Technology

BioArctic: Latest data on lecanemab to be presented at the 2024 AD/PD™ congress

Published

7 months ago

February 29, 2024

STOCKHOLM, Feb. 29, 2024 /PRNewswire/ — BioArctic AB (publ) (STO: BIOA-B) today announced that the company and its partner Eisai will present new data on lecanemab (brand name: Leqembi®) at the 2024 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD™), to be held in Lisbon, Portugal and virtually, March 5-9. In total, lecanemab will be featured in six presentations, including an oral presentation by BioArctic’s founder Professor Lars Lannfelt.

Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the anti-amyloid beta (Aβ) protofibril antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease.

At AD/PD, BioArctic will present one oral presentation and one poster on lecanemab, both focused on the binding properties of lecanemab to various types of Aβ of lecanemab compared to several other Aβ antibodies. The company will also have two other posters related to Alzheimer’s disease.

In addition to BioArctic’s presentations, Eisai will present four oral presentations on lecanemab results. From the Phase 3 Clarity AD study in early Alzheimer’s disease[1] with confirmed brain Aβ accumulation, data will include the effect of lecanemab treatment on tau[2] accumulation in whole brain regions, and outcomes of long-term efficacy of lecanemab. In addition, the differences in the binding properties of multiple anti-amyloid (Aβ) antibodies to various types of Aβ and other data will be presented.

Eisai will also sponsor a symposium featuring three prominent clinical experts in the field of Alzheimer’s disease, Dr. Jeffrey Cummings, Dr. Robert Perneczky and Dr. Miia Kivipelto. Dr. Jeffrey Cummings will chair the symposium, and provide an overview of meaningful benefits, including clinical meaningfulness and the evolution of approaches for the clinical study of Alzheimer’s disease. Dr. Robert Perneczky will discuss how to assess meaningful benefits of treatments in development for Alzheimer’s disease. Dr. Miia Kivipelto’s presentation will provide new statistical methods to measure meaningful benefits and address various stakeholder perspectives.

Furthermore, Eisai’s Chief Clinical Officer, Lynn Kramer, M.D., will give a plenary presentation titled “Novel approaches to clinical development and the future potential of simulated placebo” on March 7 at the “Aβ TARGETING THERAPIES IN AD 1” session.

Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Presentations by BioArctic and Eisai

Oral presentations

Asset in Development, Session, Time

Presentation Title

Lecanemab
Abeta Targeting Therapies in AD 01
Thursday, March 7, 13:50 – 14:05

Treatment with lecanemab disrupts tau accumulation across brain regions in early Alzheimer’s disease

Lecanemab
Abeta Targeting Therapies in AD 02
Saturday, March 9, 8:40 – 8:55

Binding characteristics of lecanemab, donanemab and other amyloid-beta antibodies to different forms of amyloid-beta in Alzheimer’s disease brains
Presented by BioArctic

Lecanemab
Abeta Targeting Therapies in AD 02
Saturday, March 9, 9:10 – 9:25

Lecanemab for the treatment of early Alzheimer’s disease: the extension of efficacy results from Clarity AD

Lecanemab
Abeta Targeting Therapies in AD 02
Saturday, March 9, 9:25-9:40

Structural dynamics of amyloid-β protofibrils and action of lecanemab as observed by high-speed atomic force microscopy

Lecanemab
Virtual Oral Presentation
VO028 / #2922

A neuro-dynamic quantitative systems pharmacology (QSP) model for Alzheimer’s disease incorporating amyloid and tau pathophysiology

Poster presentations

Asset in Development, Topic, Poster Number

Presentation Title

Lecanemab
P0213 / #1510
March 8 to 9

Characterization of amyloid-beta species in Alzheimer’s disease brain and the unique binding properties of lecanemab
Presented by BioArctic

General AD
P0110 / #562
March 8 to 9

Increased level of 12 KDA C-terminal ApoE fragments in AD brainPresented by BioArctic

