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

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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

 

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Nation’s Top 300 Teen Scientists Selected for Achievements in STEM Innovation and Leadership in Nation’s Oldest and Most Prestigious High School Competition

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Regeneron Science Talent Search Sees Record Number of Applicants; $1.2 Million to be Awarded to Nation’s Most Promising Young Scientists and Their Schools 

WASHINGTON, Jan. 8, 2025 /PRNewswire/ — Society for Science (the Society) today announced the top 300 scholars in the Regeneron Science Talent Search 2025, the nation’s oldest and most prestigious science and math competition for high school seniors. The 300 scholars will be awarded $2,000 each and their schools will be awarded $2,000 for each enrolled scholar.

The Regeneron Science Talent Search scholars were selected from nearly 2,500 entrants from 795 high schools across 48 states, American Samoa, Guam, Washington, D.C., Puerto Rico and 14 other countries. US citizens living abroad are eligible to apply.

Scholars were chosen based on their outstanding research, leadership skills, community involvement, commitment to academics, creativity in asking scientific questions and exceptional promise as STEM leaders demonstrated through the submission of their original, independent research projects, essays and recommendations. The 300 scholars hail from 200 American and international high schools in 33 states, Washington D.C., China, Hong Kong, Malaysia, and Switzerland.

The full list of scholars can be viewed here: https://www.societyforscience.org/regeneron-sts/2025-scholars/ 

“Congratulations to the 300 scholars in this year’s Regeneron Science Talent Search,” said Maya Ajmera, President and CEO, Society for Science and Executive Publisher, Science News.  “With a record-breaking number of applications, these exceptional young scientists and engineers represent the best in the nation. We are thrilled to celebrate their ingenuity, hard work, and passion for STEM.”

The Regeneron Science Talent Search recognizes and empowers our nation’s most promising young scientists who are generating innovative solutions to solve significant global challenges through rigorous research and discoveries. The competition provides students with a national stage to present new ideas and challenge conventional ways of thinking.

Now in its 103rd year, Society for Science has played a significant role in educating the public about scientific discoveries as well as in identifying future leaders in science, technology, engineering and math. Regeneron has sponsored the Science Talent Search since 2017 as part of its deep commitment to STEM education and to supporting young scientists.

This year, research projects cover topics from Medicine and Health to Computer Science and more. Other students chose to focus on Social Science. With a total of 20 research categories, the top 5 categories among scholars’ projects this year include:  Medicine and Health (12%); Environmental Science (8%); Cellular and Molecular Biology (8%); Computational Biology and Bioinformatics (8%) and Engineering (7%).

“Congratulations to the Regeneron Science Talent Search top 300 scholars, who demonstrate the extraordinary potential of nurtured STEM talent,” said Christina Chan, Senior Vice President of Corporate Affairs at Regeneron. “Our long-standing partnership with Society for Science is a cornerstone of our commitment to elevate these future scientific leaders, and we look forward to seeing how their discoveries will tackle global challenges and help improve our world.”

On January 23, 40 of the 300 scholars will be named Regeneron Science Talent Search finalists. The finalists will then compete for more than $1.8 million in awards during a week-long competition in Washington, D.C., taking place March 6-12, 2025.

For over eight decades, the Science Talent Search has rewarded talented high school seniors who dedicate countless hours to original research projects and present their results in rigorous reports that resemble graduate school theses. Collectively, STS alumni have received millions of dollars in scholarships and gone on to found world-changing companies, publish groundbreaking research, and win Nobel Prizes, Fields Medals, MacArthur Fellowships and numerous other accolades.

Important Dates for 2024:

Top 40 Finalists Announced: January 23, 2025Regeneron STS Finals Week: March 6-12, 2025Public Exhibition of Projects: March 9, 2025Winners Announced at Awards Ceremony: March 11, 2025

Resources:

Regeneron STS Top 300 Scholar ListNotable STS AlumniSTS 2024 Highlights Video

About the Regeneron Science Talent Search
The Regeneron Science Talent Search, a program of Society for Science since 1942, is the nation’s oldest and most prestigious science and math competition for high school seniors. Each year, more than 2,000 student entrants submit original research in critically important scientific fields of study and are judged by leading experts in their fields. Unique among high school competitions in the U.S. and around the world, the Regeneron Science Talent Search focuses on identifying, inspiring and engaging the nation’s most promising young scientists who are creating the ideas that could solve society’s most urgent challenges.

