WIN378 / Sichuan Kelun Pharma, Harbour BioMed, Windward Bio - LARVOL DELTA

Sichuan Kelun-Biotech Biopharmaceutical…announced that its partner, Windward Bio, has reported positive interim results from the Phase 2 portion of the POLARIS-1 clinical trial, which evaluates twice-yearly dosing of SKB378/WIN378 in asthma (PRNewswire) - "The Phase 2 portion of the study enrolled a total of 147 patients, exceeding the initial enrollment target of 120 patients, with the interim analysis conducted on the first 98 patients. The interim analysis demonstrated the following at Week 24 after a single dose of SKB378/WIN378: Dose-dependent mean increases in FEV1 of up to 174 mL (placebo-adjusted mean increase up to 256 mL, p=0.033). Dose-dependent mean reductions in FeNO of up to 24 ppb (or -43% change, p=0.006). Reductions in mean blood eosinophil count (EOS) of up to 200 cells/µL (or -51% change, p<0.0001). Near maximal effects seen as early as Week 2 and sustained through Week 24....The Phase 3 portion of the study has been initiated by Windward Bio who plans to begin a second Phase 3 study, POLARIS-2, in the first half of 2027. Data from the Phase 2 portion of POLARIS-1 will be presented at an upcoming medical congress."

New P3 trial • P2 data • Trial status • Asthma • Immunology

Lessons learned from clinical trials of thymic stromal lymphopoietin (TSLP) inhibition. (PubMed, J Allergy Clin Immunol) - "Tezepelumab is currently the only approved anti-TSLP therapy. Other TSLP-targeting agents, including ecleralimab, SHR-1905, bosakitug, verekitug, sunakiment, TAVO101, ocankitug, HBM9378, MG-ZG122, GB-0895, and solrikitug, are in clinical development."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • IL13 • IL5 • TSLP

SKB378/WIN378 (TSLP mAb): A Phase 1 clinical trial in healthy subjects has been completed in China, and its IND application for the treatment of COPD has also been approved by the NMPA. (PRNewswire)

New trial • Chronic Obstructive Pulmonary Disease • Immunology

Windward Bio…announced that the first patients have been dosed in the Phase 2 SIRIUS study of WIN378, the company’s ultra long-acting anti-TSLP monoclonal antibody, in patients with chronic obstructive pulmonary disease (COPD) (GlobeNewswire) - "SIRIUS is a global, Phase 2, randomized, double-blind, placebo-controlled, dose-finding study. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of WIN378 in patients with moderate-to-severe COPD."

Trial status • Chronic Obstructive Pulmonary Disease • 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 Trial of HBM9378 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Harbour BioMed Reports the Online Publication of Phase I Results for HBM9378 (SKB378/WIN378), a TSLP-Targeting Antibody (PRNewswire) - "Data showed that the incidence of treatment-emergent adverse events (TEAEs) was comparable between the HBM9378 dose groups and the placebo group, with no trend for increasing safety risks with dose escalation. The median time to maximum concentration (Tmax) ranged from 4.05 to 14.1 days, and the mean half-life (T1/2) ranged from 55.0 to 65.8 days. HBM9378 exposure (Cmax and AUC) increased in an approximately dose-proportional manner across the dose range of 20 to 900 mg. The incidence of anti-drug antibody (ADA) was 5% (2/40) during the study period without clinical correlate or impact on drug exposure. No injection site reactions were observed in any dose group."

P1 data • Immunology

Safety, Tolerability, and Pharmacokinetics of HBM9378 (SKB378/WIN378), a Fully Human IgG1 Monoclonal Antibody Against TSLP After Single Ascending Doses in Chinese Healthy Subjects. (PubMed, Drug Des Devel Ther) - P1 | "These results support further investigation of HBM9378 in patients with severe immunological disorders. This trial was registered on ClinicalTrials.gov (NCT05790694) and on the China Center for Drug Evaluation (CDE) platform (CTR20221961)."

Clinical • First-in-human • Journal • PK/PD data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • TSLP

The company’s lead program, WIN378, a long-acting anti-TSLP monoclonal antibody, is currently being evaluated in POLARIS, a global Phase 2 trial in asthma patients, with initial data expected in 2026 (GlobeNewswire)

P2 data • Asthma • Immunology

Kelun-Biotech's Partner Windward Bio Announces Initiation of a Global Phase 2 Asthma Trial of SKB378/WIN378 (PRNewswire) - "Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...today announced that its partner, Windward Bio AG ('Windward Bio') has launched its Phase 2 POLARIS clinical study, assessing long-acting dosing of SKB378/WIN378 for people living with asthma....The Phase 2 POLARIS trial is a global, randomized, double-blind, placebo-controlled study evaluating the dosing, safety, and efficacy of SKB378/WIN378 in patients with asthma. Initial data is expected in mid-2026. Additional clinical trials are planned with SKB378/WIN378 including in COPD in 2026."

