Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 692 |
| INN | Latozinemab |
| Status | Clinical |
| Drug code(s) | GSK4527223, AL001 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Sortilin |
| Indications of clinical studies | Amyotrophic lateral sclerosis, Frontotemporal Dementia |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 14, 2018 |
| Start of Phase 2 | September 27, 2019 |
| Start of Phase 3 | July 23, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Alector Inc. |
| Licensee/Partner | GSK |
| Comments about company or candidate | Phase 3 study for Frontotemporal dementia (NCT04374136) is active non recruiting as of October 2024. Feb. 07, 2024: Alector, Inc. and GSK plc announced that the U.S. Food and Drug Administration 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. Phase 3 study for Frontotemporal dementia (NCT04374136) is recruiting as of May 6, 2023. Aug 2022 corporate presentation discusses ongoing Phase 3 study, but does not mention plans for BLA. May 2021: Alector is on track to initiate a Phase 2 study evaluating AL001 in people with amyotrophic lateral sclerosis (ALS) caused by C9orf72 repeats, which share TDP-43 pathology with FTD-GRN in the second half of 2021. NCT04374136 Phase 3 INFRONT-3 study started in July 2020 primary completiong date in Sep 2025. NCT03987295 Phase 2 study recruiting as of Sep 2019. Alector received orphan drug designation from the FDA for AL001 for treatment of FTD. Lonza Biologics manufactures AL001 and AL002. Alector has a collaboration agreement with Adimab, LLC under which the company is developing antibodies discovered by Adimab in its AL001 and AL101 product candidates, and the company is developing antibodies optimized by Adimab in its AL002 and AL003 product candidates. In the first quarter of 2019, the dosing of the single ascending dose Phase 1a in healthy subjects was completed for AL001, initially aimed at treating a subset of frontotemporal dementia (“FTD”) patients who have a known genetic mutation that causes a deficiency in progranulin (“PGRN”), which is called FTD-GRN. There were no drug-related serious adverse events or dose limiting adverse events reported in the study, achieving the primary endpoint. Moreover, statistically significant increases in plasma and cerebrospinal fluid PGRN levels relative to baseline were also observed, successfully demonstrating proof-of-mechanism for AL001 in the central nervous systems of healthy subjects. Subsequently, in the second quarter of 2019, Alector advanced AL001 into a Phase 1b study in FTD-GRN patients. |
| Full address of company | 131 Oyster Point Blvd, Suite 600, South San Francisco, CA 94080 North America United States of America https://alector.com/contact/ |
AL001 is a recombinant human anti-human sortilin (SORT1) monoclonal IgG1. AL001 blocks the breakdown of PGRN by binding to receptors on the surface of both microglia and neurons that facilitate PGRN degradation.
| Anticipated events | BLA possble in 2026 |
| Factor(s) contributing to discontinuation | None |