General AD
P0111 / #943
March 8 to 9

Functional and morphological effects of 12 KDA C-terminal ApoE fragments in rat cortex culturesPresented by BioArctic

Eisai-Sponsored Symposium

Time

Title, Presenter

Thursday, March 7, 11:10 – 12:50

Defining meaningful benefits to patients, caregivers, and healthcare systems in Alzheimer’s diseaseJeffrey Cummings, Robert Perneczky, Miia Kivipelto,

Plenary presentation

Session, Time

Title

Abeta Targeting Therapies in AD 01
Thursday, March 7, 15:20 – 15:35

Novel approaches to clinical development and the future potential of simulated placebo

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

The information was released for public disclosure, through the agency of the contact persons below, on February 29, 2024, at 08.00 a.m. CET.

For further information, please contact:

Oskar Bosson, VP Communications and IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80

Jiang Millington, Director Corporate Communication and Social Media
E-mail: jiang.millington@bioarctic.se
Phone: +46 79 33 99 166

About lecanemab (generic name, U.S., Japan and China brand name: Leqembi®)

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., Leqembi was granted traditional approval by the US Food and Drug Administration (FDA) on July 6, 2023. Leqembi is indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the US. Treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Please see full U.S. Prescribing Information.

In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023, to manufacture and market lecanemab as a treatment for slowing progression of MCI and mild dementia due to AD. Furthermore, in China, Leqembi was approved by the National Medical Products Administration (NMPA) as a treatment of MCI due to AD and mild AD dementia in January 2024.

Eisai has also submitted applications for approval of lecanemab in 14 different countries, including EU, Canada and Great Britain.

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE) study. A maintenance dosing regimen has been evaluated as part of the Phase 2b study (Study 201).

Since July 2020 Eisai’s Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai.

Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer’s disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer’s disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world’s first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer’s disease. Leqembi has been developed together with BioArctic’s partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson’s disease and ALS as well as additional projects against Alzheimer’s disease. Several of the projects utilize the company’s proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic’s B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.se.

[1] Early Alzheimer’s disease includes mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease

[2] A protein that aggregates intracellularly in nerve cells in Alzheimer’s disease, disrupting both the function and survival of the cell. Tau levels can be measured in plasma, cerebrospinal fluid, and with a positron camera (PET).

The following files are available for download:

https://mb.cision.com/Main/9978/3937731/2636450.pdf

Latest data on lecanemab to be presented at the 2024 AD/PDâ„¢ congress

View original content:https://www.prnewswire.co.uk/news-releases/bioarctic-latest-data-on-lecanemab-to-be-presented-at-the-2024-adpd-congress-302075416.html

Technology

AIE Graduates create visual effects for Academy-nominated film

Published

55 mins ago

September 20, 2024

NAWI, a feature film whose visual effects were created by graduates from the Academy of Interactive Entertainment (AIE), has been officially nominated by Kenya for entry into the 97th Academy Awards in the category of Best International Feature Film. NAWI is a heartfelt story about a young girl’s journey towards empowerment and aims to shed light on a pressing issue that affects countless young women in the Turkana region of Kenya.

CANBERRA, Australia, Sept. 19, 2024 /PRNewswire-PRWeb/ — NAWI, a feature film whose visual effects were created by graduates from the Academy of Interactive Entertainment (AIE), has been officially nominated by Kenya for entry into the 97th Academy Awards in the category of Best International Feature Film. NAWI is a heartfelt story about a young girl’s journey towards empowerment and aims to shed light on a pressing issue that affects countless young women in the Turkana region of Kenya.

“The film has a very important social message to tell so it was rewarding in many ways to be able to contribute to this project. NAWI was a fantastic opportunity for our graduates to put their skills to the test on a full-length feature film,” said Tom Pugh.

AIE graduates and teachers were given the opportunity to work on the film’s visual effects through AIE’s ongoing partnership with Learning Lions, who produced the film with Film Crew & Baobab Pictures. AIE is proud to support Learning Lions non-profit mission to enable young adults in marginalised rural communities of East Africa to become digital creatives by providing game development training and technology.

