latozinemab (GSK4527223) / Alector, GSK - LARVOL DELTA

Alector Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Extending runway into the second half of 2027, with $354.6 million in cash, cash equivalents, and investments....Revenue. Collaboration revenue for the quarter ended March 31, 2025, was $3.7 million, compared to $15.9 million for the same period in 2024. The decrease was mainly due to the satisfaction of the performance obligation associated with the AL002 program and the latozinemab FTD-C9orf72 Phase 2 trial in the fourth quarter of 2024."

Commercial • Alzheimer's Disease

Baseline Characteristics for INFRONT-3: A Phase 3 Double-Blind, Placebo-Controlled 96-Week Study Evaluating Latozinemab in FTD-GRN (P8-3.005). (PubMed, Neurology) - P3 | "Dr. Romano has stock in Alector."

Clinical • Journal • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • GRN • SORT1

Baseline Characteristics for INFRONT-3: A Phase 3 Double-Blind, Placebo-Controlled 96-Week Study Evaluating Latozinemab in FTD-GRN (AAN 2025) - P3 | "INFRONT-3 is designed to provide evidence of efficacy and safety for latozinemab, a potential first-in-class approach for treating FTD-GRN in a representative population spanning disease severity."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • GRN • SORT1

A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) (clinicaltrials.gov) - P2 | N=33 | Completed | Sponsor: Alector Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Jun 2024 | Trial primary completion date: Jan 2026 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • GRN

Alector Reports on Recent Progress and Outlines Strategic Priorities for 2025 (GlobeNewswire) - "Topline data from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN expected by Q4 2025; Completion of enrollment in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226 for early Alzheimer’s disease anticipated in mid-2025, with approximately 75% target recruitment achieved..."

Enrollment status • P3 data: top line • Alzheimer's Disease • Dementia • Frontotemporal Lobar Degeneration

Alector Secures Flexible Credit Facility for Up to $50 Million From Hercules Capital (GlobeNewswire) - "Alector, Inc...today announced that the Company has entered into a debt financing agreement with Hercules Capital, Inc...for up to $50 million...'We anticipate transformational data from both the AL002 INVOKE-2 Phase 2 trial and the latozinemab INFRONT-3 pivotal Phase 3 trial within our runway. This credit facility provides additional funding to advance our preclinical pipeline including our proprietary, versatile Alector Brain Carrier blood-brain barrier platform and programs.' Under the terms of the agreement, Alector drew an initial $10 million at closing. An additional $15 million is available at the Company’s request through June 30, 2026, with an additional $25 million available upon lender approval."

Financing • Alzheimer's Disease • CNS Disorders • Dementia

Discovery of IGFBPL1-fusion Proteins as Multifunctional Therapeutics for Retinal Degenerative Disorders (Neuroscience 2024) - "Collectively, these observations support the further development of IGFBPL1-derived therapeutics for retinal degenerative disorders. Our results are one of the first to reduce to practice the potent pharmacology of a multifunctional, multi-targeting therapeutic for neurodegenerative disease."

CNS Disorders • IGFBP1 • NTN1 • SORT1

Alector Presents Baseline Characteristics for Pivotal INFRONT-3 Phase 3 Clinical Trial at the 14th International Conference on Frontotemporal Dementias (ISFTD 2024) (GlobeNewswire) - "Alector, Inc...today announced the presentation of a poster on participant baseline characteristics for the pivotal INFRONT-3 Phase 3 clinical trial evaluating the safety and efficacy of latozinemab in potentially slowing disease progression in individuals with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). The conference is being held in Amsterdam from September 19 – 22, 2024...A total of 119 participants were randomized in INFRONT-3, including 103 symptomatic individuals with FTD-GRN and 16 at-risk carriers for FTD-GRN. The mean age of participants at baseline was 62.1 years (range: 37-85 years). Overall, 51.3% of participants are female and 84.9% are Caucasian."

Clinical • CNS Disorders • Dementia

An anti-sortilin affibody-peptide fusion inhibits sortilin-mediated progranulin degradation. (PubMed, Front Immunol) - "Our results introduce A3-PGRNC15* as a promising new agent with therapeutic potential for the treatment of frontotemporal dementia. Furthermore, the work highlights means to increase binding affinity through synergistic contribution from two orthogonal polypeptide units."

Journal • Alzheimer's Disease • Brain Cancer • CNS Disorders • CNS Tumor • Dementia • Frontotemporal Lobar Degeneration • Glioblastoma • Oncology • Solid Tumor • GRN • SORT1

Phase 1 study of latozinemab in progranulin-associated frontotemporal dementia. (PubMed, Alzheimers Dement (N Y)) - "Data from the first-in-human phase 1 study support further development of latozinemab for the treatment of FTD-GRN."

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

FDA Grants Latozinemab Breakthrough Therapy Designation for Frontotemporal Dementia Due to a Progranulin Gene Mutation (FTD-GRN) (GlobeNewswire) - "Alector, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to latozinemab, an investigational human monoclonal antibody designed to block sortilin to elevate progranulin (PGRN) levels for the potential treatment of frontotemporal dementia with a progranulin gene mutation (FTD-GRN)....The FDA granted latozinemab Breakthrough Therapy Designation for FTD-GRN based upon data from the INVOKE-2 Phase 2 clinical trial of latozinemab in FTD-GRN participants."

