lesigercept (GI-301) / GI Innovation, Yuhan Corp, Maruho - LARVOL DELTA

A Phase 1b Study of Lesigercept, a Long-acting High-affinity IgETrap-Fc Fusion Protein: Safety, Tolerability, PK, and PD in Atopic Healthy and Allergic Subjects (EAACI 2026) - No abstract available

Clinical • P1 data • Immunology

Long-Acting IgETrap-Fc Fusion Protein YH35324 Mitigates Gliadin-Induced Anaphylaxis in a Murine Model (AAAAI 2026) - "One week later, a single subcutaneous injection of YH35324 (2.5, 10, or 40 mg/kg) or omalizumab was given. Conclusions A single administration of YH35324 provides robust protection against gliadin-induced anaphylaxis, restores Th1/Th2/Th17/Treg balance, and preserves intestinal integrity. These preclinical findings support YH35324 as a promising biologic candidate for WDEIA and other IgE-mediated food anaphylaxis."

Preclinical • Cholera • CCR4 • CCR6 • CXCR3 • FOXP3 • IFNG • IL10 • IL13 • IL17A • IL4 • IL5

The workshop also featured a presentation on 'GI-301 (development code YH35324),' GI Innovation's investigational candidate for allergic diseases. (BioNews) - "'GI-301 exhibits a binding affinity 70 times greater than that of the existing blockbuster drug Xolair, and has demonstrated robust efficacy even in patients with elevated immunoglobulin E (IgE) levels who are refractory to Xolair treatment.'"

Clinical data • Allergy

Yuhan Corporation Launches Full-Scale Global Phase 2 Trial of Allergy Drug Candidate Lesigercept (The Asia Business Daily) - "Yuhan Corporation announced on February 19 that it is moving into full-scale multinational Phase 2 clinical trials of lesigercept (development code YH35324), a novel anti-immunoglobulin E (anti-IgE) Fc fusion protein candidate, in patients with chronic spontaneous urticaria (CSU)...The Phase 2 trial is designed to evaluate the safety and efficacy of lesigercept versus placebo over 12 weeks in 150 patients with CSU. The primary endpoint is the change from baseline in UAS7 (Urticaria Activity Score over 7 days) at Week 12. The trial will be conducted in Asia and Europe, including the Republic of Korea, Japan, China, Bulgaria, and Poland....The company aims to obtain the main topline results in the fourth quarter of next year."

P2 data • Trial status • Chronic Spontaneous Urticaria

CLEAR: A Multi Dose, Phase 2 Study of YH35324 in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Yuhan Corporation

New P2 trial • Allergy • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

GI Innovation receives technology fees for GI-301 contract [Google translation] (HIT News) - "Receives 5.5 billion won in technology fees upon achieving milestones in the GI-301 license agreement with Yuhan Corporation."

Financing • Immunology

Clinical Immunology Society Reveals Phase 1b Part 2 Results of Clinical Immunology (Maeil) - P1b | N=30 | NCT05960708 | Sponsor: Yuhan Corporation | "Yuhan Corporation announced on the 15th that it announced the results of phase 1b clinical trial part 2 of its allergy treatment regurgitation therapy (YH35324) in the form of a poster at the European Allergy Clinical Immunology Society (EAACI) 2025....Clinical results showed that regsighercept strongly inhibited allergenic substances (IgE) in the blood for a long time, and also showed a clear improvement in the UAS7 (7-day urticaria activity score), an indicator of urticaria symptoms evaluation. Among the treated patients, the percentage of urticaria symptoms completely disappeared (score 0) or maintained a well-controlled state (score 6 or less) was higher than that of the control group."

P1 data • Chronic Spontaneous Urticaria

Exploratory Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of YH35324, a Long-Acting high-affinity IgETrap-Fc protein, in Patients with Chronic Spontaneous Urticaria Refractory to Omalizumab (EAACI 2025) - P1 | "One or more TEAEs were reported in 3 of the subjects (50.0%) in the YH35324 group and 2 (66.7%) of those in the placebo group; no serious or drug-related TEAEs were noted in the YH35324 group. Conclusion YH35324 demonstrated clinically meaningful symptom control in CSU patients refractory to Omalizumab, highlighting its therapeutic potential for this population."

Clinical • PK/PD data • Immunology

Therapeutic Efficacy of YH35324 on FcεRIα-Mediated Mast Cell/Basophil Activation. (PubMed, Allergy Asthma Immunol Res) - "YH represents a new therapeutic agent for IgE-mediated allergic disease. Further studies are needed to evaluate its additional effects on the FcεRIα-mediated autoimmune mechanism."

Journal • Allergy • Dermatology • Immunology • Urticaria • FCER2

"Lesigercept, blood free IgE suppression activity compared to omalizumab" [Google translation] (HIT News) - P1b | N=46 | NCT05564221 | Sponsor: Yuhan Corporation | "Yuhan Corporation...announced that it presented the results of the Phase 1b Part 1 clinical trial of lesigercept (development code name YH35324) as a poster at the 2025 annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI) on the 2nd...The purpose of Part 1 was to evaluate the characteristics of the test drugs compared to the control drugs when a single subcutaneous injection of lesigercept 3 mg/kg, 6 mg/kg or omalizumab 300 mg was administered as add-on therapy to H1 antihistamines in patients with chronic spontaneous urticaria not adequately controlled with H1 antihistamines for 8 weeks....The company said that clinical trial results showed that lesigercept showed safety in patients with chronic spontaneous urticaria and showed more potent and sustained blood free IgE suppression activity than omalizumab."

P1 data • Chronic Spontaneous Urticaria

Yuhan’s IgE inhibitor gets green light in phase 1 trial for chronic urticaria (Korea Biomedical Review) - P1 | N=30 | NCT05960708 | Sponsor: Yuhan Corporation | "According to the study’s abstract, which was released by the American Academy of Allergy, Asthma, and Immunology (AAAAI) on Monday (local time), YH35324...showed positive results in a phase 1 clinical trial in patients with chronic spontaneous urticaria (CSU)...The clinical results showed no significant differences in clinical characteristics among the three treatment groups, but YH35324 exhibited a dose-dependent pattern of increased drug exposure as the dose increased. Specifically, free IgE levels within serum in the YH35324 group decreased more significantly than those of omalizumab, with a longer duration of effect....Furthermore, when comparing the proportion of patients achieving complete control (UAS7=0) and partial control (UAS7≤6) during the eight weeks of treatment, the proportions were 16.7 percent and 50.0 percent in the YH35324 3 mg/kg group and 66.7% in the YH35324 6 mg/kg group, respectively."

P1 data • Chronic Spontaneous Urticaria

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YH35324, a Novel Long-Acting High-affinity IgETrap-Fc Fusion Protein, in patients with chronic spontaneous urticaria refractory to H1 antihistamines (AAAAI-WAO 2025) - P1 | "Five subjects (27.8%) experienced at least 1 TEAE (grade 1/2), while any serious or drug-related TEAEs were not observed. Conclusions These findings demonstrate the safety and superior therapeutic potential of YH35324 (in aspects of greater suppression of serum-free IgE and better symptom controls) in CSU patients compared to omalizumab."

Clinical • PK/PD data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

GI Innovation Registers European Material Patent for Next-Generation Allergy Treatment 'GI-301' [Google translation] (BioTimes) - "GI Innovation announced on the 3rd that the material patent for its allergy treatment drug GI-301 (YH35324) has been registered in Europe. With this registration, the material patent for GI-301 (YH35324) has been secured until 2039, and the period of validity can be extended up to 2044 after drug approval."

Patent • Allergy

A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects with Allergic Diseases (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: Yuhan Corporation | Active, not recruiting ➔ Completed

Trial completion • Allergy • Asthma • Atopic Dermatitis • CCL2 • CCL22 • IFNG • IL10 • IL13 • IL18 • IL22 • IL33 • IL4 • IL5

A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Yuhan Corporation | Active, not recruiting ➔ Completed

Trial completion • Allergy • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Yuhan Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Yuhan Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Asthma • Atopic Dermatitis • CCL2 • CCL22 • IFNG • IL10 • IL13 • IL18 • IL22 • IL33 • IL4 • IL5

A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Yuhan Corporation | Phase classification: P1b ➔ P1 | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Phase classification • Trial completion date • Trial primary completion date • Allergy • Asthma • Atopic Dermatitis • CCL2 • CCL22 • IFNG • IL10 • IL13 • IL18 • IL22 • IL33 • IL4 • IL5