The visual effects for NAWI were brought to life by AIE teachers and experienced industry professionals, Thomas Magill and Tom Pugh, who were tasked with supervising the visual effects and liaising with the film’s Directors, Apuu Mourine, Kevin Schmutzler, Tobias Schmutzler and Toby Schmutzler. They assembled a team of recent AIE graduates and worked out how to create the effects required to immerse audiences in Nawi’s world.

“Graduates were able to take the skills they had learnt in class and apply them to cinema-quality footage. There was even a bit of nervous excitement working with professional expectations and deadlines,” said Tom Pugh.

Thomas Magill explained that most of the work involved compositing such as fixing blemishes, removing unwanted folds in clothing, changing pages in a book and removing background actors that were in the wrong place.

“We had a river shot where there was only a sandbank, and we had to create an entire island! There were several shots filmed in a dry riverbed which required us to create floodwater. We had to draw upon various disciplines: not just digital compositing but also visual effects creation and fluid simulations,” said Thomas Magill.

Both teachers enthused that the directors were a pleasure to work with and the collaboration was smooth.

Learning Lions and AIE look forward to seeing NAWI progress through two rounds of voting by members of the Academy of Motion Picture Arts and Sciences to narrow the list of submitted films down to five nominees for the Best International Feature Film.

About Academy of Interactive Entertainment (AIE)

AIE offers practical, career-focused courses delivered by industry-experienced teachers in 3D animation, game development, visual effects and film. Since 2019 AIE has sponsored scholarships to their Certificate and Diploma programs to Learning Lions student. AIE provided laptops and is supporting with opportunities at various gaming companies around the world for paid part-time and full-time work.

https://aie.edu.au/

About Learning Lions

Learning Lions is fighting poverty with digital opportunity. Established in 2015, Learning Lions equips local youth with essential IT and media skills, and empowering them to become entrepreneurs and self-sustaining individuals. By leveraging digital services, these aspiring entrepreneurs not only support themselves but also provide opportunities for others through employment and mentorship.

https://www.learninglions.org/

Media Contact

Neil Boyd, Academy of Interactive Entertainment, 61 434273190, neilb@aie.edu.au, https://aie.edu.au/

Facebook, LinkedIn

View original content to download multimedia:https://www.prweb.com/releases/aie-graduates-create-visual-effects-for-academy-nominated-film-302252825.html

SOURCE Academy of Interactive Entertainment

Technology

Valhalla MSO Launches Impetus One to Enhance Valhalla Vitality’s Telehealth Platform

Published

55 mins ago

September 20, 2024

Valhalla MSO launches Impetus One, enabling healthcare providers to expand services, improve patient retention, and boost revenue with no upfront costs

MIAMI, Sept. 19, 2024 /PRNewswire-PRWeb/ — Valhalla MSO is excited to announce the launch of Impetus One (IO), a new software designed to power the Valhalla Vitality Network Provider Program. This initiative aims to expand the reach and capabilities of independent healthcare providers by offering an alternative to the traditional insurance model. With a focus on preventative medicine and wellness therapies, the platform is set to enhance patient care while creating new revenue opportunities for providers.

The Valhalla Vitality Network Provider Program addresses the gap created by insurance companies that often deny coverage for preventative medicine, wellness services, and even weight loss therapies. Insurance typically does not compensate healthcare providers for the time spent improving a patient’s overall health. Impetus One (IO) offers an alternative by providing a cash-pay marketplace where providers are fairly compensated for delivering impactful, life-changing services to their patients.

