Contrasting of Gamida Cell Ltd. (GMDA) and Aridis Pharmaceuticals Inc. (NASDAQ:ARDS)

Gamida Cell Ltd. (NASDAQ:GMDA) and Aridis Pharmaceuticals Inc. (NASDAQ:ARDS) have been rivals in the Biotechnology for quite some time. Below is a review of each business including various aspects such as dividends, analyst recommendations, profitability, risk, earnings and valuation, institutional ownership. Gamida Cell Ltd., a clinical stage biopharmaceutical company, focuses on developing cell therapies to cure cancer, and rare and serious hematologic diseases in the United States, the European Union, and internationally. The company's lead product candidate is NiCord, a nicotinamide (NAM)-expanded cord blood cell therapy that is in Phase 3 clinical trials for use as a curative stem cell graft for patients in hematopoietic stem cell transplant.

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Biognosys AG

We believe that the decoding of the proteome will impact life science more than the genome revolution a decade ago. Biognosys provides innovative services and products for protein discovery and quantification using cutting edge technology. We strive to be the company that provides the best possible solutions to support researchers in their protein analysis needs.

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MedTech

Better Purification and Recovery in Bioprocessing

Article | July 20, 2022

In the downstream portion of any bioprocess, one must pick through the dross before one can seize the gold the biotherapeutic that the bioprocess was always meant to generate. Unfortunately, the dross is both voluminous and various. And the biotherapeutic gold, unlike real gold, is corruptible. That is, it can suffer structural damage and activity loss. When discarding the dross and collecting the gold, bioprocessors must be efficient and gentle. They must, to the extent possible, eliminate contaminants and organic debris while ensuring that biotherapeutics avoid aggregation-inducing stresses and retain their integrity during purification and recovery. Anything less compromises purity and reduces yield. To purify and recover biotherapeutics efficiently and gently, bioprocessors must avail themselves of the most appropriate tools and techniques. Here, we talk with several experts about which tools and techniques can help bioprocessors overcome persistent challenges. Some of these experts also touch on new approaches that can help bioprocessors address emerging challenges.

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MedTech

Making Predictions by Digitizing Bioprocessing

Article | July 13, 2022

With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech. “Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says. Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects. “The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.” To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.

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MedTech

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | July 12, 2022

Genomics is an interdisciplinary field of biology emphasizing the structure, editing, evolution, function, and mapping of genomes. It is creating deeper inroads across the precision health domain with the increasing introduction of advanced technologies such as quantum simulation, next-generation sequencing (NGS), and precise genome manipulation. As precision health focuses on providing the proper intervention to the right patient at the right time, genomics increasingly finds applications in human and pathogen genome sequencing in clinical and research spaces. Rising Hereditary Diseases Burden Paving the Way for Genomics in Precision Health In the last few years, a significant surge in the prevalence of diseases and ailments such as diabetes, obesity, baldness, and others has been witnessed across the globe. A history of family members with chronic diseases, such as cancer, diabetes, high blood pressure, hearing issues, and heart disease, can sometimes continue into the next generation. Hence, the study of genes is extensively being conducted for predicting health risks and early treatment of these diseases. It also finds use in CRISPR-based diagnostics and the preparation of precision medication for the individual. In addition, ongoing advancements in genomics are making it possible to identify different genetic traits that persuade people to more widespread diseases and health problems. The Emergence of Genomics Improves Disease Understanding Genomics refers to the study of the complete genetic makeup of a cell or organism. Increasing scientific research in the area substantially contributes to increasing knowledge about the human genome and assists in improving the ability to understand disease etiology, risk, diagnosis, treatment, and prevention. On account of these improvements, innovative genomic technologies and tools are being developed to enable better precision health not only for the individual but for various regional populations as well. The Way Forward With growing preference for personalized medicine and an increasing need for more accurate pathogen detection and diagnostics, genomics is gaining huge popularity across the precision health domain. Also, increasing research activities for developing novel high-precision therapeutics and rising importance of gene study in the prevention, diagnosis, and management of infectious and genetic diseases will further pave the way for genomics in the forthcoming years.

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MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | October 7, 2022

Introduction The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials. For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care. Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS. Key Steps for Selecting Right Biotech Clinical Trial Management System Prioritize Study Needs Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices. Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task. Select CTMS with Multiple Integrations Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection. Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes. Ensure System Compliance and Security Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties. While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project. Assess the Scalability Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility. As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure. The Closing Thought A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.

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Spotlight

Biognosys AG

We believe that the decoding of the proteome will impact life science more than the genome revolution a decade ago. Biognosys provides innovative services and products for protein discovery and quantification using cutting edge technology. We strive to be the company that provides the best possible solutions to support researchers in their protein analysis needs.

