GSK5784283 / Jiangsu Hengrui Pharma, GSK - LARVOL DELTA

AI-guided Generation and Development of HXN-1011, A Highly Potent Anti-TSLP Biparatopic Antibody (ATS 2025) - " Epitope mapping confirmed that HXN-1011 simultaneously binds to both Site I and Site II, while other TSLP antibodies, including Tezepelumab (AstraZeneca), GSK5784283 (GSK/Hengrui), and CM326 (Keymed), bind only to Site I. HXN-1011's binding affinity is ∼100 times higher than that of Tezepelumab. HXN-1011 is a highly potent biparatopic antibody targeting TSLP. It has great potential to significantly enhance clinical efficacy and expand to other inflammatory diseases beyond asthma/COPD. Preclinical and IND-enabling studies of HXN-1011 are currently underway."

Asthma • Chronic Obstructive Pulmonary Disease • Inflammation • Pneumonia • Respiratory Diseases • CRLF2 • IL7R • STAT5 • STAT5AWqe • TSLP

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=9 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=8 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=260 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial primary completion date: Oct 2024 ➔ Apr 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=8 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study to Evaluate the AIO-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Syneos Health | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Respiratory Diseases

A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma (clinicaltrials.gov) - P1 | N=86 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=62 ➔ 86

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

Hengrui Medicine's innovative drug SHR-1905 injection for the treatment of adolescent asthma has been approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Guangdong Hengrui Medicine...received the 'Notice of Approval for Drug Clinical Trials' approved and issued by the National Medical Products Administration, agreeing to conduct clinical trials of SHR-1905 injection for asthma in adolescents aged 12-17 years."

New trial • Asthma

A phase 1 study of SHR-1905, a long-acting anti-TSLP monoclonal antibody, in healthy subjects and patients with asthma (ERS 2024) - P1 | "SHR-1905 showed favorable safety, tolerability, PK and PD profiles. Its long half-life supported extended dosing intervals (every 24 or 12 weeks) compared with clinically available anti-TSLP antibodies. Supporting information: Figure Mean (SD) change of biomarkers (EOS, FeNO, FEV1) from baseline following a single subcutaneous dose in patients with moderate-to-severe asthma"

Clinical • P1 data • Asthma • Immunology • Respiratory Diseases

A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects. (PubMed, Front Pharmacol) - P1 | "SHR-1905 demonstrated a good safety and tolerability profile with a long half-life in healthy subjects after a single administration in the dose range of 50-600 mg. clinicaltrials.gov, identifier NCT04800263."

Clinical • Journal • P1 data • PK/PD data • Stroma • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TSLP

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=248 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Enrolling by invitation ➔ Recruiting

Enrollment status • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=114 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Hengrui Medicine's innovative drug SHR-1905 is approved for clinical trials for chronic obstructive pulmonary disease [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Guangdong Hengrui Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceuticals, received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration, approving the company's Class 1 new drug SHR-1905 to carry out clinical trials for chronic obstructive pulmonary disease. "

New trial • Chronic Obstructive Pulmonary Disease

Study to Evaluate the AIO-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Syneos Health | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases

GSK completes acquisition of Aiolos Bio (GSK Press Release) - "GSK plc...announced that it has completed the acquisition of Aiolos Bio (Aiolos), a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. As previously announced, the acquisition of Aiolos includes AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma."

M&A • Asthma

GSK Enters Agreement to Acquire Aiolos Bio (Businesswire) - "GSK plc...and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments. The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps."

M&A • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Respiratory Diseases • Sinusitis

Study to Evaluate the AIO-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Syneos Health

New P1 trial • Respiratory Diseases

Aiolos Bio Launches with $245 Million Series A Investment to Advance Development of Novel, Phase 2-Ready TSLP Antibody (Businesswire) - "Aiolos Bio, Inc...today announced its launch as a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. Aiolos launches with an oversubscribed $245 million Series A investment co-led by Atlas Venture, Bain Capital Life Sciences, Forbion, and Sofinnova Investments with additional investment from RA Capital Management....The Company will advance its lead drug candidate, AIO-001, into a Phase 2 clinical trial in moderate-to-severe asthma patients and is actively evaluating additional development opportunities."

Financing • Asthma • Immunology • Respiratory Diseases

Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2023 ➔ Sep 2023

Enrollment open • Trial initiation date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Trial of SHR-1905 in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Atridia Pty Ltd. | Active, not recruiting ➔ Completed

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

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=248 | Enrolling by invitation | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Enrolling by invitation

Enrollment status • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=248 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases