BGB-45035 / BeOne Medicines - LARVOL DELTA

Anticipated R&D Milestones (Businesswire) - "BGB-45035 (IRAK4 CDAC): Phase 1/2 trial data readout for the treatment of adult patients with rheumatoid arthritis: 2H 2026...BGB-16673 (BTK CDAC): Phase 1b trial data readout for the treatment of adult patients with moderate to severe chronic spontaneous urticaria: 1H 2026."

P1 data • P1/2 data • Chronic Spontaneous Urticaria • Rheumatoid Arthritis

A Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Ascending Doses and Food Effects of BGB-45035, a Chimeric Degradation Activating Compound (CDAC), in Healthy Participants (ACR Convergence 2025) - "BGB-45035 is a potent IRAK4 degrader that was generally well tolerated in healthy participants, with a favorable safety and PK profile over a 14-day dosing period. This supports continued evaluation of BGB-45035 as a therapy for autoimmune diseases."

Clinical • P1 data • PK/PD data • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • IL33 • IRAK4

A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: BeiGene

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

BGB-45035, a highly potent IRAK4 degrader with differentiated MOA, demonstrates strong and sustained anti-inflammatory effects in murine models of autoimmune diseases (IMMUNOLOGY 2025) - "We have developed BGB-45035, a highly selective and potent IRAK4 degrader to completely inhibit IRAK4 function, which demonstrated superior performance compared to KT-474 (Kymera/Sanofi). Additionally, in a therapeutic mouse model of MC903-induced atopic dermatitis, BGB-45035 achieved deeper IRAK4 degradation in both tissue and peripheral compartments, along with improved efficacy and reduced inflammatory biomarkers. These data highlight the best-in-class potential of BGB-45035 to effectively block various immune cell functions and induce long-lasting effects to treat inflammatory and autoimmune diseases.Keywords: Cells Th1/Th2 Cells; Diseases Autoimmunity; Processes Inflammation; Tissues Skin"

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL1R1 • IL33 • IRAK4

BGB-45035 a selective IRAK4 CDAC demonstrated fast IRAK4 degradation and strong signaling inhibition and superior efficacy in preclinical disease models (IMMUNOLOGY 2025) - "Furthermore, BGB-45035 demonstrated better efficacy than KT-474 in IL-33-induced skin inflammatory disease model with stronger inhibition of ear IL-5 and Th2 cells in ear draining lymph node. These data enlightened the contribution of faster and deeper degradation to robust biological effects of IRAK4 degraders.Keywords: Animals Rodent; Processes Inflammation; Tissues Skin"

Preclinical • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • CRBN • CXCL1 • IL1R1 • IL33 • IL5 • IRAK4

BeiGene Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates (Businesswire) - "Advan-TIG-302 (TIGIT antibody): anticipate interim data readout from Phase 3 study in first-line PD(L)1-high non small cell lung cancer in the second half of 2025...BGB-43395 (CDK4 inhibitor): continued dose escalation in monotherapy and in combination with fulvestrant and letrozole in the anticipated efficacious dose range; more than 180 patients enrolled to date and proof-of-concept expected in the first half of 2025...Zanidatamab (HER2 bispecific antibody) in combination with tislelizumab and chemotherapy: anticipate primary PFS data readout from Phase 3 study in first-line HER2-positive gastroesophageal adenocarcinoma in the second half of 2025...BGB-45035 (IRAK4 CDAC): currently in dose escalation in both SAD and MAD cohorts with more than 130 subjects enrolled...Phase 2 study planned in 2025; proof-of-concept for tissue IRAK4 degradation in the second half of 2025."

Clinical data • New P2 trial • Breast Cancer • Gastroesophageal Cancer • Immunology • Non Small Cell Lung Cancer

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases (clinicaltrials.gov) - P1 | N=195 | Recruiting | Sponsor: BeiGene | N=92 ➔ 195

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Prurigo Nodularis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: BeiGene | Trial completion date: Apr 2025 ➔ Feb 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Prurigo Nodularis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 (clinicaltrials.gov) - P1 | N=92 | Not yet recruiting | Sponsor: BeiGene

New P1 trial • Immunology