LongBio Pharma (Suzhou) Co., Ltd. (referred to as “LongBio”), a leading biotech company dedicated to developing innovative protein treatments for nephrology, allergy, respiratory, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of pre-clinical data of LP-005, a novel bi-functional complement antibody-fusion protein, at the 2024 World Congress of Nephrology (WCN24) held by International Society of Nephrology (ISN).
The poster titled “Bi-functional C5 antibody-fusion protein (LP-005) with potential best-in-class bioactivity for complement inhibition” was presented by LongBio during the conference.
Date and Time: April 15, 2024, at 17:45 pm (UTC -3)
Location: Exhibition Hall and Main Foyer
Poster Number: MON-100
Methods: Eculizumab, POT-4 (also known as APL-1) was purchased from vendors. The sequences of Ravulizumab, Crovalimab, Pozelimab, Narsoplimab and Ab-fH were obtained from INN and made in-house with LP-005, LP-005C. CP, AP, LP and C3b deposition assays with head-to-head comparison were conducted. Monkey PK/PD assay of LP-005C and Ab-fH was also conducted.
Results: LP-005 shows the most potent inhibition in CP, AP and LP compared to Eculizumab, Ravulizumab, Crovalimab, Pozelimab and Narsoplimab.
In addition, it also has the most efficient inhibition in C3b assay compared to Antibody-fH fusion and POT-4 (APL-1).
The monkey PK/PD study indicates that when fusing to the same C5 antibody, LongBio’s unique inhibitor (inCibitorTM) shows a better PK/PD profile compared to the natural fH 1-5 fragment.
LP-005 is a novel bifunctional complement antibody fusion protein targeting both C3 and C5, with better bioactivity in CP, AP, LP and C3b deposition assays. Meanwhile, LP-005 is engineered to optimize surface charge (PI) and FcRn binding, making it first Q4W bi-functional complement inhibitor all over the world. With all these advantages above, LP-005 has the potential to be a best-in-class drug candidate with excellent and full complement inhibitory activity and will be explored in complement mediated disorders.
LP-005’s phase I study in healthy volunteers will be completed in 2024Q2 in China. At present, LP-005 showed expected PK/PD profile and well tolerated safety profile. More clinical data will be unveiled at 2024 European Meeting on Complement in Human Diseases in September. The phase II studies with indication of IgAN (IgA Nephropathy) and PNH (Paroxysmal nocturnal hemoglobinuria, rare disease) will initial in 2024Q2. Other indications in neurology and ophthalmology are also scheduled to develop.
About InCibitor™
InCibitorTM is a new generation of complement inhibitor platform developed by LongBio. The bi-functional complement inhibitor LP-005 developed based on this platform is going to start Phase II study of IgAN and PNH. LongBio is also exploring the development of new drugs related to hematology, nephrology, neurology, ophthalmology, oncology, and gene therapy based on this platform.
About LongBio
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 2024Q2, and prepare for BLA in 2025H1. The second leading pipeline is a bi-functional complement antibody fusion-protein (LP-005) , which is in Phase I at present, intending to start Phase II/III in 2024Q2.
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
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