Owkin’s machine learning tech to inform mesothelioma trials

pharmaphorum | October 09, 2019

A mesothelioma prognostic model from medical machine learning firm Owkin has been showcased in the journal Nature, and is being used to help further drug research into the often fatal disease. The paper, entitled “Deep learning-based classification of mesothelioma improves prediction of patient outcomes” describes Owkin’s technology called MesoNet, which has been trained using images from nearly 3,000 mesothelioma patients. Owkin used data from MESOBANK, a dataset containing images from several French institutions, and results were validated by experts in pathology at the renowned French Cancer Institute, Centre Leon Berard. As well as giving a prognosis, Owkin was able to use its deep learning technology to highlight regions of interest in the image associated with prognosis prediction. This has led to identification that helps explain different subtypes of the disease, the company said. Using insights from MesoNet, Owkin is working with pharma companies on selecting patients for clinical trials by identifying those who are best suited to try out new drugs in studies. Owkin is also collaborating with academic institutions, and has set up Owkin LOOP, a federated network of US and European academic centres, including Centre Leon Berard.

Spotlight

JSC is investigating CM in drug development on the R&D side and applications in biologics manufacturing, which could lead to reduced scale-up time and eventually shorter time-to-market.

Spotlight

JSC is investigating CM in drug development on the R&D side and applications in biologics manufacturing, which could lead to reduced scale-up time and eventually shorter time-to-market.

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Bushu Pharma's Partnership with Suzuken Group Increases Specialty Pharmaceutical Services

Bushu Pharmaceuticals Ltd. | April 28, 2021

Bushu Pharmaceuticals Ltd. has entered into a business partnership arrangement with Suzuken Co., Ltd. to provide specialty pharmaceutical producers looking to enter the Japanese market with extensive support for new product releases. In recent years, the market has seen an increase in the number of innovative specialty pharmaceuticals, such as biopharmaceuticals, regenerative medicines, and orphan drugs for rare diseases, that require strict temperature, inventory, and security control. In line with this trend, the number of pharmaceutical companies planning to bring these types of drugs to Japan has grown. These pharmaceutical manufacturers, on the other hand, often lack the necessary infrastructure, such as production facilities, delivery centers, and networks, to reach the Japanese market with minimal resources, and must therefore outsource these functions to trusted partners. Suzuken, Bushu Pharma's partner, has played an industry-leading role in Japan's pharmaceutical distribution market. Suzuken, one of the leading organizations in the industry, has a distribution network in Japan capable of supporting the international shipping of specialty pharmaceuticals. Bushu Pharma, on the other hand, has been in the contract manufacturing industry in Japan for over 20 years, holds GMP certifications from all over the world, and has a track record of exporting to over 43 countries. Bushu Pharma will establish a platform that provides one-stop holistic assistance for pharmaceutical producers seeking to penetrate the Japanese market by aligning functions and capabilities with Suzuken. About Bushu Pharmaceuticals Ltd. Bushu Pharma manufactures solid reparations, solid preparation primary packaging, injection manufacturing, and injection packaging not just for domestic pharmaceuticals but also for multinational pharmaceutical manufacturers, drawing on its expertise and understanding as a contract development and manufacturing organization (CDMO) cultivated over 20 years. Bushu Pharma has a diverse product and service offering, ranging from clinical trial supplies to commercial product development support to commercialization, as well as various production facilities and technologies. Bushu Pharma is a leading domestic contract manufacturing company in Japan that can offer optimum solutions such as technology transfer, production, packaging, and logistics from project start to project approval.

