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- | SM03 / SinoMab
Journal: SM03, an Anti-CD22 Antibody, Converts Cis-to-Trans Ligand Binding of CD22 against α2,6-Linked Sialic Acid Glycans and Immunomodulates Systemic Autoimmune Diseases. (Pubmed Central) - Jul 28, 2022
P3
This in turn increased the activity of the downstream immunomodulatory molecule Src homology region 2 domain-containing phosphatase 1 (SHP-1) and decreased BCR-induced NF-κB activation in human B cells and B cell proliferation. This mechanism of action gives rationale to support the significant amelioration of disease and good safety profile in clinical trials, as by enabling the "self" recognition mechanism of CD22 via trans binding to α2,6 sialic acid ligands on autologous cells, SM03 specifically restores immune tolerance of B cells to host tissues without affecting the normal B cell immune response to pathogens.
- || SM03 / SinoMab
Clinical, P2 data, Journal: SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II randomized, double-blind, placebo-controlled study. (Pubmed Central) - May 11, 2022
P2
In active RA Chinese patients receiving background MTX, SM03 at a cumulative dose of both 2400 mg and 3600 mg is efficacious and well-tolerated throughout the 24 weeks of treatment. Moreover, SM03 has demonstrated a good safety profile.
- || suciraslimab (SM03) / SinoMab
New P1 trial: A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - Jan 10, 2021
P1, N=8, Completed, Sponsor: SinoMab Pty Ltd
- |||| suciraslimab (SM03) / SinoMab
Trial completion date, Trial primary completion date: A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX (clinicaltrials.gov) - Jan 7, 2021
P3, N=510, Recruiting, Sponsor: SinoMab Pty Ltd
Moreover, SM03 has demonstrated a good safety profile. Trial completion date: Dec 2020 --> Jul 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| suciraslimab (SM03) / SinoMab
New P3 trial: A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX (clinicaltrials.gov) - Mar 18, 2020
P3, N=510, Recruiting, Sponsor: SinoMab Pty Ltd
- SM03 / SinoMab BioScience
[VIRTUAL] EFFICACY AND SAFETY OF SM03, A RECOMBINANT ANTI-HUMAN CD22 MONOCLONAL ANTIBODY IN CHINESE PATIENTS WITH RHEUMATOID ARTHRITIS: A PHASE II RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, PLACEBO-CONTROLLED STUDY (Dequeker) - Mar 5, 2020 - Abstract #EULAR2020EULAR_1065;
In Chinese patients with active RA, both 2400mg and 3600mg cumulative doseof SM03,in combination with MTX were efficacious and well tolerated. throughout the 24 weeks of treatment.Moreover, SM03 has demonstrated a good safety profile, especially in terms of treatment-related infection, malignancy and immunogenicity.
- |||| suciraslimab (SM03) / SinoMab
New P2 trial: A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate (clinicaltrials.gov) - Dec 9, 2019
P2, N=156, Completed, Sponsor: SinoMab Pty Ltd