A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SI-B001+SI-B003 With or Without Chemotherapy (SI-B001+SI-B003± Chemotherapy) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Phase Ib: To observe the safety and tolerability of the combination of SI-B001 and SI-B003, and to determine the recommended dose of phase II clinical study (RP2D) in the indication of locally advanced or metastatic non-small cell lung cancer. Phase II: To evaluate the efficacy of SI-B001+SI-B003 combination with or without chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer.

开始日期2023-10-30

申办/合作机构

四川百利药业有限责任公司

CTR20232081 / Recruiting临床1/2期

评价SI-B001+SI-B003双药联合或不联合化疗（SI-B001+SI-B003±化疗）治疗局部晚期或转移性非小细胞肺癌的安全性和有效性的 Ib/II 期临床研究

Ib期：1）主要目的：观察SI-B001+SI-B003双药联合的安全性和耐受性，确定在局部晚期或转移性非小细胞肺癌适应症中的II期临床研究推荐剂量（RP2D）。2）次要目的：评估SI-B001+SI-B003双药联合的初步疗效、药代动力学特征和免疫原性。3）探索性目的：探索预测SI-B001+SI-B003双药联合有效性指标的生物标志物，如EGFR和/或HER3的蛋白表达和/或基因扩增、PD-L1表达水平等。II期：1）主要目的：评价SI-B001+SI-B003双药联合或不联合化疗在局部晚期或转移性非小细胞肺癌患者中的有效性。2）次要目的：评价SI-B001+SI-B003双药联合或不联合化疗的安全性和耐受性、PK/PD和免疫原性。3）探索性目的：探索预测SI-B001+SI-B003双药联合或不联合化疗有效性指标的生物标志物，如EGFR和/或HER3的蛋白表达和/或基因扩增、PD-L1表达水平等。探索SI-B001、SI-B003的药物-药物相互作用（DDI）。

开始日期2023-10-30

申办/合作机构

四川百利药业有限责任公司

NCT05943795 / Recruiting临床3期

Phase III Clinical Study of SI-B001 Combined With Docetaxel Second-line Therapy in Patients With Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma Without Actionable Genomic Alterations Who Failed Only First-line Treatment With PD-1/PD-L1 Monoclonal Antibody Plus Platinum-Based Chemotherapy

Main objectives: To evaluate the benefit of SI-B001+ docetaxel on overall survival (OS) of bidotaxel. To evaluate the benefit of SI-B001+ Docetaxel over Docetaxel's progression-free survival (PFS) based assessment. Secondary objectives: To evaluate the investigator-evaluated progression-free survival (PFS) benefit of SI-B001+ Docetaxel against docetaxel; To evaluate the difference of objective response rate (ORR), disease control rate (DCR) and duration of response (DOR) between SI-B001+ docetaxel and bidocetaxel. To evaluate the type, frequency and severity of adverse events (TEAE) and drug-related adverse events (TRAE) during treatment with SI-B001+ docetaxel in comparison with docetaxel. The pharmacokinetic (PK) characteristics of SI-B001 will be evaluated. The immunogenicity of SI-B001 will be evaluated. Subject quality of life.

开始日期2023-07-14

申办/合作机构

四川百利药业有限责任公司

100 项与 Izalontamab 相关的临床结果

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100 项与 Izalontamab 相关的转化医学

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100 项与 Izalontamab 相关的专利（医药）

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项与 Izalontamab 相关的文献（医药）

2020-04-01·The Science of the total environment

Foliage application of selenium and silicon nanoparticles alleviates Cd and Pb toxicity in rice (Oryza sativa L.)

Article

作者: Lin, Qiang ; He, Zhenli ; Yang, Xiaoe ; Hamid, Yasir ; Sanaullah, Muhammad ; Di, Liu ; Khan, Muhammad Bilal ; Hussain, Bilal ; Hashmi, Muhammad Laeeq Ur Rehman

Direct discharge of untreated industrial waste water in water bodies and then irrigation from these sources has increased trace metals contamination in paddy fields of southern China. Among trace metals, cadmium (Cd) and lead (Pb) are classified as most harmful contaminants in farmland to many organisms including plants, animals and humans. Rice is a staple food which is consumed by half population of the world; due to longer growth period it can easily absorb and accumulate the trace metals from soil. The objective of study was to check the efficacy of Se and Si NPs (nanoparticles) alone or in combination on metals accumulation and Se-fortified rice (Oryzasativa L.) production as their efficiency remained untested. Alone as well as combined application of Se- and Si-NPs (5, 10 and 20 mg L^-¹) was achieved along with CK. All the treatments significantly reduced the Cd and Pb contents in brown rice, except CK, Se3, Si1 and Se1Si3. Combined application of Se and Si (Se3Si2) was more effective in reducing the Cd and Pb contents by 62 and 52%, respectively. In addition, foliar application of both NPs improved the rice growth and quality by increasing the grain yield, rice biomass, and Se contents in brown rice. Highest concentration of Se (1.35 mg kg^-¹) in brown rice was observed with combined application of Se- and Si-Nps (Se3Si2). Selenium speciation revealed the presence of organic species (74%) in brown rice. The combinations of different doses of Se- and Si-Nps are the main determining factor for total concentration of metals in grains. These results demonstrate that foliage supplementation of Se and Si-Nps alleviate the Cd and Pb toxicity by reducing the metals' concentration in brown rice. Additionally foliage supplementation improved the nutritional quality by reducing the phytic acid contents in rice grains.

2017-01-01·Cellular physiology and biochemistry : international journal of experimental cellular physiology, biochemistry, and pharmacology

Effect of the Serum Inhibited Gene (Si1) on Autophagy and Apoptosis in MCF-7 Breast Cancer Cells

Article

作者: Li, Yu ; Li, Meizhang ; Wang, Wenxue ; Cui, Yong ; Chen, Suiyun ; Ma, Mingxing

Background/Aims: The serum inhibited gene (Si1) was named according to its inhibited expression in response to serum exposure. Si1 has an important relationship with tumors. Autophagy and apoptosis are two types of cell death. However, there are few studies regarding the association between Si1 and autophagy, or apoptosis in tumors. In this, we investigated the effect of Si1 on the proliferation and cell cycle progression of MCF-7 cells and its influence on autophagy and apoptosis in MCF-7 cells. Methods: To investigate these functions of Si1 in tumor cells, we firstly constructed a pEGFP-Si1 overexpression vector and a pSilencer-Si1 interference vector, and we subsequently tested the proliferation and cell cycle progression of MCF-7 cells using the MTT assay and flow cytometry, and we then detected autophagy by western blotting and MDC (Monodansylcadaverine) staining as well as apoptosis by western blotting and Hoechst 33258 staining. Results: We found that the Si1 gene can significantly inhibit the viability of MCF-7 cells and arrest the cell cycle at the G2/M phase. Si1 can induce autophagy through upregulation of LC3-II and Beclin1, it can induce apoptosis through cleavage of PARP in MCF-7 cells. Conclusion: Altogether, our study indicated that Si1 can inhibit cell proliferation of MCF-7, and also induces autophagy and apoptosis. This study firstly investigated the effect of Si1 on autophagy and apoptosis in MCF-7 cells. Moreover, it also improves the current understanding of the mechanisms related to the effect of Si1 on tumor cells and also provides a foundation for gene-targeted therapy.

2015-07-27·Journal of molecular signaling

Gα13 Stimulates the Tyrosine Phosphorylation of Ric-8A

Article

作者: Dhanasekaran, Danny N ; Ha, Ji Hee ; Yan, Mingda

The G12 family of heterotrimeric G proteins is defined by their α-subunits, Gα12 and Gα13. These α-subunits regulate cellular homeostasis, cell migration, and oncogenesis in a context-specific manner primarily through their interactions with distinct proteins partners that include diverse effector molecules and scaffold proteins. With a focus on identifying any other novel regulatory protein(s) that can directly interact with Gα13, we subjected Gα13 to tandem affinity purification-coupled mass spectrometric analysis. Our results from such analysis indicate that Gα13 potently interacts with mammalian Ric-8A. Our mass spectrometric analysis data also indicates that Ric-8A, which was tandem affinity purified along with Gα13, is phosphorylated at Ser-436, Thr-441, Thr-443 and Tyr-435. Using a serial deletion approach, we have defined that the C-terminus of Gα13 containing the guanine-ring interaction site is essential and sufficient for its interaction with Ric-8A. Evaluation of Gα13-specific signaling pathways in SKOV3 or HeyA8 ovarian cancer cell lines indicate that Ric-8A potentiates Gα13-mediated activation of RhoA, Cdc42, and the downstream p38MAPK. We also establish that the tyrosine phosphorylation of Ric-8A, thus far unidentified, is potently stimulated by Gα13. Our results also indicate that the stimulation of tyrosine-phosphorylation of Ric-8A by Gα13 is partially sensitive to inhibitors of Src-family of kinases, namely PP2 and SI. Furthermore, we demonstrate that Gα13 promotes the translocation of Ric-8A to plasma membrane and this translocation is attenuated by the Src-inhibitors, SI1 and PP2. Thus, our results demonstrate for the first time that Gα13 stimulates the tyrosine phosphorylation of Ric-8A and Gα13-mediated tyrosine-phosphorylation plays a critical role in the translocation of Ric-8A to plasma membrane.

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项与 Izalontamab 相关的新闻（医药）

2024-09-10

·Pharma CMC

拟募资1.8亿美元！2家双抗biotech申请IPO

近年来的市场态势，即使对业绩良好的公司来说也是残酷无情的。2024年进行首次公开募股（IPO）的大多数公司股价都低于首日价格。在这种市场环境下，投资者更青睐临床阶段的资产，而Zenas（泽纳仕生物）和Bicara都符合这一要求。 9月6日，这两家初创公司Bicara和Zenas概述了规模几乎相同的首次公开募股计划。专注于肿瘤学的Bicara预计净收益为1.82亿美元，而自身免疫生物技术公司Zenas 的目标是1.807亿美元。Bicara计划出售的股票为1176.5万股，而Zenas的目标是1176万股。初始定价均在每股16美元到18美元之间。 Zenas是一家以免疫学和炎症（I&I）为核心的处于临床阶段的全球性生物制药公司，计划将以“BIOA”为股票代码在纳斯达克上市。 Zenas领先的I&I候选产品Obexelimab是一款CD19/FcRIIb双特异性抗体。根据迄今为止获得的现有临床数据显示通过CD19和FcγRIIb靶向B细胞系可以抑制B细胞，且耐受性良好。目前正在开发的前四个适应症包括：免疫球蛋白G4相关疾病（IgG4-RD）适应症处于III期临床阶段，多发性硬化症、系统性红斑狼疮和温抗体-自身免疫性溶血性贫血(wAIHA)适应症均处于II期临床阶段。在2023年9月， Zenas与BMS签订许可和合作协议，在日本、韩国、台湾、新加坡、香港和澳大利亚开发用于治疗自身免疫性疾病的Obexelimab并将其商业化。首付款为5000万美元；此外，BMS对Zenas进行股权投资。除Obexelimab外，Zenas的临床项目还包括从Viridian Therapeutics引进的IGF1R抗体ZB001，从Xencor引进ZB002、ZB004，从Dianthus Therapeutics引进的ZB005。 2024年5月7日，Zenas宣布完成2亿美元的C轮优先股融资，本轮融资募集的款项将用于支持公司主要候选分子Obexelimab的中后期临床研发项目。公司经过四轮融资总计融资约4.6亿美元。根据IPO文件，Zenas今年上半年研发投入5645万美元，去年为3026万美元，其中大部分是投入到CD19/FcγRIIb双抗Obexelimab项目中。截至6月底，该公司拥有1.83亿美元的现金。 Bicara Therapeutics是一家专注于开发潜在“first-in-class”生物制品的临床阶段的生物技术公司，计划将以“BCAX”为股票代码在纳斯达克上市。 Bicara公司的主要产品ficerafusp alfa（BCA101）是一种潜在“first-in-class”的EGFR/TGF-β双抗。通过这种双重靶向机制，使得BCA101能够抑制肿瘤增殖，同时恢复局部免疫细胞的细胞毒活性。 BCA101正处于联合K药治疗头颈鳞癌的临床1/1b期试验中，中期数据显示BCA101联合K药一线治疗HPV阴性R/M HNSCC展现出了具有临床意义的抗肿瘤活性，且安全性良好。Bicara计划在2024年第四季度末或 2025年第一季度初启动一项关键性2/3期试验，将BCA101与Keytruda(K药)联用，作为复发/转移性HNSCC和口咽鳞状细胞癌（OPSCC）的一线疗法。 2023年12月12日，Bicara Therapeutics宣布完成1.65亿美元的超额认购C轮融资，截至目前公司总计融资金额约3.6亿美元。根据IPO文件，Bicara在2024年上半年的研发支出2278万美元，比去年同期增加了1300多万美元，这反映了公司在临床研究上的扩展。截至6月底，Bicara拥有2.03亿美元的现金及等价物。排在Bicara和Zenas后面的是多肽生物技术公司MBX Biosciences和抗肥胖与衰老初创公司BioAge Labs，预计它们将在未来几周内公布定价计划。双抗药物是抗体类药物发展的一个重要方向，目前我国领先双抗产品已陆续进入临床II、III期，双抗时代即将开启。从目前企业的布局情况来看，国外企业由于起步较早，因此双抗研发管线较为丰富。拥有最多双抗研发管线的企业是 Roche，Amgen和强生紧随其后。国内企业方面，拥有较多双抗药物布局的企业主要有康宁杰瑞、康方生物、信达生物和友芝友等。目前在研双抗药物中，大部分双抗产品仍然处于I期临床试验，伴随研发逐步推进，未来3-5年将有望迎来双抗药物上市井喷。从适应症布局来看，超过80%的管线集中在肿瘤领域，其中实体瘤赛道最为热门。根据东方证券数据，目前全球约有24款进入III期阶段或申请上市阶段的双抗药物（不包括双抗ADC），其中包括国内自主研发的双抗产品：石药集团CD3/EpCAM双抗M701、康宁杰瑞CTLA4/PDL1双抗erfonrilimab、百利天恒HER3/EGFR双抗izalontamab。参考资料：公司招股书内容来源于网络，如有侵权，请联系删除。

