INDUSTRIAL IMPACT
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 | 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 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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