Humanized Anti-IgE monoclonal antibody(Tianchen Biomedical)

SAN DIEGO, March 12, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the Phase I data of LP-003 (new generation of anti-IgE antibody) at the 2024 American Academy of Dermatology Association annual meeting (2024AAD). The presentation of the poster titled "A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody" by Longbio Pharma marked a significant moment during the conference. Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody Abstract Submission ID: 50484 Presentation Time: Mar 8-12, 2024 Location: Poster Exhibits Center Results: In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into 5 groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 44.6 days to 76.5 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 168 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. Chronic spontaneous urticaria (CSU) stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Despite SoC treatment, the efficacy and duration of relief remain significant challenges for patients and healthcare providers alike. Anti-IgE therapy was approved as a second-line treatment, however, only approximately 40% of patients achieving complete response following 300 mg Omalizumab dosing. Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed. The successful Phase II study of Ligelizumab points a way that anti-IgE antibody with higher IgE affinity and more potent efficacy (FcεRI inhibition) retains the potential to be superior against Omalizumab. In this study, Longbio Pharma developed a new generation of anti-IgE antibody, LP-003, of higher IgE binding affinity, stronger FcεRI inhibition bioactivity, compared to Omalizumab and even Ligelizumab. Meanwhile, LP-003 has a much longer half-life (approximately 45∽76 days) compared to Omalizumab (approximately 17∽20 days). Moreover, a Phase II clinical trial (NCT06228560) of total 200 adult refractory CSU patients, despite up-dosing anti-histamine (H1) treatment, are being enrolled into 5 distinct groups (n=40/group), including three LP-003 treatment groups, one omalizumab treatment group, to provide a head-to-head comparison, and one placebo group. The topline results are expected to be released in early 2025. About LP-003 LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity (FcεRI and FcεRII/CD23 inhibition), off-target binding and animal study (Tox and efficacy) was conducted. LP-003 just accomplished its Phase II study of allergic rhinitis. The current data shows LP-003 has the potential to become a best-in-class treatment. About Longbio Pharma LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and complement diseases, serving patients and society. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma

WASHINGTON, Feb. 25, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of preliminary Phase II data for LP-003, the new generation anti-IgE antibody, at the 2024 American Academy of Allergy, Asthma & Immunology annual meeting (AAAAI 2024). The presentation of the poster titled "A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis" by Longbio Pharma marked a significant moment during the conference. Title: A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis ClinicalTrials.gov ID: NCT06046391 Date and Time: February 25, 2024, at 9:45 am (UTC -5) Location: Convention Center, Level 2, Hall D Poster Number: 591 Methods: A randomized, double-blind, placebo-controlled Phase II clinical study (NCT06046391), 180 adult patients with moderate to severe seasonal AR despite standard therapy in the previous 2 seasons were randomized to receive LP-003 100mg (n=40), LP-003 200 mg (n=80) or placebo (n=60). All patients received concomitant nasal corticosteroids with/without antihistamines as SoC. The primary endpoint was the mean nasal symptom score during the peak pollen period (PPP). Secondary endpoints included mean ocular symptom score, immunogenicity and safety profile etc. Results: the TNSS (mean nasal symptom score) during PPP was significantly lower in the LP-003 groups (3.17±2.17 for 100mg group and 3.45±2.45 for the whole groups) than that in the placebo group (4.25±2.74), with both P values <0.05. Meanwhile, LP-003 exhibited a favorable safety profile, with similar incidence of adverse events (AEs) between LP-003 groups and placebo group. The most common AEs (>2% in either group) reported were hyperuricemia, upper respiratory tract infection and nasopharyngitis. Comparing to the first-generation anti-IgE antibody, omalizumab, 100mg LP-003 demonstrate comparable efficacy to 300mg omalizumab in this study. Moreover, subgroup analysis revealed potential superior bioactivity of LP-003 compared to omalizumab using comparable pollen density conditions. "Anti-IgE therapy has been proven to be effective in AR treatment, however, Omalizumab's dosing regimen has limited its clinical application. This Phase II study shows that 100mg LP-003 significantly improved nasal symptoms (TNSS score) of uncontrolled seasonal allergic rhinitis patients despite SoC treatment. In addition, LP-003's fixed and reduced dose promises to alleviate the cost burden on insurance and patients, enhance drug accessibility, and maximize pharmacoeconomic value," exclaimed by Dr. Sun, Nai-chau, co-founder of Longbio Pharma, also the inventor of omalizumab and co-founder of Tanox Inc. " AAAAI is recognized as the premier global conference in the field of allergic diseases. We are honored to unveiled the exciting Phase II results of LP-003, the first registrational clinical trial of anti-IgE antibody for AR conducted in China." As Longbio Pharma charts its course forward, the successful Phase II study of LP-003 in allergic rhinitis represents a pivotal milestone in advancing the treatment landscape for allergic diseases. With Phase III clinical trials set to commence around 2024 March, the company is poised to continue its legacy of excellence, forge international partnerships, and shape the future of allergy treatment on a global scale. About LP-003 LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity, off-target binding and animal study (Tox and efficacy) was conducted. The current data of Phase I and Phase II shows LP-003 is potentially to become a best-in-class treatment. Simultaneously, a Phase II study focusing on chronic spontaneous urticaria (CSU) is underway (NCT06228560), showcasing Longbio Pharma's commitment to exploring diverse therapeutic avenues. The company expects to start the phase III study of allergic rhinitis at 2024 Q1/2, and will get the topline result for LP-003 Phase III study by the end of 2024. About Longbio Pharma LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare diseases, serving patients and society. LongBio Pharma aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is about to start Phase III study in 2024Q1, and prepare for BLA in 2025H1. Another leading pipeline is a bifunctional complement inhibitor (LP-005) , which is in Phase I at present, intending to start Phase II/III in 2024Q2. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma