Alligator Bioscience presents positive biomarker data demonstrating proof of mechanism in mitazalimab clinical Phase I study

PR Newswir | September 04, 2020

Alligator Bioscience (Nasdaq Stockholm: ATORX) announced today biomarker data from a recently performed clinical Phase I study of the drug candidate mitazalimab, its wholly owned CD40 antibody in development primarily for the treatment of pancreatic cancer. The data will be presented today at the scientific conference PEGS: The Essential Protein Engineering Summit being held virtually August 31- September 4, 2020. "The presented biomarker data confirm the proof of mechanism and strengthen our belief in mitazalimab as a powerful therapeutic agent. The observed induction of PD-L1-genes supports that mitazalimab has a potential to make tumors more responsive to PD-1 therapy. This is a very important factor and provides an opportunity for a clear path to the market and for adding benefit to patients," commented Per Norlén, CEO at Alligator Bioscience. The study identified a large number of upregulated genes after treatment with mitazalimab, such as PD-L1, which supports a clinical development plan for mitazalimab in combination studies with PD-1 inhibition. Furthermore, it was demonstrated that RNA sequencing can be successfully used to discover pharmacodynamic biomarkers following CD40 activation with mitazalimab.

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Department of Chemical Engineering, Biotechnology and Environmental Engineering research at the intersection of science and technical disciplines with a focus on global challenges and local opportunities and solutions.

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Department of Chemical Engineering, Biotechnology and Environmental Engineering research at the intersection of science and technical disciplines with a focus on global challenges and local opportunities and solutions.

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INDUSTRIAL IMPACT

Omega Therapeutics Announces Strategic Research Collaboration with Stanford University School of Medicine

Omega Therapeutics, Inc | October 14, 2021

Omega Therapeutics, Inc. ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programing™ platform, today announced a strategic research collaboration with researchers at the Stanford University School of Medicine to explore the therapeutic potential of Omega Epigenomic Controllers (OECs) to control ocular disease genes associated with inflammation or regeneration of ocular tissues. Under the terms of the collaboration, Omega and members of the Ophthalmology Department of Stanford University School of Medicine will use the OMEGA Epigenomic Programming platform to discover and research novel ocular targets for potential future OEC development candidates. Albert Wu, M.D., Ph.D., FACS, Associate Professor of Ophthalmology, will serve as principal investigator. Other contributors will include Jeffrey Goldberg, M.D., Ph.D., Professor and Chair of Ophthalmology, and Michael Kapiloff, M.D., Ph.D., Associate Professor (Research) of Ophthalmology. "Through this research collaboration, we aim to expand the reach of our OMEGA platform within regenerative medicine, immunology, and inflammation with ocular disease targets. We will continue exploration of the broad potential of our disruptive platform and OECs, our new class of mRNA therapeutics as programmable epigenetic medicines." Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics About Omega Therapeutics Omega Therapeutics is a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming™ platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. The OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers™, target specific intervention points amongst the thousands of mapped and validated novel DNA-sequence-based epigenomic loci to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control™. Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

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AI

Peptilogics and Cerebras Systems Partner on AI Solutions to Advance the Future of Peptide Therapeutics

Cerebras Systems , Peptilogics | August 19, 2021

Cerebras Systems, the pioneer in high performance artificial intelligence (AI) compute, and Peptilogics, a biotechnology platform company and an emerging leader in leveraging computation to design novel therapeutics, today announced a collaboration to accelerate the development cycle of peptide therapeutics through AI. Leveraging the revolutionary Cerebras CS-2 system – powered by the world’s fastest AI processor – Peptilogics will be able to push the boundaries of innovation in drug design and novel peptide therapeutics. This cutting-edge exploration of innovation is a scientific game changer with the potential to meaningfully reduce the time from bench to bedside. “Our mission at Peptilogics is to radically alter drug development and realize the full potential of peptides as therapeutics,” said Nick Nystrom, PhD, SVP and Head of Computation and Data, Peptilogics. “By partnering with Cerebras, we will be able to accelerate our research by orders of magnitude for important areas such as membrane proteins, including G protein coupled receptors (GPCRs). Traditional drug discovery operates on the time scale of one new drug in ten years. We aim to flip that to ten new leads in one year.” Peptides are sequences of amino acids, essentially small proteins, that play critical roles in how our bodies operate. They offer relatively unexplored opportunities for therapeutics, conferring potential advantages over other types of drugs. The “design space,” or number of possible peptide structures, is vastly larger than could be explored through traditional drug discovery. AI – specifically deep learning – is well-suited to identify ideal peptide structures as drug candidates. Through this collaboration, Cerebras and Peptilogics scientists will use the CS-2 system to develop and run advanced models to identify novel peptide therapeutics that meet specific biological activity and biophysical criteria. By accelerating the slowest step of the research cycle and training deep learning models on big data, Peptilogics with Cerebras will be positioned to deliver better therapeutics sooner. Peptilogics joins other life science leaders, including GSK and AstraZeneca, in leveraging Cerebras’ industry-leading AI technology to advance drug discovery. “Peptilogics is operating at the forefront of AI-enabled drug design. With Cerebras, they are part of a select group of partners that share similar interests in pushing the boundaries of scientific research and AI computing to radically accelerate innovation for better healthcare outcomes,” said Andy Hock, VP of Product at Cerebras. “Cerebras Systems makes world-leading AI compute accessible and easy to use so that our partners at Peptilogics can test more ideas quickly, reduce the cost of curiosity, and achieve their mission of discovering peptide therapeutics in record time.” About Cerebras Systems Cerebras Systems is a team of pioneering computer architects, computer scientists, deep learning researchers, and engineers of all types. We have come together to build a new class of computer to accelerate artificial intelligence work by three orders of magnitude beyond the current state of the art. The CS-2 is the fastest AI computer in existence. It contains a collection of industry firsts, including the Cerebras Wafer Scale Engine (WSE-2). The WSE-2 is the largest chip ever built. It contains 2.6 trillion transistors and covers more than 46,225 square millimeters of silicon. By comparison, the largest graphics processor on the market has 54 billion transistors and covers 815 square millimeters. In artificial intelligence work, large chips process information more quickly producing answers in less time. As a result, neural networks that in the past took months to train, can now train in minutes on the Cerebras CS-2 powered by the WSE-2. About Peptilogics Peptilogics is a clinical-stage biotechnology platform company that designs and develops novel peptide therapeutics. The company is supported by investors including Presight Capital, Founders Fund, and Peter Thiel, who are known for their investments in companies such as AbCellera (NASDAQ: ABCL), Compass Pathways (NASDAQ: CMPS), SpaceX, and Synthego. Through its computational platform, Peptilogics is advancing drug discovery to uncover new, previously unexplored chemical design space, while ensuring biological viability and scalable manufacturing. Peptilogics’ anti-infectives pipeline includes a novel clinical stage anti-infective, PLG0206, that has been granted FDA Orphan Drug Designation and Qualified Infectious Disease Product Designation for its initial focus on the treatment of prosthetic joint infections, an urgent unmet medical need.

