Bayer taps Roche's Foundation Medicine for Vitrakvi diagnostic development

fiercebiotech | May 29, 2019

Bayer has teamed up with Foundation Medicine to develop genetic diagnostic tests for several of its cancer therapies-starting with the tissue-agnostic Vitrakvi in solid tumors with TRK fusion mutations.Acquired from Loxo Oncology, Bayer’s Vitrakvi (larotrectinib) was the first targeted cancer drug to be developed and approved specifically for a pan-cancer indication, based not on a tumor’s organ site but on its genetic makeup.

Spotlight

A new wave of therapies based on RNA interference is on the brink of making it to the market. A technology that was awarded the Nobel prize in 2006, RNAi could be used to target virtually any gene of the human genome that’s causing disease to stop his expression. Thus unlocking molecular targets that were inaccesible before.All the answers to these and more questions about RNAi, in this awesome infographic.

Spotlight

A new wave of therapies based on RNA interference is on the brink of making it to the market. A technology that was awarded the Nobel prize in 2006, RNAi could be used to target virtually any gene of the human genome that’s causing disease to stop his expression. Thus unlocking molecular targets that were inaccesible before.All the answers to these and more questions about RNAi, in this awesome infographic.

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INDUSTRIAL IMPACT

Ginkgo Bioworks and the Rwanda Development Board Announce Plans to Develop and Implement New Biosecurity Capabilities in Rwanda

Ginkgo Bioworks | August 12, 2022

Ginkgo Bioworks the leading horizontal platform for cell programming, and the Rwanda Development Board representing the government of the Republic of Rwanda, today announced that they have entered into a Memorandum of Understanding with the intent of developing and implementing new biosecurity capabilities in Rwanda. The initial goal of the planned partnership is to support Rwanda's public health institutions as they work to address biosecurity challenges in the region. Ginkgo, through its biosecurity and public health initiative, Concentric by Ginkgo, plans to collaborate on the ground with RDB to equip these institutions with biosecurity tools and training as well as the secure data infrastructure they need to leverage automation, data analysis, bioinformatics capabilities, and other critical genomic sequencing technologies. Concentric leverages a nationwide laboratory network to provide pathogen monitoring capabilities across thousands of sites in the U.S., including schools, airports, and other congregate settings. Concentric aims to build sustainable global biosecurity infrastructure to prepare for the next new variant or novel pathogen, and this planned partnership with RDB is a significant milestone in its international expansion as it continues to scale its biosecurity offering. RDB, a Rwandan government institution, was established in 2008 to accelerate Rwanda's economic development by enabling private sector growth. Ginkgo will build relationships with Rwandan public health institutions and private sector-led biotechnology initiatives in Rwanda; the RDB will contribute expertise in skills development and on-the-ground support for the partnership. Concentric and RDB recognize the importance of international collaboration and cooperation to promote global health security as biological threats emerge. Effective pathogen monitoring and data sharing capabilities can empower government officials, community leaders, and other stakeholders to make informed public health decisions. In the long-term, these capabilities can also be leveraged to form the foundation for a sustainable regional bioeconomy. For example, in the context of this MOU, Ginkgo and RDB plan to collaborate to inform workforce development priorities in the areas of biotechnology, biomanufacturing, and bioengineering, and to explore potential opportunities for Rwanda to leverage its biodiversity as a foundation for innovation within its bioeconomy. "The future of biosecurity is global—COVID-19 has shown us all that pathogens don't recognize national borders. To prepare for the next biological threat, we need the infrastructure in place to build a global weather map tracking the spread and evolution of infectious diseases. We deeply appreciate Rwanda's leadership working to define a new era of biosecurity, and we are incredibly excited to use our platform to support Rwanda's public health institutions with critical capabilities that we believe will help them face challenges ranging from this pandemic to agricultural and travel biosecurity." Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks Clare Akamanzi, Chief Executive Officer of the Rwanda Development Board, noted, "The COVID-19 pandemic has exposed the need for robust public health and biotechnology infrastructure in Rwanda and around the world. We are excited about our plans to partner with Ginkgo to bring cutting-edge biosecurity capabilities to Rwanda across various sectors including health and agriculture. We believe this will stimulate our growing bioeconomy and help us learn more about our biodiversity." About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. About the Rwanda Development Board The Rwanda Development Board is a government agency responsible for leading the country's transformation into a dynamic global hub for business, investment, tourism and innovation. Its mission is to fast-track economic development in Rwanda by enabling private sector growth.

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INDUSTRIAL IMPACT

Active Motif and EpiCypher Execute Cross-Licensing Agreement and End Ongoing Litigation Involving Targeted Transposition Technology for Epigenomics

EpiCypher and Active Motif | August 01, 2022

CUT&Tag is a targeted transposition technique that allows high-resolution genomic mapping of histone modifications and chromatin-associated proteins through the precise insertion of DNA sequences into the genome using the Tn5 transposase enzyme. EpiCypher and Active Motif each own or control patents covering complementary aspects of targeted transposition. Active Motif and EpiCypher have leveraged their respective IP to independently create successful genomic mapping tools that allow researchers to employ targeted transposition / CUT&Tag for advanced epigenomics research. Since 2020, there has been a patent dispute between the companies that culminated in patent infringement litigation. EpiCypher and Active Motif have recently agreed to put their differences aside and today announced the signing of a global settlement ending the ongoing litigation, and a mutual cross-licensing agreement of their respective intellectual property. These developments will effectively resolve all outstanding legal issues between the two companies in the targeted transposition / CUT&Tag space. The companies agreed that both Active Motif and EpiCypher's IP are equally valid, and that both sets of IP are required to commercialize products and services that use technology involving targeted transposition techniques such as CUT&Tag. As part of the cross-licensing agreement, EpiCypher and Active Motif each agreed to provide to the other company a non-exclusive, royalty-bearing license to enable commercialization of products, kits, and services that use targeted Tn5 / CUT&Tag-based workflows. The companies also agreed to pool their IP and work together to sublicense targeted tagmentation technology for emerging fields of use, including single cell and spatial genomics assays. This places Active Motif and EpiCypher in a very strong position in the targeted transposition market. "Today's announcement is great for EpiCypher, Active Motif, and our collective customers", said Dr. Martis Cowles, Chief Business Officer of EpiCypher. "The Partnership between EpiCypher and Active Motif is a natural fit, and we look forward to working with Active Motif to maximize the impact of CUT&Tag technology on chromatin science and drug development". "Targeted transposition technology has become increasingly important in simplifying the study of Protein-DNA interactions. We are pleased to be collaborating with EpiCypher to bring targeted transposition to the research and biotech communities." Ted DeFrank, President and CEO of Active Motif. Joe Fernandez, the Founder of Active Motif About EpiCypher EpiCypher® is dedicated to developing transformative epigenetic solutions that advance the science of epigenetic regulation and improve human health. Most recently, EpiCypher has been at the leading edge of chromatin profiling technology with highly sensitive CUTANA™ epigenomic mapping assays for ChIC, CUT&RUN, and CUT&Tag. The Company also manufactures and sells the largest collection of defined "designer" nucleosomes on the market and offers a range of high-throughput nucleosome-based assays and services for chromatin research and drug development. About Active Motif Active Motif, Inc. is dedicated to developing, manufacturing and delivering epigenetics-based research tools to analyze nuclear function. Its customers include scientists from academic and government institutions; biotechnology and pharmaceutical companies. Active Motif operates globally through its corporate headquarters in Carlsbad, California and offices in Shanghai China, Tokyo Japan and Waterloo Belgium. Active Motif applies a multi-disciplinary approach to create new and modify existing technologies to meet the current and future needs of life science researchers.

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MEDTECH

NeuroSense Therapeutics and NeuraLight Collaborate to Detect ALS Oculometric Biomarkers Using AI and ML

NeuroSense and NeuraLight | July 29, 2022

NeuroSense Therapeutics Ltd. a company developing treatments for severe neurodegenerative diseases, and NeuraLight, a company developing objective and sensitive biomarkers for neurological disorders, today announced a collaboration to advance the science of digital biomarkers in the detection and monitoring of neurological diseases including amyotrophic lateral sclerosis. NeuraLight's platform, uses proprietary computer vision and deep learning algorithms to extract over 100 occulometic markers from facial videos captured with a standard webcam. NeuroSense is conducting a Phase IIb PARADIGM trial, which is a double-blind, placebo-controlled study evaluating the efficacy of NeuroSense's lead combination drug candidate, PrimeC, in the treatment of ALS. The NeuroSense-NeuraLight collaboration entails sharing and tracking patient data to advance the identification and use of ALS digital biomarkers in a parallel study conducted by NeuraLight. This collaboration marks NeuraLight's first clinical trial and comes on the heels of NeuraLight's $25M Series A raise. "There is compelling value in the use of precise biomarkers to diagnose and track the progression of neurodegenerative diseases. We are very pleased to work with the stellar team at NeuraLight who are pioneering the development of digital oculometric biomarkers, which complement our extensive evaluation of biological markers of ALS. We believe these tools have the potential to enable patient stratification and increase the likelihood of success in a future NeuroSense pivotal trial of PrimeC in the treatment of ALS. This is a first step in what we envision as a long-term collaboration with NeuraLight in ALS as well as future studies we plan for Alzheimer's disease and Parkinson's disease." NeuroSense CEO Alon Ben-Noon Dr. Rivka Kreitman, NeuraLight's Chief Innovation Officer, commented, "Along with advancing a promising therapy for ALS, we look forward to demonstrating that oculometrics serve as a robust proxy for the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) through this partnership. The validation of our technology's efficacy will improve success rates of trials moving forward – ensuring objectivity, reliability, and replicability, as well as reducing costs and friction." About ALS Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years of diagnosis. In the US alone, over 5,000 patients are diagnosed yearly with ALS, and researchers anticipate the number of ALS patients in the US to grow 24 percent by 2040. The cause of ALS is unknown, making it difficult for researchers to develop disease-modifying therapies for the neurodegenerative disease. About PrimeC PrimeC, NeuroSense's lead drug candidate is a combination therapy that was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. Through a collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs), NeuroSense is working to further determine the biological changes in ALS-related pathologies and the effect of PrimeC on relevant targets. Results from this study are expected Q2 2022. About NeuraLight NeuraLight is on a mission to transform the lives of billions of people impacted by neurological disorders by digitizing neurological evaluation and care. Our AI-driven platform integrates multiple digital markers to accelerate and improve drug development, monitoring, and precision care for patients with neurological disorders. The technology driving the platform includes proprietary Deep Learning algorithms which automatically extract a host of digital oculometric markers from facial videos captured with a standard webcam or smartphone. Our founders are repeat entrepreneurs and industry veterans (including both the co-founder of Chorus.ai and the founding CTO of Flatiron health) leading a 25-strong team, supported by renowned neurologists and 2 Nobel laureates as well as a stellar Scientific Advisory Board, and have raised $30.5M to date. About NeuroSense NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

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