gerilimzumab (ARGX-109) / Walvax, argenx - LARVOL DELTA

Phase 1 study for ARGX-109 expected to complete by end of 2025; Phase 1 studies for ARGX-213 and ARGX-121 expected to complete in first half of 2026 (argenx Press Release)

Trial completion date • Immunology

A Study to Assess the Safety of ARGX-109 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: argenx | Recruiting ➔ Completed

Trial completion

Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program (GlobeNewswire) - "argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed....Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026."

P1 data • Pipeline update • Immunology • Inflammation

Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program (GlobeNewswire) - "argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed. Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 study and ARGX-121 study expected in first half of 2026."

Clinical data • Pipeline update • Immunology

A Study to Assess the Safety of ARGX-109 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: argenx

New P1 trial

argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update (GlobeNewswire) - "argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this new class of medicine; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed. Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025; Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025..."

IND • New P1 trial • Pipeline update • Immunology • Inflammation

Pharmacokinetics, pharmacodynamics, safety and immunogenicity of Gerilimzumab (GB224), a recombinant humanized interleukin-6 monoclonal antibody, in healthy Chinese adults: A randomized controlled dose-escalation study. (PubMed, Expert Opin Investig Drugs) - "Gb224 had a well-tolerated safety profile, desirable pharmacokinetics and a low immunogenicity following a single-dose subcutaneous administration in healthy Chinese subject. These findings warrant further investigation."

Journal • PK/PD data • IL6

A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Genor Biopharma Co., Ltd.

Clinical • Combination therapy • New P1 trial

Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects (clinicaltrials.gov) - P1; N=58; Recruiting; Sponsor: Genor Biopharma Co., Ltd.

Clinical • New P1 trial