WIN027 / Qyuns Therap, Windward Bio - LARVOL DELTA

A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending and Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of WIN027 in Healthy Adult Participants (ANZCTR) - P1 | N=30 | Not yet recruiting | Sponsor: Windward Bio 27 AG

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

QX027N obtains two clinical trial approvals for chronic obstructive pulmonary disease and chronic rhinosinusitis with nasal polyps (HKEXnews)

New trial • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Windward Bio Announces $165M Crossover Financing to Advance Pipeline of Long-Acting Immunology Therapies With Best-in-Disease Potential (GlobeNewswire) - "The financing will accelerate the development of WIN378, which is currently being studied in the Phase 2/3 POLARIS program in asthma. The Phase 2 dose-ranging component of POLARIS is fully recruited, with initial data expected in second half of 2026. The first Phase 3 study of WIN378 is expected to begin in the fourth quarter of 2026. The Phase 2 SIRIUS study in chronic obstructive pulmonary disease (COPD) is anticipated to start in the second quarter of 2026...WIN027 is currently in a Phase 1 study with data readout expected by the end of 2026. The financing will support multiple proof-of-concept studies across respiratory and dermatology indications starting in Q4 2026."

Financing • New P2 trial • New P3 trial • P1 data • P2 data • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Immunology

A multicentre, randomised, double-blind, single- and multiple-dose escalation, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic profile, pharmacodynamic effects, and immunogenicity of QX027N in healthy subjects and patients with moderate-to-severe atopic dermatitis. (ChiCTR) - P1 | N=65 | Not yet recruiting | Sponsor: Hangzhou First People's Hospital; Qyuns Therapeutics Co., Ltd.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13

Windward Bio and Qyuns Therapeutics announce licensing agreement for WIN027, a highly potent, long-acting bispecific antibody with best-in-disease potential in respiratory and dermatology (GlobeNewswire) - "Under the terms of the agreement, Windward Bio will gain exclusive rights to develop, manufacture, and commercialize WIN027 outside of China. Total deal value is up to $700M, including upfront payment, equity, and milestones that may be paid to Qyuns Therapeutics, contingent upon the achievement of specific development, regulatory, and commercial milestones, as well as tiered royalties on product sales."

Licensing / partnership • Asthma • Dermatology • Immunology

LONG-ACTING BISPECIFIC ANTIBODY QX027N OBTAINS TWO CLINICAL TRIAL APPROVALS (HKEXnews) - "...Approvals from the Center for Drug Evaluation of the National Medical Products Administration (Acceptance Nos.: CXSL2500757, CXSL2500758), intended for the treatment of asthma and atopic dermatitis."

New trial • Asthma • Atopic Dermatitis • Immunology