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Apellis Presents Phase 3 Functional Analyses of SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy

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  • Showed visual function and quality-of-life benefits in patients with extrafoveal lesions
  • Slowed the loss of retinal pigmented epithelial and photoreceptor cells, both of which are required for visual function
  • Eight abstracts, including three oral presentations, highlighted at ARVO annual meeting

WALTHAM, Mass., April 23, 2023 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced post hoc analyses from the 24-month, Phase 3 OAKS and DERBY studies evaluating SYFOVRE™ (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The analyses were reported during oral presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting taking place April 23-27 in New Orleans.

SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions (≥0.25 mm from the foveal center). Additionally, SYFOVRE showed a meaningful reduction in the loss of photoreceptor and retinal pigmented epithelial (RPE) cells, which are both required for vision. These analyses utilized data from patients with SPECTRALIS® optical coherence tomography (OCT) images, which allowed for artificial intelligence (AI)-based automated segmentation of the photoreceptor and RPE layers as well as determination of the amount of the central foveal region covered by the GA lesion (foveal occupancy).

SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions

In the 24-month analysis, SYFOVRE-treated patients compared to sham demonstrated:

  • Preservation of 5.6 letters, equivalent to more than one line of vision on an ETDRS chart, as measured by best corrected visual acuity (BCVA).
  • A 4.1-point benefit in vision-related quality-of-life outcomes, as measured by the NEI-VFQ-25. The questionnaire assesses outcomes, such as social function, driving, and dependency on others. Four points is considered clinically meaningful.1

“Vision loss caused by GA can profoundly impact a person’s independence and well-being, so it is vital that SYFOVRE has shown slower vision loss and better quality of life compared to sham in this post hoc analysis. These data also support earlier treatment with SYFOVRE,” said Allen Chiang, M.D., presenting author and associate professor of ophthalmology at Wills Eye Hospital, Mid Atlantic Retina, and Thomas Jefferson University. “As the first and only approved medicine for GA, SYFOVRE represents a new treatment era for this devastating disease.”

Due to sample size considerations, every-other-month and monthly data from OAKS and DERBY were combined for the SYFOVRE (n=131) and sham (n=61) groups. These data are in addition to the functional benefit outcomes previously reported in the post hoc junctional zone microperimetry analysis.

SYFOVRE slowed photoreceptor and RPE cell loss compared to sham

In the 24-month analysis of OAKS (n=456) and DERBY (n=435), SYFOVRE demonstrated a meaningful reduction in the loss of both photoreceptor and RPE cells compared to sham (all p-values nominal):

  • Photoreceptor cells
    • Every-other-month: 46% (OAKS; p<0.0001) and 46% (DERBY; p<0.0001)
    • Monthly: 53% (OAKS; p<0.0001) and 47% (DERBY; p<0.0001)
  • RPE cells
    • Every-other-month: 20% (OAKS; p=0.0002) and 21% (DERBY; p=0.0005)
    • Monthly: 22% (OAKS; p=0.0002) and 27% (DERBY; p<0.0001)

RPE cells maintain the integrity of photoreceptor cells, and both types of cells are required for vision. Data were consistent when comparing SYFOVRE-treated study eyes to the untreated fellow eyes.

“We are proud to share these data as part of our eight presentations at this year’s ARVO meeting, which showcase our leadership in GA and retina,” said Caroline Baumal, M.D., chief medical officer at Apellis. “SYFOVRE is a gamechanger for GA as the first and only treatment for this relentless disease, and we look forward to exploring its potential to treat other complement-driven retina diseases with significant unmet needs.”

Marketing applications are currently under review with five regulatory agencies worldwide. A decision in the EU is expected in early 2024, and decisions in Canada, Australia, Switzerland, and the United Kingdom are expected in the first half of 2024.

Presentations will be available on the “Events and Presentations” page of the “Investors and Media” section of the company’s website.

About the Visual Function Methodology
The visual function analysis accounts for key predictors of vision loss including distance to the fovea (≥0.25 mm from the foveal center) and foveal occupancy. The analysis was adjusted for baseline imbalances in disease characteristics, including foveal occupancy.

About the Phase 3 OAKS and DERBY Studies
OAKS (n=637) and DERBY (n=621) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of SYFOVRE™ (pegcetacoplan injection) with sham injections across a broad and heterogenous population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The studies evaluated the efficacy of monthly and every-other-month SYFOVRE in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence.

In Phase 3 studies at 24 months, both every-other-month and monthly SYFOVRE reduced GA lesion growth with increasing effects over time and showed a well-demonstrated safety profile.

About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.2,3 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.4

About SYFOVRE™ (pegcetacoplan injection)
SYFOVRE™ (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration.