Breakthrough therapy designation • CNS Disorders • Dementia

Continuation Study for Latozinemab (clinicaltrials.gov) - P3 | N=35 | Enrolling by invitation | Sponsor: Alector Inc. | Recruiting ➔ Enrolling by invitation

Enrollment status • CNS Disorders

A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3) (clinicaltrials.gov) - P3 | N=110 | Active, not recruiting | Sponsor: Alector Inc. | Recruiting ➔ Active, not recruiting | N=180 ➔ 110 | Trial completion date: Dec 2023 ➔ Oct 2027 | Trial primary completion date: Oct 2023 ➔ Sep 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • NEFL

Continuation Study for Latozinemab (clinicaltrials.gov) - P3 | N=35 | Recruiting | Sponsor: Alector Inc.

New P3 trial • CNS Disorders

Twelve-month results in FTD-C9orf72 participants from INFRONT-2: a phase 2 study of latozinemab (AL001) in FTD (CTAD 2023) - P2 | "Latozinemab treatment effects were not observed on the rate of clinical disease progression or on plasma biomarkers other than PGRN. The small sample size and a high degree of variability in disease progression in both groups rendered the results uninformative regarding treatment effect in this open-label study. However, there remains a great unmet need for effective therapies in FTD."

Late-breaking abstract • P2 data • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • GFAP • GRN • SORT1 • TARDBP

Alector Announces Achievement of Target Enrollment in the Pivotal INFRONT-3 Phase 3 Clinical Trial of Latozinemab in Individuals with Frontotemporal Dementia Due to a Progranulin Gene Mutation (FTD-GRN) (Yahoo Finance) - "Alector, Inc...today announced that it has achieved target enrollment in INFRONT-3, the pivotal Phase 3 clinical trial of latozinemab (AL001)....Alector and GSK achieved target enrollment in INFRONT-3 with 101 symptomatic participants."

Enrollment closed • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

Latozinemab, a novel progranulin-elevating therapy for frontotemporal dementia. (PubMed, J Transl Med) - P1 | "These findings support the development of latozinemab for the treatment of FTD-GRN and other neurodegenerative diseases where elevation of PGRN may be beneficial. Trial registration ClinicalTrials.gov, NCT03636204. Registered on 17 August 2018, https://clinicaltrials.gov/ct2/show/NCT03636204 ."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • SORT1

"New publication from @AlectorTx & @RobersonLabUAB describing MoA & target engagement for #Latozinemab (AL001), now in Ph3 trials for #GRN-FTD. Blocking the sortilin-PGRN interaction Grn+/- mice rescued the hets' social dominance phenotype in tube test. https://t.co/proJYI1TDB" (@BluefieldProj)

SORT1

A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: Alector Inc. | N=45 ➔ 5 | Trial completion date: Feb 2023 ➔ Oct 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2023 ➔ Oct 2022; The Sponsor is considering a subsequent study in ALS, potentially with different inclusion/exclusion criteria.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFL • Plasma NfL

Alector Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Progranulin Assets (Latozinemab, AL101): The company expects to report follow-up data from the INFRONT-2 Phase 2 clinical trial of latozinemab in frontotemporal dementia patients with a C9orf72 genetic mutation (FTD-C9orf72) in 2023....Alector will present a poster, Repeat IV and SC dosing of the Anti-Sortilin Antibody AL101, with data from the Phase 1 trial of AL101 in healthy volunteers at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference, being held in San Francisco, California from November 29 to December 2, 2022...the company plans to investigate AL101 for the treatment of Alzheimer’s disease (AD) and Parkinson’s disease (PD)....Novel MS4A Asset (AL044): Safety and biomarker data from this study are anticipated in 2023....Total research and development expenses for the quarter ended September 30, 2022, were $48.3 million...The increase in R&D expenses was mainly driven by increased personnel-related expenses as well as an increase in AL002 expenses."

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

A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Alector Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: May 2023 ➔ Jun 2026 | Trial primary completion date: Mar 2023 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Immunology

A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS (clinicaltrials.gov) - P2 | N=45 | Active, not recruiting | Sponsor: Alector Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Amyotrophic Lateral Sclerosis • CNS Disorders • Plasma NfL

Alector Presents AL001 (latozinemab) Data from the FTD-C9orf72 Cohort of the INFRONT-2 Phase 2 Clinical Trial (GlobeNewswire) - P2 | N=40 | INFRONT-2 (NCT03987295) | Sponsor: Alector Inc. | “Alector, Inc…presented results from the INFRONT-2 Phase 2 clinical trial of AL001 (latozinemab) in frontotemporal dementia patients (FTD) with a C9orf72 genetic mutation (FTD-C9orf72) at the AD/PD™ 2022 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders taking place virtually and in person in Barcelona, Spain….INFRONT-2 Phase 2 Clinical Trial Results: Latozinemab was well tolerated in the INFRONT-2 study. Twenty-eight study participants from all three cohorts were assessed for safety, with twenty-one patients treated for 12 months or more. Within the FTD-C9orf72 cohort there were a total of seven treatment related AEs, all of which were mild or moderate.”

P2 data • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

Alector to Present New AL001 Data at AD/PD 2022 (GlobeNewswire) - "Alector, Inc...announced an oral presentation at the upcoming 2022 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PDTM) being held March 15-20, 2022 virtually and in person in Barcelona, Spain."

P2 data • Alzheimer's Disease • CNS Disorders • Depression

"$ALEC Alector to Present New AL001 Data at AD/PD™ 2022 https://t.co/kWyyDtiLko" (@stock_titan)