Diverse Biotech announces orphan-drug designation for treatment of newly diagnosed glioblastoma

Diverse Biotech | May 04, 2020

Diverse Biotech, Inc. www.diversebiotech.com has announced the U.S. Food & Drug Administration (FDA) has granted an orphan-drug designation request for one of its investigational new therapies for treatment of newly diagnosed glioblastoma, in conjunction with standard treatment, following adjuvant combined chemo-radiation.  Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, (Orphan Drug Act) including tax credits for qualified clinical testing. For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria. "We are very excited about the FDA orphan-drug designation for an investigational therapy the company is currently researching.  Glioblastoma is a devastating disease with very low 5-year survival rates.  The orphan drug designation helps Diverse Biotech to advance our program, designed to combat such a terrible disease, and potentially improve the survival rates.  We are committed to developing unique and powerful new medicines to help patients with diseases where there may be limited treatment alternatives.  Our aspiration is to develop new drugs to change the standards of care in different diseases starting with glioblastoma," said Stella Vnook, Diverse Biotech's Chief Executive Officer.

Spotlight

Human adult stem cells have attracted considerable interest in the field of regenerative medicine in recent years. Adult stem cells include mesenchymal stem cells, neural stem cells, hematopoietic stem cells, cardiac stem cells, hepatic stem cells etc.They are capable of differentiating into the major specialized cells of the tissue in which they resided, therefore helping to repair and regenerate damaged tissues and organs. With its regenerative potential, human adult stem cells have been studied in numerous clinical settings, including musculoskeletal, neurological, vascular, immune-mediated, respiratory, liver, cardiac diseases etc.


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MEDICAL

Aspect Biosystems Announces Partnership with JDRF to Advance Development of a Bioengineered Tissue Therapeutic to Treat Type 1 Diabetes

Aspect Biosystems | April 07, 2022

Aspect Biosystems ("Aspect"), a biotechnology company developing bioengineered tissue therapeutics to transform how we treat disease, is pleased to announce a partnership with JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization. The JDRF-Aspect partnership supports Aspect's focus on developing a bioengineered tissue therapeutic for type 1 diabetes that will provide insulin independence and control of blood sugar without the need for chronic immune suppression. In addition to funding, JDRF is also contributing strategic support through its deep expertise and vast network in the diabetes field. Aspect is leveraging its proprietary bioprinting technology, therapeutic cells, and materials science to create a pipeline of cell-based tissue therapeutics that replace or repair damaged organ functions. These therapeutics are rationally engineered to be biologically functional, immune-protective, and suitable for surgical implantation to treat diseases such as type 1 diabetes. For more than 20 years, JDRF has been a leader in cell-based tissue therapy research for type 1 diabetes, This funding partnership with Aspect Biosystems will support and continue scientific advancements in the field and undeniably take us closer to finding a cure." Esther Latres, Assistant Vice President of Research at JDRF. Together with JDRF, we are aligned on the mission to develop a curative therapy for the millions of patients around the world who are affected by type 1 diabetes, This partnership will help advance our cutting-edge pancreatic tissue program and bring us a step closer to human trials." Tamer Mohamed, CEO at Aspect Biosystems. About Aspect Biosystems Aspect Biosystems is a biotechnology company creating bioengineered tissue therapeutics to transform how we treat disease. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced therapeutics and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine. About JDRF International JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D.