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BUSINESS INSIGHTS

EyePoint Pharmaceuticals announced a debt refinancing with Silicon Valley Bank for $45 million in credit facilities

EyePoint Pharmaceuticals, Inc. | March 10, 2022

A pharmaceutical company, EyePoint Pharmaceuticals, Inc.dedicated to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced that it has entered into a loan agreement with Silicon Valley Bank to replace its existing credit facility with CRG Servicing LLC for senior secured credit facilities for $45 million (CRG). A $30 million term loan facility and an asset-based revolving credit facility of up to $15 million will be used to replace the existing approximately $40.5 million in liabilities under the previous CRG credit facility, according to the provisions of the new deal. The new facility represents a considerable improvement in economics, lowering the loan interest rate from 12.5 percent to a blended rate of around 5%, saving an estimated $2.8 million in annualized interest. The Silicon Valley Bank agreement stipulates the following: • A $30 million term loan facility with an interest rate equal to the higher of I the Wall Street Journal prime rate plus 2.25 percent or (ii) 5.50 percent. For the first two years of the term loan facility, just interest payments will be required; and • A $15 million asset-based revolving credit facility pays interest at the Wall Street Journal prime rate. The revolving credit facility's availability will be constrained by a borrowing base value of the Company's accounts receivable. “We are very pleased to enter into the new loan agreement with Silicon Valley Bank and replace our existing credit facility with improved economic terms. After strong execution in 2021, we ended the year with over $210 million of cash and investments, positioning EyePoint for these new credit facilities and further improving our balance sheet. We are grateful for the support of our partners at CRG, and we look forward to continued execution of our plan to meet near-term milestones and drive shareholder value.” George O. Elston, Chief Financial Officer of EyePoint Pharmaceuticals "We are delighted to support EyePoint in their pursuit of helping patients with serious eye disorders facing significant unmet need,” said Lauren Cole, Head of East Coast Biotech Credit Solutions at Silicon Valley Bank. “Their pipeline candidate, EYP-1901, a potential six-month intravitreal treatment targeting wet age-related macular degeneration, is a great example of what their proprietary Durasert® technology may accomplish." The terms of the new credit facility with Silicon Valley Bank will be disclosed in the Company's Annual Report on Form 10-K, which is scheduled to be filed with the Securities and Exchange Commission on or before March 11, 2022. The Company has $211.6 million in cash and investments as of December 31, 2021, including over $230 million from two successful follow-on equity offerings in 2021.

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PHARMACY MARKET

Takeda is poised to commercialize next generation Hunter's disease therapy through collaboration with JCR Pharmaceuticals

