APG333 / Apogee Therap - LARVOL DELTA

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Inhibits Central and Local Drivers of Obstructive Airway Disease (ATS 2025) - "Benchmark mAbs dupilumab (anti-IL-4Rα), lebrikizumab (anti-IL-13), and tezepelumab (anti-TSLP) were produced based on publicly available sequences. Consistent with TSLP and IL-13 having distinct roles in mediating obstructive airway disease pathology, administration of APG777+APG333 provided potent and broad inhibition of biomarkers of central inflammation and local airway response in primary human cells. Effects were greater and broader than those observed with benchmarks, suggesting that targeting orthogonal drivers of obstructive airway disease is a promising approach for the treatment of Th2-driven respiratory diseases. These data support the continued development of APG777+APG333 for Th2-driven inflammatory diseases."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CCL11 • CD4 • CRLF2 • IL13 • IL5 • IL6 • POSTN

Apogee Therapeutics Provides Pipeline Progress and Reports Full Year 2024 Financial Results (GlobeNewswire) - "Apogee plans to initiate a...Phase 2b trial in asthma in the second half of 2025 with data expected in 2026...A Phase 1 trial of APG333 in healthy volunteers is underway, with data expected in the second half of 2025. Apogee plans to evaluate APG777 and APG333 monotherapies in respective Phase 1b trials in patients with asthma in 2025 to support advancement into future combination trials in asthma and COPD...Apogee is also evaluating APG808 in a Phase 1b trial in patients with asthma, with data expected in the first half of 2025."

New P1 trial • New P2b trial • P1 data • P2b data • Asthma • Immunology • Respiratory Diseases

Preclinical and Pharmacokinetic Characterization of APG333: A Fully Human Monoclonal Antibody that Binds TSLP with High Affinity and Potently Inhibits Downstream Signaling (AAAAI-WAO 2025) - "An antibody based on the published sequence of tezepelumab was included as a control across in vitro and in vivo experiments characterizing APG333. The pharmacokinetic profile of APG333 in NHPs shows a reduced clearance and long half-life comparable with those seen with other half-life–extended mAbs. Conclusions In vitro potency and pharmacokinetic data support continued development of APG333 for the treatment of inflammatory diseases."

PK/PD data • Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CRLF2 • STAT5 • TSLP

The Combination of APG777 (anti-IL-13) and APG333 (anti-TSLP) Improves Type 2 Inflammatory Suppression Compared to Single Agents (AAAAI-WAO 2025) - "Dupilumab and tezepelumab controls were produced based on publicly available sequences. Conclusions The combination of APG777+APG333 mediates greater suppression of Th2 immune response markers compared with both single-agent controls and benchmarks. These data support continued development of APG777+APG333 for Th2-driven inflammatory diseases."

Inflammation • CRLF2 • IL13 • TSLP

Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG333, its Novel Half-Life Extended TSLP Antibody for the Treatment of Respiratory and Broader I&I Conditions (GlobeNewswire) - "Apogee Therapeutics, Inc...announced that it has initiated dosing of healthy volunteers in its clinical trial of APG333, a novel, subcutaneous (SQ) half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which is being evaluated initially as a treatment for people living with asthma, COPD and broader I&I conditions....The study will evaluate the safety, tolerability and pharmacokinetics (PK) of APG333 and is expected to enroll approximately 32 healthy adults into 4 cohorts. Apogee expects interim data from the trial in the second half of 2025."

P1 data • Trial status • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A first-in-human study of APG333 in healthy participants (ANZCTR) - P1 | N=32 | Not yet recruiting | Sponsor: Apogee Therapeutics, Inc.

New P1 trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases