GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that it has submitted the Marketing Authorisation Application (MAA) for its lead product LUMEVOQ® to the European Medicines Agency (EMA), seeking approval for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy (LHON) caused by mutation in the ND4 mitochondrial gene.
"This first regulatory submission for GenSight is a major milestone in our progression from a pure research organization to one with commercial capabilities. It validates a technology platform that has the potential to address the high unmet medical needs of patients suffering from a range of rare diseases. I would like to thank all GenSight employees and partners whose motivation, focus and effort made this submission possible,” said Bernard Gilly, Co-founder and Chief Executive Officer of GenSight Biologics.
LHON is a rare, mitochondrial genetic disease, mainly affecting young males. The ND4 mutation results in the worst visual outcomes, with most patients becoming legally blind. There continues to be a high unmet medical need for the 800-1200 new LHON patients in Europe and the U.S. each year, particularly those who are struck blind in their prime working years.
Lenadogene nolparvovec (tradename: LUMEVOQ®) is a recombinant adeno-associated viral vector, serotype 2 (rAAV2/2), containing a cDNA encoding the human wild-type mitochondrial NADH dehydrogenase 4 protein (ND4), which has been specifically developed for the treatment of LHON associated with mutation in the ND4 gene. It received orphan drug designation status for the treatment of LHON from the EMA in 2011 and from the U.S. Food and Drug Administration (FDA) in 2013.
GenSight submitted the MAA based on the benefit-risk balance established by results from a Phase-I/IIa study (CLIN-01), two pivotal Phase-III efficacy studies (CLIN-03A: RESCUE, and CLIN-03B: REVERSE) and the long-term follow up study of RESCUE and REVERSE (CLIN 06 - readout at Year 3 post injection). To demonstrate the efficacy of LUMEVOQ® in the context of a contralateral effect, the Company used a statistics-based indirect comparison methodology to assess the visual outcomes in LUMEVOQ®-treated patients (from LUMEVOQ® efficacy studies) against those in untreated patients from Natural History studies and GenSight’s REALITY Natural History Registry.
GenSight expects to submit the Biologics License Application (BLA) for LUMEVOQ® to the FDA in H2 2021. First-in-human data from GenSight’s second clinical stage program, GS030, are expected to be available in H2 2021.
About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to the eye by intravitreal injection to offer patients a sustainable functional visual recovery.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200914005857/en/
What you need to know:
Combining Verizon’s on-site 5G Edge network capabilities with Microsoft Azure can bring more computing power even closer to end customers, allowing businesses to create extremely low lag experiences
Ice Mobility is already using 5G and mobile edge computing (MEC) to help with quality control in their pick and pack process by using computer vision to drive efficiencies
NEW YORK and REDMOND, Wash., Oct. 19, 2020 (GLOBE NEWSWIRE) -- Verizon is joining forces with Microsoft Corp. to create new ways for enterprises to accelerate the delivery of fast and secure 5G applications, benefiting from reliable and low latency connections. Verizon’s on-site 5G Edge network integrated with Azure edge services can enable ultra-low latency, many times faster than the blink of an eye, which can help businesses tap into real-time data analysis and delivery.
Applications incorporating computer vision, augmented, mixed and virtual reality, digital twins or machine learning can be enhanced with 5G and MEC on the customer premise, helping transform the way industries such as retail, transportation, and logistics operate: Think of automated high-precision asset localization, tracking and positioning in manufacturing. In healthcare, the increased speed, reduced latency and high bandwidth connectivity of 5G networks could enable real-time precision medicine leveraging mixed reality and AI capabilities as well as seamless and fast sharing of large files to improve patient care.
The collaboration brings Azure cloud and edge capabilities together with Verizon’s on-site 5G Edge, a mobile edge computing platform designed to enable developers to build applications for mobile end-users and wireless edge devices with ultra-low latency. By providing on-site private 5G, businesses will realize increased power efficiencies and reduced costs of end user devices, while helping to address their privacy and security needs.
“We have built a network that provides real-world, 5G-enabled solutions TODAY,” said Rima Qureshi, EVP and Chief Strategy Officer at Verizon. “By bringing together Verizon’s 5G network and on-site 5G Edge platform with Microsoft’s expertise in cloud services, we will enable the development of the next generation technologies everyone has been envisioning.”
Logistics and supply chain solutions company Ice Mobility is already testing on Verizon’s on-site 5G Edge platform, integrated with Microsoft Azure. The company is using 5G and MEC to help with computer vision assisted product packing. By gathering data in near real-time on product packing errors, the company has the potential to improve on-site quality assurance and save 15% to 30% in processing time.
“We are especially excited to join Verizon and Microsoft to test how 5G and MEC can improve the quality assurance process,” said Mike Mohr, CEO of Ice Mobility. “They truly have listened to our needs to provide automated real-time quality oversight and feedback, which will enable us to cost-effectively launch unique new products, while maintaining the highest execution standards, significantly increasing throughput and reducing costs. And, this is just the beginning.”
“By leveraging Verizon’s 5G network integrated with Microsoft’s cloud and edge capabilities, developers and businesses can benefit from fast, secure and reliable connections to deliver seamless digital experiences from massive industrial IoT workloads to precision medicine,” said Yousef Khalidi, corporate vice president Azure for Operators at Microsoft.
Moving forward, Verizon will explore opportunities to co-innovate with Microsoft to deliver new value to industries ranging from manufacturing to healthcare.
Verizon’s 5G Ultra Wideband network enables throughput at least 25 times faster than today’s 4G networks*; delivers ultra-low latency; and offers very high bandwidth. Verizon 5G Ultra Wideband is expected to eventually enable 100 times larger data volumes than 4G; and the ability to connect more than a million devices per kilometer. Verizon’s 5G Ultra Wideband service is available to people in 55 cities and its 5G Nationwide service is available to more than 200 million people in more than 1,800 cities around the US.
Learn more information about Verizon 5G Edge, Verizon’s 5G technology and explore how Microsoft is working with operators.
View the Ice Mobility video here.
Verizon Communications Inc. (NYSE, Nasdaq: VZ) was formed on June 30, 2000 and is celebrating its 20th year as one of the world’s leading providers of technology, communications, information and entertainment products and services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $131.9 billion in 2019. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control.
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* Source: Based on analysis by Ookla® of Speedtest Intelligence® data median download speeds from Verizon 5G results compared to the median 4G LTE speeds of top U.S. carriers combined in Q3 2020. Ookla trademarks used under license and reprinted with permission.
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China posted a GDP growth of 4.9 in the third quarter, lower than 5.2% expected from market’s analysts Retail sales climbed by 3.3% in September, marking a 0.9% surge in Q3 The SHCOMP price closed 0.71% lower yesterday after Chinese GDP missed the market’s estimates Shanghai Composite Index (SHCOMP) price fell yesterday after the latest GDP data shows that the country’s economy grew at a lower-than-expected rate. Fundamental analysis: ‘Complicated international environment’ A new data from the National Bureau of Statistics of China showed that the country’s economy has grown in the third quarter, continuing its recovery from the coronavirus. Are you looking for fast-news, hot-tips and market analysis? Sign-up for the Invezz newsletter, today. China posted a GDP growth of 4.9%, compared to the same period last year. This means that during the first three quarters of the year, China’s economy expanded by 0.7% compared to the same period a year ago. The growth in the third quarter was lower than expected as Chinese economists were projecting an expansion of 5.2%. “Generally speaking, the overall national economy continued the steady recovery and significant results have been delivered in coordinating epidemic prevention and development,” National Bureau of