U.S. Important Safety Information for SYFOVRE™ (pegcetacoplan injection)
CONTRAINDICATIONS

  • SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation

WARNINGS AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments
    • Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
  • Neovascular AMD
    • In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.
  • Intraocular Inflammation
    • In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.
  • Increased Intraocular Pressure
    • Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

ADVERSE REACTIONS

  • Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Please see accompanying full Prescribing Information for more information.

About Apellis 
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.

Apellis Forward-Looking Statement 
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of the commercial availability of SYFOVRE. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether SYFOVRE will be commercially available when expected; whether clinical trials of SYFOVRE indicate an apparent positive effect that is greater than the actual positive effect, whether SYFOVRE will receive approval from foreign regulatory agencies for GA when expected or at all; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 21, 2023 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Media Contact:
Lissa Pavluk
[email protected]
617.977.6764

Investor Contact:
Meredith Kaya
[email protected]
617.599.8178

1Suner et al. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: Validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci 2009;50(8):3629-35.
2Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.
3 Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
4 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.

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Latest VIPRE Security Group Email Threat Trends Research Exposes Global Phishing and Malware Threat Landscape

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May 9, 2024

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The US, UK, Ireland, and Japan emerge as the main source of spam; manufacturing, government, and IT sectors are most victimized; Pikabot top malware family 
LONDON, May 9, 2024 /PRNewswire/ — VIPRE Security Group, a global leader and award-winning cybersecurity, privacy, and data protection company, today released its Q1 2024 Email Threat Trends report, based on an analysis of 1.8 billion emails. The findings reveal the evolving landscape of email-based threats and emerging tactics malicious actors are employing.

The US, UK, Ireland, and Japan top the spam sources listThe report identifies the US as the top source of spam emails globally, followed by the U.K., Ireland, and Japan. The US, UK, and Canada are the top three countries most subjected to email-based attacks.
Attackers aim at the manufacturing sectorThe manufacturing, government, and IT sectors are the most victimized by malicious actors. In Q1 2024, the manufacturing sector suffered 43% of email-based attacks, with the government (15%) and IT (11%) trailing well behind. This is a change from Q1 2023, when attackers targeted the financial (25%), healthcare (22%), and education (15%) sectors most often.
Scams surpassing phishing This research warns that ‘scams’ within the spam category are growing in popularity among cybercriminals, overtaking phishing emails in the first quarter of 2024.
There’s been a notable increase in phishing emails masquerading as communications from Human Resources, falsely claiming to relate to employee benefits, compensation, or insurance within a company. These emails contain malicious attachments in .html or .pdf formats, featuring phishing QR codes that redirect recipients to phishing sites upon scanning.
New phishing trends and techniquesIn email phishing campaigns, 75% of emails leverage links, 24% favor attachments, and 1% use QR codes. Attackers are employing links in phishing emails for URL redirection (54%), compromised websites (22%), and newly created domains (15%).
Emerging tactics employed by cybercriminals to execute phishing attacks include the use of .ics calendar invite and .rtf attachment file formats to trick recipients into opening malicious content.
Malspam links and top malware familyEncouraged by the success of password-oriented phishing emails that use links, cybercriminals are opting for malicious links in malspam emails instead of attachments. Malware is increasingly being hidden in cloud storage platforms such as Google Drive. The use of malware-based emails employing attachments has increased to 22% in Q1 2024, from only 3% in Q1 2023.
Due to the void left by the dismantled Qakbot malware, Pikabot has emerged as the top malware family, with IceID a distant second.
Exploiting software vulnerabilitiesCriminals are exploiting a web application vulnerability, most notably Reflected Cross-Site Scripting (XSS), focusing on the tag attribute “href”, to circumvent detection by using a variety of tactics such as images as the entire email content, encoding URLs, and directing the victim through multiple URLs.
Malicious actors are also finding success with thread hijacking of NTLM (NT LAN Manager), a security protocol used by Microsoft Windows operating systems for authentication. By hijacking the authentication thread, attackers extract NTLM challenge-response hashes from legitimate SMB (Server Message Block) sessions, to enable them to impersonate authenticated users and gain unauthorized access.
“Criminals are using email with success to scam, infiltrate networks, and unleash malicious payloads,” warns Usman Choudhary, Chief Product and Technology Officer, VIPRE Security Group. “We’re witnessing bad actors relentlessly exploiting human vulnerabilities and software flaws, circumventing email gateways and security measures with alarming precision. Robust email and endpoint defenses, coupled with a vigilant human frontline, remain our strongest defense against these unyielding attacks.”
To read the full report, click here: VIPRE’s Email Threat Trends Report: Q1 2024.
VIPRE leverages its unique understanding of email security to equip organizations with the information they need to protect themselves. This report is based on proprietary intelligence gleaned from round-the-clock vigilance of the cybersecurity landscape.
About VIPRE Security Group VIPRE Security Group, part of Ziff Davis, Inc., is a leading provider of internet security solutions purpose-built to protect businesses, solution providers, and home users from costly and malicious cyber threats. With over 25 years of industry expertise, VIPRE is one of the world’s largest threat intelligence clouds, delivering exceptional protection against today’s most aggressive online threats. Our award-winning software portfolio includes next-generation antivirus endpoint cloud solutions, advanced email security products, along with threat intelligence for real-time malware analysis, and security awareness training for compliance and risk management. VIPRE solutions deliver easy-to-use, comprehensive layered defense through cloud-based and server security, with mobile interfaces that enable instant threat response. VIPRE is a proud Advanced Technology Partner of Amazon Web Services operating globally across North America and Europe.
The group operates under various brands, including VIPRE®, StrongVPN®, IPVanish®, Inspired eLearning®, Livedrive®, and SugarSync®. www.VIPRE.com