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MEDICAL

Light Bio Partners with Ginkgo Bioworks to Optimize the Brightness of Glowing Plants through Bioluminescence Engineering

Light Bio | April 18, 2022

Light Bio, Inc., a company that is creating bioluminescent plants for home and garden, and Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced a collaboration to leverage Ginkgo's plant cell assays for bioluminescence engineering. Through the agreement, Ginkgo aims to help improve the luminescent output and efficiency of the enzymes within Light Bio's glowing ornamental plants. The scientists at Light Bio have discovered a new type of bioluminescence mechanism and are using synthetic biology to engineer plants to efficiently emit light. The original light emission pathway Light Bio uses in its glowing plants comes from bioluminescent mushrooms, and the company is now focused on expanding its engineering capabilities to support the creation of glowing plants. We are excited to collaborate with Ginkgo toward additional multifold output and efficiency improvements powered by Ginkgo's plant cell engineering capabilities across both individual enzyme and metabolic pathway improvements, Light Bio has already achieved strong light emission results on our glowing plant luminescence to date." Keith Wood, CEO, Light Bio. Nothing captures the wonder of biology quite like seeing glowing plants in person, Our platform enables developers to imagine with biology and to design all types of cells, from bacteria and yeast to mammalian and plant cells. We're so excited to bring this unique application onto our platform and to help Light Bio bring the magic of glowing plants to people." Jason Kelly, CEO, Ginkgo Bioworks. About Light Bio Light Bio creates novel biodesigns in living light. Through consumer-led applications of synthetic biology, Light Bio is opening new markets with products that have never existed before. Led by a team with deep experience in the development and commercialization of bioluminescence products, the company is sustained by its proprietary technologies backed by a strong patent portfolio. 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.

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INDUSTRIAL IMPACT

Cellarity Expands Leadership Team to Continue Evolution of a Breakthrough Platform to Encode Biology and Purposefully Create New Medicines

