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Lifetime Achievement Award, lecanemab and biomarkers in focus at CTAD

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BioArctic AB announced that its founder, Lars Lannfelt, will receive the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the CTAD Conference in Madrid from October 29 to November 1. The conference will feature presentations on lecanemab, including data on its clinical practice use and plasma biomarkers in the AHEAD 3-45 trial. Key sessions include three symposia focusing on lecanemab's continued treatment importance, real-world evidence from the U.S. and Japan, and combination therapy considerations. Two oral presentations will discuss lecanemab's treatment efficacy and AI-derived prognostic covariates, along with a poster presentation on transitioning from clinical trials to practice.

BioArctic AB ha annunciato che il suo fondatore, Lars Lannfelt, riceverà il Lifetime Achievement Award nella Ricerca Terapeutica per l'Alzheimer durante la Conferenza CTAD a Madrid, dal 29 ottobre al 1 novembre. La conferenza includerà presentazioni su lecanemab, comprensive di dati sul suo utilizzo nella pratica clinica e sui biomarcatori plasmatici nello studio AHEAD 3-45. Le sessioni principali comprenderanno tre simposi che si concentrano sull'importanza del trattamento continuato con lecanemab, sulle evidenze del mondo reale dagli Stati Uniti e dal Giappone, e sulle considerazioni riguardanti la terapia combinata. Due presentazioni orali discuteranno l'efficacia del trattamento con lecanemab e i covariati prognostici ottenuti tramite AI, insieme a una presentazione poster sul passaggio dalle sperimentazioni cliniche alla pratica.

BioArctic AB anunció que su fundador, Lars Lannfelt, recibirá el Lifetime Achievement Award en Investigación Terapéutica sobre la Enfermedad de Alzheimer en la Conferencia CTAD en Madrid, del 29 de octubre al 1 de noviembre. La conferencia contará con presentaciones sobre lecanemab, incluyendo datos sobre su uso en la práctica clínica y biomarcadores plasmáticos en el ensayo AHEAD 3-45. Las sesiones clave incluirán tres simposios centrados en la importancia del tratamiento continuo con lecanemab, evidencia del mundo real desde EE. UU. y Japón, y consideraciones sobre terapia combinada. Dos presentaciones orales discutirán la eficacia del tratamiento con lecanemab y los covariables pronósticos derivados de IA, junto con una presentación poster sobre la transición de ensayos clínicos a la práctica.

BioArctic AB는 그 창립자인 Lars Lannfelt가 10월 29일부터 11월 1일까지 마드리드에서 열리는 CTAD 회의에서 알츠하이머 병 치료 연구에서의 평생 공로상을 수상할 것이라고 발표했습니다. 이 회의에서는 lecanemab에 대한 발표가 포함되며, 임상 실습에서의 사용 및 AHEAD 3-45 시험에서의 혈장 바이오마커에 대한 데이터가 다루어질 것입니다. 주요 세션에는 lecanemab의 지속적인 치료 중요성, 미국과 일본의 실제 증거, 그리고 병용요법에 대한 고려를 중심으로 한 세 개의 심포지엄이 포함됩니다. 두 개의 구두 발표에서는 lecanemab의 치료 효능과 AI 기반의 예후 공변량에 대해 논의하며, 임상 시험에서 실제로의 전환에 대한 포스터 발표도 포함됩니다.

BioArctic AB a annoncé que son fondateur, Lars Lannfelt, recevra le Lifetime Achievement Award en Recherche Thérapeutique sur la Maladie d'Alzheimer lors de la Conférence CTAD à Madrid, du 29 octobre au 1 novembre. La conférence comportera des présentations sur lecanemab, y compris des données sur son utilisation en pratique clinique et des biomarqueurs plasmatiques dans l'essai AHEAD 3-45. Les sessions clés comprendront trois symposiums se concentrant sur l'importance du traitement continu avec lecanemab, des preuves du monde réel provenant des États-Unis et du Japon, ainsi que des considérations sur les thérapies combinées. Deux présentations orales aborderont l'efficacité du traitement avec lecanemab et les covariables pronostiques dérivés de l'IA, accompagnées d'une présentation poster sur la transition des essais cliniques à la pratique.

BioArctic AB hat angekündigt, dass sein Gründer, Lars Lannfelt, den Lifetime Achievement Award in der therapeutischen Forschung zur Alzheimer-Krankheit auf der CTAD-Konferenz in Madrid vom 29. Oktober bis 1. November erhalten wird. Die Konferenz wird Präsentationen über lecanemab beinhalten, einschließlich Daten zur klinischen Anwendung und Plasma-Biomarkern in der AHEAD 3-45-Studie. Zu den wichtigsten Sitzungen gehören drei Symposien, die sich auf die anhaltende Behandlungsrelevanz von lecanemab, realistische Beweise aus den USA und Japan sowie Überlegungen zur Kombinationsbehandlung konzentrieren. Zwei mündliche Präsentationen werden die Wirksamkeit der Behandlung mit lecanemab und AI-abgeleitete prognostische Kovariaten diskutieren, sowie eine Posterpräsentation über den Übergang von klinischen Studien in die Praxis.

