Delving into the Latest Updates on Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms-

Target

CD52

Action

inhibitors

Mechanism

CD52 inhibitors(CAMPATH-1 antigen inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

B-Cell Prolymphocytic LeukemiaChronic Lymphocytic LeukemiaDiffuse Large B-Cell Lymphoma+ [5]

Inactive Indication-

Originator Organization

Lanzhou Institute of Biological Products Co. Ltd.

Active Organization

Shanghai Taiyin Biological Engineering Co., Ltd.

Lanzhou Institute of Biological Products Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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多中心、单臂、开放、非随机化评价重组人源化抗CD52 单克隆抗体注射液治疗复发难治的 NHL（包括CLL/SLL、 PLL、 PTCL、弥漫大 B 细胞淋巴瘤、滤泡细胞淋巴瘤、套细胞淋巴瘤、边缘区淋巴瘤）、初治的 T-PLL 安全及耐受性、药代动力学特征并初步探索疗效的Ⅰ期临床研究。

[Translation] This is a multicenter, single-arm, open, non-randomized Phase I clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics, and preliminary efficacy of recombinant humanized anti-CD52 monoclonal antibody injection in the treatment of relapsed or refractory NHL (including CLL/SLL, PLL, PTCL, diffuse large B-cell lymphoma, follicular cell lymphoma, mantle cell lymphoma, marginal zone lymphoma) and newly diagnosed T-PLL.

主要研究目的是评价单次、多次不同剂量重组人源化抗 CD52 单克隆抗体注射液在患者体内的安全性及耐受性，并确定剂量限制性毒性（DLT）和最大耐受剂量（MTD），为Ⅱ期推荐剂量（RP2D）。次要研究目的是评价单次、多次不同剂量重组人源化抗 CD52 单克隆抗体注射液在患者体内的药代动力学（PK）特征并初步探索疗效。

[Translation]

The primary study objective is to evaluate the safety and tolerability of single and multiple doses of recombinant humanized anti-CD52 monoclonal antibody injection in patients, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), which is the recommended dose for Phase II (RP2D). The secondary study objective is to evaluate the pharmacokinetic (PK) characteristics of single and multiple doses of recombinant humanized anti-CD52 monoclonal antibody injection in patients and to preliminarily explore the efficacy.

Start Date25 Nov 2020

Sponsor / Collaborator

Shanghai Taiyin Biological Engineering Co., Ltd.

[+1]

100 Clinical Results associated with Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.)

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100 Translational Medicine associated with Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.)

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100 Patents (Medical) associated with Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.)

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26

Literatures (Medical) associated with Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.)

01 Oct 2024·Multiple Sclerosis and Related Disorders

Siponimod following Alemtuzumab in secondary progressive MS: investigating sequential therapy–A case series

Article

Author: Zanghì, Aurora ; Di Filippo, Paola Sofia ; Avolio, Carlo ; D'Amico, Emanuele

Alemtuzumab, a humanized anti-CD52 monoclonal antibody, is approved for treatment of highly active relapsing multiple sclerosis (MS) but requires vigilant post-treatment monitoring due to associated risks. The prescription of subsequent therapies following Alemtuzumab, as mandated by label guidance for a treatment-free period of at least 5 years, presents a complex challenge, particularly if there is concurrent conversion to secondary progressive disease course. We described a case-series of five patients starting therapy with Siponimod and followed up for 12 months period converted to secondary progressive MS previously exposed to Alemtuzumab. All patients received Siponimod 2 mg. Clinical evaluation measured with Expanded Disability Status Scale and cognitive evaluation measured with Brief International Cognitive Assessment for Multiple Sclerosis were stable after 12 months on therapy. No severe lymphopenia was recorded, nor serious adverse events. In conclusion, the long-term management of patients treated with Alemtuzumab transitioning to secondary progressive MS requires a proactive and multidisciplinary approach. By addressing the challenges associated with treatment limitations and short-term monitoring recommendations while considering alternative therapeutic options like Siponimod, clinicians can optimize outcomes and ensure continuity of care for individuals with MS.

