Delving into the Latest Updates on Recombinant human IL-17A/F humanized antibody(Livzon Pharmaceutical Group) with Synapse

主要目的：以治疗16周时达到ASAS 40的患者比例评价XKH004治疗中重度活动性AS的疗效关键次要目的：以治疗16周时达到ASAS 20的患者比例评价XKH004治疗中重度活动性AS的疗效其他次要目的：以其他疗效指标评价XKH004治疗中重度活动性AS的疗效评价XKH004对中重度活动性AS患者生活质量的改善作用评价XKH004在活动性AS患者中的群体药代动力学（PPK）特征进一步评价XKH004在活动性AS患者中的安全性和免疫原性

[Translation]

Primary objective: To evaluate the efficacy of XKH004 in the treatment of moderately to severely active AS by the proportion of patients reaching ASAS 40 at 16 weeks of treatment Key secondary objectives: To evaluate the efficacy of XKH004 in the treatment of moderately to severely active AS by the proportion of patients reaching ASAS 20 at 16 weeks of treatment Other secondary objectives: To evaluate the efficacy of XKH004 in the treatment of moderately to severely active AS by other efficacy indicators To evaluate the effect of XKH004 on the improvement of the quality of life of patients with moderately to severely active AS To evaluate the population pharmacokinetic (PPK) characteristics of XKH004 in patients with active AS To further evaluate the safety and immunogenicity of XKH004 in patients with active AS

Start Date21 Sep 2023

Sponsor / Collaborator

Livzon MABPharm Inc.

[+1]

NCT06110676 / RecruitingPhase 3

A Muti-center, Randomized, Double Blind, Positive Control Phase III Clinical Study to Evaluate the Efficacy and Safety of LZM012 in Moderate to Severe Chronic Plaque Psoriasis Patients

This study is a muti-center, randomized, double blind, positive control phase III clinical study to evaluate the efficacy and safety of LZM012 in moderate to severe chronic plaque psoriasis patients

Start Date21 Aug 2023

Sponsor / Collaborator

Livzon Pharmaceutical Group, Inc.

CTR20231931 / Active, not recruitingPhase 3

评价LZM012在中度至重度慢性斑块状银屑病受试者中的有效性和安全性的多中心、随机、双盲、阳性对照（司库奇尤单抗）III期临床试验

[Translation] A multicenter, randomized, double-blind, active-controlled (secukinumab) Phase III clinical trial to evaluate the efficacy and safety of LZM012 in subjects with moderate to severe chronic plaque psoriasis

主要目的：以第12周时达到银屑病面积与严重程度指数（PASI）100 的受试者比例（PASI100应答率）为主要终点，比较LZM012和司库奇尤单抗治疗成人中度至重度慢性斑块状银屑病受试者的疗效。次要目的： (1)比较LZM012和司库奇尤单抗治疗后第52周的疗效； (2)比较LZM012和司库奇尤单抗治疗后第4周、12周的疗效；其他目的： (1)评价LZM012的其他疗效； (2)评价LZM012的安全性； (3)评价LZM012的药代动力学（PK）特征； (4)评估LZM012的免疫原性。

[Translation]

Primary objective: The primary endpoint was the proportion of subjects achieving Psoriasis Area and Severity Index (PASI) 100 at week 12 (PASI 100 response rate), to compare the efficacy of LZM012 and secukinumab in the treatment of adult subjects with moderate to severe chronic plaque psoriasis. Secondary objectives: (1) To compare the efficacy of LZM012 and secukinumab at week 52 after treatment; (2) To compare the efficacy of LZM012 and secukinumab at weeks 4 and 12 after treatment; Other objectives: (1) To evaluate other efficacy of LZM012; (2) To evaluate the safety of LZM012; (3) To evaluate the pharmacokinetic (PK) characteristics of LZM012; (4) To evaluate the immunogenicity of LZM012.

Start Date17 Aug 2023

Sponsor / Collaborator

Livzon MABPharm Inc.