Key Benefits for Providers

Impetus One Software Integration: The platform integrates seamlessly with Valhalla Vitality, offering an e-commerce marketplace that connects patients with a wide range of health services. Providers can easily adopt the system to deliver therapies and other services, ensuring smooth payment processing and order fulfillment.No Upfront Costs: Providers can join the Network Provider Program without any initial fees. They simply share a unique link with patients, allowing for easy access to services, and payments are processed as orders are placed. Partner pharmacies handle medication shipments directly, creating a hassle-free experience for providers.Boosting Patient Retention: The platform includes a VIP Rewards Program, designed to increase patient retention and loyalty. Patients earn points for discounts and exclusive benefits, which encourages ongoing engagement and care continuity.E-commerce and Wellness Integration: Unlike typical affiliate programs, Valhalla Vitality allows providers to retain full control of their patient relationships. Providers can generate revenue through the integrated e-commerce system without worrying about referral fees or kickbacks, enabling them to focus solely on delivering high-quality patient care.

By joining the Valhalla Vitality Network Provider Program, healthcare providers gain access to a scalable model that helps increase profits, introduce new services, and enhance patient satisfaction. The VIP Rewards Program also strengthens the bond between patients and providers, making healthcare more accessible and rewarding for all.

Healthcare providers looking to grow their practices and increase revenue can join the Valhalla Vitality Network by visiting http://www.providevitality.com. Valhalla MSO’s new platform is a powerful tool for delivering advanced, patient-centric healthcare with a focus on accessibility and quality.

For more information, visit Valhalla Vitality at http://www.valhallavitality.com.

Media Contact

Chris K., Valhalla Vitality, 888-888-8888, ck@s99agency.com, https://valhallavitality.com/

View original content to download multimedia:https://www.prweb.com/releases/valhalla-mso-launches-impetus-one-to-enhance-valhalla-vitalitys-telehealth-platform-302253701.html

SOURCE Valhalla Vitality

Technology

Ultima Markets Wins Two Prestigious Awards at Global Forex Awards–Retail 2024!

Published

55 mins ago

September 20, 2024

LIMASSOL, Cyprus, Sept. 19, 2024 /CNW/ — Ultima Markets, a leading global forex and CFDs brokerage, is thrilled to announce its double success at the prestigious Global Forex Awards – Retail 2024. The company won two distinguished awards: “Best Affiliates Brokerage – Global” and “Best Fund Safety – Global.”

The awards were presented during the event in Limassol, Cyprus, where Jean Philippe, Board Advisor, Corporate Governance and Sustainability at Ultima Markets, accepted the honours.

The Global Forex Awards – Retail has celebrated excellence in trading innovation for seven consecutive years. Ultima Markets’ dual wins reflect its commitment to quality, client-centric strategies, and strong partnerships across the financial services sector.

The “Best Affiliates Brokerage—Global” award recognises Ultima Markets’ exemplary affiliate programme, which has successfully driven its global expansion. It is celebrated for its transparency and competitive rewards tailored to affiliate needs.

Receiving the “Best Fund Safety – Global” award highlights Ultima Markets’ efforts to safeguard client assets. Through its partnership with Willis Towers Watson, the company provides up to USD$1,000,000 in insurance per account, while its Financial Commission membership ensures clients access to up to €20,000 in compensation funds.

These recognitions underscore Ultima Markets’ priority to security and transparency, including segregated accounts and robust risk management practices. The broker also assures affiliate partners of exceptional standards.

Commenting on the awards, Jean Philippe said, “These recognitions reflect the exceptional work of our teams to ensure the safety of traders’ funds and our dedication to creating value for our partners and clients. We will continue to evolve and innovate to meet the market’s demands.”

Ultima Markets is renowned for its extensive range of trading products and personalised customer service, designed to meet clients’ diverse needs worldwide. The dual recognition marks a significant milestone in the company’s global growth and reaffirms its reputation for delivering fund safety and robust affiliate opportunities.

“We are delighted to be recognised with these awards, which reflect our mission to create a secure trading environment and build strong, rewarding partnerships,” said Jack Li, Ultima Markets’ Regional Business Director.

About Ultima Markets

Ultima Markets is a fully licensed, fast-growing broker offering access to 250+ financial instruments. With a team of 2,000+ professionals in 15 global offices, we serve clients in 172 countries. Check out more about our awards on Facebook, X, Instagram, LinkedIn and YouTube.