Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™
Denali Therapeutics (NASDAQ: DNLI) has announced multiple presentations at the upcoming 21st Annual WORLDSymposium™ in San Diego, February 3-7, 2025. The presentations will focus on their investigational therapeutic tividenofusp alfa (DNL310) for Hunter syndrome (MPS II), which utilizes their proprietary TransportVehicle™ platform technology.
Key presentations include an interim analysis of tividenofusp alfa's efficacy and safety, a targeted literature review on Hunter Syndrome treatment needs, and research on age-dependent reference intervals for various biomarkers. The company will also sponsor a satellite symposium titled 'Voices in Unison' featuring insights from medical experts and patient community perspectives.
The TransportVehicle™ platform is designed to deliver various therapeutic molecules across the blood-brain barrier to all body tissues, including the brain. All presentations are scheduled for February 6, 2025, with the symposium taking place on February 5.
Denali Therapeutics (NASDAQ: DNLI) ha annunciato diverse presentazioni al prossimo 21° Annual WORLDSymposium™ a San Diego, dal 3 al 7 febbraio 2025. Le presentazioni si concentreranno sul loro trattamento sperimentale tividenofusp alfa (DNL310) per la sindrome di Hunter (MPS II), che utilizza la loro tecnologia proprietaria TransportVehicle™.
Le presentazioni chiave includono un'analisi intermedia dell'efficacia e della sicurezza di tividenofusp alfa, una revisione mirata della letteratura sulle esigenze di trattamento della sindrome di Hunter e ricerche sugli intervalli di riferimento dipendenti dall'età per vari biomarcatori. L'azienda sponsorizzerà anche un simposio satellite intitolato 'Voci in Unisono' che presenterà approfondimenti da esperti medici e prospettive della comunità dei pazienti.
La piattaforma TransportVehicle™ è progettata per consegnare varie molecole terapeutiche attraverso la barriera emato-encefalica a tutti i tessuti del corpo, incluso il cervello. Tutte le presentazioni sono programmate per il 6 febbraio 2025, con il simposio che si terrà il 5 febbraio.
Denali Therapeutics (NASDAQ: DNLI) ha anunciado múltiples presentaciones en el próximo 21° Annual WORLDSymposium™ en San Diego, del 3 al 7 de febrero de 2025. Las presentaciones se centrarán en su terapia de investigación tividenofusp alfa (DNL310) para el síndrome de Hunter (MPS II), que utiliza su tecnología de plataforma patentada TransportVehicle™.
Las presentaciones clave incluyen un análisis interino de la eficacia y seguridad de tividenofusp alfa, una revisión selectiva de la literatura sobre las necesidades de tratamiento del síndrome de Hunter y una investigación sobre los intervalos de referencia dependientes de la edad para varios biomarcadores. La compañía también patrocinará un simposio satélite titulado 'Voces en Unísono', que contará con opiniones de expertos médicos y perspectivas de la comunidad de pacientes.
La plataforma TransportVehicle™ está diseñada para entregar varias moléculas terapéuticas a través de la barrera hematoencefálica a todos los tejidos del cuerpo, incluido el cerebro. Todas las presentaciones están programadas para el 6 de febrero de 2025, con el simposio que tendrá lugar el 5 de febrero.
데날리 테라퓨틱스 (NASDAQ: DNLI)가 2025년 2월 3일부터 7일까지 샌디에고에서 열리는 제21회 세계 심포지엄™에서 여러 발표를 할 것이라고 발표했습니다. 발표는 헌터 증후군 (MPS II)에 대한 실험적 치료제인 티비덴오프스프 알파 (DNL310)에 초점을 맞추며, 그들의 독자적인 TransportVehicle™ 플랫폼 기술을 이용합니다.
주요 발표에는 티비덴오프스프 알파의 효능 및 안전성에 대한 중간 분석, 헌터 증후군 치료 필요성에 대한 타겟 문헌 검토, 다양한 바이오 마커에 대한 연령 의존적 기준 범위에 대한 연구가 포함됩니다. 회사는 의학 전문가와 환자 공동체의 관점을 공유하는 '정화된 목소리'라는 제목의 위성 심포지엄도 후원합니다.
TransportVehicle™ 플랫폼은 다양한 치료 분자를 혈뇌 장벽을 넘어 모든 신체 조직, 특히 뇌로 전달하도록 설계되었습니다. 모든 발표는 2025년 2월 6일로 예정되어 있으며, 심포지엄은 2월 5일에 열릴 예정입니다.
Denali Therapeutics (NASDAQ: DNLI) a annoncé plusieurs présentations lors du 21ème Annual WORLDSymposium™ à San Diego, du 3 au 7 février 2025. Les présentations porteront sur leur traitement expérimental tividenofusp alfa (DNL310) pour le syndrome de Hunter (MPS II), qui utilise leur technologie de plateforme propriétaire TransportVehicle™.
Les présentations clés comprennent une analyse intermédiaire de l'efficacité et de la sécurité de tividenofusp alfa, une revue ciblée de la littérature sur les besoins de traitement du syndrome de Hunter et des recherches sur les intervalles de référence dépendants de l'âge pour divers biomarqueurs. L'entreprise parrainera également un symposium satellite intitulé 'Voix en Unisson', présentant des perspectives d'experts médicaux et de la communauté des patients.