Positive
  • Recognition of company founder with prestigious Lifetime Achievement Award strengthens scientific credibility
  • Multiple presentations and symposia featuring lecanemab data indicate strong clinical development progress
  • Real-world evidence from U.S. and Japan markets demonstrates commercial implementation
Negative
  • None.

STOCKHOLM, Oct. 24, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) founder Lars Lannfelt will be presented with the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the Clinical Trials for Alzheimer's Disease Conference (CTAD) held in Madrid, Spain, and virtually from October 29 to November 1. Lars Lannfelt will be one of the keynote speakers at the conference. In addition, BioArctic's partner Eisai present lecanemab data in two oral and one poster presentation at the meeting and three symposia will focus on lecanemab. Data shared will include the importance of continued treatment of Alzheimer's disease, a progressive neurodegenerative disease that begins before plaque deposition and continues after plaque removal.

At CTAD 2024, Eisai will present the latest information on the use of lecanemab in clinical practice and the use of plasma biomarkers in the AHEAD 3-45 trial to screen for preclinical Alzheimer's disease. The full list of presentations related to lecanemab can be found below.

CTAD Lifetime Achievement Award October 29, 4:20 p.m. to 4:55 p.m. (CET)

  • CTAD Lifetime Achievement Award Alzheimer's Disease Therapeutic Research
  • KEYNOTE 1: Professor Lars Lannfelt. Lecanemab: from a mutation to a treatment for Alzheimer's disease

Late Breaking Symposium 1 – The AHEAD 3-45 Study: Design and Results of a Novel Screening Process for a Preclinical AD Trial
From 6:10 to 6:50 p.m. (CET) on October 29 (Tuesday). This late breaking symposium will present the design of the AHEAD 3-45 trial focused on lecanemab in pre-clinical Alzheimer's disease and the findings on use of plasma biomarkers, amyloid and tau PET imaging in screening.

Late Breaking Symposium 2 – One-Year Experience on the Use of Lecanemab in Clinical Practice
From 3:30 to 4:10 pm (CET), on October 30 (Wednesday). This symposium will discuss real-world evidence from clinical practice with lecanemab in the U.S. and Japan.

Symposium 1 – Does the Current Evidence Base Support Continued Dosing with Lecanemab for Early Alzheimer's Disease?
From 9:40 to 10:20 p.m. (CET) on October 30 (Wednesday). This symposium is an update of Perspectives sessions conducted at AAIC 2024.

Roundtable – Advancing Combination Therapy: Discussion on Key Considerations, Perspectives, and Promising Avenues for the Future of Alzheimer's Treatments
From 1:45 to 2:15 p.m. (CET) on October 30 (Wednesday)

Oral Presentations

Asset/Project, Presentation Time (CET)

Presentation Number, Title



Lecanemab


Oct 30 (Wed) 11:20 – 11:35 a.m. 

LB6Lecanemab for the Treatment of Mild Cognitive Impairment and Mild Dementia Due to Alzheimer's Disease in Adults That Are Apoliprotein E ɛ4 Heterozygotes or Non-Carriers



Lecanemab


Oct 30 (Wed) 3:35 – 3:50 p.m. 

LB18AI-Derived Prognostic Covariates Enhance the Precision of Lecanemab Efficacy Assessments and Optimize Alzheimer's Disease Clinical Trials

Poster Presentations

Asset/Project 

Presentation Number, Title

Lecanemab


Oct 29 (Tue) – Oct 30 (Wed)

LP017Transitioning from Clinical Trial to Clinical Practice for Long-Term Lecanemab Treatment in Early Alzheimer's Disease: Perspectives from an Alzheimer's Disease Treatment Center

 

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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 an investigational agent will successfully complete clinical development or gain health authority approval.

The information was released for public disclosure, through the agency of the contact person below, on October 24, 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 

About lecanemab (Leqembi®)

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Lecanemab marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union.

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.com.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/bioarctic/r/lifetime-achievement-award--lecanemab-and-biomarkers-in-focus-at-ctad,c4055757

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Lifetime Achievement Award, lecanemab and biomarkers in focus at CTAD

 

Cision View original content:https://www.prnewswire.com/news-releases/lifetime-achievement-award-lecanemab-and-biomarkers-in-focus-at-ctad-302285556.html

SOURCE BioArctic

FAQ

What award will BioArctic's (BIOA B) founder receive at CTAD 2024?

Lars Lannfelt will receive the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the CTAD Conference in Madrid.

What are the main lecanemab presentations at CTAD 2024?

The conference features two oral presentations on lecanemab's treatment efficacy and AI-derived prognostics, one poster presentation on clinical practice transition, and three symposia focusing on continued treatment, real-world evidence, and combination therapy.

When and where will the CTAD 2024 conference take place?

The CTAD Conference will be held in Madrid, Spain, and virtually from October 29 to November 1, 2024.

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