New trial • P2 data • Trial status • Asthma • Chronic Obstructive Pulmonary Disease

UPFRONT PAYMENT IN CASH AND EQUITY RECEIVED UNDER THE LICENSE AGREEMENT WITH WINDWARD BIO AG FOR SKB378/HBM9378/WIN378 (HKEXnews) - "Reference is made to the announcement...of the Company dated January 10, 2025 in relation to the entry into an exclusive license agreement for SKB378/HBM9378/WIN378, among (i) the Company and HBM Holdings Limited as licensors and (ii) Windward Bio AG as the licensee. Unless otherwise defined, capitalized terms used herein shall have the same meanings as those defined in the Announcement....The Board is pleased to announce that the Company has received an upfront payment from Windward Bio in line with the terms of the License Agreement as disclosed in the Announcement including: (i) a cash payment, which was received in February 2025, and (ii) an equity interest in the parent company of Windward Bio, which was settled in May 2025 upon satisfaction of relevant regulatory approvals in mainland China and other closing conditions." "

Financing • Asthma • Chronic Obstructive Pulmonary Disease

UPFRONT PAYMENT RECEIVED UNDER THE LICENSE AGREEMENT WITH WINDWARD BIO AG FOR HBM9378/SKB378 (HKEXnews) - "Reference is made to the announcement of the Company dated 10 January 2025, in relation to the entry into an exclusive license agreement (the 'Agreement') for HBM9378/SKB378, among the Company and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ('Kelun-Biotech', stock code: 06990) as licensors and Windward Bio AG ('Windward Bio') as the licensee. The board of directors of the Company (the 'Board') is pleased to announce that the Company has received an upfront payment from Windward Bio in line with the Agreement, including both cash payment and an equity interest in the parent company of Windward Bio. The receipt of this upfront payment will further bolster the Company’s cash reserves."

Financing • Asthma • Chronic Obstructive Pulmonary Disease

Harbour BioMed Receives NMPA IND Clearance for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease (PRNewswire) - "Harbour BioMed...announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM9378/SKB378 (also known as WIN378), a fully human antibody targeting thymic stromal lymphopoietin (TSLP), for the treatment of chronic obstructive pulmonary disease (COPD)."

New trial • Chronic Obstructive Pulmonary Disease

Novo Holdings invests in $200M Series A for Windward Bio launch to advance long-acting treatments for asthma and COPD (PRNewswire) - "Novo Holdings...today announced that it has invested in a $200M Series A launch financing for Windward Bio...The Company is preparing to begin a Phase 2 trial investigating WIN378 in severe asthma, with initial clinical readouts expected in 2026...The Series A financing supports the advancement of two undisclosed programs through Investigational New Drug (IND)–enabling studies."

Financing • New P2 trial • P2 data • Asthma

Harbour BioMed Announces License Agreement with Windward Bio for HBM9378/SKB378, an Anti-TSLP Fully Human Antibody for Immunological Diseases (PRNewswire) - "Harbour BioMed...today announced that the Company and Sichuan Kelun Biotech BioPharmaceutical...have entered into a license agreement with Windward Bio AG ('Windward Bio') for HBM9378/SKB378, an anti-thymic stromal lymphopoietin (TSLP) fully human monoclonal antibody co-developed by Harbour BioMed and Kelun-Biotech...Under the terms of the agreement, Windward Bio is granted an exclusive license to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries...In connection with the license agreement, Windward Bio announced a $200 million Series A financing round led by OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities, along with co-investors SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners."

Financing • Licensing / partnership • Asthma • Chronic Obstructive Pulmonary Disease

Harbour BioMed Announces Submission of IND Application for HBM9378/SKB378 in the Treatment of Chronic Obstructive Pulmonary Disease (PRNewswire) - "Harbour BioMed....today announced the submission of an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration of China for HBM9378/SKB378, a fully human antibody targeting thymic stromal lymphopoietin (TSLP), for the treatment of chronic obstructive pulmonary disease (COPD)."

New trial • Chronic Obstructive Pulmonary Disease

A Trial of HBM9378 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.

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