IPO引进/卖出

2024-09-09

·PRNewswire

SystImmune, Inc. to Present New BL-B01D1 Data in Urothelial, Biliary Tract, and Esophageal Squamous Cell Carcinoma at ESMO Congress 2024

- Initial safety & efficacy in Urothelial Carcinoma (UC), Esophageal Squamous Cell Carcinoma (ESCC) and Biliary Tract Carcinoma (BTC) patients will be presented from clinical studies evaluating BL-B01D1, an EGFRxHER3 bispecific topoisomerase inhibitor- based antibody-drug conjugate (ADC) REDMOND, Wash., Sept. 9, 2024 /PRNewswire/ -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that three abstracts on BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 taking place on September 13–17 in Barcelona, Spain. BL-B01D1 is being jointly developed by SystImmune and Bristol Myers Squibb under an exclusive license and collaboration agreement. Expanded results from clinical trials of BL-B01D1 will include data from patients with advanced stages of Urothelial Carcinoma, Biliary Tract Carcinoma, and Esophageal Squamous Cell Carcinoma and having multiple cycles of prior therapies. The data to be presented at ESMO highlights continued progress in BL-B01D01 clinical development and builds upon the previously reported clinical data in lung and breast cancer patients at ASCO, ESMO and SABCS in 2023. "These data support our continued conviction that BL-B01D1 has a manageable safety profile and add to the body of evidence that shows encouraging signals of efficacy across a wide variety of tumors" said Jonathan Cheng, M.D., CMO of SystImmune. "This positions BL-B01D1 as a versatile therapeutic option that may address the unmet medical needs of patients with limited treatment options. We are committed to advancing this therapy through clinical trials, exploring its potential not only as a monotherapy but also in combination with other agents, to improve outcomes for cancer patients globally." Details on the presentations at ESMO are below: BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (UC) Session Title: Proffered paper session 1: GU tumours, non-prostate Presentation Number: 19590 Speaker: Dingwei Ye (Shanghai, China) Session Date & Time: Friday, September 13th, 2024, 2:00 PM-3:30 PM CEST BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Biliary Tract Carcinoma (BTC) Presentation Number: 54P Speaker: Zhihao Lu (Beijing, China) Onsite Poster display date: Monday, September 16th, 2024 BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Presentation Number: 1426P Speaker: Liu Chang (Beijing, China) Onsite Poster display date: Monday, September 16th, 2024 About BL-B01D1 The company is developing BL-B01D1, a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induces genotoxic stress activating pathways leading to cancer cell death. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider. This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements. While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. For additional information about the company, please visit . SOURCE SystImmune, Inc.

