solrikitug (MK-8226) / Merck (MSD), Uniquity Bio - LARVOL DELTA

Late Breaking Abstract - Structural and mechanistic basis of TSLP neutralization by solrikitug (ERS 2026) - "Unlike other anti-TSLP antibodies that inhibit TSLP binding to TSLPR, solrikitug uniquely neutralizes TSLP by combining IL7Rα-like engagement of the hydrophobic AC face of TSLP's helical bundle with recognition and stabilization of a flexible loop region. This novel binding mode provides the structural basis for solrikitug's inhibition of TSLPR/IL7Rα dimerization and downstream signaling, supporting clinical potential in TSLP-driven diseases."

Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL7 • IL7R • TSLP

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

A Study to Evaluate Solrikitug in Participants With COPD (ZION) (clinicaltrials.gov) - P2 | N=182 | Active, not recruiting | Sponsor: Uniquity One (UNI) | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Sep 2026

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

RAINIER: A Study to Evaluate Solriktug in Adult Participants With Asthma (clinicaltrials.gov) - P2 | N=140 | Active, not recruiting | Sponsor: Uniquity One (UNI) | Recruiting ➔ Active, not recruiting

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

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Uniquity One (UNI) | Recruiting ➔ Completed

Trial completion

RAINIER: A Study to Evaluate Solriktug in Adult Participants With Asthma (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Uniquity One (UNI) | Trial completion date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

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

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Uniquity One (UNI) | Trial primary completion date: Aug 2025 ➔ Jan 2026

Trial primary completion date

A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (clinicaltrials.gov) - P2 | N=157 | Active, not recruiting | Sponsor: Uniquity One (UNI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

A potent anti-TSLP mAb reduces type 2 inflammation in primary COPD epithelial cells (ERS 2025) - "Solrikitug significantly reduced markers of type 2 inflammation in BECs of both COPD and non- COPD participants. These findings support the potential therapeutic role of solrikitug in patients with COPD who have enhanced type 2 immunity."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • IL13

A Phase 1 randomized, double-blind study of safety, tolerability and pharmacokinetics of Solrikitug in healthy participants (ERS 2025) - P1 | "Only 2/36 participants had post-baseline positive anti-drug antibodies (ADA) for solrikitug with low transient titers, with no apparent impact of ADA on PK and safety. These results support SC administration of this novel, potent anti-TSLP mAb, in ongoing studies in COPD, asthma and eosinophilic esophagitis."

Clinical • P1 data • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Dermatology • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Uniquity One (UNI) | Active, not recruiting ➔ Completed

Trial completion

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Uniquity One (UNI) | Not yet recruiting ➔ Recruiting

Enrollment open

In-vitro Characterization of Solrikitug, A Differentiated Anti-TSLP Antibody, Provides Distinct Epitope Binding Profile and Superior Potency Compared to Tezepelumab (ATS 2025) - "Solrikitug is a potent anti-TSLP monoclonal antibody in development for the treatment of respiratory and gastrointestinal inflammatory diseases. Solrikitug demonstrates unique epitope binding compared to the approved in class comparator, tezepelumab. Moreover, solrikitug demonstrates potentially best-in-class functional inhibition."

Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate Solrikitug in Participants With COPD (ZION) (clinicaltrials.gov) - P2 | N=171 | Recruiting | Sponsor: Uniquity One (UNI) | Trial completion date: Aug 2025 ➔ Oct 2026 | Trial primary completion date: Apr 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

RAINIER: A Study to Evaluate Solriktug in Adult Participants With Asthma (clinicaltrials.gov) - P2 | N=124 | Recruiting | Sponsor: Uniquity One (UNI) | N=84 ➔ 124 | Trial completion date: Aug 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Dec 2025

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

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Uniquity One (UNI)

New P1 trial

Differentiated anti-TSLP antibody provides meaningful reductions BAL eosinophils and TARC in the OVA-induced mouse model of asthma (AAAAI-WAO 2025) - "22E5, shows promise as a tool compound to evaluate attenuation of key markers of Type 2 inflammation in a murine asthma model. Solrikitug's enhanced potency over tezepelumab suggests a potential for differentiated efficacy in the treatment of asthma."

Preclinical • Asthma • Immunology • Inflammation • Respiratory Diseases

A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults with Eosinophilic Esophagitis (clinicaltrials.gov) - P2 | N=157 | Recruiting | Sponsor: Uniquity One (UNI) | Not yet recruiting ➔ Recruiting

Enrollment open • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (clinicaltrials.gov) - P2 | N=157 | Not yet recruiting | Sponsor: Uniquity One (UNI)

New P2 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

A Study to Evaluate Solrikitug in Participants With COPD (ZION) (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Uniquity One (UNI) | Not yet recruiting ➔ Recruiting

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

RAINIER: A Study to Evaluate Solriktug in Adult Participants With Asthma (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Uniquity One (UNI) | Not yet recruiting ➔ Recruiting

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

RAINIER: A Study to Evaluate Solriktug in Adult Participants With Asthma (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Uniquity One (UNI)

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

A Study to Evaluate Solrikitug in Participants With COPD (ZION) (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Uniquity One (UNI)

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

Blackstone Life Sciences Launches Uniquity Bio to Develop Novel Medicines in Immunology & Inflammation (Businesswire) - "Blackstone...today announced the launch of the Blackstone Life Sciences ('Blackstone') portfolio company Uniquity Bio...Uniquity Bio is emerging from stealth with an FDA acceptance of its Phase 2 investigational new drug ('IND') application for solrikitug, a monoclonal antibody targeting TSLP, and up to $300 million in capital from Blackstone to advance the asset in multiple indications....In the next month, Uniquity Bio will launch Phase 2 clinical trials in chronic obstructive pulmonary disease ('COPD') — the third leading cause of death worldwide, according to the World Health Organization — and asthma, which the WHO estimates affects more than 260 million people across the globe."

Financing • IND • New P2 trial • Asthma • Chronic Obstructive Pulmonary Disease