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Archive - Jun 5, 2017

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Exosomes Are Focus of Lonza Investment for Next-Generation Life Science Applications; Global Biopharma Leader Acquires HansaBioMed & Makes Strategic Investment in Exosomics Siena

On May 16, 2017, Lonza, a global leader in the field of biopharmaceutical development and manufacturing, announced the acquisition of HansaBioMed Life Sciences OÜ (HBM-LS), based in Tallinn, Estonia, a start-up company dedicated to the research and development, manufacturing, and distribution of products for the exosomes research market. Lonza has also agreed to make a strategic investment in Exosomics Siena S.p.A. (Exosomics), an Italian start-up company developing exosome-based, early-stage cancer screening and molecular diagnostic tests. Exosomes are nano-sized vesicles released by all living cells in a finely regulated manner. They are found in biological fluids and contain genetic material, proteins, and other cellular molecules reflecting the characteristic of their cells of origin. Functioning as nano-bullets with multiple surface receptors for crossing biological barriers, tissue targeting, and delivery of bioactive molecules, they have the potential of being developed for various applications in life sciences. Exosomes’ acknowledged role as effectors in tissue regeneration, immune response, and inflammation shows their potential as the next generation of vaccine development, drug delivery, and off-the-shelf, cell-free regenerative therapies. “Exosomes represent a dynamically growing segment in life sciences with opportunities in research, diagnostics, and therapeutic applications,” said Dr. Uwe Gottschalk, Chief Technology Officer for Lonza Pharma & Biotech. “Exosomes may play an important role in the promising field of liquid biopsies and could become the next generation of cell-free therapies in regenerative medicine," he added. "With our financial support, technical and commercial expertise, Lonza is well suited to leverage these opportunities through HBM-LS and Exosomics.” Dr.

Time To Starting Cancer Therapy Is Increasing, Associated With Worsening Survival, Cleveland Clinic Researchers Report; Findings Based on Analysis of Common Solid Tumors in Study Population of Nearly 3.7 Million

After reviewing nearly 3.7 million patient records, Cleveland Clinic researchers have shown that newly diagnosed cancer patients are having to wait longer to begin treatment, a delay that is associated with a substantially increased risk of death. This research was presented today at the ASCO Annual meeting and is abstract 6557 (http://abstracts.asco.org/199/AbstView_199_185804.html). The researchers used prospective data from the National Cancer Database and examined the number of days between diagnosis and the first treatment for those newly diagnosed with early-stage solid-tumor cancers from 2004 to 2013. The study population of 3,672,561 patients included breast, prostate, colorectal, non-small cell lung, renal, and pancreas cancers. The median time between diagnosis and treatment - referred to as "time to treatment initiation," or TTI - has increased significantly in recent years, from 21 days in 2004 to 29 days in 2013. Delays were more likely if patients changed treatment facilities or if they sought care at academic centers. Longer delays between diagnosis and initial treatment were associated with worsened overall survival for stages I and II breast, lung, renal, and pancreas cancers, and stage II colorectal cancers, with increased risk of mortality of 1.2 percent to 3.2 percent per week of delay, adjusting for comorbidities and other variables. Prolonged TTI of greater than six weeks was associated with substantially worsened survival. For example, five-year survival for stage I non-small cell lung cancer was 56 percent for TTI of less than or equal to six weeks, versus 43 percent for TTI greater than six weeks, and for stage I pancreas cancer was 38 percent versus 29 percent, respectively. "In addition to its impact on outcomes, delayed TTI can cause unnecessary stress and anxiety for patients," said Dr.

Early Research Suggests First Immunotherapy for Mesothelioma on Horizon

Malignant pleural mesothelioma or MPM is a rare cancer, but its incidence has been rising. This cancer is usually associated with asbestos exposure, and patients have a median life expectancy of only 13-15 months. All patients relapse despite initial chemotherapy, more than 50% of them within six months after stopping treatment. There are currently no effective therapeutic options for patients with MPM. Early findings from an ongoing phase II clinical trial in France, MAPS-2, show that immunotherapy may slow the growth of MPM after relapse. At 12 weeks, cancer had not worsened in 44% of patients who received nivolumab (Opdivo) and in 50% of those who received nivolumab with ipilimumab (Yervoy). The study will be featured in a press briefing on June 5, 2017 and presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. "Our findings suggest that immunotherapy may provide new hope to patients with relapsed mesothelioma," said lead study author Arnaud Scherpereel, MD, PhD, Head of the Pulmonary and Thoracic Oncology Department at the University Hospital (CHU) of Lille in Lille, France. "This randomized phase II trial may be enough to support the use of immune checkpoint inhibitors in this setting, but it is too early to conclude whether nivolumab alone or the combination of nivolumab and ipilimumab is better." This multi-center clinical trial enrolled 125 patients with advanced MPM who had received up to two prior treatments, including standard platinum-based chemotherapy. The majority of patients (80%) were male, and the median age was 72 years. The patients were randomly assigned to treatment with nivolumab alone or nivolumab with ipilimumab until the cancer worsened; 70% of patients received at least 3 cycles of either treatment.

GRAIL Announces Data from Early Research Using Its High-Intensity Sequencing Approach on Circulating Cell-Free DNA (cfDNA); Data Will Inform Future Development of Blood Tests for Early Detection of Cancer

On June 3, 2017, GRAIL, Inc., a life sciences company focused on the early detection of cancer, announced results from a study evaluating a novel high-intensity sequencing approach for detecting tumor signals in the bloodstream. Historically, research has focused on detecting a small number of clinically-actionable mutations in circulating cell-free DNA (cfDNA). This study evaluated the ability of a high-intensity sequencing approach to detect a more diverse range of tumor signals, including those that are less common. This broader and deeper approach will be required to develop tests that can detect the tiny amounts of tumor DNA in the blood, and accurately capture the diversity in genomic alterations that characterize the tumors of every person with cancer. In the study, blood and tumor tissue samples from 124 patients with various advanced cancers were sequenced with a 508-gene panel, yielding approximately 100 times more sequencing data than previous approaches. In 89 percent of patients, at least one of the mutations detected in the tumor tissue was also detected in the blood. When evaluating all genetic variations, including those present at high levels in tumor tissue as well as those at low levels, 627 of 864 mutations (73 percent) detected in tumor tissue were also detected in patients’ blood. “These encouraging results showed our high-intensity sequencing approach is able to detect a broad range of tumor mutations in the bloodstream with high levels of concordance with all mutations detected in tumor tissue,” said Alex Aravanis, MD, PhD, Head of Research & Development at GRAIL. “These important foundational data support the feasibility of our approach and will inform further development of blood tests to detect early cancer.