Cellarity | February 11, 2022

Cellarity, a life sciences company founded by Flagship Pioneering to encode and simulate human biology to reimagine the way we create medicines, announced today the expansion of its executive leadership team with three key appointments. As Chief Scientific Officer, Laurens Kruidenier, Ph.D., will lead the continued evolution of Cellarity’s platform and pipeline and oversee cross functional integration across all aspects of computation, drug creation, and optimization. As Chief People Officer, Anna O’Driscoll will lead the development of human resources and talent development strategies to enable the fast growth of Cellarity and make the company a top place to work for talent. As Senior Vice President and Head of Data and Software Engineering, Parul Doshi will spearhead the development of a leading and scalable data infrastructure to support the entire drug creation and development process. “We are building a transformative company and bringing together a strong team of people with a track record of making things happen. Laurens is not only an exceptional translational scientist, with experience and success advancing primary research into clinical-stage programs, he is also a team and company builder, helping integrate and mature drug discovery platforms.” Fabrice Chouraqui, Ph.D., CEO of Cellarity and a CEO-Partner at Flagship Pioneering Dr. Chouraqui continued, “Anna brings deep experience in talent and leadership development in the biotech industry, and she is known for her passion to positively impact the employee experience. Parul not only brings broad expertise in data infrastructure across the entire pharma value chain, from preclinical and clinical to tech operations and commercialization but also hands-on expertise in software engineering. I am excited that these top leaders have joined us at this pivotal time as Cellarity grows our team, advances key programs, and scales a pipeline of important new therapeutics.” Cellarity has developed unique capabilities to encode biology and model computationally the changes that occur between health and disease to design breakthrough medicines. Cellarity's transformative approach to drug creation looks beyond an individual molecular target to understand the complex biological network of cellular changes that underlie the start and progression of a disease. Built at the confluence of systems biology, single cell data, and machine learning, the Cellarity platform leverages a more complete view of cell biology to purposefully create drugs. Since all diseases stem from a disorder at the cellular level, Cellarity’s approach can be applied to virtually every disease and uncovers new biology and treatments that are unlikely to be found through target-based discovery. “Despite the tremendous progress the industry has made in advancing medical treatments, most diseases do not have curative therapies, and there are thousands of conditions that lack treatments,” said Dr. Kruidenier. “I’m impressed with Cellarity’s drug creation engine, which looks beyond the single target and embraces the full complexity of human disease. I look forward to working with the team to realize the truly transformative nature of the Cellarity platform and advance into the clinic novel medicines in diverse therapeutic areas to meet a wide range of patient needs.” Laurens Kruidenier, Ph.D., Chief Scientific Officer Dr. Kruidenier has more than 25 years of experience in discovery research, both in academic settings as well as in the life sciences industry and a track-record of success in drug discovery and development, driving research programs into clinical study and integrating teams and technologies for growth and scale. Prior to joining Cellarity, Dr. Kruidenier was Chief Scientific Officer (CSO) at Prometheus Biosciences, a precision medicine company in the immune-mediated disease space. At Prometheus, he helped mature the company from an early, seed-stage Cedars-Sinai-spinout into a Nasdaq-listed, platform-driven portfolio company with three active Phase 2 clinical trials. Previously, he held the roles of Vice President of Discovery at Second Genome, where he was responsible for a portfolio of microbiome programs and Head of GI Immunology Research at Takeda Pharmaceuticals, where he was responsible for developing the global discovery research and business development strategy into inflammatory diseases of the bowel. Earlier in his career, Dr. Kruidenier held various positions at different discovery units at GlaxoSmithKline, where he led preclinical teams and projects in immuno-inflammation, epigenetic, and protein degradation drug discovery. He completed his post-doctoral training at the University of London and holds an M.Sc. in medical biology from Utrecht University and a Ph.D. in mucosal immunology from Leiden University. His research has resulted in multiple publications in top tier scientific journals, including Nature. Anna O’Driscoll, Chief People Officer Ms. O’Driscoll has more than a decade of experience in human resources and was most recently Vice President of Human Resources at Alnylam Pharmaceuticals, where she worked in roles spanning R&D, Commercial, Corporate Functions, Learning and Development, and Employee Relations as Alnylam evolved from a research organization to a leading biotech company. Prior to Alnylam, she was Head of Talent Strategy and Process at Shire and in the Human Resources Leadership Development Program at Johnson & Johnson. Ms. O’Driscoll graduated with an MBA from the Institute of Chartered Financial Analysts and a bachelor’s degree in marketing and languages from Dublin City University. Parul Doshi, Senior Vice President, Head of Data and Software Engineering Ms. Doshi has more than twenty years of experience in information technology (IT) and software engineering and was most recently Head of IT & Digital for Takeda’s Vaccine division. She spent the past 16 years at Takeda, in roles of increasing seniority across several divisions of the company. She notably led the IT programs to launch oncology products NINLARO® and ALUNBRIG® as well as the consolidation of the Vaccines Business Unit to Cambridge, Massachusetts and integration of ARIAD Pharmaceuticals post acquisition. Prior to Takeda, Ms. Doshi worked as a developer at Patni Computer Systems, servicing major companies such as Fidelity Investments and LEGO®. Ms. Doshi graduated with an MBA in information technology and finance from Savitribai Phule Pune University, and a bachelor’s in economics and applied statistics from the University of Rajasthan. About Cellarity Cellarity's mission is to fundamentally transform the way medicines are created through the development of the first full stack digital cell. Founded by Flagship Pioneering in 2017, Cellarity has developed unique capabilities combining high-resolution data, single cell technologies, and machine learning to encode biology, model interventions, and purposefully design breakthrough medicines. By focusing on the cellular changes that underlie disease instead of a single target, Cellarity’s approach uncovers new biology and treatments and is applicable to a vast array of disease areas. The company currently has programs underway in metabolic disease, hematology, immuno-oncology, and respiratory disease. The company has raised $123 million as part of a Series B funding round with contributions from funds and accounts managed by Blackrock, The Baupost Group, Banque Pictet on behalf of their clients, and eight other investors alongside Flagship Pioneering. About Flagship Pioneering Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $140 billion in aggregate value. To date, Flagship has deployed over $2.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics.