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MedTech

Entos and BioMarin Enter into Agreement for Product Candidates Incorporating Entos' Fusogenix Drug Delivery Platform

Entos Pharmaceuticals, Inc., BioMarin | November 16, 2021

Entos Pharmaceuticals, Inc. (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that they have entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Under the agreement, Entos will create specially formulated product candidates for BioMarin, a world leader in developing and commercializing innovative biopharmaceuticals for genetic diseases driven by genetic causes. Entos' Fusogenix platform utilizes a PLV formulation with a novel mechanism of action to deliver molecular payloads, intact and unmodified, directly into target cells. By combining well-tolerated neutral lipids with proprietary fusion-associated small transmembrane (FAST) proteins, the Fusogenix platform efficiently delivers mRNA or DNA to target tissue with excellent tolerability. Fusogenix technology has been applied to a wide range of therapeutic approaches, including vaccines, gene therapy, and gene editing. "As a company committed to addressing the unmet therapeutic needs of patients living with genetic diseases, BioMarin values novel technologies that enable the development of transformative therapies," said Brinda Balakrishnan, M.D., Ph.D., Group Vice President, Corporate and Business Development at BioMarin. "We believe that Entos' Fusogenix platform offers potentially unique benefits for safe and effective tissue targeting compared with other lipid-based delivery systems. The Fusogenix PLV formulations generated under this agreement are a critical first step in determining how we may incorporate this promising platform into our drug development efforts." "With a 20-year track record of successfully discovering, developing, and commercializing first- or best-in-class therapies for diverse rare diseases, the BioMarin team has extensive expertise in harnessing the potential of breakthrough technologies. We believe this licensing agreement helps validate the potential of our Fusogenix platform. It also provides additional opportunities for incorporating our technology into cutting-edge treatments that may have significant clinical and commercial value." John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Under the terms of the agreement, Entos will use its Fusogenix nucleic acid delivery system to specially formulate BioMarin products directed at multiple undisclosed genetic disease indications. BioMarin will conduct preclinical studies of the Fusogenix-formulated candidates to evaluate their potential as therapies to prevent or treat these conditions. Entos' most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate host adaptive and innate immune systems. Formulated using the Fusogenix platform, Covigenix VAX-001 is the subject of an ongoing phase 2 clinical trial in South Africa, with additional trials planned in other regions. Licensees of the Fusogenix platform include Oisín Biotechnologies and OncoSenX, which are using the technology for age-related diseases and oncology applications, respectively. pH Partners, LLC served as financial advisor to Entos. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and preclinical product candidates. About Entos Pharmaceuticals, Inc. Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix is formulated with FAST proteins to deliver mRNA or DNA directly into the cytosol of target cells for translation into protective and therapeutic vaccines and medicines.

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Medical

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

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MedTech

Entos and BioMarin Enter into Agreement for Product Candidates Incorporating Entos' Fusogenix Drug Delivery Platform

Entos Pharmaceuticals, Inc., BioMarin | November 16, 2021

Entos Pharmaceuticals, Inc. (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that they have entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Under the agreement, Entos will create specially formulated product candidates for BioMarin, a world leader in developing and commercializing innovative biopharmaceuticals for genetic diseases driven by genetic causes. Entos' Fusogenix platform utilizes a PLV formulation with a novel mechanism of action to deliver molecular payloads, intact and unmodified, directly into target cells. By combining well-tolerated neutral lipids with proprietary fusion-associated small transmembrane (FAST) proteins, the Fusogenix platform efficiently delivers mRNA or DNA to target tissue with excellent tolerability. Fusogenix technology has been applied to a wide range of therapeutic approaches, including vaccines, gene therapy, and gene editing. "As a company committed to addressing the unmet therapeutic needs of patients living with genetic diseases, BioMarin values novel technologies that enable the development of transformative therapies," said Brinda Balakrishnan, M.D., Ph.D., Group Vice President, Corporate and Business Development at BioMarin. "We believe that Entos' Fusogenix platform offers potentially unique benefits for safe and effective tissue targeting compared with other lipid-based delivery systems. The Fusogenix PLV formulations generated under this agreement are a critical first step in determining how we may incorporate this promising platform into our drug development efforts." "With a 20-year track record of successfully discovering, developing, and commercializing first- or best-in-class therapies for diverse rare diseases, the BioMarin team has extensive expertise in harnessing the potential of breakthrough technologies. We believe this licensing agreement helps validate the potential of our Fusogenix platform. It also provides additional opportunities for incorporating our technology into cutting-edge treatments that may have significant clinical and commercial value." John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Under the terms of the agreement, Entos will use its Fusogenix nucleic acid delivery system to specially formulate BioMarin products directed at multiple undisclosed genetic disease indications. BioMarin will conduct preclinical studies of the Fusogenix-formulated candidates to evaluate their potential as therapies to prevent or treat these conditions. Entos' most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate host adaptive and innate immune systems. Formulated using the Fusogenix platform, Covigenix VAX-001 is the subject of an ongoing phase 2 clinical trial in South Africa, with additional trials planned in other regions. Licensees of the Fusogenix platform include Oisín Biotechnologies and OncoSenX, which are using the technology for age-related diseases and oncology applications, respectively. pH Partners, LLC served as financial advisor to Entos. About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and preclinical product candidates. About Entos Pharmaceuticals, Inc. Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix is formulated with FAST proteins to deliver mRNA or DNA directly into the cytosol of target cells for translation into protective and therapeutic vaccines and medicines.

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Medical

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

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