Delving into the Latest Updates on Recombinant anti-CD20 humanized monoclonal antibody (Shanghai Jiaolian Drug) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Target

Mechanism

CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), T lymphocytes stimulants

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [3]

Active Indication

Idiopathic Membranous GlomerulonephritisGlomerulonephritis, MembranousMyasthenia Gravis+ [2]

Inactive Indication

CD20 Positive B-Cell Non-Hodgkin Lymphoma

Originator Organization

Shanghai Jiaolian Drug Development Co. Ltd.

Active Organization

Shanghai Jiaolian Drug Development Co. Ltd.

Shanghai Pharmaceuticals Holding Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

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BACKGROUNDOcrelizumab is a recombinant humanized anti-CD20 monoclonal IgG1, approved by FDA and EMA for adult patients with multiple sclerosis (MS). The data on the efficacy and safety of Ocrelizumab for pediatric MS cases are limited.OBJECTIVEHere, we describe pediatric relapsing-remitting MS (P-RRMS) cases who were treated with Ocrelizumab as a disease-modifying drug.METHODP-RRMS cases who were started Ocrelizumab below 18 years-of-age and followed-up >12 months with Ocrelizumab treatment were included. The primary end-points were annualized relapse rate (ARR) and magnetic resonance imaging (MRI) activity (new/enlarging T2 lesions and new gadolinium (Gd) enhancing lesions). The secondary end-points were the percentage of patients who remain relapse-free and/or free from Gd enhancing lesions, Expanded Disability Status Scale (EDSS) score, and the safety profile of Ocrelizumab.RESULTSOf 18 P-RRMS cases receiving Ocrelizumab, 10 patients fulfilled the inclusion criteria for our study. The median duration of follow-up under Ocrelizumab was 28,3 months (min: 15 months, max: 46 months). Mean ARR decreased from 2.01 (±0.71) to 0 during the follow-up of Ocrelizumab treatment (P < 0.0001). None of the patients had MRI activity during the treatment. Mean EDSS decreased from 1.75 (±1.09) to 1.20 (±0.63) from the initiation of Ocrelizumab to the last follow-up of the patients (P = 0.024). None of the patients had serious side effects, except one patient who experienced anaphylaxis.CONCLUSIONOcrelizumab can be considered a safe and effective treatment option in highly active P-RRMS.

01 Jul 2021·Journal of Dental ResearchQ2 · MEDICINE

Host Modulation and Treatment of Periodontal Disease

Q2 · MEDICINE

Review

Author: Blix, I.J. ; Balta, M.G. ; Papathanasiou, E. ; Van Dyke, T.E.

Periodontitis is the sixth-most prevalent disease in the world and the first cause for tooth loss in adults. With focus shifted to the inflammatory/immune response in the pathogenesis of periodontitis, there is a critical need to evaluate host modulatory agents. Synthetic and biological disease-modifying antirheumatic drugs are a cornerstone for the treatment of inflammatory diseases. Recent prospective cohort studies showed that synthetic disease-modifying antirheumatic drugs improved periodontal clinical parameters following nonsurgical periodontal treatment in patients with rheumatoid arthritis. Treatment with recombinant humanized monoclonal antibodies against CD20 (rituximab) and IL-6 receptor (tocilizumab), the latter also in clinical trials for the treatment of COVID-19 pneumonia, resulted in decreased periodontal inflammation and improved periodontal status. Studies on the effect of TNF-α inhibitors in patients with periodontitis yielded inconsistent results. Recent data suggest that probiotics provide anti-inflammatory clinical benefit, as do nutritional supplements, such as n-3 fatty acids, when combined with periodontal therapy. Probiotics reduce the production of proinflammatory cytokines/chemokines by suppressing NF-κB pathways and promote the accumulation of T regulatory cells. Statins, like aspirin, have been shown to exhibit anti-inflammatory and bone-preserving actions by upregulating production of Specialized Proresolving Mediators (SPMs). Currently, there is insufficient scientific support for the topical delivery of statins or bisphosphonates as adjuncts to periodontal therapy. Here, we present a critical review of the most recent host modulatory agents applied in humans and the key immune pathways that they target. Emerging evidence from novel drug candidates, including SPMs and complement inhibitors as previously studied in animal models and currently in human clinical trials, suggests future availability of adjunctive therapeutic strategies for the management of periodontitis.

01 Jan 2020·Multiple Sclerosis Journal - Experimental, Translational and Clinical

An exploratory analysis of the efficacy of ocrelizumab in patients with multiple sclerosis with increased disability

Article

Author: Fox, Edward J ; Wolinsky, Jerry S ; Pradhan, Ashish ; Markowitz, Clyde ; Pei, Jinglan ; Engmann, Natalie J

BACKGROUNDOcrelizumab, an anti-CD20 humanized monoclonal antibody, reduced disease progression in pivotal trials of patients with relapsing (OPERA I, OPERA II) and primary progressive (ORATORIO) multiple sclerosis (MS). These effects may be particularly important among patients with increased disability.OBJECTIVEIn this post hoc exploratory analysis, we evaluated the efficacy of ocrelizumab on disability progression among a subgroup of patients with MS who had increased baseline disability levels (Expanded Disability Status Scale scores ≥4.0) in the pivotal trials.METHODSDuring the double-blind period, patients received ocrelizumab 600 mg intravenously every 24 weeks for 96 weeks in the OPERA trials (versus interferon β-1a 44 μg subcutaneously three times per week) and for 120 weeks in ORATORIO (versus placebo). Kaplan-Meier and Cox survival analyses were used to assess disability outcome measures.RESULTSBaseline demographic, disease, and treatment characteristics were generally comparable across treatment groups in patients with increased disability from the OPERA and ORATORIO trials. Ocrelizumab treatment numerically, and in some instances significantly, reduced confirmed disability progression versus the comparator in these patients.CONCLUSIONSIn patients with increased baseline disability, ocrelizumab reduced the risk of confirmed disability progression versus interferon β-1a in patients with relapsing-onset MS and versus placebo in patients with progression-onset MS.

100 Deals associated with Recombinant anti-CD20 humanized monoclonal antibody (Shanghai Jiaolian Drug)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	Phase 3	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	30 Jul 2024
Glomerulonephritis, Membranous	Phase 3	CN	Shanghai Jiaolian Drug Development Co. Ltd.	16 Jul 2024
Myasthenia Gravis	Phase 3	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	01 Jul 2024
Pemphigus	Phase 3	CN	Shanghai Jiaolian Drug Development Co. Ltd.	26 Jun 2024
Nephrosis	Phase 1	CN	Shanghai Jiaolian Drug Development Co. Ltd.	03 Sep 2022
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 1	CN	Shanghai Jiaolian Drug Development Co. Ltd.	16 Nov 2021