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Eiger BioPharmaceuticals Appoints Market Access, Public Policy Expert, and Biotech Veteran Amit K. Sachdev to Board of Directors

Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of therapies for serious rare and ultra-rare diseases, announced today the appointment of Amit K. Sachdev, JD to its Board of Directors.  Mr. Sachdev is currently Executive Vice President and Chief Regulatory Officer at Vertex Pharmaceuticals Incorporated, where he serves on its Executive Committee and has been an executive officer since 2007.  In addition to overseeing Global Regulatory Affairs, Mr. Sachdev established and managed core business functions, including global market access, health economics and outcomes research, corporate affairs and patient advocacy to support its commercial drug launches in hepatitis C and cystic fibrosis.

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How to Choose a Reliable Biotech Clinical Trial Management System?

Article | July 11, 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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MedTech

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | October 7, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

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MedTech

Next-Gen Gene Therapy to Counter Complex Diseases

Article | July 16, 2022

Gene therapy has historically been used to treat disorders with in-depth knowledge caused by a single genetic mutation. Thanks to the introduction of new generation technologies, the potential of gene therapy is expanding tAo treat diseases that were previously untreatable. Evolution of Gene Therapy One of the major success stories of the twenty-first century has been gene therapy. However, it has not been the same in the past. The field's journey to this point has been long and mostly difficult, with both tragedy and triumph along the way. Initially, genetic disorders were thought to be untreatable and permanently carved into the genomes of individuals unfortunate enough to be born with them. But due to the constant technological advancement and research activities, gene therapy now has the potential to treat various genetic mutation-causing diseases with its ability to insert a new copy and replace faulty genes. Gene Therapy is Finding New Roads in the Medical Sector Gene therapy can help researchers treat a variety of conditions that fall under the general heading of epilepsy, instead of only focusing on a particular kind of disorder brought on by a genetic mutation. Following are some of the domains transformed by gene therapy. Neurology – Gene therapy can be used for the treatment of seizures by directly injecting it into the area causing an uncontrolled electrical disturbance in the brain. Furthermore, by using DNA sequences known as promoters, gene therapy can be restricted to specific neurons within that area. Ophthalmology – Genetic conditions such as blindness can be caused due to the mutation of any gene out of over 200 and resulting in progressive vision loss in children. With advanced gene therapies such as optogenetics, lost photoreceptor function can be transferred to the retinal cells, which are responsible for relaying visual information to the brain. This might give patients the ability to navigate in an unknown environment with a certain level of autonomy. The Future of Gene Therapy The news surrounding gene therapy has been largely favorable over the past few years, with treatment after treatment obtaining regulatory approvals, successful clinical trials, and garnering significant funds to begin development. With more than 1,000 clinical trials presently underway, the long-awaited gene therapy revolution might finally be here.

Read More
MedTech

Immunology: A New Frontier in Medical Science

Article | July 16, 2022

Introduction Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders. Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities. Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices. Accelerating Investments: Paving the Way for Immunology The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments. Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments. For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science. These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy. The Way Forward Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases. With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space. Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.

Read More
MedTech

Biotech in 2022

Article | July 11, 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.

Read More
MedTech

How to Choose a Reliable Biotech Clinical Trial Management System?

Article | October 7, 2022

Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies. Growing Cancer Encourages Advancements in Genetic Technologies With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing. As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030. Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022. Amid a New Market: Genetics Will Attract Massive Investments Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain. Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain. For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production. Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR. The Future of Genetics Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments. This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.

