199 0 Kommentare Alector Provides 2021 Corporate Portfolio Update - Seite 2

AL001 to be evaluated in patients with amyotrophic lateral sclerosis (ALS) caused by C9orf72 repeats, which share TDP-43 pathology with FTD-GRN. Alector plans to initiate a Phase 2 study in ALS-C9orf72 patients in 2021.

AL101 Phase 1a data in healthy volunteers expected in 2021. The Company anticipates reporting final findings from its Phase 1a trial of AL101 in healthy volunteers in 2021. Alector is evaluating the possibility of a subcutaneous administration of AL101 in neurological diseases, including Parkinson’s disease with specific genetic mutations and Alzheimer’s disease (AD).

Alzheimer’s Disease Portfolio:

INVOKE-2, Phase 2 trial evaluating AL002 in participants with early Alzheimer’s disease has initiated patient screening. In collaboration with its partner AbbVie, Alector initiated a Phase 2 trial evaluating AL002 in patients with early AD. The randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 study will enroll approximately 265 participants with early AD at up to 90 sites globally. The primary endpoint of the Phase 2 study will measure disease progression utilizing the Clinical Dementia Rating Sum of Boxes (CDR-SB). The study will also measure multiple fluid and imaging biomarkers, and assess several secondary clinical, pharmacokinetic and pharmacodynamic endpoints, as well as safety.
Phase 1b study evaluating AL003 in participants with Alzheimer’s disease to report data in 2021. The AL003 clinical development program, also being developed in collaboration with AbbVie, has completed enrollment of AD patients in the Phase 1b study and continues to progress with preliminary data expected to be presented at a scientific medical meeting in 2021.
Planning for first-in-human study for ADP014, product candidate targeting the MS4A4A receptor is underway. In the next 18 months, Alector plans to initiate Phase 1 development for its latest prioritized product candidate that targets MS4A4A, a major risk gene for AD that encodes a transmembrane receptor protein that is expressed selectively in microglia in the brain and is associated with control of microglia functionality and potential viability.

Immuno-oncology Portfolio:

In collaboration with Innovent Biologics, planning for the first-in-human study for AL008 is underway. In the next 18 months, AL008, a novel, investigational, antibody product candidate with a dual mechanism of action that combines inhibition of the CD47-SIRP-alpha (SIRPα) pathway, with stimulation of activating Fc receptors to yield a potential best-in-class product will enter into clinical development. AL008 is being developed in collaboration with Innovent Biologics in China, with Alector retaining global rights outside of China.

Planning for the first-in-human study of ADP009, the company’s latest prioritized investigational product candidate. In the next 18 months, Alector plans to initiate the clinical development of ADP009, a first-in-class multi-Siglec inhibitor that works to enhance the innate and adaptive immune system response by blocking a critical glycan checkpoint pathway that drives immune inhibition. This product candidate is initially being developed for oncology indications and may also have potential therapeutic application in certain neurodegenerative disorders, such as AD.