bosakitug (BSI-045B) / Biosion, Sino Biopharm, Aclaris - LARVOL DELTA

TQC2731-III-01: TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection (clinicaltrials.gov) - P3 | N=660 | Recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders:..Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs. Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025...Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor...Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025..."

IND • New P2b trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Pulmonary Disease • Ulcerative Colitis

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Human Monoclonal Antibody TQC2731 Targeting Thymic Stromal Lymphopoietin (TSLP) in Health Chinese Adults (ATS 2025) - No abstract available

Clinical • PK/PD data • Stroma • Immunology • Inflammation • Respiratory Diseases • TSLP

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection (clinicaltrials.gov) - P3 | N=660 | Not yet recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TQC2731-Ⅱ-04: A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=258 | Recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=258 | Not yet recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Biosion Announces Exclusive, Global License Agreement with Aclaris Therapeutics on two potential First-in-Class and Best-in-Class Immunology Assets (PRNewswire) - "Biosion, Inc...today announced that it has entered into an exclusive license agreement with Aclaris Therapeutics...for worldwide rights (excluding Greater China) to BSI-045B, a potential First-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. Under the terms of the agreement, Biosion shall receive over $40 million cash payment as upfront license fee and reimbursement for certain development costs & drug product materials. Biosion shall also receive 19.9% shares of common stock of Aclaris Therapeutics. Additional regulatory and sales milestone payments exceed $900M with tiered low-to-mid single digit royalty based upon a percentage of annual net sales."

Licensing / partnership • Asthma • Atopic Dermatitis • Immunology

ADAMANT: POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=22 | Completed | Sponsor: Biosion, Inc. | Recruiting ➔ Completed | N=80 ➔ 22

Enrollment change • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody TQC2731 targeting thymic stromal lymphopoietin (TSLP) in healthy Chinese adults. (ERS 2024) - "TQC2731 was well tolerated at all doses administered during the study in healthy Chinese adults. Our results support further clinical development of TQC2731 for asthma and other related diseases mediated by Th2 inflammation."

Clinical • PK/PD data • Stroma • Asthma • Immunology • Infectious Disease • Inflammation • Otorhinolaryngology • Respiratory Diseases • TSLP

SINO BIOPHARM To Present Research Results of 2 Innovative Drugs at ERS in Sep [Google translation] (iis.aastocks.com) - "SINO BIOPHARM...announced that the research results of two innovative drugs developed by the Group, 'TQC3721 (PDE3/4 inhibitor) and 'TQC2731 (TSLP monoclonal antibody)', will be presented at the 2024 annual meeting of European Respiratory Society (ERS 2024) to be held on 7-11 September."

Clinical data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Biosion Today Presented Key Phase 2 POC Clinical Study Results for Bosakitug, an Anti-TSLP mAb, in Atopic Dermatitis Subjects at the Revolutionizing Atopic Dermatitis Conference (PRNewswire) - P2a | N=80 | ADAMANT (NCT05932654) | Sponsor: Biosion, Inc. | "Biosion...presented key results from the ADAMANT study, a phase 2 proof-of-concept trial in AD subjects treated with Bosakitug, a high potency anti-TSLP mAb, in a podium presentation at the Revolutionizing Atopic Dermatitis conference....Dr. Parish highlighted the favorable safety profile and the exceptional responses exhibited by Bosakitug monotherapy with 94%, 69% and 25% of the subjects achieving an EASI 75, 90 and 100% response, respectively and a 94% IGA 0/1 response at week 25 following four weekly 300 mg induction doses and ten 300 mg maintenance doses. Bosakitug was able to maintain EASI 75 responses for the overall population through 12 weeks post last dose."

P2a data • Atopic Dermatitis

A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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

ADAMANT: POC Study to Evaluate BSI-045B Monotherapy and BSI-045B add-on Therapy With Dupilumab in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Biosion, Inc. | Phase classification: P2a ➔ P2

Monotherapy • Phase classification • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Investigational thymic stromal lymphopoietin inhibitors for the treatment of asthma: a systematic review. (PubMed, Expert Opin Investig Drugs) - "Currently, the only TSLP inhibitor approved for the treatment of severe asthma is the immunoglobulin G (IgG) 2λ anti-TSLP monoclonal antibody (mAb) tezepelumab...Ecleralimab, an inhaled antibody fragment antigen binding, shows promising evidence in enhancing efficacy and reducing systemic adverse events. SAR443765, with its NANOBODY® formulation and bispecific inhibition of TSLP and IL-13, offers improved tissue penetration and efficacy. The mAB TQC2731 exhibits high in vitro bioactivity, and the strength of the mAb UPB-101 is to act against the TSLP receptor...This systematic review highlights the potential of TSLP inhibitors as valuable additions to asthma treatment, even in milder forms of the disease. Future research and cost-reduction efforts are needed to expanding access to these promising therapies."

Journal • Review • Stroma • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL13 • TSLP

A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

ADAMANT: POC Study to Evaluate BSI-045B Monotherapy and BSI-045B add-on Therapy With Dupilumab in Atopic Dermatitis (clinicaltrials.gov) - P2a | N=80 | Recruiting | Sponsor: Biosion, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety and Tolerability of BSI-045B in Healthy Adult Subjects and Patients With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: Biosion, Inc. | Recruiting ➔ Completed | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Nov 2022 ➔ Feb 2023

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Biosion Announces Phase II Study Start for Anti-TSLP mAb BSI-045B in Atopic Dermatitis (ADAMANT) (PRNewswire-Asia) - "Biosion USA...announced the phase 2 study initiation for the evaluation of BSI-045B, an anti-TLSP mAb, in the treatment of atopic dermatitis (AD)....The phase II study is designed to assess the efficacy of BSI-045B as monotherapy as well as in combination therapy with Dupixent® to further increase therapeutic effectiveness for patients who are suffering from AD."

Trial status • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

ADAMANT: POC Study to Evaluate BSI-045B Monotherapy and BSI-045B add-on Therapy With Dupilumab in Atopic Dermatitis (clinicaltrials.gov) - P2a | N=80 | Not yet recruiting | Sponsor: Biosion, Inc.

Monotherapy • New P2a trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Biosion Initiates Phase II Clinical Trial of BSI-045B in Atopic Dermatitis (PRNewswire) - "Biosion USA, Inc...today announced that it has successfully opened an IND following review by the U.S. Food and Drug Administration to initiate a Phase 2 clinical trial of BSI-045B, an anti-TSLP monoclonal antibody (mAb) for the treatment of atopic dermatitis (AD), severe asthma and other eosinophilic, Th2 immune-related....The phase I study of BSI-045B demonstrated its potential to be a first-in-class treatment for AD due to its single dose activity in a cohort of AD patients, excellent PK and favorable safety profile. The phase II study is designed to assess the efficacy of BSI-045B as monotherapy as well as in combination therapy with Dupixent® to further increase therapeutic effectiveness for patients who are suffering from AD."

IND • New P2 trial • Atopic Dermatitis • Immunology

"$NVS CSJ117, Keymed's CM326 & Biosion's BSI045B are apparently the only anti-TSLP MAbs challenging $AMGN $AZN tezepelumab https://t.co/JEDcieq56y" (@JacobPlieth)