Read More
MedTech

Immunology: A New Frontier in Medical Science

Article | July 16, 2022

Gene therapy has historically been used to treat disorders with in-depth knowledge caused by a single genetic mutation. Thanks to the introduction of new generation technologies, the potential of gene therapy is expanding tAo treat diseases that were previously untreatable. Evolution of Gene Therapy One of the major success stories of the twenty-first century has been gene therapy. However, it has not been the same in the past. The field's journey to this point has been long and mostly difficult, with both tragedy and triumph along the way. Initially, genetic disorders were thought to be untreatable and permanently carved into the genomes of individuals unfortunate enough to be born with them. But due to the constant technological advancement and research activities, gene therapy now has the potential to treat various genetic mutation-causing diseases with its ability to insert a new copy and replace faulty genes. Gene Therapy is Finding New Roads in the Medical Sector Gene therapy can help researchers treat a variety of conditions that fall under the general heading of epilepsy, instead of only focusing on a particular kind of disorder brought on by a genetic mutation. Following are some of the domains transformed by gene therapy. Neurology – Gene therapy can be used for the treatment of seizures by directly injecting it into the area causing an uncontrolled electrical disturbance in the brain. Furthermore, by using DNA sequences known as promoters, gene therapy can be restricted to specific neurons within that area. Ophthalmology – Genetic conditions such as blindness can be caused due to the mutation of any gene out of over 200 and resulting in progressive vision loss in children. With advanced gene therapies such as optogenetics, lost photoreceptor function can be transferred to the retinal cells, which are responsible for relaying visual information to the brain. This might give patients the ability to navigate in an unknown environment with a certain level of autonomy. The Future of Gene Therapy The news surrounding gene therapy has been largely favorable over the past few years, with treatment after treatment obtaining regulatory approvals, successful clinical trials, and garnering significant funds to begin development. With more than 1,000 clinical trials presently underway, the long-awaited gene therapy revolution might finally be here.

Read More
MedTech

Immunology: A New Frontier in Medical Science

Article | July 16, 2022

Introduction Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders. Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities. Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices. Accelerating Investments: Paving the Way for Immunology The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments. Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments. For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science. These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy. The Way Forward Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases. With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space. Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.

Read More
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Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other application

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Flagship Pioneering Announces the Merger of Two Leading Programmable Medicine Platforms to Form Sail Biomedicines

PR Newswire | October 25, 2023

Flagship Pioneeringannounced the combination of Laronde and Senda Biosciences to launch Sail Biomedicines, a company pioneering the design and deployment of fully programmable medicines to transform patient care. Sail harnesses the power of first-in-category programmable payloads of Endless RNA™ (eRNA), first-in-category programmable nanoparticles, and emerging, proprietary AI technologies, to unlock the comprehensive programming of medicines for the first time. Guillaume Pfefer, Ph.D., MBA, who is also CEO-Partner at Flagship Pioneering, will become Sail's CEO and board member, while John Mendlein, Ph.D., who also serves as Executive Partner, Flagship Pioneering, will become the company's Executive Chairman. Sail unites Laronde and Senda Biosciences, two companies that deliver more than eight years of combined data and multi-product platform building. Senda's platform was the first to leverage a universal chemical code of natural nanoparticles that enables directed and repeatable deployment of payloads, such as translatable RNA, directly to cells and tissues of choice. Laronde pioneered eRNA, a new class of synthetic, translatable RNA that can be programmed to express diverse proteins inside the body, with vast therapeutic potential. "Endless RNA has the potential to create an entirely new class of programmable medicines across therapeutic areas that we will now be able to deliver directly to cells and tissues via deployment molecules with unique properties to confer specificity and greater tolerability," said Mendlein. "We believe these programmable medicines will be greatly enhanced via our proprietary generative AI technologies and rapid prototyping abilities to achieve breakthroughs currently beyond the grasp of the human mind. I look forward to working with the Sail Biomedicines team in this exciting new chapter." "Our deployment platform utilizes natural nanoparticles to shuttle biomolecules into human cells, with unique tropism, potency, and redosability," said Pfefer. "I look forward to leading the integration of these two teams to accelerate the development of new product candidates, build strategic partnerships, and enable diverse value pools, with the goal of swiftly delivering life-changing vaccines and therapies for the people who need them." "Sail Biomedicines builds on the progress made by two leading Flagship bioplatform companies and will enable integrative design for more effective programmable medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering. "I am confident the combined leadership team and board will carry forward this company to realize its bold ambitions and ultimately deliver maximum impact for patients." In addition to Mendlein and Pfeffer, the Sail Biomedicines Board of Directors will comprise all current members of the Laronde and Senda Biosciences boards, as follows Pablo Cagnoni, M.D., President and Head of Research & Development, Incyte Jose "Pepe" Carmona, MBA, Chief Financial Officer, ADC Therapeutics Paula Hammond, Ph.D., Institute Professor, Massachusetts Institute of Technology, Head of Department of Chemical Engineering, Massachusetts Institute of Technology Avak Kahvejian, Ph.D., General Partner, Flagship Pioneering Ignacio Martinez, MBA, General Partner, Flagship Pioneering Sheri McCoy, M.S., MBA, Former Vice Chairman, Johnson & Johnson Mary Szela, MBA, CEO and President, TriSalus Life Sciences About Sail Biomedicines Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail's platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. About Flagship Pioneering Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