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Logicalis unites Australia and Asia operations as Logicalis Asia Pacific, creating a regional powerhouse

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May 9, 2024

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LONDON, May 9, 2024 /PRNewswire/ — Logicalis, a leading global technology services provider, has announced the creation of a new Asia Pacific entity, combining its Logicalis Australia and Logicalis Asia operations. This strategic realignment will be effective from June 01, 2024, and positions Logicalis to amplify its market presence through increased synergy within the APAC region.

The combined Logicalis Asia Pacific entity will consolidate 1,600 employees with a collective revenue upwards of $US350 million across 10 countries, including Singapore, Malaysia, Hong Kong, China, Thailand, Indonesia, Taiwan, Philippines, Vietnam, and now Australia. The newly formed entity will be led by Chong-Win Lee as the Chief Executive Officer (CEO) of Logicalis Asia Pacific with Anthony Woodward continuing in his role as CEO of Logicalis Australia and reporting to Chong-Win Lee. In addition to his current responsibilities, Woodward will lead a special task force focused on fostering innovation and identifying synergistic, joint opportunities across the region.
Chong-Win Lee, CEO, Logicalis APAC, said, “The strategic consolidation of Logicalis’ operations across Australia and Asia marks a pivotal moment in the company’s continued growth and evolution. The aim of this reorganisation is to build a powerhouse capable of delivering high-impact technology solutions more efficiently for customers across Asia Pacific, while still providing the local expertise and support that Logicalis customers value.”
The combination is designed to enhance service delivery and bring a cohesive solution portfolio to customers, reflecting the alignment of Logicalis Asia’s strategy to enable XaaS operating models to support digital transformation, and Logicalis Australia’s commitment to becoming the best MSP in the country. The combined operation will deliver seamless access to Logicalis’ experience in industry sectors such as financial services, government and healthcare, empowering teams to build skill and capacity for data and application modernisation, cloud managed services, artificial intelligence (AI), and more. From a security perspective, it will reinforce the company’s powerful customer proposition, giving customers access to the global network of threat intelligence research and experience encapsulated in the regional Logicalis Security Operations Centre (SOC).
Anthony Woodward, CEO, Logicalis Australia, said, “Formally combining the strengths of Logicalis Australia and its Asia counterparts is an acceleration of what has already been happening organically. This evolution lets Logicalis Australia and our customers leverage high-value digital capabilities from across the region, ensuring faster, more competitive, and more comprehensive service offerings. It also strengthens the local team’s onshore capabilities while integrating best practices and expertise from across Asia, enabling the delivery of scalable, cost-effective managed service options for customers.”
The announcement comes at a time when Logicalis has been increasingly focusing on expanding its core Microsoft and Cisco businesses, enhancing its capabilities in cloud, cybersecurity, and managed services. Logicalis Asia has also recently brought Atlassian onboard as a strategic vendor. Chong-Win Lee, CEO, Logicalis Asia Pacific, said, “The Logicalis Asia Pacific entity will help the company to achieve greater influence with vendors and deliver even greater outcomes for customers into the future.”
Bob Bailkoski, global CEO, Logicalis said, “The goal for Logicalis is clear: to harness the collective strengths of the company’s diverse operations to drive innovation and growth throughout Australia, Asia, and the globe. This reorganisation represents a strategic response to the evolving IT landscape and reinforces Logicalis’ commitment to developing solutions that support its customers’ success in the digital age.”
About Logicalis 
We are Architects of Change™. We help organisations succeed in a digital-first world. At Logicalis, we harness our collective technology expertise to help our clients build a blueprint for success, so they can deliver sustainable outcomes that matter.
Our lifecycle services across cloud, connectivity, collaboration, and security are designed to help optimise operations, reduce risk and empower employees.
As a global technology service provider, we deliver next-generation digital managed services, to provide our clients with real-time visibility and actionable insights across the performance of their digital ecosystem including; availability, user experience, security, economic performance and sustainability.
Our 7000+ ‘Architects of Change’ are based in 30 territories around the globe, helping our 10,000+ clients across a range of industry sectors create sustainable outcomes through technology.
Logicalis has annualised revenues of $1.7 billion, from operations in Europe, North America, Latin America, Asia Pacific, and Africa.
It is a division of Datatec Limited, listed on the Johannesburg Stock Exchange, with revenues of over $5.1 billion.
For more information visit https://www.logicalis.com
For media enquiries, contact:
Logicalis Team at Another Word 
Email: [email protected]
Tel: 020 3176 0014
 