In 2017, Regeneron became only the third sponsor of the Science Talent Search, making a 10-year, $100 million commitment to help reward, celebrate and encourage the best and brightest young scientific minds. Regeneron’s investment nearly doubled the overall award distribution to $3.1 million annually, increasing the top award to $250,000 and doubling the awards for the top 300 scholars to $2,000 and their schools to $2,000 for each enrolled scholar to inspire more young people to engage in science.

Learn more at https://www.societyforscience.org/regeneron-sts/

About Society for Science
Society for Science is a champion for science, dedicated to promoting the understanding and appreciation of science and the vital role it plays in human advancement. Established in 1921, Society for Science is best known for its award-winning journalism through Science News and Science News Explores, its world-class science research competitions for students, including the Regeneron Science Talent Search, the Regeneron International Science and Engineering Fair and the Thermo Fisher Scientific Junior Innovators Challenge and its outreach and equity programming that seeks to ensure that all students have an opportunity to pursue a career in STEM. A 501(c)(3) membership organization, Society for Science is committed to inform, educate and inspire. Learn more at www.societyforscience.org and follow us on FacebookTwitter,  Instagram and LinkedIn.

Media Contact
Gayle Kansagor, Society for Science 
703-489-1131, gkansagor@societyforscience.org

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SOURCE Society for Science

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Net Health Acquires Alinea Engage to Further Optimize Patient Engagement and Outcomes in Rehab Therapy

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Investment will advance Net Health’s mission to provide patient-centric care by streamlining administrative processes for rehab therapy

PITTSBURGH, Jan. 8, 2025 /PRNewswire/ — Net Health, a trusted source for specialized software solutions that empower restorative care providers across the continuum of care, today announced that it has acquired Alinea Engage (Alinea). Alinea provides web-based, enterprise level automation and patient engagement software for private and senior rehabilitation therapy providers. As part of Net Health, Alinea will help clients deliver exceptional care through patient engagement and increase revenue by improving reimbursement efficiency through revenue cycle automation and the reduction of claims denials.

“I’m excited to welcome the Alinea team, and clients, to the Net Health family,” said Ron Books, CEO of Net Health. “Over the years we have built lasting relationships with Alinea, and it became apparent that we share a common mission and a set of core values. Foremost among those values is a mandate to put clients at the heart of everything we do, by providing high-value technology that enables them to deliver better outcomes. By acquiring Alinea, we are reinforcing that commitment and strengthening our organizational portfolio to ultimately offer best-in-class, specialized solutions for all.”

Net Health’s clients will now have access to Alinea’s current features, including patient onboarding automation; patient and family engagement; and workflow automation for prior authorization and direct bill processes. Additionally, Net Health is committed to ensuring the Alinea team has the resources it needs to continue to help their clients grow. That includes investing in future generations of products, an aligned roadmap to help clients address market needs, and a robust client experience and support infrastructure.

Alinea clients will continue to benefit from the solutions they know and the expertise of the team they trust. Led by CEO and founder Carol Vance, the Alinea team will operate with the same independence that has contributed to their success. “We are thrilled to become part of the Net Health family, and excited about the opportunity to continue our work with greater investment, powerful product alignment with Net Health, and the infrastructure needed to strengthen our client partnerships.”

To learn more about Net Health and how its technology offerings are helping to improve outcomes for restorative care providers, visit http://nethealth.com. To learn more about Alinea Engage, visit https://alineawellness.com/.

About Net Health  
Net Health is a trusted source for more than 25,000 healthcare organizations across the continuum of care. Our specialized software solutions enable restorative care providers and their organizations to improve both patient outcomes and financial performance. Over 30 years of expertise in wound care and rehab therapy inform our electronic health record (EHR) software, patient engagement tools, and predictive analytics. Our technology platforms help administrators manage workflow, specialists engage with patients, and executives drive business growth. Net Health is a portfolio company of The Carlyle Group, Level Equity, and Silversmith Capital Partners. Learn more at www.nethealth.com.

About Alinea Engage
Alinea is a web-based platform that streamlines and automates workflows to help rehabilitation providers drive productive, profitable, person-centric care. Alinea reduces the administrative burden on clinicians, increases the capacity of revenue cycle and compliance teams, and effectively engages patients, responsible parties, and families. Exclusively integrated with Net Health, Alinea is on a mission to optimize care and connection for senior adults in Senior Living Communities, Skilled Nursing Facilities, and Private Homes by giving the rehabilitation providers that serve them the edge they need to deliver the best care possible. For more information, visit alineawellness.com.

