CAL101 / Calluna Pharma, Cancer Research UK - LARVOL DELTA

Calluna Pharma Announces U.S. FDA Orphan Drug Designation Granted to CAL101 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) (Businesswire) - "CAL101 being investigated in Phase 2 IPF Study; enrollment ongoing at sites in the USA, UK, EU, Turkey and South Korea."

Orphan drug • Trial status • Idiopathic Pulmonary Fibrosis • Immunology

Calluna Pharma Announces Initiation of Phase 2 AURORA Study of CAL101 for Idiopathic Pulmonary Fibrosis (Businesswire) - "The study aims to enroll 150 individuals with IPF across more than 50 sites, primarily in the US, UK, EU, Turkey and South Korea."

Trial status • Idiopathic Pulmonary Fibrosis

Calluna Announces Three Poster Presentations at the 2025 American Thoracic Society International Conference (Businesswire) - "Calluna Pharma AS (Calluna)...today announced that the company will present three posters related to both of its pipeline programs at the American Thoracic Society (ATS) 2025 International Conference (ATS 2025). ATS 2025 is being held May 16 – 21, 2025 at the Moscone Center in San Francisco."

Clinical data • Chronic Obstructive Pulmonary Disease • Idiopathic Pulmonary Fibrosis

A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis. (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Arxx Therapeutics | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Calluna Pharma Successfully Completes Phase 1 Clinical Study of CAL101, a First-in-Class Therapeutic for Fibrotic and Fibro-Inflammatory Indications (Businesswire) - P1 | N=57 | "The study demonstrated a favorable safety, pharmacokinetic (PK) and immunogenicity profile for the mAb....CAL101 demonstrated a favorable safety profile and was well tolerated with no Serious Adverse Events across all doses tested....CAL101 demonstrated a favorable PK profile with dose-dependent increases in exposure, supporting once monthly dosing....Target engagement data supports complete target coverage at clinically relevant doses."

P1 data • Trial completion • Fibrosis • Immunology • Psoriasis • Systemic Sclerosis

THE ROLE OF SYSTEMIC S100A4 LEVELS IN SCLERODERMA AS A PREDICTOR OF TREATMENT RESPONSE AND EARLY PROGRESSION (EULAR 2024) - "Inhibition of S100A4 by murine mAbs (6B12) prevented the progression and induced regression of established dermal fibrosis induced by bleomycin... Systemic levels of S100A4 were measured by ELISA (CUSABIO, Houston, USA) in 104 age-/sex-matched healthy controls (HC) and four different cohorts: 1) cross-sectional SSc patients (n=117; 67 lcSSc/50 dcSSc; mean age 55.8, disease duration 5.0 years); 2) SSc patients with active interstitial lung disease (ILD) treated with 6 (n=24) or 12 (n=16) months of iv cyclophosphamide; 3) SSc patients with progressive skin involvement and/or arthritis and/or ILD non-responsive to methotrexate/cyclophosphamide/mycophenolate treated with 2 (n=8) or 3 (n=16) 6-month cycles of rituximab; and 4) VEDOSS (Very Early Diagnosis of SSc) patients with Raynaud´s phenomenon who did not progress (n=15) or progressed (n=11) to SSc... Systemic S100A4 levels are elevated in SSc (especially in ILD), decrease with cs/bDMARD treatment, and predict the..."

Cardiovascular • CNS Disorders • Depression • Fatigue • Fibrosis • Gastrointestinal Disorder • Immunology • Inflammation • Interstitial Lung Disease • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis • S100A4

Calluna Pharma Launches and Announces EUR 75 Million Series A Financing to Develop Novel Therapies for Inflammatory and Fibrotic Diseases (Businesswire) - "Oxitope Pharma (Oxitope) and Arxx Therapeutics (Arxx)...announced their merger to form Calluna Pharma Inc. (Calluna). Calluna has raised EUR 75 million in a series A financing and is backed by Oxitope and Arxx’s existing lead investors, Forbion, Sarsia, p53, and Investinor....Its clinical stage lead program, CAL101, is a monoclonal antibody that neutralizes the bioactivity of S100A4, a DAMP protein implicated in serious and life-threatening diseases such as idiopathic pulmonary fibrosis, chronic kidney disease, systemic sclerosis, rheumatoid arthritis, and severe (steroid insensitive) asthma. Of particular interest is another of its programs, CAL102, a monoclonal antibody neutralizing oxidized phospholipids – these play a significant role in onset and progression of a wide range of acute and chronic inflammatory and fibrotic diseases. CAL102 demonstrated efficacy in several preclinical disease models."

M&A • Idiopathic Pulmonary Fibrosis • Immunology • Rheumatoid Arthritis • Systemic Sclerosis

A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis. (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Arxx Therapeutics | Trial completion date: Apr 2024 ➔ Jul 2024 | Trial primary completion date: Apr 2024 ➔ Jul 2024

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

A First in Human Study of AX-202 in Healthy Subjects and Patients With Psoriasis. (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Arxx Therapeutics

New P1 trial • Dermatology • Immunology • Psoriasis

Clinical and pathogenic significance of S100A4 overexpression in systemic sclerosis. (PubMed, Ann Rheum Dis) - "Our findings provide compelling evidence for a profibrotic role for S100A4 in SSc and suggest that serum level may be a biomarker of major organ manifestations and disease severity. This study supports examining the therapeutic potential of targeting S100A4 in SSc."

Journal • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • S100A4

S100A4 neutralizing monoclonal antibody 6B12 counteracts the established experimental skin fibrosis induced by bleomycin. (PubMed, Rheumatology (Oxford)) - "Targeting S100A4 by the 6B12 mAb demonstrated potent antifibrotic and anti-inflammatory effects on bleomycin-induced dermal fibrosis and provided further evidence for the vital role of S100A4 in the pathophysiology of SSc."

Journal • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis • CCL11 • CCL2 • S100A4 • SMAD3

Arxx Therapeutics initiates first-in-human trial of AX-202 – a monoclonal antibody under development for fibrotic diseases (PipelineReview) - "Arxx Therapeutics...announces that the first cohort of healthy volunteers have successfully been dosed with AX-202 – a first-in-class anti-S100A4 monoclonal antibody (mAb). The trial is led by Professor David Singh at the Medicines Evaluation Unit in Manchester, UK....The double-blind, placebo-controlled trial aims to establish the safety and tolerability of AX-202 and is expected to enroll a total of 40 healthy volunteers and 18 patients with mild to moderate psoriasis. Trial results are expected in 2024, aiming to support the initiation of a clinical program in patients with systemic sclerosis."

P1 data • Trial status • Immunology • Psoriasis • Systemic Sclerosis