01 Jun 2023·Multiple Sclerosis and Related Disorders

A real-life study of alemtuzumab in persons with multiple sclerosis: Kuwait's experience

Article

Author: Al-Hashel, Jasem ; Ahmed, Samar Farouk ; AlMojel, Malak ; Alroughani, Raed

BACKGROUNDAlemtuzumab, a humanized anti-CD52 monoclonal antibody, has been approved as a treatment in persons with active relapsing-remitting multiple sclerosis (RRMS). Real-world data in middle east is very limited. We aimed to evaluate the effectiveness and safety of alemtuzumab in a real-world clinical setting.METHODSThis observational, registry based study assessed persons with multiple sclerosis (PwMS) who were treated with alemtuzumab and completed at least follow up one year after second course. Baseline clinical and radiological characteristics within one year prior to alemtuzumab initiation were collected. The relapse rate, disability measures, radiological activity and adverse events at last follow-up visits were assessed.RESULTSData of seventy-three persons with multiple sclerosis (MS) was analyzed, of which 53 (72.6%) were females. Mean age and mean disease duration were 34.25 ± 7.62 and 9.23 ± 6.20 years respectively. Alemtuzumab was started in 32 (43.8%) naïve patients due to highly active disease and in 25 (34.2%) (PwMS) who were on prior therapies and in 16 (22%) patients due to adverse events on prior medications. Mean follow-up period was 4 ± 1.67 years. In the last follow-up visits, most of our cohort was relapse free (79.5% vs. 17.8%; p < 0.001) compared to baseline before alemtuzumab treatment while mean EDSS score was reduced (2.21 ± 2.15 vs. 2.41 ± 1.85; p < 0.059). The proportion of PwMS who had MRI activity (new T2/ Gd-enhancing) lesions were significantly reduced compared to baseline (15.1% vs. 82.2%; p < 0.001). NEDA-3 was achieved in 57.5% of (PwMS). NEDA-3 was significantly better in naïve patients (78% versus. 41.5%; p < 0.002) and in patients with disease duration < 5 years, (82.6% v 43.2%; p < 0.002). Several adverse events such as infusion reactions (75.3%), autoimmune thyroiditis (16.4%) and glomerulonephritis (2.7%) were reported.CONCLUSIONThe effectiveness and safety profile of alemtuzumab in this cohort were consistent with data of clinical trials. Early initiation of Alemtuzumab is associated with favorable outcome.

01 Apr 2020·BioTechniquesQ4 · ENGINEERING & TECHNOLOGY

A Cell-Based Assay for the Detection of Neutralizing Antibodies Against Alemtuzumab

Q4 · ENGINEERING & TECHNOLOGY

ArticleOA

Author: Giovannoni, Gavin ; Schmierer, Klaus ; Jones, Meleri ; Gammon, Luke ; Leisegang, Georgia R ; Kang, Angray S ; Baker, David ; Saxena, Gauri ; Ali, Liaqat ; Gnanapavan, Sharmilee

Aim: The humanized anti-CD52 monoclonal antibody alemtuzumab depletes lymphocytes and is currently used to treat relapsing multiple sclerosis. During treatment, anti-alemtuzumab antibodies may develop and reduce effective lymphocyte depletion in future treatment cycles. Results: Alemtuzumab–Alexa Fluor 488 conjugate binding to the CHO-CD52 cell surface was inhibited by anti-alemtuzumab antibodies. Conclusion: In this proof-of-concept study, a CHO-CD52 cell line has been developed and used to detect the presence of anti-alemtuzumab neutralizing antibodies. This platform provides the basis of an assay for routine screening of serum for neutralizing antibodies from patients treated with alemtuzumab.

100 Deals associated with Recombinant anti-CD52 humanized monoclonal antibody(Lanzhou Institute of Biological Products Co. Ltd.)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Prolymphocytic Leukemia	Phase 1	China	Lanzhou Institute of Biological Products Co. Ltd.	25 Nov 2020
B-Cell Prolymphocytic Leukemia	Phase 1	China	Shanghai Taiyin Biological Engineering Co., Ltd.	25 Nov 2020
Chronic Lymphocytic Leukemia	Phase 1	China	Shanghai Taiyin Biological Engineering Co., Ltd.	25 Nov 2020
Chronic Lymphocytic Leukemia	Phase 1	China	Lanzhou Institute of Biological Products Co. Ltd.	25 Nov 2020
Follicular Lymphoma	Phase 1	China	Lanzhou Institute of Biological Products Co. Ltd.	25 Nov 2020
Follicular Lymphoma	Phase 1	China	Shanghai Taiyin Biological Engineering Co., Ltd.	25 Nov 2020
Mantle-Cell Lymphoma	Phase 1	China	Lanzhou Institute of Biological Products Co. Ltd.	25 Nov 2020
Mantle-Cell Lymphoma	Phase 1	China	Shanghai Taiyin Biological Engineering Co., Ltd.	25 Nov 2020
Peripheral T-Cell Lymphoma	Phase 1	China	Lanzhou Institute of Biological Products Co. Ltd.	25 Nov 2020
Peripheral T-Cell Lymphoma	Phase 1	China	Shanghai Taiyin Biological Engineering Co., Ltd.	25 Nov 2020

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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