BGB-45035 / BeiGene - LARVOL DELTA

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