引进/卖出抗体药物偶联物

2024-08-26

·同写意

中国双抗投资地图2024

CGT产业何去何从？8月底，北京！九大论坛将直面产业创新与监管挑战。国药集团中国生物副总裁孙京林老师将在本次会议讲解“创新生物药的分段生产管理”。武汉科技大学生命科学与健康学院院长，波睿达生物董事长张同存教授将与会报告“CAR-T细胞治疗现状和展望”。默沙东再次对中国创新药资产出手，这一次瞄准的不再是ADC药物，而是双抗药物。 8月9日，默沙东与同润生物达成BD交易，以7亿美元首付款的价格，拿下了CD3/CD19双抗药物CN201的全球权益。这也是继百利天恒之后，中国创新药license-out第二高的首付款。图：中国双抗管线BD一览，来源：锦缎研究院无论是之前百利天恒的BL-B01D1，还是同润生物的CN201，它们都是基于双抗平台的技术。算上2022年以5亿美金首付款授权给Summit公司的AK112，双抗平台屡现大交易。中国双抗资产接连获得MNC的青睐，这与前两年MNC扫货中国ADC如出一辙。中国双抗管线，似乎开始接替ADC，成为全球大药企最关注的前沿资产。 1 中国资产崭露头角截至目前，全球共有15款双抗药物曾获批上市，除首款双抗产品Catumaxomab因市场表现不佳退市外，其他14款产品均正常销售。其中就包括康方生物获批上市的两款双抗产品，中国创新药公司已经在全球双抗赛道中占据一席之地。 2024年上半年，全球双抗药物市场销售额超60亿美元，这还是在没有考量很多2023年刚进入商业化阶段潜力产品的情况下。也就是说，全球双抗药物市场规模将在2024年首次突破百亿美元大关。图：全球已上市双抗药物一览，来源：锦缎研究院复盘全球双抗药物发展之路，商业化进程并不平坦。Catumaxomab作为全球首款上市的双抗药物，用于治疗EpCAM阳性肿瘤引起的恶性腹水，率先在癌症领域开启了双抗治疗时代。然而，这款药物售价高昂，副作用大，几乎没有市场。2014年被停止销售，最终在2017年6月正式退市。受限于首款双抗药物孱弱的市场表现，动摇了药企在双抗赛道中的信心。至2020年之前，全球也仅有两款双抗药物上市，分别是2014年上市的Blinatumomab和2017年上市的Emicizumab。不过这两款上市的双抗产品很快向市场证明，不是双抗平台不给力，而是Catumaxomab做得太差劲。安进Blinatumomab营收一路增长，有望在今年突破10亿美元大关；罗氏Emicizumab营收更是突破50亿美元，成为药王级别的产品。受这两款双抗产品带动，药企开始重新关注双抗平台，尤其是2022年更是成为双抗药物的爆发之年，仅当年就有5款产品获批上市。此后，每年均有数款产品获批，双抗赛道真正进入了活跃期，就连早已退市的Catumaxomab，也在凌腾医药的临床管线上又起死回，重启了恶性腹水适应症研发，还试图向胃癌和膀胱癌适应症扩展。值得一提的是，双抗并非聚焦于癌症技术平台，除了在癌症领域表现出节节攀高的获批数量外，在非癌领域市场显得异常活跃。2024年4月，Nature刊发了CD19/CD3双抗Blinatumomab成功治疗6名难治性类风湿性关节炎患者的研究，为双抗市场又打开了一扇大门。默沙东巨额拿下CN201的原因，除了看中CN201在恶性肿瘤患者中具有良好的治疗前景外，更重要的是，早期临床数据已有力证明CN201对于靶向并耗竭循环B细胞和组织B细胞具备潜力，默沙东将研究其自免疾病新型可扩展疗法的潜力。双抗药物的路越走越宽，这也是为何MNC将被目光聚焦于中国双抗资产的原因。 2 康方生物：敢与药王试比高康方生物无疑是国内双抗龙头，已获批上市了卡度尼利和依沃西两款双抗药物，且每款都有全球首发的头衔。卡度尼利是全球首个肿瘤免疫治疗双抗新药；依沃西是全球首个获批上市的“肿瘤免疫+抗血管生成”机制的双抗新药。基于双抗药物的放量，康方生物业绩也迎来了暴涨时代。2023年总收入为45.26亿元，同比增长达440%，其中开坦尼（PD-1/CTLA-4）2023年销售额为13.58亿元，占产品总销售额83%，不仅抵消了其他产品51%的销售额下滑，还为总销售额带来高达48%的正增长。图，康方生物业绩一览，来源：康方生物除商业化层面的成功外，康方生物亦是BD出海的大赢家之一。依沃西（PD-1/VEGF）还未上市，就在2022年底成功BD给了美股公司Summit，仅首付款就高达5亿美元。也正是凭借依沃西的海外权益，Summit在美股中重新焕发活力，今年股价暴涨仅350%。今年5月底，康方生物发布依沃西Ⅲ期研究HARMONi-2临床结果，再次将双抗药物推向高潮。数据显示，依沃西单药对比K药单药一线治疗PD-L1表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）患者，达到无进展生存期（PFS）的主要研究终点，获决定性胜出阳性结果，成为全球首个且唯一在Ⅲ期单药头对头临床研究中证明疗效显著优于K药的药物。随即，Summit在2024年6月与康方生物修订许可协议，在原美国、加拿大、欧洲及日本的许可地区基础上，扩大至中美洲、南美洲、中东及非洲地区。根据新修订协议，康方生物可获得7000万美元首付款和里程碑款，以及销售提成。除两款已经上市的药物外，康方生物还有多款潜在全球首创或同类最佳的双抗药物，包括AK129（PD-1/LAG-3）、AK130（TIGIT/TGF-β）、AK131（PD-1/CD73）和AK132（Claudin18.2/CD47）。 