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Zenfold Leverages Ginkgo Enzyme Services to Enable Veterinary Active Ingredient Development with Sustainable Biology

PR Newswire | October 17, 2023

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, today announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method. "This collaboration marks a significant step forward in Zenfold's mission to bring sustainable manufacturing technology to the veterinary medicine industry," said Dr. BSV Prasad, CEO and Managing Director of Zenfold Sustainable Technologies. "By utilizing Ginkgo's expertise and innovation, we are well-positioned to develop a sustainable solution that will have a lasting impact on the Indian market and beyond." "We are excited to partner with Zenfold, which brings a powerful vision of sustainable biotechnology to veterinary active ingredient development. This collaboration will enable us to apply our state-of-the-art enzyme discovery module to enable more innovation in the veterinary medicine space," said Jennifer Wipf, SVP, Head of Commercial, Cell Engineering at Ginkgo. "The project involves creating a broad library of cDNA candidates from a metagenomic collection of billions of enzyme sequences. That's the kind of scale visionary projects like this need, and Ginkgo is committed to scaling up this solution for the betterment of animal health and the environment." About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About Zenfold Zenfold Sustainable Technologies is a pioneer in the field of sustainable biology, with a focus on veterinary actives and enzyme supply. This collaboration with Ginkgo Bioworks marks Zenfold's expansion into the global veterinary market and further emphasizes their commitment to environmental responsibility and innovative biological solutions.

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Ichnos Sciences Enters Licensing Agreement For Ox40 Antagonist Monoclonal Antibody Portfolio With Astria Therapeutics

PR Newswire | October 12, 2023

Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific antibodies for oncology, announced that the company has entered into an exclusive worldwide licensing agreement for its OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics, a biopharmaceutical company developing therapies for rare allergic and immunological diseases. With the execution of this agreement, Ichnos has successfully licensed its two assets for inflammatory and immunological diseases, a key milestone in the company's prioritization of its pipeline of oncology drug candidates. Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications. In exchange, Ichnos will receive up to $320 million in upfront, development, regulatory and sales milestone payments in addition to up to low double-digit royalties. Ichnos has also agreed to allow Astria to draw down on its existing investigational drug substance and drug product stocks at normalized costs to facilitate development. Telazorlimab is a novel, humanized IgG1 monoclonal antibody that targets OX40 on T cells responsible for inflammation and immunity diseases. Excessive OX40 signaling, expressed on activated T cells, is the feature of several inflammatory diseases, including atopic dermatitis (AD). Astria plans to develop an affinity-matured version of telazorlimab and apply YTE half-life extension technology to create a product that aims to address the need for a safe, effective, and infrequently administered AD treatment. "As Ichnos continues to grow as a biotechnology company, this agreement enables our team to focus on advancing our robust pipeline of clinical-stage multispecific antibodies in oncology generated by our proprietary BEAT® platform1, as well as continue the discovery and development of our NK-cell engaging programs for solid tumors," said Cyril Konto, M.D., President and CEO of Ichnos. "I am proud of the work achieved by the Ichnos team in successfully completing the Phase 2b with telazorlimab in atopic dermatitis and potentially opening up a new therapeutic class for this disease. Ichnos is confident in Astria Therapeutics' capabilities and vision for pursuing the development of its OX40 program and delivering a potentially life-changing treatment to patients with inflammatory and immune diseases." "We are looking forward to building on the foundational work that Ichnos has done with their OX40 portfolio," said Jill Milne, Ph.D., co-founder and CEO of Astria Therapeutics. "We believe that by using Ichnos' affinity-matured next generation monoclonal antibody OX40 antagonist and applying YTE half-life extension technology, we have the potential to deliver a best-in-class profile for atopic dermatitis patients; one that we think can be safe, effective, and long-acting. In addition to OX40 antagonism already being a clinically validated mechanism in atopic dermatitis, we also are excited about the opportunity for potential expansion into additional indications." About Ichnos Sciences Inc. A fully integrated, global biotech with the spirit of a start-up, Ichnos is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology. The company, with headquarters in New York, N.Y., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and to treat patients holistically. With its patented BEAT® technology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare.

