ASP2390 / Astellas, HLB Bio Group - LARVOL DELTA

It is not always as it seems: Reviewing by NGS a type1 von Willebrand disease in an Italian family. (ISTH 2025) - "In the proband, the VWF gene was specifically targeted.PCR and Sanger Sequencing in VWF gene regions where proband variants were located, then NGS as described above were performed in the niece.Franklin-Genoox platform and EAHAD disease databases were checked. Results In the proband, two missense variants in the VWF gene were identified by NGS: NM_000552.5: c.7170T>A (p.Asp2390Glu), of uncertain clinical significance, and c.7390C>T (p.Arg2464Cys), pathogenic.However, these variants were not identified by direct sequencing in the niece.NGS with concomitant VWF and F8 gene analysis then allowed to identify a F8 pathogenic missense mutation (NM_000132.4: c.409A>G, p.Thr137Ala).This variant was then confirmed in the proband."

Next-generation sequencing • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases • F8

Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites. (PubMed, J Allergy Clin Immunol Glob) - "There were no substantial changes in allergen-specific immunoglobulin levels, basophil activation, or T helper cell subpopulations, and no difference in allergic clinical responses compared to placebo. Intradermal DNA vaccine ASP2390 is safe and well tolerated but does not show an immunologic or clinical response in a small sample of adults allergic to HDM."

Clinical • Journal • P1 data • Allergic Rhinitis • Allergy • Fatigue • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pain • Respiratory Diseases

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Trial primary completion date: Dec 2026 ➔ Dec 2022

Trial primary completion date • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Feb 2023 ➔ Dec 2026; Trial primary completion date: Feb 2023 ➔ Dec 2026

Clinical • Trial completion date • Trial primary completion date • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Aug 2026 ➔ Feb 2023; Trial primary completion date: Aug 2026 ➔ Feb 2023

Clinical • Trial completion date • Trial primary completion date • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Apr 2026 ➔ Aug 2026; Trial primary completion date: Apr 2026 ➔ Aug 2026

Clinical • Trial completion date • Trial primary completion date • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Initiation date: Feb 2020 ➔ Oct 2020

Clinical • Trial initiation date • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Suspended ➔ Recruiting

Clinical • Enrollment open • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Suspended; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Suspended

Clinical • Trial suspension • Immunology

A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open

Newly added product (clinicaltrials.gov) - P1, Immunology

Pipeline update