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INDUSTRIAL IMPACT

Canopy Biosciences Launches Next-Generation ChipCytometry™ Instrument for Spatial Biology with Sub-Cellular Resolution

Canopy Biosciences | March 04, 2022

Canopy Biosciences, a Bruker Company, announced the commercial launch of the CellScapeTM system, the next generation in ChipCytometryTM instrumentation, advancing the cutting-edge for quantitative in situ spatial phenotyping. ChipCytometry delivers single-cell targeted spatial proteomics for complex whole-tissue analysis of the tumor microenvironment, as well as deep immune profiling for applications in immunology, neuroscience, and infectious disease. The new benchtop CellScape system builds on the existing core strengths of the original ChipCytometry instrument, the ZellScannerONE™, which has enabled spatial biology research with sub-cellular resolution and a large field of view suitable for whole slide pathology imaging, on both tissue samples and cell suspensions since 2016. The CellScape system , with its multiplexed fluidics integration, adds complete walk-away automation, improved optical performance, sub-cellular resolution and massively increased throughput for whole slide imaging of millions of cells, while maintaining the key features of the core ChipCytometry technology, including high-plex phenotyping with single-cell resolution, very high dynamic range imaging for detection and quantification of both high- and low-expressing targets, and compatibility with standard commercially available fluorescently labelled antibodies, requiring no proprietary antibody conjugation. This powerful combination of features will significantly improve researchers’ workflow, accelerate spatial biology discovery, and drive broader adoption of high-plex spatial omics for translational and clinical applications. “The ChipCytometry platform has been a great tool for us in developing high content staining approaches for in-depth spatial immune profiling of human tissue samples. The improvements to throughput and automation of the CellScape system gives the opportunity to scale up studies and explore larger cohorts – and accelerate studies aimed at improving patient care.” Paul Klenerman, Ph.D., Professor of Gastroenterology at The University of Oxford “Following the acquisition of Canopy Biosciences by Bruker in 2020, we were able to leverage Bruker’s advanced fluorescence microscopy expertise to design the CellScape instrument as an integrated, multiplexed imaging system that is highly optimized for the application of high-throughput quantitative spatial omics with sub-cellular resolution,” added Thomas Campbell, Ph.D., Product Manager at Canopy Biosciences. “The improved optical performance of the system builds on the high resolution and high dynamic range that was already best-in-class with our ChipCytometry technology.” About the CellScape Instrument Through enhanced optics and automation, the throughput of CellScape is markedly improved compared to the previous generation of ChipCytometry instrumentation. Combined with multi-sample automated processing, which is available standard with every CellScape, the platform will have among the highest throughput of any highly multiplexed spatial proteomics system available today. CellScape will also be available with an optional FalconFastTM configuration, which provides an even greater increase in throughput, bringing into reach large-scale clinical studies that have previously not been possible at a high plex. About Canopy Biosciences, a Bruker Company Canopy Biosciences was formed in 2016 and rapidly built a comprehensive portfolio of products and services for spatial biology, multi-omics, and bioprocessing. Canopy offers its ChipCytometry technology for precise spatial multiplexing in cells and tissue samples, along with other technologies of ultrasensitive DNA sequencing (RareSeq), RNA-Seq, and gene expression analysis for services. Canopy Biosciences is headquartered in St. Louis, Missouri, with a CLIA site in California, and a site in Germany to serve researchers at universities, research institutions, and biotechnology and pharmaceutical companies worldwide. Canopy was acquired by Bruker Corporation in 2020.

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Spotlight

Human adult stem cells have attracted considerable interest in the field of regenerative medicine in recent years. Adult stem cells include mesenchymal stem cells, neural stem cells, hematopoietic stem cells, cardiac stem cells, hepatic stem cells etc.They are capable of differentiating into the major specialized cells of the tissue in which they resided, therefore helping to repair and regenerate damaged tissues and organs. With its regenerative potential, human adult stem cells have been studied in numerous clinical settings, including musculoskeletal, neurological, vascular, immune-mediated, respiratory, liver, cardiac diseases etc.

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