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

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

GI Innovation transfers technology for allergy treatment drug 'GI-301' to Japan's Maruho (HIT News) - "GI Innovation...announced on the 16th that it had transferred the technology of its allergy treatment drug 'GI-301 (development code name)' to Japan-based Maruho for approximately KRW 298 billion. Through this contract, GI Innovation will receive step-by-step milestones from Maruho, including a down payment without obligation to return and royalties from clinical development, commercialization, and sales. Maruho will lead the clinical trials and commercialization of GI-301 in Japan....Meanwhile, GI Innovation transferred the global copyright of GI-301 (YH35324), excluding Japan, to Yuhan Corporation in 2020 for 1.4 trillion won. GI-301 is currently undergoing phase 1b clinical trials in Korea."

Licensing / partnership • Allergy • Immunology

Medidata provides ‘patient-centered clinical electronic questionnaire’ to Yuhan Corporation [Google translation] (HIT News) - "Medidata...announced on the 19th that it had introduced the 'patient-centered clinical trial electronic questionnaire (Medidata eCOA)' developed by the company into the phase 1 clinical trial of a new drug candidate for allergic diseases being conducted by Yuhan Corporation....A Medidata official said, ''Medidata eCOA', which Yuhan Corporation used in the clinical trial, is an electronic questionnaire solution that can easily and accurately collect clinical trial data from patients, clinicians, and caregivers.'"

Trial status • Allergy • Atopic Dermatitis • Chronic Spontaneous Urticaria • Immunology • Urticaria

Yuhan Corporation registers patients for phase 1 clinical trial for allergy treatment… “Starting the 2nd Rekraza” [Google translation] (FETV- Financial Economic TV) - "Yuhan Corporation...has begun full-scale domestic clinical trials of ‘YH35324’, which is being developed as a treatment for chronic idiopathic urticaria. This is an initial clinical trial to secure the second indication following the indication for treatment of allergic patients suffering from atopy. According to the Ministry of Food and Drug Safety on the 30th, Yuhan Corporation completed registration of the first patient in phase 1 clinical trials on the 23rd to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of 'YH35324' for various allergic diseases....The results of the Phase 1 clinical trial of YH35324 are expected to be released between the end of this year and the first half of next year."

P1 data • Trial status • Chronic Spontaneous Urticaria • Immunology • Urticaria

GI Innovation nets European patent for allergy microbiome combo (Korea Biomedical Review) - "GI Innovation, a Korean drug developer, said on Thursday that it successfully registered a European patent for its allergy drug GI-301 (YH35324) and microbiome combination therapy. Accordingly, the patent not only has no sequence limitation for IgE TRAP, but also covers the microbiome, securing a broad scope of rights and blocking competitor’s commercialization of microbiom utilizing the lgE Trap-Fc fusion protein."

Patent • Allergy • Immunology

A Single Dose, Phase 1 Study of YH35324 in Patients With Various Allergic Diseases (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Yuhan Corporation

New P1 trial • Allergy • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

GI Innovation to pursue license out deal for allergy treatment with Japanese firms (Korea Biomedical Review) - "GI Innovation expressed its intention to pursue a license out deal for GI-301, an allergy treatment, with Japanese companies at a press conference at the Grand InterContinental Seoul Parnas Hotel, in southern Seoul, on Monday. 'We are currently in talks with three Japanese pharmaceutical companies to transfer technology for GI-301, and we will finalize the transfer within this year'"

Licensing / partnership • Allergy • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Inflammation • Respiratory Diseases • Urticaria