Longbio Pharma Presents Promising LP-003 Drug Data at AAD 2024

Longbio Pharma Co., Ltd., an eminent enterprise in the biotechnological field devoted to the creation of novel protein-based therapies aimed at allergy, lung conditions, skin disorders, blood-related illnesses, eye health, as well as various autoimmune and uncommon diseases, enthusiastically unveiled the initial stage clinical trial results for its pioneering treatment, LP-003, during the yearly conference of the American Academy of Dermatology Association held in 2024.

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During the symposium, Longbio Pharma's unveiling of their poster, entitled “A Phase 1 Study in Healthy Participants Examining LP-003, an Innovative Extended-Duration, High Specificity Anti-IgE Monoclonal Antibody,” signified an important event.

This initial Phase I clinical trial was designed as a randomized, placebo-controlled, single-dose escalation study involving 32 volunteers. These individuals were split into five distinct cohorts to receive one intravenous infusion of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, or 10 mg/kg of the drug. Investigators monitored for safety, as well as assessed pharmacokinetic and pharmacodynamic responses.

The pharmacokinetic analysis indicated an anomalous pattern, with LP-003's elimination half-life varying between 44.6 and 76.5 days, nearly double to triple the duration seen with Omalizumab. Notably, concentrations of free-IgE plunged below measurable limits for a span exceeding 168 days following administration within the 1 mg/kg to 10 mg/kg dosage range.

The tolerance profile for LP-003 was favorably received, with no incidents of severe treatment-emergent adverse events (Grade 3 or higher) observed, providing a robust platform for future research and progressive development steps.

Findings from the subsequent Phase II investigation of Ligelizumab suggest that anti-IgE monoclonal antibodies with enhanced affinity for IgE and intensified therapeutic action may prove to be more efficacious than Omalizumab.

Throughout this study, Longbio Pharma has pioneered a next-gen anti-IgE monoclonal antibody, LP-003, demonstrating superior IgE binding affinity and potentiated FcεRI inhibition activity, which surpasses both Omalizumab and Ligelizumab. Importantly, LP-003 also achieves a markedly prolonged half-life in relation to Omalizumab.

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According to the data provided by the Synapse Database, As of March 14, 2024, there are 3 investigational drugs for the CD3 and GD2 target, including 10 indications, 4 R&D institutions involved, with related clinical trials reaching 6, and as many as 5481 patents.

Bispecific antibodies like LP-003 have gained significant attention in the pharmaceutical industry due to their ability to simultaneously target two different antigens. By targeting CD3 and GD2, LP-003 aims to enhance the immune response against cancer cells, potentially leading to improved treatment outcomes for patients with the indicated diseases.