A Phase 1, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 Administered Subcutaneously in Patients With Plaque-type Psoriasis

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.

开始日期2018-01-04

申办/合作机构

Celgene Corp.

NCT02934269

/ Completed临床1期

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of CC-90006 following administration of single subcutaneous doses in healthy subjects.

开始日期2016-11-21

申办/合作机构

Celgene Corp.

100 项与 CC-90006 相关的临床结果

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100 项与 CC-90006 相关的转化医学

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100 项与 CC-90006 相关的专利（医药）

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项与 CC-90006 相关的文献（医药）

2026-12-31·mAbs

Dual agonism and selective T-cell depletion activity of a PD-1-directed antibody for treating autoimmune diseases

Article

作者: Xu, John L. ; Zhou, Ling ; Zhao, Ranran ; Sun, Tian ; Xue, Weili ; Li, Xue ; Jin, Lei ; Jin, Xiaoliang ; Ma, Guangli ; Fan, Lishi ; He, Xuzhi ; Song, Lei ; Xu, Qian ; Yuan, Xinghang ; Gu, Fei ; Chu, Xuebin ; Zhu, Aisi ; Wang, Siqin ; Jiang, Wenbo ; Li, Lingyun

Precise inhibition of autoreactivity without concomitant induction of general immunosuppression is an overarching goal that remains elusive for the treatment of autoimmune diseases. PD-1 is preferentially expressed on activated T cells that drive autoimmunity. These PD-1⁺ T cells could serve as a target for therapeutic intervention. Here, we report the discovery of a unique PD-1 agonist antibody, GenSci120, that exhibited potent and selective T-cell inhibition in vitro and T-cell depletion activity both in vitro and in vivo. Target engagement by GenSci120 directly promoted SHP2 recruitment into the PD-1 signaling pathway but also enhanced the binding of PD-1 to its natural ligands and augmented PD-L1-induced PD-1 signaling. Moreover, GenSci120 exhibited robust efficacy in several animal models of human autoimmune disease. Thus, GenSci120, by selectively depleting PD-1⁺ T cells and by directly (via PD-1 binding and SHP2 recruitment) or indirectly (via enhancing PD-1 and ligand interaction) stimulating PD-1 signaling, has the capability to restore immune balance in autoimmunity. In a first-in-human study in healthy adults (NCT06827457), GenSci120 demonstrated favorable safety/tolerability and pharmacokinetic profiles as well as robust pharmacodynamic effect. Together, these findings suggest the potential of GenSci120 as an innovative precision medicine for treating autoimmune diseases and support further evaluation of this investigational new drug in future clinical trials.

2023-07-01·Nature reviews. Drug discovery

PD1 agonist antibody passes first phase II trial for autoimmune disease

作者: Mullard, Asher

2023-01-13·Science immunology

Anti–PD-1 antibodies recognizing the membrane-proximal region are PD-1 agonists that can down-regulate inflammatory diseases

Article

作者: Oshiro, Yuya ; Nakano, Kohei ; Ohta, Akio ; Nagata, Satoshi ; Tajima, Masaki ; Honjo, Tasuku ; Kamada, Haruhiko ; Tokumaru, Yosuke ; Kihara, Miho ; Suzuki, Kensuke

The PD-1 receptor triggers a negative immunoregulatory mechanism that prevents overactivation of immune cells and subsequent inflammatory diseases. Because of its biological significance, PD-1 has been a drug target for modulating immune responses. Immunoenhancing anti–PD-1 blocking antibodies have become a widely used cancer treatment; however, little is known about the required characteristics for anti–PD-1 antibodies to be capable of stimulating immunosuppressive activity. Here, we show that PD-1 agonists exist in the group of anti–PD-1 antibodies recognizing the membrane-proximal extracellular region in sharp contrast to the binding of the membrane-distal region by blocking antibodies. This trend was consistent in an analysis of 81 anti-human PD-1 monoclonal antibodies. Because PD-1 agonist antibodies trigger immunosuppressive signaling by cross-linking PD-1 molecules, Fc engineering to enhance FcγRIIB binding of PD-1 agonist antibodies notably improved human T cell inhibition. A PD-1 agonist antibody suppressed inflammation in murine disease models, indicating its clinical potential for treatment of various inflammatory disorders, including autoimmune diseases.