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Flagship Pioneering Announces the Merger of Two Leading Programmable Medicine Platforms to Form Sail Biomedicines

PR Newswire | October 25, 2023

Flagship Pioneeringannounced the combination of Laronde and Senda Biosciences to launch Sail Biomedicines, a company pioneering the design and deployment of fully programmable medicines to transform patient care. Sail harnesses the power of first-in-category programmable payloads of Endless RNA™ (eRNA), first-in-category programmable nanoparticles, and emerging, proprietary AI technologies, to unlock the comprehensive programming of medicines for the first time. Guillaume Pfefer, Ph.D., MBA, who is also CEO-Partner at Flagship Pioneering, will become Sail's CEO and board member, while John Mendlein, Ph.D., who also serves as Executive Partner, Flagship Pioneering, will become the company's Executive Chairman. Sail unites Laronde and Senda Biosciences, two companies that deliver more than eight years of combined data and multi-product platform building. Senda's platform was the first to leverage a universal chemical code of natural nanoparticles that enables directed and repeatable deployment of payloads, such as translatable RNA, directly to cells and tissues of choice. Laronde pioneered eRNA, a new class of synthetic, translatable RNA that can be programmed to express diverse proteins inside the body, with vast therapeutic potential. "Endless RNA has the potential to create an entirely new class of programmable medicines across therapeutic areas that we will now be able to deliver directly to cells and tissues via deployment molecules with unique properties to confer specificity and greater tolerability," said Mendlein. "We believe these programmable medicines will be greatly enhanced via our proprietary generative AI technologies and rapid prototyping abilities to achieve breakthroughs currently beyond the grasp of the human mind. I look forward to working with the Sail Biomedicines team in this exciting new chapter." "Our deployment platform utilizes natural nanoparticles to shuttle biomolecules into human cells, with unique tropism, potency, and redosability," said Pfefer. "I look forward to leading the integration of these two teams to accelerate the development of new product candidates, build strategic partnerships, and enable diverse value pools, with the goal of swiftly delivering life-changing vaccines and therapies for the people who need them." "Sail Biomedicines builds on the progress made by two leading Flagship bioplatform companies and will enable integrative design for more effective programmable medicines," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering. "I am confident the combined leadership team and board will carry forward this company to realize its bold ambitions and ultimately deliver maximum impact for patients." In addition to Mendlein and Pfeffer, the Sail Biomedicines Board of Directors will comprise all current members of the Laronde and Senda Biosciences boards, as follows Pablo Cagnoni, M.D., President and Head of Research & Development, Incyte Jose "Pepe" Carmona, MBA, Chief Financial Officer, ADC Therapeutics Paula Hammond, Ph.D., Institute Professor, Massachusetts Institute of Technology, Head of Department of Chemical Engineering, Massachusetts Institute of Technology Avak Kahvejian, Ph.D., General Partner, Flagship Pioneering Ignacio Martinez, MBA, General Partner, Flagship Pioneering Sheri McCoy, M.S., MBA, Former Vice Chairman, Johnson & Johnson Mary Szela, MBA, CEO and President, TriSalus Life Sciences About Sail Biomedicines Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail's platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. About Flagship Pioneering Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

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Zenfold Leverages Ginkgo Enzyme Services to Enable Veterinary Active Ingredient Development with Sustainable Biology

