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AL 003

Drug Profile

AL 003

Alternative Names: AL003

Latest Information Update: 02 Oct 2021

At a glance

  • Originator AbbVie; Alector
  • Class Antidementias; Monoclonal antibodies
  • Mechanism of Action CD33 antigen inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Alzheimer's disease

Most Recent Events

  • 17 Sep 2021 Biomarkers information updated
  • 06 May 2021 Alector completes a phase I trial in Alzheimer's disease in the US and Australia (IV) (NCT03822208)
  • 31 Dec 2020 Alector has patent protection for SIGLEC 3 program in USA

Development Overview

Introduction

AL 003, a monoclonal antibody targeting Siglec-3 (CD33) is being developed by Alector in collaboration with AbbVie for the treatment of Alzheimer's disease. Early clinical development is underway in the US and Australia.

Siglec-3, is a transmembrane glycoprotein which is expressed on the surface of myeloid progenitor cells, mature monocytes and macrophages. Siglec-3 contains putative immunoreceptor tyrosine based inhibitory motifs which inhibit cellular activity. Upon activation, Siglec-3 constitutively repress monocyte-derived pro-inflammatory cytokines as well as microglia and their ability to dispose of the accumulated debris which cause Alzheimer's disease.

AL 003 has emerged from a research programme of Alector in collaboration with AbbVie on antibody therapeutics [see Adisinsight drug profile 800050570].

Company Agreements

In October 2017, AbbVie entered into a global research and development agreement with Alector, to develop and commercialise immune therapies for the treatment of Alzheimer's disease and other neurodegenerative disorders. Under the terms of the agreement, AbbVie and Alector have agreed to research a portfolio of antibody targets and AbbVie has an option to global development and commercial rights to two targets which include a triggering receptor expressed on myeloid cells 2 (TREM2) and Siglce-3 receptor. Alector will conduct exploratory research, drug discovery and development for lead programs up to the conclusion of the proof of concept studies including the design and execution of phase I and phase II studies. Upon exercising the option, AbbVie will lead development and commercialisation activities. Alector and AbbVie will co-fund development and commercialisation and will share global profits equally after marketing approval. Alector will receive a $US205 million upfront payment and a potential, future equity investment of up to $US20 million if AbbVie exercises its option for either program (or both programs), Alector is eligible for additional option exercise and milestone payments totaling up to $US986M. [1] [2] [3]

Key Development Milestones

In May 2021, Alector completed a phase I trial of AL 003 in healthy volunteers and in patients with mild to moderate Alzheimer's disease (AL003-1, NCT03822208). The trial is designed to evaluate the safety, immunogenicity, tolerability, pharmacokinetics and pharmacodynamics of AL 003. The randomised, double-blind, placebo-controlled, dose escalation, first in human (FIH) trial was initiated in March 2019 and enrolled 54 participants in the US and Australia [4] .

Financing information

In July 2018, Alector secured $US133 million in Series E financing round. The company has previously raised $US282 million. The company expect to utilize the proceeding from the financing to advance Alector’s clinical programs and expand the company’s discovery platform [5] .

Patent Information

Alector owned five patent families directed to the SIGLEC 3 program covering the compositions and uses of our SIGLEC 3 program product candidates. Two patent families are expected to expire in 2036, the third patent family in 2038, the fourth patent family in 2039, and the fifth patent family in 2040, in all cases excluding any patent term adjustments and any patent term extensions [6] [7] .

Drug Properties & Chemical Synopsis

  • Route of administration IV
  • Formulation Infusion
  • Class Antidementias, Monoclonal antibodies
  • Target CD33 antigen
  • Mechanism of Action CD33 antigen inhibitors
  • WHO ATC code

    N06D-X (Other anti-dementia drugs)

  • EPhMRA code

    N7D (Anti-Alzheimer Products)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

Alzheimer's disease

Outcome Measure

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

1

Biomarker

Drug Name Biomarker Name Biomarker Function
AL 003 Granulocyte-macrophage colony-stimulating factor (GM-CSF) Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Alzheimer's disease - - Phase I Australia IV / Infusion Alector 29 Mar 2019
Alzheimer's disease - - Phase I USA IV / Infusion AbbVie, Alector 29 Mar 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
Alector Originator USA
AbbVie Originator USA
Alector Owner USA
AbbVie Owner USA

Future Events

Expected Date Event Type Description Updated
31 Mar 2019 Trial Update Alector plans a phase I trial for Alzheimer’s disease in March 2019 (NCT03822208) 03 May 2019
31 Dec 2018 Trial Update Alector plans a clinical trial for Alzheimer’s disease (Monotherapy, Combination therapy) in 2018 [8] 01 Feb 2019

Development History

Event Date Update Type Comment
17 Sep 2021 Biomarker Update Biomarkers information updated Updated 02 Oct 2021
06 May 2021 Trial Update Alector completes a phase I trial in Alzheimer's disease in the US and Australia (IV) (NCT03822208) Updated 27 Sep 2021
31 Dec 2020 Patent Information Alector has patent protection for SIGLEC 3 program in USA [6] Updated 18 Jun 2021
29 Mar 2019 Phase Change - I Phase-I clinical trials in Alzheimer's disease in USA (IV) (NCT03822208) Updated 27 Sep 2021
29 Mar 2019 Phase Change - I Phase-I clinical trials in Alzheimer's disease in Australia (IV) (NCT03822208) Updated 03 May 2019
28 Mar 2019 Patent Information Alector has patents pending for SIGLEC 3 program in USA [7] Updated 04 Apr 2019
31 Jan 2019 Trial Update Alector plans a phase I trial for Alzheimer’s disease in March 2019 (NCT03822208) Updated 03 May 2019
30 Jul 2018 Trial Update Alector plans a clinical trial for Alzheimer’s disease (Monotherapy, Combination therapy) in 2018 [8] Updated 01 Feb 2019
25 Jul 2018 Phase Change - Preclinical Preclinical trials in Alzheimer's disease in USA (Parenteral) [5] Updated 30 Jul 2018
24 Oct 2017 Licensing Status Alector and AbbVie agree to co-promote and co-develop antibody therapeutics worldwide for Alzheimer's disease and Neurodegenerative disorders [1] Updated 30 Jul 2018
24 Oct 2017 Phase Change Early research in Alzheimer's disease in USA (Parenteral) [1] Updated 30 Jul 2018

References

  1. Alector and AbbVie Announce Collaboration to Advance a Novel Class of Immune Therapies for Patients with Alzheimer's Disease.

    Media Release
  2. Alector Snags $133M to Activate Immune Cells Against Neurodegeneration. Internet-Doc 2018;.

    Available from: URL: https://www.xconomy.com/san-francisco/2018/07/25/alector-snags-133m-to-activate-immune-cells-against-neurodegeneration/2/
  3. Alector Announces Publication of Preclinical and Phase 1 Data Validating Potential of AL002, a TREM2 Activating Antibody for the Treatment of Alzheimers Disease, in The Journal of Experimental Medicine.

    Media Release
  4. A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL003 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease.

    ctiprofile
  5. Alector Announces $133 Million in Series E Financing to Advance Broad Portfolio of Immuno-Neurology and Immuno-Oncology Programs.

    Media Release
  6. Alector SEC filing, Form 10-K. Internet-Doc 2021;.

    Available from: URL: https://www.sec.gov/Archives/edgar/data/1653087/000156459021008860/alec-10k_20201231.htm
  7. Alector Closes $133 Million to Expand Alzheimer?s Programs. Internet-Doc 2018;.

    Available from: URL: https://www.biospace.com/article/alector-closes-133-million-to-expand-alzheimer-s-programs/
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