项与 CC-90006 相关的新闻（医药）

2025-12-24

·bilibili

BioSIM抗人CD279/PD1抗体SIM0463：PD-1靶向治疗的国产替代

在肿瘤免疫治疗领域，PD-1（程序性死亡受体1）作为关键的免疫检查点分子，已成为科研与临床关注的焦点。而针对PD-1的抗体产品，尤其是生物类似药，正逐步成为推动相关研究的重要工具。BioSIM 抗人CD279/PD1抗体（CC-90006 生物类似药）科研级作为一款高质量、高纯度的科研级抗体，由艾美捷科技代理，凭借其优质的性能和严格的质量控制，赢得了广大科研工作者的高度认可。一、产品概述BioSIM 抗人CD279/PD1抗体（CC-90006 生物类似药）是一款针对人类CD279（即PD1）的重组生物类似药抗体，采用无动物源性生产技术，确保了产品的安全性和稳定性。该产品由InvivoCrown品牌出品，货号为 SIM0463，规格包括 1mg 和 5mg，适用于多种实验需求。其亚型为 IgG1-kappa，靶标明确，专用于人类样本的研究。二、产品优势解析1. 高质量生产标准BioSIM 抗体的生产过程完全遵循国际先进的生物制药标准。其制造环境为无动物源性设施，采用无蛋白细胞培养技术，有效避免了潜在的污染风险。此外，产品经过多步纯化工艺，包括Protein A/G 色谱法，确保了最终产品的高纯度（≥ 99%），满足科研对精确性的严苛要求。2. 广泛的应用场景该抗体适用于多种实验方法，包括 ELISA、FACS、功能性实验及体内研究，能够广泛应用于免疫调节机制、肿瘤免疫微环境分析、免疫检查点抑制剂开发等多个研究方向。无论是基础研究还是转化医学，BioSIM 抗体都能提供可靠的实验数据支持。3. 稳定性与安全性保障为了确保产品的稳定性和使用便利性，BioSIM 抗体采用PBS 缓冲液配方，pH 值为 7.4，不含任何稳定剂或防腐剂，适合多种实验条件。同时，产品经过0.2 μm 过滤灭菌处理，内毒素含量低于 1.0 EU/mg，符合高标准的生物试剂要求。4. 明确的储存与运输规范为延长产品有效期，建议用户按照以下方式保存：短期使用可置于 4°C（1-2周），长期存储则应放在 -20°C（最长12个月），若需更长时间保存，推荐 -80°C。运输过程中，产品以 2-8°C 冷藏+蓝冰方式运输，确保在到达实验室前保持最佳状态。三、科学背景与应用价值PD-1 是一种重要的免疫抑制性受体，主要表达于活化的T细胞、B细胞和NK细胞上。当PD-1与其配体PD-L1或PD-L2结合时，会抑制T细胞的活性，从而帮助肿瘤细胞逃避免疫系统的攻击。因此，阻断PD-1信号通路成为抗肿瘤免疫治疗的关键策略之一。CC-90006 是一款已上市的PD-1单克隆抗体药物，其生物类似药BioSIM 抗人CD279/PD1抗体（CC-90006 生物类似药）在结构、功能和疗效上均与原研药高度相似，但成本更低，更适合科研使用。通过该抗体，研究人员可以更深入地探索PD-1在免疫调控中的作用机制，为后续药物开发和临床试验提供坚实的数据支撑。四、专业服务，品质保障作为优质的生物试剂供应商，艾美捷科技始终致力于为科研用户提供高品质、高性价比的产品和服务。BioSIM 抗体作为其重点推广产品之一，不仅拥有完善的质量体系，还配备专业的技术支持团队，确保客户在使用过程中获得全方位的指导与帮助。无论您是从事肿瘤免疫研究的学者，还是专注于新药开发的企业研发人员，BioSIM anti-Human CD279/PD1 Antibody (CC-90006 Biosimilar) 都将是您不可或缺的科研伙伴。