3 百利天恒：玩出多抗新花样双抗是肿瘤免疫的迭代产品，ADC是化疗的迭代产品，而免疫治疗+ADC是未来肿瘤联合治疗的核心方向之一。当多数药企还在尝试开展双抗与ADC联合治疗时，百利天恒已在双抗技术基础上研发双抗ADC，创下出海首付款之最的双抗ADC药物BL-B01D1，正是基于其自研的双抗SI-B001研制而来。 2024年7月，BL-B01D1治疗晚期实体瘤I期临床研究结果在国际顶级杂志《柳叶刀肿瘤》发表，在既往治疗失败的多种实体肿瘤患者中均表现出突破性疗效，特别是在多药耐药后晚期肺癌和鼻咽癌上，客观缓解率（ORR）是目前所有治疗药物中最高的。临床数据显示，在EGFR突变非小细胞肺癌患者中，BL-B01D1客观缓解率（ORR）达52.5%，疾病控制率（DCR）达87.5%，而目前标准治疗ORR为26.7%—48.1%；在EGFR野生型非小细胞肺癌患者中，BL-B01D1的ORR达30.6%，DCR达87.1%，而目前标准治疗药物有效率仅为16.6%；在鼻咽癌患者中，BL-B01D1的ORR达37.8%，DCR达100%，而标准治疗ORR为23.5%—37.6%。据百利天恒官网显示，BL-B01D1针对非小细胞肺癌、小细胞肺癌、鼻咽癌、食管鳞癌、乳腺癌等多种癌症开展了单药及联合用药的11项临床试验，其中，EGFR突变型非小细胞肺癌、EGFR野生型非小细胞肺癌、鼻咽癌、食管鳞癌、三阴乳腺癌、HER2-HR+乳腺癌等6项临床试验已处于Ⅲ期阶段。图：BL-B01D1临床试验开展情况，来源：百利天恒官网既然双抗能成药，那么多抗理论上也行得通，百利天恒除了在研的SI-B001、SI-B003等双抗外，又开发了GNC-038、GNC-039和GNC-035等3款全新机制创新药，目前均已进入Ⅰ期临床试验阶段，该3款新药是全球前3个进入临床研究阶段的四体分子，此外，还有3款未披露靶点的多抗药物处于临床前阶段。图：百利天恒多抗临床管线，来源：公司官网在双抗的赛道上，百利天恒不仅从双抗升级到多抗，且与ADC融合开发双抗ADC，在临床开发上，又进行双抗ADC（BL-B01D1）和双抗（SI-B003）用于多种癌症的临床试验，堪称最具备想象空间的选手。 4 同润生物：起得早又赶得巧同润生物是药明生物在2018年孵化成立的biotech药企。据CDE官网显示，其从成立以来一共进行了CN201、CN202、CN401和CN1等4款1类新药的临床试验。在创新药寒冬的持续下，包括MNC在内的药企均受到较大的资金压力，砍管线成了应对寒冬的必要手段，同润生物也不例外。据润生物官网显示，其目前的临床管线上仅剩下CN201和CN808002等两款产品，除了CN201处于临床试验阶段外，CN808002仍处于临床前阶段。图：同润生物临床管线，来源：公司官网安进的Blinatumomab作为全球首款且唯一获批的CD3/CD19双抗，至今已过去十年，但仍未有相同靶点的双抗获批上市。虽然安进经营该款药物十年，才有机会将其孵化成“十亿美元分子”，但Blinatumomab自上市以来的市场表现非常稳定，年度销售额一直持续增长，这也为CD3/CD19靶点留下了良好的印象。国内CD3/CD19双抗管线本就不多，而作为在该赛道“起床”最早的同润生物，在应对创新药寒冬的管线调整上，最终只保留了CN201。2024年美国临床肿瘤学会（ASCO）年会上，同润生物公布了CN201治疗复发/难治性成人急性B淋巴细胞白血病（R/R B-ALL）Ⅰ期研究结果。临床数据显示，在目标剂量达到20 mg及以上的剂量组，总缓解率达70%以上，且获得缓解的患者90%以上为MRD阴性。此外，在安全性方面，总体CRS发生率不到30%，且以1或2级为主，3级CRS发生率为3.9%，无4级以上CRS发生，入组的51例成人患者，尚未出现ICANS。对比Blinatumomab治疗R/R B-ALL患者需24 h持续静脉输注，共28天的给药方式，CN201因增加了Fc段，半衰期较长，每周只需给药一次，且每次只需持续2—3h左右，患者依从性得到了显著提高。优异的临床数据和颠覆市场现有CD19/CD3双抗给药方式的“临门一脚”，让急于布局自免领域的默沙东看中了CN201。 5 信达生物：铁树何时开花？信达生物是国内最早布局双抗管线的药企之一，但却并没有实际成绩。尤其是这些年信达生物在双抗上的布局，略显浮躁。对比2021年以来年报中临床管线规划，不难看出信达生物在双抗布局上的彷徨。2021年报显示，信达共有6款双抗管线；而2022年报中，IBI-321、IBI-319和IBI-315消失不见；2023年报中，之前的IBI-323又消失不见。图：信达生物双抗管线产品变化，来源：锦缎研究院加上在2021年消失不见的IBI-318，信达生物一共砍掉了5个双抗管线产品。更有意思的是，信达生物砍双抗管线的同时，可整体双抗管线布局却是增加的。2022年和2023年增加的4款双抗产品中，除了三抗IBI3003用于治疗肿瘤领域，其他3款分布在眼科和自免领域，而此前，其双抗布局为单一的肿瘤领域。信达之所以这么做，或许是看到了罗氏Faricimab的潜力。Faricimab首个不完整年度的销售额就达到了6.88亿美元，今年上半年更是创下21.54亿美元的销售佳绩，这让信达生物也看到了VEGF双抗在眼科领域的巨大前景。为了在眼科双抗赛道上分一杯羹，信达双抗注意力也逐渐从肿瘤转移到眼科。同写意媒体矩阵，欢迎关注↓↓↓

