NANJING, China, June 17,
2024 /PRNewswire/ -- At the recent European League
Against Rheumatism (EULAR) Congress in Vienna, Austria, Nanjing Leads Biolabs Co.,
Ltd. (Leads Biolabs) delivered an oral presentation on its highly
innovative therapeutic candidate LBL-047. LBL-047 is a
first-in-class, long-acting TACI/BDCA2 bispecific antibody fusion
protein. LBL-047 is composed of a Transmembrane Activator and a
Calcium Modulator and Cyclophilin Ligand Interactor (TACI) domain
fused to an antibody targeting Blood Dendritic Cell Antigen 2
(BDCA2). The bispecific antibody is further modified with the YTE
mutation on the Fc region to prolong the half-life in circulation,
thereby, enabling less frequent dosing, and improved patient
compliance.
LBL-047 has demonstrated excellent activity and pharmacokinetic
properties in multiple preclinical experiments.
- Significantly inhibit INF-α release
- Robust depletion of pDCs in vitro and in vivo
- Superior inhibition of B cell and plasma cell function in vitro
and in vivo compared to marketed TACI fusion protein
- Significantly alleviated clinical symptoms and inhibited B cell
and plasma cell function in EAE mouse model (MS model)
- Excellent PK profile and markedly reduced IgM, IgA, IgG in
cynomolgus monkey for up to six weeks
These results indicate that LBL-047 can simultaneously inhibit B
cell function and deplete interferon-secreting pDCs, thereby
attenuating autoimmune activity. This innovative research offers
new possibilities for treating a wide range of autoimmune related
diseases, including Systemic Lupus Erythematosus (SLE), Cutaneous
Lupus Erythematosus (CLE), Lupus Nephritis (LN), Sjogren's
Syndrome, and Myasthenia Gravis. Engineered to significantly
prolong the dosing interval, LBL-047 presents an optimal product
profile for subsequent clinical and commercial development.
Huang Xiao, Vice President of
Discovery Research at Leads Biolabs, said: "EULAR is a highly
anticipated event in the fields of rheumatology and immunology. We
are honored to be featured in this prestigious gathering of over
18,000 experts and scholars from more than 130 countries to share
the exciting data we have generated. LBL-047, independently
developed and fully owned by Leads Biolabs, represents a
significant achievement arising from our differentiated innovation
strategy. Its unique design is based on our profound understanding
of autoimmune diseases and target mechanisms, integrating extensive
antibody engineering technologies and optimization efforts. We are
very pleased with the results we have seen in preclinical studies.
Leads Biolabs is dedicated to our corporate philosophy of 'care for
life, focus on innovation, and win-win cooperation,' and is
committed to providing safer and more effective treatment options
for patients. Currently, LBL-047 is in the preclinical research
stage, and we will continue to efficiently promote the development
of this drug candidate to bring effective treatments to patients
with autoimmune diseases as soon as possible."
About LBL-047
B cells and pDCs play a crucial and synergistic role in the
pathogenesis of many autoimmune diseases. Inhibiting the function
of B cells and pDCs is a potential therapeutic strategy for
treating various autoimmune diseases. LBL-047 is a long-acting
TACI/anti- BDCA2 bispecific fusion protein, obtained by fusing an
engineered TACI domain with a defucosylated anti-BDCA2 humanized
monoclonal antibody.
TACI is the natural high-affinity receptor for B cell activation
factor of the tumor necrosis factor family (BAFF) and a
proliferation-inducing ligand (APRIL), which are key cytokines that
promote B cell and plasma cell survival, maturation, and function.
Engineered TACI domain can be used to trap BAFF and APRIL,
inhibiting B-cell function.
BDCA2 is specifically expressed on pDCs and BDCA2 agonist
antibody can suppress the IFNs release. Additionally, anti-BDCA2
antibodies can directly eliminate pDCs through mechanisms such as
ADCC, inhibiting pDC-mediated immune responses. The defucosylated
anti-BDCA2 antibody has stronger ADCC activity, and the
introduction of YTE mutation in the Fc region further prolongs the
half-life of the antibody.
Preclinical studies have demonstrated that LBL-047 can potently
inhibit the functions of B cells and pDCs simultaneously, and
possesses excellent pharmacokinetic properties, indicating broad
clinical applications and market prospects in the treatment of
various autoimmune diseases.
About Leads Biolabs
Nanjing Leads Biolabs Co., Ltd. is a clinical-stage
biotechnology company founded in Nanjing by a team of senior U.S.-trained
antibody drug developers. Since 2014, Leads Biolabs has been
dedicated to the discovery and development of novel antibody drugs
with independent intellectual property rights for the treatment of
oncology and other major diseases of high unmet medical needs,
particularly the challenges in cancer immunotherapy. Our extensive
R&D pipeline consist of more than twenty novel tumor
immunotherapy, autoimmunity and ADC molecules based on monoclonal
and bispecific antibody technology platforms. Leads Biolabs is
committed to providing safe, effective, accessible, and affordable
new drugs to address the unmet needs of patients around the
world.
Contact
BD@leadsbiolabs.com
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SOURCE Leads Biolabs