PR Newswire | October 17, 2023

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, today announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method. "This collaboration marks a significant step forward in Zenfold's mission to bring sustainable manufacturing technology to the veterinary medicine industry," said Dr. BSV Prasad, CEO and Managing Director of Zenfold Sustainable Technologies. "By utilizing Ginkgo's expertise and innovation, we are well-positioned to develop a sustainable solution that will have a lasting impact on the Indian market and beyond." "We are excited to partner with Zenfold, which brings a powerful vision of sustainable biotechnology to veterinary active ingredient development. This collaboration will enable us to apply our state-of-the-art enzyme discovery module to enable more innovation in the veterinary medicine space," said Jennifer Wipf, SVP, Head of Commercial, Cell Engineering at Ginkgo. "The project involves creating a broad library of cDNA candidates from a metagenomic collection of billions of enzyme sequences. That's the kind of scale visionary projects like this need, and Ginkgo is committed to scaling up this solution for the betterment of animal health and the environment." About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. About Zenfold Zenfold Sustainable Technologies is a pioneer in the field of sustainable biology, with a focus on veterinary actives and enzyme supply. This collaboration with Ginkgo Bioworks marks Zenfold's expansion into the global veterinary market and further emphasizes their commitment to environmental responsibility and innovative biological solutions.

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Ichnos Sciences Enters Licensing Agreement For Ox40 Antagonist Monoclonal Antibody Portfolio With Astria Therapeutics

PR Newswire | October 12, 2023

Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific antibodies for oncology, announced that the company has entered into an exclusive worldwide licensing agreement for its OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics, a biopharmaceutical company developing therapies for rare allergic and immunological diseases. With the execution of this agreement, Ichnos has successfully licensed its two assets for inflammatory and immunological diseases, a key milestone in the company's prioritization of its pipeline of oncology drug candidates. Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications. In exchange, Ichnos will receive up to $320 million in upfront, development, regulatory and sales milestone payments in addition to up to low double-digit royalties. Ichnos has also agreed to allow Astria to draw down on its existing investigational drug substance and drug product stocks at normalized costs to facilitate development. Telazorlimab is a novel, humanized IgG1 monoclonal antibody that targets OX40 on T cells responsible for inflammation and immunity diseases. Excessive OX40 signaling, expressed on activated T cells, is the feature of several inflammatory diseases, including atopic dermatitis (AD). Astria plans to develop an affinity-matured version of telazorlimab and apply YTE half-life extension technology to create a product that aims to address the need for a safe, effective, and infrequently administered AD treatment. "As Ichnos continues to grow as a biotechnology company, this agreement enables our team to focus on advancing our robust pipeline of clinical-stage multispecific antibodies in oncology generated by our proprietary BEAT® platform1, as well as continue the discovery and development of our NK-cell engaging programs for solid tumors," said Cyril Konto, M.D., President and CEO of Ichnos. "I am proud of the work achieved by the Ichnos team in successfully completing the Phase 2b with telazorlimab in atopic dermatitis and potentially opening up a new therapeutic class for this disease. Ichnos is confident in Astria Therapeutics' capabilities and vision for pursuing the development of its OX40 program and delivering a potentially life-changing treatment to patients with inflammatory and immune diseases." "We are looking forward to building on the foundational work that Ichnos has done with their OX40 portfolio," said Jill Milne, Ph.D., co-founder and CEO of Astria Therapeutics. "We believe that by using Ichnos' affinity-matured next generation monoclonal antibody OX40 antagonist and applying YTE half-life extension technology, we have the potential to deliver a best-in-class profile for atopic dermatitis patients; one that we think can be safe, effective, and long-acting. In addition to OX40 antagonism already being a clinically validated mechanism in atopic dermatitis, we also are excited about the opportunity for potential expansion into additional indications." About Ichnos Sciences Inc. A fully integrated, global biotech with the spirit of a start-up, Ichnos is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology. The company, with headquarters in New York, N.Y., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and to treat patients holistically. With its patented BEAT® technology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare.

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