AL003 / Alector - LARVOL DELTA

A Phase 1 Study of AL003 in Healthy Volunteers and Participants with Alzheimer’s disease (AAN 2022) - "AL003 was generally safe and well tolerated and the Phase 1 HV data demonstrated target engagement in peripheral and central nervous system compartments up to 60 mg/kg. AL003 is being considered for investigation in a proof-of-concept Phase 2 study."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Infectious Disease • Pain • Respiratory Diseases

Alector Presents New Data from Multiple Pipeline Programs at 2021 CTAD Conference (Yahoo Finance) - P1, N=54; INTERCEPT (NCT03822208); P1, N=53; NCT04111666; Sponsor: Alector Inc.; “Alector, Inc…shared data from its AL003 and AL101 programs in poster presentations…AL003 showed a favorable safety and pharmacokinetic profile for once-monthly intravenous dosing. AL003 demonstrated target engagement of CD33 in both blood and central nervous system (CNS) compartments at well tolerated doses…Phase 2 trial evaluating AL003 for the treatment of early Alzheimer’s disease is being planned for the second half of 2022….AL101 was found to be generally safe and well tolerated. The majority of on-study adverse events (AEs) were considered mild to moderate in severity, with the most frequent AEs being headache, anemia and procedural pain….Data for AL003 and AL101, as well as a trial design poster for the Phase 3 INFRONT-3 clinical trial of AL001, are being presented at CTAD in poster presentations.”

Clinical protocol • New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration

Alector to Present New Data from Multiple Pipeline Programs at 2021 CTAD Conference and SITC Annual Meeting (GlobeNewswire) - “Alector, Inc…announced presentations at the 14th Clinical Trials on Alzheimer's Disease (CTAD) conference being held November 9-12, 2021 virtually and in Boston, and the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting held November 12-14, 2021 virtually and in Washington, D.C. Among the data being presented at CTAD are twelve-month biomarker and clinical data from the open-label Phase 2 INFRONT-2 study evaluating AL001 in individuals with frontotemporal dementia due to progranulin gene mutation (FTD-GRN). Alector will also present data from its Phase 1 study of AL003 in healthy volunteers and participants with Alzheimer’s disease. AL003 is being developed in collaboration with its partner, AbbVie.”

P1 data • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

A Phase 1 Study of AL003 in Healthy Volunteers and Participants with Alzheimer’s disease (CTAD 2021) - "To date AL003 has been seen to be generally safe and well tolerated and the Phase 1 HV data demonstrated target engagement in both peripheral and central nervous system compartments up to 60 mg/kg. AL003 is being considered for investigation in a proof-of-concept Phase 2 study."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Immunology • Infectious Disease • Pain • Respiratory Diseases • Amyloid PET

First in Human Study for Safety and Tolerability of AL003. (clinicaltrials.gov) - P1; N=54; Completed; Sponsor: Alector Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Alzheimer's Disease • CNS Disorders

Alector Reports 2020 Fourth Quarter and Full Year Financial Results and Provides Business Update (GlobeNewswire) - "Alector plans to present updated data from the ongoing Phase 2 open-label study evaluating AL001, in 2021. The Company plans to present additional data in pre-symptomatic and symptomatic FTD-GRN participants at medical conferences in 2021....Phase 1a study evaluating AL101...The Company anticipates reporting preliminary findings from the Phase 1a study in 2021....Data from the Phase 1b study evaluating AL003 in participants with Alzheimer’s disease is expected in 2021....Preliminary results from the study are expected to be presented at a scientific medical meeting in 2021."

P1 data • P2 data • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration

Alector Reports Third Quarter 2020 Financial Results and Provides Corporate Update - "Global Phase 3 INFRONT-3 trial evaluating AL001 for treatment of frontotemporal dementia due to a progranulin gene mutation (FTD-GRN) currently enrolling participants...Alector plans to present additional data from the Phase 2 trial of AL001 in pre-symptomatic and symptomatic FTD-GRN participants and an additional cohort of FTD-C9orf72 patients in 2021....Company expects to initiate a Phase 2 trial evaluating AL002 in patients with Alzheimer’s disease in 2020....A Phase 1b trial of AL003 in Alzheimer’s disease, also being developed in collaboration with AbbVie, continues to progress, with data expected in 2021."

