Acriva Trinova, World's First and Only Sinusoidal Trifocal Intraocular Lens

June 11, 2019 | 32 views

Acriva Trinova is the first and only sinusoidal trifocal IOL designed with Sinusoidal Vision Technology (SVT) that minimizes halo / glare complaints and provides the highest light transfer to the retina.

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OncoSec

OncoSec is a San Diego-based biotechnology company pioneering new technologies to stimulate the body’s immune system to target and attack cancer. Through our proprietary technology, we hope to deliver safer and more effective cancer treatments that can provide long-term benefits for patients.

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RESEARCH

2022 U.S. Market Research Report with COVID-19 Forecasts2

Article | July 11, 2022

The global biotechnology market is expected to grow at a compound annual growth rate (CAGR) of 13.9 percent from 2022 to 2030, with a value estimated at USD 1,023.92 billion in 2021. The market is being propelled by strong government support in the form of initiatives aimed at modernizing the regulatory framework, improving approval processes and reimbursement policies, and standardizing clinical studies. The growing presence of personalized medicine and an increasing number of orphan drug formulations are opening up new avenues for biotechnology applications and driving the influx of emerging and innovative biotechnology companies, which is driving market revenue even further. The 2022 Biotech Research and Development Market Research Report is one of the most comprehensive and in-depth assessments of the industry in the United States, containing over 100 data sets spanning the years 2013 to 2026. This Kentley Insights report contains historical and forecasted market size, product lines, profitability, financial ratios, BCG matrix, state statistics, operating expense details, organizational breakdown, consolidation analysis, employee productivity, price inflation, pay bands for the top 20 industry jobs, trend analysis and forecasts on companies, locations, employees, payroll, and much more. Companies in the Biotech Research and Development industry are primarily engaged in biotechnology research and experimental development. Biotechnology research and development entails the investigation of the use of microorganisms and cellular and bimolecular processes to create or modify living or non-living materials. This biotechnology research and development may result in the development of new biotechnology processes or prototypes of new or genetically altered products that can be replicated, used, or implemented by various industries. This report was created using the findings of extensive business surveys and econometrics. The professionals follow reports with accurate and apt information on market sizing, benchmarking, strategic planning, due diligence, cost-cutting, planning, understanding industry dynamics, forecasting, streamlining, gap analysis, and other ana

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MEDTECH

Biotech in 2022

Article | July 20, 2022

The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further. Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians. We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others. Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact. Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.

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MEDTECH

Next-Gen Genetics Cancer Therapies Creating Investment Prospects

Article | July 5, 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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MEDICAL

Advancement in Genomics Accelerating its Penetration into Precision Health

Article | June 22, 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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OncoSec

OncoSec is a San Diego-based biotechnology company pioneering new technologies to stimulate the body’s immune system to target and attack cancer. Through our proprietary technology, we hope to deliver safer and more effective cancer treatments that can provide long-term benefits for patients.

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INDUSTRIAL IMPACT

Synlogic Announces Synthetic Biotic for Gout Developed in Partnership with Ginkgo Bioworks

Ginkgo Bioworks | August 12, 2022

Synlogic, Inc. a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced a new drug candidate for the treatment of gout developed in partnership with Ginkgo Bioworks the leading horizontal platform for cell programming. The new candidate, SYNB2081, is a Synthetic Biotic and is the second product to advance to clinical development through a research collaboration between Synlogic and Ginkgo, following the investigational new drug candidate SYNB1353 for the potential treatment of homocystinuria. Gout is a complex form of inflammatory arthritis that occurs when excess uric acid in the body forms crystals in the joints. Patients experience symptoms such as intense joint pain, inflammation and redness, and limited range of motion in the affected joints. Current treatment options present limitations in both safety and efficacy, highlighting a need for new approaches. In addition, gout is a recognized risk factor in chronic kidney disease. SYNB2081 is a Synthetic Biotic designed to lower uric acid. "With our second drug candidate into clinical development, this not only demonstrates the value of combining Ginkgo's platform with our Synthetic Biotic platform, but also highlights the potential to develop Synthetic Biotics across a range of diseases, giving us the potential to provide meaningful new treatment options to patients in need," Dr. David Hava, Chief Scientific Officer, Synlogic SYNB2081 is named after one of the largest and best-preserved Tyrannosaurus rex specimens in the world. Nicknamed "Sue," the specimen is housed at the Field Museum in Chicago and is officially named FMNH PR 2081. Data from "Sue" suggests that dinosaurs like the Tyrannosaurus rex suffered from gout much in the same way as other reptiles and birds do. "The advancement of SYNB2081 and SYNB1353 are clear indicators of the transformative platform Synlogic has created to develop new Synthetic Biotics through synthetic biology," said Patrick Boyle, Head of Codebase for Ginkgo. "We're honored to work with the Synlogic team in this pioneering next step to potentially help patients living with gout. As we've seen the Synlogic pipeline develop over the past year, we're eager to continue supporting Synlogic in generating additional therapeutic candidates." About Synlogic Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogic's pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the first half of 2023, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic's reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. In addition to its clinical programs, Synlogic has a research collaboration with Roche on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease. Synlogic has also developed two drug candidates through a research collaboration with Ginkgo Bioworks: SYNB1353, designed to consume methionine for the potential treatment of HCU, and SYNB2081, designed to lower uric acid for the potential treatment of gout. 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