生物类似药免疫疗法

2025-11-28

·精诚智研

精诚智评：PD-1激动剂在自免类适应症中的成药性

点击蓝字关注我们 2025年11月10日，专注于PD-1激动剂的生物技术公司Anaptys Bio宣布其PD-1激动剂抗体Rosnilimab在中重度溃烂性肠炎患者（UC）的2期临床试验中未能达到临床主要及次要终点，后续将中断在该适应症的开发。此前，Rosnilimab在类风湿性关节炎（RA）的2期临床试验中达到了主要终点，并显示出不错的治疗效果。关于PD-1激动剂在自免和炎症类适应症中的成药性的争论再次摆上台面。 PD-1是百年一遇的药物靶点，以PD-1/PD-L1为代表的免疫治疗方案已经成为肿瘤免疫领域的基石疗法，撑起了数百亿美元的药物市场，并出现了PD-1/VEGF双抗，PD-1抗体联合ADC等革命性的第二代免疫治疗方案，真正满足了未满足的临床需求，为患者带来了临床获益和生存希望，成为最近十几年引领肿瘤药物开发的引擎，PD-1的发现者本庶佑也因此获得2018年的诺贝尔生理学或医学奖。从宏观角度来讲，我们经常说肿瘤和自身免疫病是一个硬币的两面。肿瘤细胞的产生是由于细胞内不断累积的突变突破了免疫系统的监视和清除，并反过来限制了局部免疫微环境中免疫细胞的功能，从而在局部形成新的实体发展为危害健康的肿瘤。而自身免疫性疾病的起因在于自身抗原特异性T细胞的异常活跃，打破了自身的免疫耐受机制，从而对自身抗原和组织产生攻击和破坏。所以对于肿瘤免疫来讲，我们要重建免疫系统清除异常肿瘤细胞的能力；而对于自身免疫性疾病来讲，我们要限制自身抗原特异性免疫细胞尤其是T和B细胞的功能。在药物研发历史上，有一个靶点既在自免领域获批了适应症，也在肿瘤免疫领域成为突破性疗法，这个靶点就是大名鼎鼎的CTLA-4。 2005年，BMS开发了CTLA-4的融合蛋白类药物Abatacept（阿巴西普），成功获批多项自免适应症，包括RA，银屑病关节炎（PsA）和幼年特发性关节炎（pJIA）等。2024年阿巴西普的全年销售额为36.82亿美元，虽然没有像多款TNF抑制剂药物一样成为超级重磅药物，但阿巴西普也是BMS最畅销的自免类产品，可谓差强人意。 2011年，同样是BMS，开发了针对CTLA-4的阻断性抗体Ipilimumab，被FDA批准用于治疗晚期黑色素瘤，为后续的肿瘤免疫疗法打响了第一枪。可惜的是，由于CTLA-4复杂的生物学机制（如靶点蛋白的内吞和循环利用，pH对蛋白表面丰度的影响，CTLA-4在不同T细胞亚群的分布等），Ipilimumab在后续的临床开发中遇到了比较大的挑战，其适应症的广度及在临床运用中的认可度远远不及后来居上的PD-1单抗类药物。2024年Ipilimumab的全年销售额为46.7亿美元，与PD-1抗体药物Keytruda全年294.82亿美元的销售额不可同日而语。再回到PD-1，其激动剂的开发几经波折。礼来是开发PD-1激动剂药物较早的药企。2023年5月18日，礼来在The New England Journal of Medicine 上发表了其PD-1激动剂抗体Peresolimab治疗RA的2期临床结果。结果显示，Peresolimab在RA患者的2a期临床试验中显示出疗效，达到临床预设的主要终点。然而在随后的2024年，礼来宣布因为公司总体研发策略以及Peresolimab的风险/效益比问题而终止该款药物的开发，整个PD-1激动剂研发领域都因此蒙上了一层阴影。 Rosnilimab是继Peresolimab之后全球范围内临床进展最快的PD-1激动剂，相比于Peresolimab，Anaptys Bio宣称Rosnilimab具有全方位的优势。 2023年发表于Science Immunology的研究论文提供了开发PD-1激动剂抗体的示范。该项研究表明激动剂PD-1 抗体一般结合 PD-1 的膜近端区域，并与APC上的 Fc 受体结合，促成PD-1交联和抑制信号的传递。 Anaptys Bio在PD-1激动剂领域已经驶入无人区，目前适应症开发已经聚焦到RA领域，后续关键临床3期的结果将决定这一赛道的成败，一切有待临床数据的获得和揭示。关于PD-1激动剂的药物开发和转化研究，有几点值得思考： 1. 在自免适应症中，PD-1阳性T细胞与自身抗原特异性T细胞overlap的程度。这是一个关键的问题，也是PD-1激动剂开发的基石。 2. PD-1激动剂抗体抑制自身反应性T细胞的效果不容易量化，而这一指标是决定药物疗效的重要依据。 3. PD-1的表达具有时空特异性，在临床试验中，是否可以通过biomarker将患者进行分层和筛选，达到更好的治疗效果。 4. PD-1激动剂的ADCC效应是否必需：从历史数据来看，PD-1不仅表达于效应T细胞，也表达于调节性T细胞，清除PD-1阳性细胞是否会导致负面效应？ 5. PD-1在免疫稳态中发挥重要功能，过度激活（如果会）是否会影响免疫稳态，导致长期的免疫低下，从而增加各种感染风险，甚至癌症发生的风险？ Reference： Alexandra Schnell et al., Cancer Research, 2020, 30:285. The yin and yang of co-inhibitory receptors: toward anti-tumor immunity without autoimmunity. Jay Tuttle et al., The New England Journal of Medicine, 2023, 388:1853. A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. Kensuke Suzuki et al., Science Immunology, 2023, 8: eadd4947. Anti-PD-1 antibodies recognizing the membrane-proximal region are PD-1 agonists that can down-regulate inflammatory diseases.