Enrollment status • New P2 trial • P2 data • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Frontotemporal Lobar Degeneration

First in Human Study for Safety and Tolerability of AL003. (clinicaltrials.gov) - P1; N=54; Active, not recruiting; Sponsor: Alector Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Alzheimer's Disease • CNS Disorders

Alector Provides 2021 Corporate Portfolio Update (GlobeNewswire) - "AL101 Phase 1a data in healthy volunteers expected 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)....INVOKE-2, Phase 2 trial evaluating AL002 in participants with early Alzheimer’s disease has initiated patient screening....Phase 1b study evaluating AL003 in participants with Alzheimer’s disease to report data in 2021: The AL003 clinical development program...has completed enrollment of AD patients in the Phase 1b study...Planning for first-in-human study for ADP014...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..."

Enrollment closed • New P1 trial • P1 data • Trial status • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

First in Human Study for Safety and Tolerability of AL003. (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Alector Inc.; Trial completion date: Feb 2021 ➔ Aug 2021; Trial primary completion date: Dec 2020 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

First in Human Study for Safety and Tolerability of AL003. (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Alector Inc.; Trial completion date: Jul 2020 ➔ Feb 2021; Trial primary completion date: Apr 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Alector Reports 2020 First Quarter Financial Results and Business Highlights (GlobeNewswire, Alector LLC) - "Initial Phase 1a data of AL101 in healthy volunteers are also expected during in 2020. Alzheimer’s Disease Portfolio:...Following the completion of the Phase 1a study with AL002...Alector has closed enrollment for the Phase 1b study of AL002 and will proceed with initiating a Phase 2 trial in Alzheimer’s disease patients in 2020; The Company continues to advance the Phase 1b trial of AL003 in Alzheimer’s disease."

Enrollment closed • New P1 trial • New P2 trial • Trial status • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration

A Path Toward Precision Medicine for Neuroinflammatory Mechanisms in Alzheimer's Disease. (PubMed, Front Immunol) - "Robust biomarker-drug codevelopment pipelines are expected to enrich large-scale clinical trials testing new-generation compounds active, directly or indirectly, on neuroinflammatory targets and displaying putative disease-modifying effects: novel NSAIDs, AL002 (anti-TREM2 antibody), anti-Aβ protofibrils (BAN2401), and AL003 (anti-CD33 antibody). As a next step, taking advantage of breakthrough and multimodal techniques coupled with a systems biology approach is the path to pursue for developing individualized therapeutic strategies targeting neuroinflammation under the framework of precision medicine."

Journal • Review • Alzheimer's Disease • CNS Disorders • Immunology • Oncology • Solid Tumor • Tauopathies And Synucleinopathies • CHI3L1 • IL6

[VIRTUAL] A PHASE 1 STUDY OF AL003, AN ANTI-SIGLEC 3 ANTIBODY, IN HEALTHY VOLUNTEERS AND PATIENTS WITH MILD-TO-MODERATE ALZHEIMER’S DISEASE (AAT-ADPD 2020) - "Conclusions To date, AL003 appears to have an acceptable safety profile and to engage the target receptor. It is being considered for investigation in a proof-of-concept Phase 2 study."

Clinical • P1 data • Amyloid PET

Alector Announces Initiation of Phase 1b Study of AL003 in Alzheimer’s Disease Patients (GlobeNewswire, Alector LLC) - "Alector, Inc....today announced the dosing of the first Alzheimer’s disease patient in the Phase 1b portion of the INTERCEPT clinical study of AL003....The Phase 1b portion of the INTERCEPT clinical study will assess the safety of multiple doses of AL003 in approximately 12 patients with mild to moderate Alzheimer’s disease."

Trial status

Alector showcases progress in immuno-neurology clinical programs and research portfolio at R&D day (GlobeNewswire) - "In the 38-healthy-volunteer Phase 1 study initiated earlier this year, single dose AL003 demonstrated dose dependent and long-lasting change in SIGLEC 3 in the blood, indicating target engagement....The Company is progressing the Phase 1b portion of the study in Alzheimer’s disease patients and is planning to announce proof-of-mechanism data in 2020."

P1 data • Trial status

Alector Reports Recent Business Highlights and Second Quarter 2019 Financial Results (GlobeNewswire, Alector, LLC) - - Completed planned enrollment of AL001 Phase 1b trial and demonstrated proof-of-mechanism in Frontotemporal Dementia patients. - AL101 granted Orphan Drug Designation from U.S. FDA. “We are very encouraged by the recent data from our AL001 program in patients suffering from frontotemporal dementia. In addition, with the continued progress of our AL002 and AL003 programs targeting Alzheimer’s disease and our fourth program, AL101, moving towards the clinic, we believe we have the opportunity to transform treatment for patients suffering from these devastating diseases.”.

Clinical • Enrollment status • Regulatory

First in Human Study for Safety and Tolerability of AL003. (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: Alector Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open