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

Ginkgo Bioworks | August 12, 2022

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

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INDUSTRIAL IMPACT

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Novaliq GmbH | August 10, 2022

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announced the submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval for CyclASol® a proposed novel treatment for the signs and symptoms of dry eye disease. CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints. "This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol® as a drug carrier. CyclASol® is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eye care professionals. If approved by the FDA, CyclASol® addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration." Christian Roesky, Ph.D., CEO, Novaliq Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1,2 Inflammation and immunologic processes play a key role in the pathology of the disease. A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries.3,4 The impact of the corneal surface damage secondary to DED on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains for better tolerated drugs with an early onset of therapeutic effect, which are compelling to be used and prescribed.5,6 "We are very proud to see another product rapidly moving to the market, which marks yet another important inflection point and milestone in Novaliq's growth trajectory", said Dr. Mathias Hothum, board member and managing director of dievini. "We are currently evaluating the commercialization strategies which includes talking to interested parties." About CyclASol® CyclASol® is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol® excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances. The NDA is supported by safety and efficacy results in over 1,000 patients with DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study and its open label extension study.7,8 CyclASol® has demonstrated in two independent adequate and well-controlled, multicenter studies clinically meaningful and statistically significant improvements in the indication. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining score favoring CyclASol® in both studies at Days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Responders showed also statistically significant improvements in a variety of symptoms compared to non-responders at day 29. The ASCRS guidelines recognize corneal staining as the single most important clinical sign of DED as it indicates the level of epithelial damage and visual impairment, and if left undertreated, DED can become chronic and more difficult to treat.3 Effect on tear production: In both studies, compared to vehicle at the end of treatment, there was a statistically significant (p<0.05) higher percentage of patients with increases of ≥ 10 mm from baseline in Schirmer's tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. Meeting this endpoint in two independent studies is clinically meaningful on its own and considered to demonstrate efficacy for the treatment of signs and symptoms of DED. Head-to-head data versus Restasis™ from the phase 2 study suggest that CyclASol® has a stronger and faster therapeutic effect on the ocular surface.8 Maintenance of effect results from the long-term study CYS-005 confirmed that the effect of CyclASol® was maintained, and even improved for most endpoints, over the 52-week treatment period. Safety and Tolerability: Tolerability of CyclASol® was shown by high drop comfort patient ratings in both studies. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported in > 2% of the patients was visual acuity reduced (2.7%). About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. EyeSol® is Novaliq's proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases.

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INDUSTRIAL IMPACT

Synlogic Announces Synthetic Biotic for Gout Developed in Partnership with Ginkgo Bioworks

