Pfizer, Astellas' Xtandi racks up more data for new prostate cancer approval

fiercepharma | June 02, 2019

Pfizer and Astellas’ Xtandi is gunning for a new indication in prostate cancer, and they say Sunday's new data complement the supporting evidence they’ve already generated. Sunday at the American Society of Clinical Oncology annual meeting, researchers trumpeted datafrom an investigator-sponsored study in metastatic hormone-sensitive prostate cancer (mHSPC). The study showed Xtandi slashed the risk of death by 33% compared with other non-steroidal androgen-fighting drugs. Eighty percent of men taking the Pfizer-Astellas drug were alive after three years compared with 72% of men who received the hormone-based chemo drugs bicalutamide, nilutamide or flutamide alongside standard treatment.The results from the phase 3 study, dubbed Enzamet and led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, back up the companies’ own results from the phase 3 Arches trial. “The two studies actually are complementary of one another,” said Andrew Krivoshik, M.D., Astellas' vice president of medical science for oncology. The types of patients overlapped, but endpoints and eligibility criteria differed, he said. Arches, detailed in February, showed that combining Xtandi and androgen deprivation therapy (ADT) cut the risk of cancer worsening or death by 61% versus ADT alone. At the time of analysis, patients in the ADT-only group had gone a median 19.4 months before showing evidence of radiographic disease progression, an endpoint commonly used in prostate cancer trials. Meanwhile, in the Xtandi-ADT group, the median hadn’t yet been reached.

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Pharmacokinetics describes how the body affects a specific xenobiotic/chemical after administration through the mechanisms of absorption and distribution, as well as the metabolic changes of the substance in the body (e.g. by metabolic enzymes such as cytochrome P450 or glucuronosyltransferase enzymes), and the effects and routes of excretion of the metabolites of the drug.[2] Pharmacokinetic properties of chemicals are affected by the route of administration and the dose of administered drug.


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NextRNA Launches with $56 Million in Funding to Bring Transformative Non-Coding RNA-Directed Medicines to Patients

NextRNA Therapeutics | March 02, 2022

NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop transformative therapeutics, announces its launch with $9.3 million in seed financing and a $46.8 million Series A led by Cobro Ventures and Lightchain Capital, with additional participation from Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors. Proceeds will be used by the company to augment its target and drug discovery engine, expand its pipeline, and advance lead programs. The vast majority of DNA is copied into RNAs that do not make proteins. These RNA molecules, called “non-coding RNAs,” play essential roles in cells by interacting with and modulating the activities of proteins. These interactions can drive pathogenic processes in multiple disease areas, including oncology, immunology, and neurology. Non-coding RNAs, in particular long non-coding RNAs, and their interacting proteins therefore represent a vast and untapped class of novel therapeutic targets. “NextRNA is uniquely positioned to be the leader in non-coding RNA-directed medicines. We have established a robust target and drug discovery engine to systematically identify disease-relevant long non-coding RNAs and their interacting proteins. By developing selective small molecules to drug these interactions, we plan to translate discoveries of non-coding RNA targets into a robust pipeline of transformative therapies across multiple disease areas.” Dominique Verhelle, Ph.D., MBA, co-founder, chief scientific officer, and interim chief executive officer, NextRNA NextRNA was established based on pioneering work by Carl Novina, M.D., Ph.D., at Dana-Farber Cancer Institute. “By understanding the interactions between long non-coding RNAs and specific proteins, we can decode the function of long non-coding RNAs and apply it to create medicines,” said Dr. Novina, co-founder of NextRNA. Since its founding in January of 2021, NextRNA has established its initial team, built out the target and drug discovery engine, and advanced two small molecule programs in oncology and immunology. “NextRNA is at the forefront of innovation in the field of non-coding RNAs,” said Todd Kaloudis, Managing Director at Cobro Ventures. “There is growing excitement around the potential of non-coding RNA-directed medicines, and we are pleased to have such an experienced team focused on NextRNA’s vision of bringing transformative therapies to patients.” About NextRNA Therapeutics NextRNA is a biotechnology company with a mission to translate pioneering science into transformative therapeutics for the benefit of patients. The company is leveraging its proprietary technology platform to systematically identify disease-relevant non-coding RNAs and their interacting proteins, and to develop selective small molecules to drug these interactions. NextRNA investors include Cobro Ventures, Lightchain Capital, Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors.

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Agilent Announces the Innovative Seahorse XF Pro Analyzer

Agilent Technologies Inc. | January 25, 2022

Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function. Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies. “With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.” Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses "The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.” The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ). About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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Long Island University Extends Partnership with Dassault Systèmes to Innovation and Research in Life Sciences