La plateforme TransportVehicle™ est conçue pour délivrer diverses molécules thérapeutiques à travers la barrière hémato-encéphalique vers tous les tissus corporels, y compris le cerveau. Toutes les présentations sont prévues pour le 6 février 2025, avec le symposium qui se tiendra le 5 février.
Denali Therapeutics (NASDAQ: DNLI) hat mehrere Präsentationen beim bevorstehenden 21. Annual WORLDSymposium™ in San Diego vom 3. bis 7. Februar 2025 angekündigt. Die Präsentationen werden sich auf ihr experimentelles Therapeutikum tividenofusp alfa (DNL310) für das Hunter-Syndrom (MPS II) konzentrieren, das ihre proprietäre TransportVehicle™-Plattformtechnologie nutzt.
Wichtige Präsentationen umfassen eine Zwischenanalyse der Wirksamkeit und Sicherheit von tividenofusp alfa, eine gezielte Literaturübersicht zu den Behandlungsbedürfnissen des Hunter-Syndroms und Forschung zu altersabhängigen Referenzintervallen für verschiedene Biomarker. Das Unternehmen wird auch ein Satellitensymposium mit dem Titel 'Stimmen in Einheit' sponsern, das Erkenntnisse von medizinischen Experten und Perspektiven der Patienten Gemeinschaft umfasst.
Die TransportVehicle™-Plattform ist so konzipiert, dass sie verschiedene therapeutische Moleküle durch die Blut-Hirn-Schranke zu allen Körpergeweben, einschließlich des Gehirns, transportieren kann. Alle Präsentationen sind für den 6. Februar 2025 geplant, während das Symposium am 5. Februar stattfindet.
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SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which will be held February 3-7, 2025, in San Diego, California. The oral presentation includes clinical results related to its Hunter syndrome (MPS II) investigational therapeutic, tividenofusp alfa (DNL310). Tividenofusp alfa is enabled by the Denali TransportVehicle™ platform, which is designed to effectively deliver enzyme, oligonucleotide, or antibody therapeutics to all tissues in the body, including the brain by crossing the blood-brain barrier.
The presentation schedule at WORLDSymposium™ 2025 is as follows:
Title: Interim Analysis of Efficacy and Safety of Weekly Intravenous Tividenofusp Alfa in Mucopolysaccharidosis Type II (MPS II) – Platform Presentation
Session: Clinical Applications Platform Presentations
Date: Thursday, February 6, 2025
Session Time: 8:30 AM Pacific Time
Title: Unmet Needs in the Treatment and Care of Somatic Manifestations in People with Mucopolysaccharidosis Type II (Hunter Syndrome): A Targeted Literature Review – Poster #44
Session: Translational Research – Poster Session II
Date: Thursday, February 6, 2025
Session Time: 3:30 – 5:30 PM Pacific Time
Title: Age-Dependent Reference Intervals for Cerebrospinal Fluid (CSF) and Urine Heparan Sulfate (HS) and Dermatan Sulfate (DS) and CSF Gangliosides – Poster #132
Session: Clinical Applications – Poster Session III
Date: Thursday, February 6, 2025
Session Time: 3:30 – 5:30 PM Pacific Time
Denali is also sponsoring the following satellite symposium event at WORLDSymposium™ 2025:
Title: Voices in Unison – Insights into the Unmet Needs in MPS II from Patient Community and Physician Perspectives (Chair: Barbara K. Burton, M.D.; Speakers: Joseph Muenzer, M.D., Ph.D. and Kristin McKay, President and Executive Director of Project Alive)
Date: Wednesday, February 5, 2025
Time: 6:45 – 7:45 AM Pacific Time
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the blood-brain barrier and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements by Denali Therapeutics Inc. (“Denali” or the “Company”) regarding Denali’s planned presentations and events at the 2025 WORLDSymposium™ and expectations related to Denali's TransportVehicle™ (TV) platform. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Denali’s dependence on successful development of its BBB platform technology and TV-enabled product candidates; Denali’s ability to initiate and enroll patients in its current and future clinical trials; Denali’s ability to conduct or complete clinical trials on expected timelines; Denali’s reliance on third parties for the manufacture and supply of its product candidates for clinical trials; the potential for clinical trial results to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities, or other undesirable side effects; the risk that results from early clinical biomarker studies will not translate to clinical benefit in late clinical studies; the risk that product candidates may not receive regulatory approval necessary to be commercialized; developments relating to Denali’s competitors and its industry, including competing product candidates and therapies; Denali’s ability to obtain, maintain, or protect intellectual property rights; and other risks and uncertainties. In light of these risks, uncertainties, and assumptions, the forward-looking statements in this press release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Denali's product candidates are investigational, and their safety and efficacy profiles have not yet been established. No Denali product candidates have been approved by any health authority for any use. Information regarding additional risks and uncertainties may be found in Denali’s Annual and Quarterly Reports filed on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and November 6, 2024, respectively, and Denali’s future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali’s expectations, except as required by law.
Investor Contact
Laura Hansen, Ph.D.
Vice President, Investor Relations
(650) 452-2747
hansen@dnli.com
Media Contact
Rich Allan
FGS Global
(503) 851-0807
rich.allan@fgsglobal.com
FAQ
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