Ginkgo Bioworks | August 12, 2022

Synlogic, Inc. a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced a new drug candidate for the treatment of gout developed in partnership with Ginkgo Bioworks the leading horizontal platform for cell programming. The new candidate, SYNB2081, is a Synthetic Biotic and is the second product to advance to clinical development through a research collaboration between Synlogic and Ginkgo, following the investigational new drug candidate SYNB1353 for the potential treatment of homocystinuria. Gout is a complex form of inflammatory arthritis that occurs when excess uric acid in the body forms crystals in the joints. Patients experience symptoms such as intense joint pain, inflammation and redness, and limited range of motion in the affected joints. Current treatment options present limitations in both safety and efficacy, highlighting a need for new approaches. In addition, gout is a recognized risk factor in chronic kidney disease. SYNB2081 is a Synthetic Biotic designed to lower uric acid. "With our second drug candidate into clinical development, this not only demonstrates the value of combining Ginkgo's platform with our Synthetic Biotic platform, but also highlights the potential to develop Synthetic Biotics across a range of diseases, giving us the potential to provide meaningful new treatment options to patients in need," Dr. David Hava, Chief Scientific Officer, Synlogic SYNB2081 is named after one of the largest and best-preserved Tyrannosaurus rex specimens in the world. Nicknamed "Sue," the specimen is housed at the Field Museum in Chicago and is officially named FMNH PR 2081. Data from "Sue" suggests that dinosaurs like the Tyrannosaurus rex suffered from gout much in the same way as other reptiles and birds do. "The advancement of SYNB2081 and SYNB1353 are clear indicators of the transformative platform Synlogic has created to develop new Synthetic Biotics through synthetic biology," said Patrick Boyle, Head of Codebase for Ginkgo. "We're honored to work with the Synlogic team in this pioneering next step to potentially help patients living with gout. As we've seen the Synlogic pipeline develop over the past year, we're eager to continue supporting Synlogic in generating additional therapeutic candidates." About Synlogic Synlogic is a clinical-stage biotechnology company developing medicines through its proprietary approach to synthetic biology. Synlogic's pipeline includes its lead program in phenylketonuria (PKU), which has demonstrated proof of concept with plans to start a pivotal, Phase 3 study in the first half of 2023, and additional novel drug candidates designed to treat homocystinuria (HCU) and enteric hyperoxaluria. The rapid advancement of these potential biotherapeutics, called Synthetic Biotics, has been enabled by Synlogic's reproducible, target-specific drug design. Synlogic uses programmable, precision genetic engineering of well-characterized probiotics to exert localized activity for therapeutic benefit, with a focus on metabolic and immunologic diseases. In addition to its clinical programs, Synlogic has a research collaboration with Roche on the discovery of a novel Synthetic Biotic for the treatment of inflammatory bowel disease. Synlogic has also developed two drug candidates through a research collaboration with Ginkgo Bioworks: SYNB1353, designed to consume methionine for the potential treatment of HCU, and SYNB2081, designed to lower uric acid for the potential treatment of gout. 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

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

Ginkgo Bioworks | August 12, 2022

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

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INDUSTRIAL IMPACT

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Novaliq GmbH | August 10, 2022

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announced the submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval for CyclASol® a proposed novel treatment for the signs and symptoms of dry eye disease. CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints. "This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol® as a drug carrier. CyclASol® is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eye care professionals. If approved by the FDA, CyclASol® addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration." Christian Roesky, Ph.D., CEO, Novaliq Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1,2 Inflammation and immunologic processes play a key role in the pathology of the disease. A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries.3,4 The impact of the corneal surface damage secondary to DED on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains for better tolerated drugs with an early onset of therapeutic effect, which are compelling to be used and prescribed.5,6 "We are very proud to see another product rapidly moving to the market, which marks yet another important inflection point and milestone in Novaliq's growth trajectory", said Dr. Mathias Hothum, board member and managing director of dievini. "We are currently evaluating the commercialization strategies which includes talking to interested parties." About CyclASol® CyclASol® is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol® excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances. The NDA is supported by safety and efficacy results in over 1,000 patients with DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study and its open label extension study.7,8 CyclASol® has demonstrated in two independent adequate and well-controlled, multicenter studies clinically meaningful and statistically significant improvements in the indication. Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining score favoring CyclASol® in both studies at Days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Responders showed also statistically significant improvements in a variety of symptoms compared to non-responders at day 29. The ASCRS guidelines recognize corneal staining as the single most important clinical sign of DED as it indicates the level of epithelial damage and visual impairment, and if left undertreated, DED can become chronic and more difficult to treat.3 Effect on tear production: In both studies, compared to vehicle at the end of treatment, there was a statistically significant (p<0.05) higher percentage of patients with increases of ≥ 10 mm from baseline in Schirmer's tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. Meeting this endpoint in two independent studies is clinically meaningful on its own and considered to demonstrate efficacy for the treatment of signs and symptoms of DED. Head-to-head data versus Restasis™ from the phase 2 study suggest that CyclASol® has a stronger and faster therapeutic effect on the ocular surface.8 Maintenance of effect results from the long-term study CYS-005 confirmed that the effect of CyclASol® was maintained, and even improved for most endpoints, over the 52-week treatment period. Safety and Tolerability: Tolerability of CyclASol® was shown by high drop comfort patient ratings in both studies. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported in > 2% of the patients was visual acuity reduced (2.7%). About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. EyeSol® is Novaliq's proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases.

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