免疫疗法临床2期突破性疗法抗体药物偶联物临床1期

2025-11-10

·FierceBiotech

AnaptysBio abandons rosnilimab for ulcerative colitis after phase 2 fail

AnaptysBio said it will provide an update on its plans for its PD-1 agonist in rheumatoid arthritis in the first half of next year.\n AnaptysBio has abandoned plans to develop rosnilimab for ulcerative colitis (UC) after the PD-1 agonist flunked a phase 2 study.The San Diego-based biopharma assessed rosnilimab in the midstage study of 136 patients with moderate to severe UC across the U.S. and Europe. The study’s main goal was to demonstrate a mean change from baseline as measured by the modified Mayo Score (mMS) at Week 12, with key secondary endpoints evaluating clinical response and clinical remission.Patients who received 400 mg of subcutaneous rosnilimab every four weeks or 800 mg every two weeks only achieved clinical remission rates of 7% , which was no better than the placebo cohort, Anaptys explained in a Nov. 10 release.“While preliminary data suggest an increase in remission rates between week 12 and week 24, week 24 remission rates did not meet our six-month target product profile,” Anaptys added.The results dent the high hopes for rosnilimab generated by a phase 2 win in rheumatoid arthritis (RA) in February. That success had offered some welcome clinical validation for Anaptys after the company had jettisoned an atopic dermatitis candidate three months early when the compound failed to reduce eczema area and itch severity in a phase 2b trial.“Rosnilimab was safe and well tolerated, but we are disappointed in the lack of adequate efficacy and will discontinue the UC trial,” Anaptys CEO Daniel Faga said in this morning’s release.The CEO attempted to focus investors\' attention on ANB033, a CD122 antagonist already undergoing a phase 1b study for celiac disease. “We plan to announce a phase 1b in another inflammatory disease in 2026,” Faga pointed out.Today’s decision to discontinue the UC trial for rosnilimab will save the company around $10 million, according to the release. Anaptys said it will provide an update on its plans for the PD-1 agonist in RA in the first half of next year, with this program needing to be funded by “strategic or other sources of capital without diluting our royalties.”Next year, AnaptysBio plans to split into two publicly traded companies. One entity will take forward the biopharma’s clinical-stage pipeline, and the other will oversee its royalty-based agreements, headlined by Jemperli, the PD-1 blocking antibody that Anaptys discovered and has since brought GSK $2.7 billion in sales as an endometrial cancer and solid tumor drug.

临床2期临床结果临床3期临床1期

100 项与 CC-90006 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
银屑病	临床1期	美国	AnaptysBio, Inc.	2022-03-15
斑块状银屑病	临床1期	美国	Celgene Corp.	2018-01-04
斑块状银屑病	临床1期	加拿大	Celgene Corp.	2018-01-04

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2012	N/A	晚期恶性实体瘤	240	BMS-936558	艱鹽鏇淵醖廠鑰蓋選鏇(夢範繭簾餘艱繭艱製網) = 餘膚夢鑰鑰顧觸齋餘醖積膚壓選廠構繭繭蓋醖 (壓淵繭夢構鏇鹽壓蓋醖 ) 更多	-	2012-06-20
ASCO2012	N/A	黑色素瘤	240	BMS-936558	繭網願顧遞觸壓鹽繭膚(鬱廠膚積膚網繭廠衊鑰) = 廠獵顧壓鑰積遞鏇鹽顧醖艱艱簾範觸製鏇蓋願 (膚糧憲築夢築鹹範築窪 ) 更多	-	2012-05-20
ASCO2012	临床1期	-	240	BMS-936558 10 mg/kg	壓齋艱醖遞齋網繭製鹽(衊廠簾廠製鏇淵餘觸衊) = 襯糧鹽壓衊繭憲獵觸選壓製壓蓋齋蓋遞願願壓 (鹽願鹽廠襯淵壓範築鏇 )	-	2012-05-20
ASCO2012	临床1期	-	240	BMS-936558 1 mg/kg	範窪選壓淵齋繭選網積(鑰鹽蓋繭糧願齋鬱範製) = 獵醖襯積憲範齋衊簾築積願製夢積蓋醖壓糧淵 (淵鹹壓夢遞夢範憲簾鬱 )	-	2012-05-20