Takeda Pharmaceutical Company Limited | October 01, 2021

Takeda Pharmaceutical Company Limited and JCR Pharmaceuticals Co., Ltd. today announce a geographically focused exclusive collaboration and license agreement to commercialize JR-141, a recombinant fusion protein under development of a next-generation antibody against the human transferrin receptor and the enzyme iduronate- 2-sulfatase (IDS), used to treat Hunter's disease (also called mucopolysaccharidosis type II or MPS II). Hunter's disease is caused by the lack of IDS and manifests itself in different forms. Administered with J-Brain Cargo®, JCR's proprietary blood-brain barrier (BBB) ​​technology, the JR-141 was designed to deliver the therapeutic enzyme across the blood-brain barrier directly to the brain and somatic and address neuronopathic manifestations of the disease, Under the exclusive collaboration and license agreement, Takeda will exclusively market the JR-141 outside of the United States, including Canada, Europe, and other regions (excluding Japan and certain other Asia Pacific countries). JCR will receive an upfront payment for the ex-US license and is eligible to receive additional development measures and commercial milestones as well as multi-tier royalties on potential product sales. Both companies will work together to provide this form of therapy to patients as soon as possible after the completion of the global Phase III program run by JCR. Takeda has an option under a separate option agreement that allows Takeda to acquire an exclusive license to commercialize JR-141 in the United States upon completion of the Phase III program. Takeda is committed to continuously improving the therapy it offers to treat Hunter's disease. JR-141 introduces a new way of delivering proteins by crossing the blood-brain barrier. This will overcome our current challenges in treating the underlying neuronopathic manifestations of Hunter's disease and help maintain or improve cognitive function in these patients, We will work closely with JCR to apply our expertise in enzyme replacement therapies with the hope of delivering this potentially transformative form of therapy to patients as soon as possible. - Dan Curran, MD, Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda. JR-141 met its primary endpoint in an open-label Phase II / III study in Japanand was able to show a significant reduction in heparan sulfate (HS) concentrations in the CSF. HS is a biomarker for assessing the effectiveness of the drug in reducing the disease-causing substrate in the central nervous system. This proof could be provided in all patients for whom measurements were available after 52 weeks of treatment. Somatic disease control was retained in patients switched from standard enzyme replacement therapy (ERT). The study also showed an improvement in somatic symptoms in participants who had not received standard ERT prior to the start of the study. In addition, an assessment of neurocognitive development in 21 of 25 patients at one year showed the maintenance or improvement of age-appropriate function.1 About JR-141 JR-141 is a recombinant fusion protein of an antibody against the human transferrin receptor and the enzyme iduronate-2-sulfatase. This enzyme is absent or defective in patients with Hunter's disease. It is expected to be effective against neuronopathic manifestations of the disease by crossing the blood-brain barrier (BBB) ​​through transferrin receptor-mediated transcytosis using J-Brain Cargo®, JCR's proprietary BBB technology. Uptake into the cells is mediated by the transferrin receptor and the mannose-6-phosphate receptor. JCR has driven development activities by allowing the company to maintain the necessary evidence from the molecular design phase through to the non-clinical and clinical study phases. In addition, JCR has confirmed that using J-Brain Cargo® technology, enzymes are absorbed into different brain tissues. A decrease in substrate accumulation could also be confirmed in an animal model of Hunter's disease. 2,3,4 In several clinical studies with JR-141, JCR was able to show a reduction in CSF heparan sulfate concentrations. This is a biomarker for assessing the effectiveness of drugs by reducing the disease-causing substrate in the central nervous system. This is done in accordance with the results obtained in non-clinical studies. JCR also produced clinical results that could show the positive effects of JR-141 on neurocognition. 5,6,7,8 JR-141 is approved by the Ministry of Health, Labor and Social Affairs and has been marketed under the brand name "IZCARGO® IV Infusion 10mg" since May 2021. About Hunter's Disease Hunter's disease is a severely debilitating, rare lysosomal disease caused by insufficient activity of the enzyme iduronate-2-sulfatase. This enzyme has the task of breaking down substances known as glycosaminoglycans (GAG) in the body. 9 The absence of this enzyme (GAG) can trigger a number of symptoms. 9,10 Around two in three people with Hunter's disease also experience progressive loss of cognitive function. 11 Hunter's disease affects 1 in 162,000 live births and almost exclusively male patients. 12th About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited is a global, values-based, leading group with a focus on research and development in the biopharmaceutical sector headquartered in Japan. His pursuit of life-changing treatments is shaped by his dedication to patients, people, and the planet. Takeda's research and development efforts focus on four therapeutic areas: Oncology, Rare Genetic Diseases and Hematology, Neuroscience and Gastroenterology (GI). We also invest parts of our research and development budget specifically in therapies with plasma derivatives and vaccines. We focus on developing highly innovative drugs that help improve people's quality of life. To this end, we are opening up new treatment options and using our improved, synergistic research area and our combined skills to create a robust pipeline based on different modalities. Our employees are committed to improving the quality of life for patients and work with our healthcare partners in around 80 countries and regions. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. is a global specialty pharmaceutical company that is redefining expectations and expanding opportunities for those with rare hereditary diseases around the world. We continue to build on our 46 year tradition in Japan as we expand our presence in the United States, Europe and Latin America. We improve the lives of patients by applying our scientific expertise and unique technologies to research, develop and deliver next generation therapies. Our approved products in Japan include therapies for the treatment of stunted growth, Fabry disease, acute graft versus host disease and renal anemia. Our test products, which are being developed around the world, aim, among other things, at the treatment of rare diseases, including MPS I (Hurler's disease, Hurler-Scheie and Scheie syndrome), MPS II (Hunter's disease) and Pompe disease. JCR strives to expand the possibilities for patients as the company accelerates medical advancement on a global basis. Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we reach greater heights.

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