[+1]

100 Clinical Results associated with Recombinant human IL-17A/F humanized antibody(Livzon Pharmaceutical Group)

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100 Translational Medicine associated with Recombinant human IL-17A/F humanized antibody(Livzon Pharmaceutical Group)

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100 Patents (Medical) associated with Recombinant human IL-17A/F humanized antibody(Livzon Pharmaceutical Group)

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Literatures (Medical) associated with Recombinant human IL-17A/F humanized antibody(Livzon Pharmaceutical Group)

01 May 2007·Cell ResearchQ1 · BIOLOGY

A novel heterodimeric cytokine consisting of IL-17 and IL-17F regulates inflammatory responses

Q1 · BIOLOGY

Article

Author: Seon Hee Chang ; Chen Dong

CD4+ helper T (TH) cells play crucial roles in immune responses. Recently a novel subset of TH cells, termed TH(IL-17), TH17 or inflammatory TH (THi), has been identified as critical mediators of tissue inflammation. These cells produce IL-17 (also called IL-17A) and IL-17F, two most homologous cytokines sharing similar regulations. Here we report that when overexpressed in 293T cells, IL-17 and IL-17F form not only homodimers but also heterodimers, which we name as IL-17A/F. Fully differentiated mouse THi cells also naturally secrete IL-17A/F as well as IL-17 and IL-17F homodimeric cytokines. Recombinant IL-17A/F protein exhibits intermediate levels of potency in inducing IL-6 and KC (CXCL1) as compared to homodimeric cytokines. IL-17A/F regulation of IL-6 and KC expression is dependent on IL-17RA and TRAF6. Thus, IL-17A/F cytokine represents another mechanism whereby T cells regulate inflammatory responses and may serve as a novel target for treating various immune-mediated diseases.

European Journal of Immunology

Innate T‐cell‐derived IL‐17A/F protects from bleomycin‐induced acute lung injury but not bleomycin or adenoviral TGF‐β1‐induced lung fibrosis in mice

Article

Author: Kolb, Martin ; Prinz, Immo ; Stolper, Jennifer ; Aschenbrenner, Franziska ; Jonigk, Danny ; Maus, Ulrich A. ; Moog, Marie T. ; Röpke, Tina ; Baltes, Melina ; Maus, Regina

AbstractThe pathobiology of IL‐17 in lung fibrogenesis is controversial. Here we examined the role of IL‐17A/F in bleomycin (BLM) and adenoviral TGF‐β1‐induced lung fibrosis in mice. In both experimental models, WT and IL17af−/− mice showed increased collagen contents and remodeled lung architecture as assessed by histopathological examination, suggesting that IL‐17A/F is dispensable for lung fibrogenesis. However, IL17af−/− mice responded to the BLM challenge with perturbed lung leukocyte subset recruitment. More specifically, bleomycin triggered angiocentric neutrophilic infiltrations of the lung accompanied by increased mortality of IL17af−/− but not WT mice. WT bone marrow transplantation failed to correct this phenotype in BLM‐challenged IL17af−/− mice. Conversely, IL17a/f−/− bone marrow transplantation → WT did not perturb lung leukocytic responses upon BLM. At the same time, IL17af−/− mice treated with recombinant IL‐17A/F showed an attenuated lung inflammatory response to BLM. Together, the data show that the degree of BLM‐driven acute lung injury was critically dependent on the presence of IL‐17A/F, while in both models, the fibrotic remodeling process was not.

100 Deals associated with Recombinant human IL-17A/F humanized antibody(Livzon Pharmaceutical Group)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ankylosing Spondylitis	Phase 3	CN	Livzon MABPharm Inc.	21 Sep 2023
Ankylosing Spondylitis	Phase 3	CN	Beijing Kanova Biopharmaceutical Co., Ltd.	21 Sep 2023
Plaque psoriasis	Phase 3	CN	Beijing Kanova Biopharmaceutical Co., Ltd.	17 Aug 2023