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SOURCE Net Health Systems, Inc.

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Cengage Group Earns Equality 100 Award in Human Rights Campaign Foundation’s 2025 Corporate Equality Index

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Cengage Group has been recognized for the fifth consecutive year as a leader in LGBTQ+ workplace inclusion

BOSTON, Jan. 8, 2025 /PRNewswire/ — Cengage Group, a global edtech company, today announced its score of 100 on the Human Rights Campaign Foundation’s (HRCF) 2025 Corporate Equality Index (CEI). The CEI is the nation’s foremost benchmarking survey and report measuring corporate policies and practices related to LGBTQ+ workplace equality. This year’s CEI includes 1,449 businesses –the highest number of companies rated since the start of the CEI in 2002.

This marks the fifth consecutive year Cengage Group has been included in the CEI, and the third year it earned a score of 100. Notably, this score reflects the company’s swift efforts to meet new LBGTQ+ benefits guidelines introduced by HRCF in 2023. The company launched a comprehensive guide for employees in early 2024, which helped return its score to 100.

“Once again, we are incredibly proud to receive recognition from the HRC, as it reaffirms our unwavering commitment to inclusion and belonging,” said Jeri Herman, Chief People Officer of Cengage Group. “At Cengage Group, we foster a culture that values transparency, collaboration and the authentic expression of our diverse workforce. We know that a more diverse workforce is not just the right thing to do, it helps drive business success; this is why we remain committed to attracting and retaining talent with a range of backgrounds and experiences.”

Herman continued, “We are able to advance these efforts through various initiatives that prioritize listening, learning and allyship. Additionally, our employee resource groups (ERGs) play a vital role in developing programming that builds community and understanding across the organization.”

Along with 1,449 U.S. businesses, including Fortune magazine’s 500 largest publicly traded businesses, Cengage Group was rated against performance criteria falling under four central pillars:

Non-discrimination policies across business entities;Equitable benefits for LGBTQ+ workers and their families;Supporting an inclusive culture; and,Corporate social responsibility.

“The CEI is so much more than a score on paper. For decades businesses have relied on the CEI as a tool for transparency and leveling the playing field for all workers, making sure LGBTQ+ people and their families can share in fair, respectful and supportive workplaces and benefits,” said RaShawn “Shawnie” Hawkins, SHRM-CP, HRCF Senior Director of Workplace Equality. “Our goal at the Human Rights Campaign Foundation is to work in a spirit of partnership with companies, providing educational resources and leading benchmarking. The work of the CEI is to help businesses to expand their consumer base and attract top, innovative talent by supporting the LGBTQ+ community.”

To learn more about CEI and Cengage Group’s recognition, view the full report at: http://www.hrc.org/cei.

About Cengage Group

With more than 100 years of serving learners, Cengage Group is a global edtech company that enables student choice. No matter how, where, when or why someone wants to learn, our portfolio of education businesses supports all students, from middle school through graduate school and skills education, with quality content and technology. Collectively, our three business units – Cengage Academic, Cengage Work, and Cengage Select – help millions of students each year in more than 125 countries achieve their education and career goals and lead choice-filled lives. Visit us at www.cengagegroup.com or find us on LinkedIn and Twitter.

About the Human Rights Campaign Foundation

The Human Rights Campaign Foundation is the educational arm of the Human Rights Campaign (HRC), America’s largest civil rights organization working to achieve equality for lesbian, gay, bisexual, transgender and queer (LGBTQ+) people. Through its programs, the HRC Foundation seeks to make transformational change in the everyday lives of LGBTQ+ people, shedding light on inequity and deepening the public’s understanding of LGBTQ+ issues, with a clear focus on advancing transgender and racial justice. Its work has transformed the landscape for more than 15 million workers, 11 million students, 1 million clients in the adoption and foster care system and so much more. The HRC Foundation provides direct consultation and technical assistance to institutions and communities, driving the advancement of inclusive policies and practices; it builds the capacity of future leaders and allies through fellowship and training programs; and, with the firm belief that we are stronger working together, it forges partnerships with advocates in the U.S. and around the globe to increase our impact and shape the future of our work.

Media Contact:
Emily Featherston, Vice President, Corporate Communications, External
Emily.featherston@cengage.com

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SOURCE Cengage Group

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