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INDUSTRIAL IMPACT

Adaptive Biotechnologies Announces New Data Demonstrating ImmunoSEQ® Technology Can Identify T-Cell Receptors Associated with Crohn’s Disease

Adaptive Biotechnologies | February 19, 2022

Adaptive Biotechnologies Corporation a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, presented data on T-cell receptor (TCR) sequences associated with Crohn’s disease (CD) during an oral presentation today at the 17th Congress of European Crohn’s and Colitis Organisation (ECCO) being held virtually February 16-19. The study identified and characterized TCR sequences associated with CD utilizing Adaptive’s immunoSEQ® technology, providing fundamental insights into the body’s response to CD at the cellular level. The immunoSEQ assay uses sequencing technology to decipher the complexity of the adaptive immune system. This multi-national study, which was also recently published in The Journal of Crohns and Colitis, utilized immunoSEQ technology to analyze TCRs from blood samples of 1,738 CD cases and 4,970 healthy donors. Intestinal tissue samples from a subset of 380 cases were also analyzed. Through this analysis, 1,121 CD-associated TCRs were identified in patients’ blood and verified in tissue. The identification of disease-specific TCRs is an important first step in identifying a signal and developing an algorithm to inform development of a diagnostic test for CD. “The study identified Crohn’s-specific TCRs in both the blood and tissue of patients with Crohn’s disease, including a large subset that are ’public,’ or shared among patients. These findings suggest that blood-based testing for this often-debilitating disease could be used to diagnose and more effectively manage the disease through the identification of these disease specific T-cell receptors.” Matthieu Allez, MD, PhD, Professor and Head, Department of Gastroenterology, Hospital Saint-Louis, Paris T cells can have a significant impact on inflammation in CD, but until now, disease-associated TCRs have been largely unknown and underleveraged in diagnostics for the disease.1 These findings show that immunoSEQ can successfully identify TCRs for CD in a blood sample, which is reflective of the TCRs in intestinal tissue. The average length of time from onset of symptoms to diagnosis for a CD patient can be 1-2 years in the US but may be much longer in other countries, so the potential to open a new path to identify the disease earlier is significant.2,3 Furthermore, the amount of Crohn’s-related TCRs can provide insights into disease characteristics such as the phenotype and location of the disease, with possible clinical implications. In addition to TCR findings, the analysis also studied the possible association between human leukocyte antigens (HLAs) alleles and CD-associated TCRs, which live on most cells in the body, by leveraging the novel immunoSEQ HLA Classifier. HLA alleles are genetic factors that have been found to contribute to a small portion of risk for CD. In this study, nearly 400 CD-associated TCRs were found to be associated with specific HLA alleles. These TCR associations highlight the importance of studying TCRs in the context of HLA type and potentially point to new risk factors and insights for CD such as the involvement of specific antigens that the immune system may be reacting to in people living with CD. “We’re excited to see these results and their potential to advance the scientific community’s understanding of the immune response to Crohn’s disease. The use of immunoSEQ and characterization of TCRs in the blood have the potential to uncover new knowledge on the development and progression of the disease, with the potential to eventually improve diagnostic options and disease management for people living with Crohn’s,” said Harlan Robins, PhD, Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies. “We look forward to continuing our research and advancing the development of our T-Detect test to include an application in the diagnosis of Crohn’s disease.” CD is a subtype of inflammatory bowel disease, a group of diseases impacting about 6.8 million adults globally.4 Early treatment with effective medications can prevent disease progression towards complications, surgery and disability. However, CD is difficult to diagnose and treat, with more than half of patients initially misdiagnosed. No single blood test currently exists for diagnosis of CD. Instead, patients often undergo a series of tests – often invasive – in order to reach a conclusive diagnosis. Based on the results of this study, Adaptive is further investigating specific TCR signatures that are associated with CD related behavior and disease activity to further the development of T-Detect in this indication. Additional research will also focus on signal optimization and clinical validation to explore commercial utility. About the immunoSEQ® Assay Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and/or B-cell receptors from a single sample in exquisite detail. The immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures. About T Detect™ T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID is the first clinical test launched from this collaboration and the first commercially available T-cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect COVID is not FDA-cleared or approved, it has received an EUA from the FDA and is available for prescription use only. About Adaptive Biotechnologies Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in our Immune Medicine and Minimal Residual Disease (MRD) businesses. We have three commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases.

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