 

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Raiinmaker to make a splash on Yield App Angel Launchpad

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May 9, 2024

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ROME, May 9, 2024 /PRNewswire/ — Raiinmaker, a Web3 and AI Technology company that has developed the Raiinmaker AI Super App and Raiinmaker Network is revolutionizing the monetization of users’ contribution to AI infrastructure. Today, Yield App proudly announced that an exclusive $200,000 allocation of Raiinmaker’s native token, $COIIN, will be the second-ever offering on its Angel Launchpad!

Established in 2018, Raiinmaker is on a mission to empower anyone with a smartphone anywhere in the world, to earn cryptocurrency through training AI models and running an independent validator node. By leveraging groundbreaking Web3 and AI technology, Raiinmaker provides a decentralized platform for AI developers and validators to collaborate securely and exchange AI models.
Validators on Raiinmaker earn rewards for their contributions, fostering a culture of active engagement and top-tier performance. The platform operates on a transparent governance framework, allowing community members to play a pivotal role in decision-making processes.
Raiinmaker’s token and platform are designed with interoperability in mind, ensuring seamless integration with major blockchain networks. The Raiinmaker Network Protocol harnesses decentralized AI and scalable Web3 infrastructure to redefine the value associated with identity, data, and behavior. Built on this network, Raiinmaker’s Super App is set to transform how users monetize their contributions to AI infrastructure via the platform’s native token, $COIIN.
Raiinmaker’s team is composed of industry veterans from corporate giants such as Disney, Oracle and Boeing. With a wealth of experience and a shared passion for innovation, this team is driving Raiinmaker’s mission to revolutionize the digital landscape.
“We’re excited to be the second project with our native token, $COIIN, as an offering on the Yield App Angel Launchpad and we share the same vision of providing investment opportunities for crypto enthusiasts,” said J.D. Seraphine, Founder and CEO of Raiinmaker.
Raiinmaker’s $COIIN token will be offered on the Yield App Angel Launchpad on 9 May 2024. To prepare for launch day, Yield App users can ensure they have a positive USDT balance in their Yield App wallet. This will be used for token allocation during the pledge period.
Before making their pledge, Yield App users must also have Gold tier, Diamond tier, or Angel status. This can be achieved by staking YLD on the Yield App platform. For more details on YLD and the loyalty program, visit the YLD page on Yield App’s website.
With Angel status, users enjoy exclusive benefits such as guaranteed minimum allocation on each Launchpad launch and no maximum pledge cap. Plus, Angel status includes all the benefits of Diamond tier, including top rates on all products. Users can now unlock unlimited access to Angel Launchpad by buying Lifetime Angel status with a one-time fee of 50,000 YLD or by staking 100,000 YLD.
During the pledge period, participants will need to submit a Base Protocol (BASE) address to receive their token allocation, paving the way for a seamless user experience.
“We are thrilled to welcome Raiinmaker and their innovative $COIIN token to the Yield App Angel Launchpad,” said Tim Frost, CEO of Yield App. “Our second Launchpad offering aligns with our vision of empowering users in the digital asset space, and opens up an exciting opportunity for our users with Gold tier, Diamond tier, or Angel status.”
For more updates on the official offering of $COIIN token, visit the Yield App Angel Launchpad website.
About Raiinmaker
Raiinmaker is a Web3 and AI Technology Company that has developed the Raiinmaker AI Super App and Raiinmaker Network Protocol, which revolutionizes the monetization of users’ contribution to AI infrastructure.
About Yield App
Yield App is a digital wealth platform that serves as a digital wealth partner to its customers. The company’s mission is to provide safe custody for digital assets and enable users to exchange and earn at market-leading rates. Yield App achieves this through its innovative technology that seamlessly bridges traditional and decentralized finance, offering users a more efficient and user-friendly way to manage their portfolios.
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