Therapeutic efficacy of YH35324 on FcεRIα-mediated mast cell activation (EAACI 2024) - "This study aims to evaluate the therapeutic potential of YH as an anti-IgE immunomodulator compared to omalizumab (Oma). The level of serum soluble FcεRIα was significantly higher in the YH-administration group than in the Oma-administered group, while no differences were noted in serum levels of soluble CD23 and MRGPRX2 between the two groups. Conclusion These findings suggest that YH can be a new therapeutic option for IgE-mediated allergic disease."

Clinical • Allergy • Immunology • FCER2

Yuhan Corporation, sales in the first quarter of KRW 444.6 billion… maintained first place in the industry [Google translation] (Health Korea News) - "According to Yuhan Corporation's first quarter performance disclosure (consolidated financial statements) released on the 16th, sales were KRW 444.6 billion, an increase of 0.35% compared to the same period last year (KRW 443 billion)...'R&D expenses increased compared to the previous year due to the progress of the clinical stage pipeline YH32324 (allergy treatment, clinical trial phase 1b) and YH32367 (HER2x4-1BB bispecific antibody, clinical trial phase 1/2)....'Leclaza', a new drug for non-small cell lung cancer, is expected to contribute to improving profitability starting in the second quarter due to the expansion of nursing care benefits to patients receiving first-line treatment for EGFR non-small cell lung cancer and the final drug price being determined."

Commercial • Allergy • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Single Dose, Phase 1 Study of YH35324 in Patients With Various Allergic Diseases (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Yuhan Corporation | Trial completion date: Mar 2024 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Allergy • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Yuhan Corporation announces results of phase 1 clinical trial at AAAAI for allergic disease treatment [Google translation] (Medifonews) - P1 | N=68 | NCT05061524 | Sponsor: Yuhan Corporation | "Yuhan Corporation...announced the results of the Phase 1a clinical trial Part B of YH35324 at the poster presentation session on Saturday, February 25th at the 2024 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI)....As a result of clinical trials, YH35324 showed an excellent safety profile in patients with elevated total IgE levels (> 700 IU/mL) and stronger and more sustained IgE suppression activity than existing treatments. Meanwhile, the results of Part A of this phase 1a clinical trial were announced at the European Association of Allergy and Clinical Immunology (EAACI) 2023 annual meeting held last year."

P1 data • Allergy • Immunology

Yuhan Corporation publishes phase 1a results of allergy drug candidate 'YH35324' in academic journal [Google translation] (HIT News) - P1 | N=68 | NCT05061524 | Sponsor: Yuhan Corporation | "Yuhan Corporation...announced that the full results of the phase 1a clinical trial of 'YH35324', a new drug candidate for allergic diseases, were published on the 20th in 'International Immunopharmacology (Impact Factor 5.6)', an SCI-level international academic journal....According to the study results, YH35324 was confirmed to be significantly tolerable and safe at all doses, and dose proportional in terms of pharmacokinetics. Regarding ‘blood free IgE’, a major pharmacodynamic biomarker, it showed more powerful and sustained IgE inhibition activity compared to placebo or omalizumab."

P1 data • Allergy • Immunology

Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of YH35324, a novel Long-Acting High-Affinity IgETrap-Fc protein in subjects with Atopy: Results from the First-in-Human study. (PubMed, Int Immunopharmacol) - "This study showed that YH35324 has a favorable safety profile and is effective in reducing serum-free IgE levels in subjects with atopic conditions."

Clinical • Journal • P1 data • PK/PD data • Allergic Rhinitis • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Inflammation • Urticaria

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YH35324, a Novel Long-Acting High-Affinity IgETrap-Fc Fusion Protein, in Atopic Subjects with a Total IgE > 700 IU/mL (AAAAI 2024) - "The study demonstrates the favorable safety profile and promising therapeutic potential of YH35324 by effectively suppressing serum free IgE in subjects with high serum total IgE levels, supporting for the continued development of YH35324 as a therapeutic option for IgE-mediated allergic diseases."

Clinical • PK/PD data • Allergic Rhinitis • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Inflammation • Urticaria