific immunotherapy lacks tumor cell specificity with the risk of massive autoimmune reactions, this new active therapy is totally tumor target specific.

Geert Mudde, PhD, inventor of the S-TIR™ technology and OncoQR’s Chief Scientific Officer, said, “We are proud and excited to have finally demonstrated the ability to activate and use the full potential of the patient’s own immune system to eradicate cancer. Previously, we had already shown all forms of antibody mediated tumor killing – now we have the definite proof that our S-TIR™ vaccines are able to simultaneously induce and activate tumor specific T Cell killing as well. With our approach, the tumor has no more chance to escape the immune system – it is attacked from all possible sides at the same time.”

Economical Aspects

Christof Langer, Chief Executive Officer of OncoQR ML, said: “These spectacular results confirm the viability and huge potential of our proprietary S-TIR™ platform. Besides constituting a significant milestone in the development of our immunotherapy platform technology, to our knowledge, no other anti-cancer drug has shown comparable results so far. The new data are not only spectacular from a scientific point of view: The S-TIR technology will also break the trend that new cancer therapies have to be unethically expensive. Our therapeutic vaccines are designed to have low cost of goods which is paired with a personalized low treatment frequency at low treatment dose. Drugs based on our technology can be used as monotherapy but can also be combined with existing therapies (like chemotherapy). Therefore, all in all, groundbreaking news for patients, and healthcare organizations, but of course also for us and our future partners.”

Lilly and Nektar Therapeutics announce alliance to develop a novel autoimmune therapy

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Eli Lilly and Company and Nektar Therapeutics have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358, which achieved first human dose in Phase 1 clinical development in March of 2017, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

NKTR-358 is a potential first-in-class resolution therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

“We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions,” said Thomas F. Bumol, Ph.D., Senior Vice President of Biotechnology and Immunology Research at Lilly. “NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly’s commitment to sustain a flow of innovative medicines in our pipeline.”

Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.

“We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market,” said Howard W. Robin, Nektar’s President and Chief Executive Officer. “Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic.”

Roche acquires mySugr to form a leading open platform for digital diabetes management

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Roche and mySugr have signed an agreement under which Roche acquired all shares of mySugr GmbH. Counting more than one million users globally, mySugr is one of the leading mobile diabetes platforms in the market and will become an integral part of Roche’s new patient-centered digital health services platform in diabetes care. The acquisition allows Roche to expand its leading position in the area of diabetes management.

“We are excited about this agreement, as we will be able to offer seamlessly accessible patient solutions within an open platform to better respond to the unmet needs of people with diabetes. Our aim is to support people with diabetes to spend more time in their ideal glucose target range and improve their quality of life,” said Roland Diggelmann, CEO Roche Diagnostics. “Having partnered with mySugr since 2014, we see an excellent cultural fit, as both our companies are passionate about taking diabetes management to the next level and making a difference in managing diabetes.”

 
“We started mySugr to solve our everyday problems and simplify diabetes therapy through smartphones,” said Frank Westermann, CEO and Co-Founder of mySugr. “The mySugr team has filled a gap for over a million loyal users so far, and with Roche’s diabetes expertise and global network, mySugr will become an indispensable companion for hassle-free life.”

As a focal point for Roche`s integrated diabetes management strategy, mySugr is foreseen to remain a separate legal entity with an open platform for all diabetes devices and services. Users will continue to have the ability to automatically upload blood glucose data from their preferred device into the mySugr logbook app as well as the facilitated data sharing with healthcare professionals and caregivers.

Sarepta Therapeutics Opens its Research and Manufacturing Center at Andover

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Sarepta Therapeutics, a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, has announced the grand opening of its Research and Manufacturing Center in Andover, Massachusetts.

The 60,000 square foot state-of-the-art facility significantly enhances Sarepta’s research and manufacturing capabilities as it expands its global commercial footprint and rapidly advances its Duchenne muscular dystrophy (DMD) pipeline, which comprises a robust exon skipping platform, and next generation approaches such as gene therapy and utrophin upregulation programs. The current focus of the manufacturing facility will be to advance Sarepta’s development pipeline and research programs. By the end of the year, Sarepta could have up to seven investigational DMD treatments in the clinic.

Ultimately, Sarepta’s goal is to help as many individuals with DMD as possible. To support this objective, Sarepta plans to expand its headcount in Andover by 100 percent over the next 12 to 18 months, adding to the approximately 50 employees currently based in Andover.

“Since first moving to Massachusetts in 2013, Sarepta has benefited enormously from the Commonwealth’s talented and highly-educated workforce,” said Edward Kaye of Sarepta. “This expansion underscores our ongoing commitment to patients with Duchenne and investment in the vibrant Massachusetts economy. We are grateful to Governor Baker, the Massachusetts Life Sciences Center, MassBio, the Town of Andover, and other state and local officials who support our mission to serve the greater DMD community.”