Long Island University | March 23, 2022

Long Island University announced a new research and innovation partnership with Dassault Systèmes in life sciences. The partnership will focus on research with high societal impact to advance the fields of pharmaceutical sciences, precision medicine and health care in the digital age. Research includes precision medicine using "Virtual Twins," or exact digital models of human anatomy being developed by LIU and Dassault Systèmes; pandemic preparedness and the digitization of healthcare; innovation in medical devices; and telemedicine through the "Internet of Things," or the exchange and analysis of data between physical objects that are connected digitally. In addition, the partnership aims to provide a platform for technology transfer, or the sharing and transformation of inventions and scientific outcomes into commercialized products or services that benefit society. "Long Island University is at the forefront of revolutionizing health care training and research in higher education with our ongoing partnership with Dassault Systèmes. We are investing in opportunities and technology to ensure our students become future leaders and innovators in emerging industries." President Kimberly R. Cline As part of this commitment to students, LIU has also been designated as a Dassault Systèmes 3DEXPERIENCE Edu Center of Excellence. Dassault Systèmes created the global 3DEXPERIENCE Edu Centers of Excellence program in October 2021. The program is aimed at providing students, professionals, learners, businesses and governments with a network of centers dedicated to experiential, lifelong learning with its 3DEXPERIENCE platform that enables the current and future workforce to accelerate the digital transformation of industry. "At Dassault Systèmes, we have the profound belief that the virtual world extends and improves the real world helping to address today's social and environmental challenges," said Rama Kondru, Ph.D. co-CEO of Medidata, a Dassault Systèmes company. "This strategic initiative with LIU brings enormous opportunities since it is helping to prepare the next generation of life science experts to innovate in tomorrow's more sustainable economy, transform healthcare, and solve some of the biggest medical challenges in areas such as cancer and Alzheimer's disease." LIU is the second Center of Excellence in the U.S. in addition to Purdue University, which opened as a Center of Excellence in Advanced Composites in 2020. Additional centers have been established in France, Mexico, Germany, Switzerland, Brazil and India, and focus on various industry sectors. "Earning the distinction of being named a 3DEXPERIENCE Edu Center of Excellence is a testament to Long Island University's standing as a preeminent academic institution," said LIU Board of Trustees Chair Eric Krasnoff. "We are proud to partner with Dassault Systèmes to create an ecosystem where students, faculty and industry partners can collaborate on real-world, impactful learning." The University's extended and ongoing partnership with Dassault Systèmes, world leader in 3D design and engineering software, is in line with its vision to advance academic excellence through innovation, provide extraordinary and distinctive experiences to students, and create solutions for a sustainable global future. Forged in 2019, the partnership provides LIU students with hands-on experience using cutting-edge artificial intelligence and digital engineering technologies, and to collaborate on multidisciplinary research in the life sciences. "The LIU-Dassault Systèmes research partnership is centered on solving real-world problems through an integrated approach to education while simultaneously developing the future workforce for precision medicine, healthcare and pharmacy," said Dr. Randy Burd, senior vice president for academic affairs at LIU. "We look forward to using Dassault Systèmes' incredible technology to expand and enhance life sciences, liberal arts, humanities and performing arts degree programs throughout the University." In 2021, the University opened a state-of-the-art simulation laboratory that allows students to use Dassault Systèmes' patented 3D, augmented reality and virtual reality software to conduct experiential research, education and training. The laboratory is used in several areas of study, including artificial intelligence, robotics, virtual reality gaming, cybersecurity, data analytics, and drug discovery and development. LIU also employs Dassault Systèmes' cloud-based 3DEXPERIENCE platform in classrooms across the University. "LIU has entered a truly transformative niche in higher education by aligning with a digital healthcare industry that is on the rise," said Dr. Mohammed Cherkaoui, vice president for academic affairs at LIU. "We are honored to work with Dassault Systèmes, combining its content expertise and research tools to become a global leader in the innovation of healthcare." About Long Island University Long Island University, founded in 1926, continues to redefine higher education, providing high quality academic instruction by world-class faculty. Recognized by Forbes for its emphasis on experiential learning and by

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Can-Fite Granted Key NASH Patent in Israel

Can-Fite BioPharma Ltd. | May 17, 2022

Can-Fite BioPharma Ltd. a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced that its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" has been granted by the Israel Patent Office. This patent has been issued in approximately 40 countries and territories including Japan, South Korea, Hong Kong, Mexico, and in the European Union. It addresses the use of the A3 Adenosine Receptor ligand, the target receptor for Can-Fite's drug platform technology, for the treatment of ectopic fat accumulation particularly in fatty liver as manifested in non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. The treatment of NASH is a market estimated to reach $35 billion by 2025. Can-Fite is currently enrolling and treating patients in a Phase IIb NASH study of its liver drug candidate Namodenoson. The multi-center, randomized, double blind, and placebo controlled study of biopsy-confirmed NASH patients will measure efficacy periodically through biomarkers, with a primary efficacy endpoint determined by liver biopsy at the end of the treatment period. In a prior Phase IIa study, Namodenoson met endpoints including reduced liver fat content, anti-inflammatory effects, and decreased body weight with excellent safety. “The treatment of NASH is an enormous unmet need that Can-Fite seeks to meet through our advanced stage clinical trial and our expanding patent estate for the use of our target A3AR in the treatment of fatty liver disease,” Can-Fite CEO Dr. Pnina Fishman About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor. Namodenoson is being evaluated in a pivotal Phase III trial as a second line treatment for hepatocellular carcinoma, and in a Phase IIb trial as a treatment for non-alcoholic steatohepatitis. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.

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Pharmacokinetics describes how the body affects a specific xenobiotic/chemical after administration through the mechanisms of absorption and distribution, as well as the metabolic changes of the substance in the body (e.g. by metabolic enzymes such as cytochrome P450 or glucuronosyltransferase enzymes), and the effects and routes of excretion of the metabolites of the drug.[2] Pharmacokinetic properties of chemicals are affected by the route of administration and the dose of administered drug.

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