引进/卖出细胞疗法免疫疗法抗体药物偶联物

100 项与 Izalontamab 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
肺腺癌	临床3期	中国	四川百利药业有限责任公司	2023-07-14
鳞状细胞癌	临床3期	中国	四川百利药业有限责任公司	2023-07-14
鳞状细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2023-07-14
非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2023-07-14
局部晚期非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2022-01-06
复发性非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2022-01-06
局部晚期头颈部鳞状细胞癌	临床2期	中国	四川百利药业有限责任公司	2023-02-10
腺上皮肿瘤	临床2期	中国	四川百利天恒药业股份有限公司	2022-01-30
头颈部鳞状细胞癌	临床2期	中国	四川百利药业有限责任公司	2021-12-22
复发性食管鳞状细胞癌	临床2期	中国	四川百利药业有限责任公司	2021-12-13

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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


NCT05054439 \| NCT05044897 (ASCO2023) 人工标引	临床2期	转移性头颈部鳞状细胞癌	22	SI-B001 16mg/kg IV QW (S209)	廠淵製淵憲選蓋願憲襯(選積壓膚觸鬱夢鑰蓋範) = 憲齋網鏇蓋製齋蓋範醖繭構鏇顧夢選憲獵窪觸 (夢繭鬱遞鑰醖繭願艱製 ) 更多	积极	2023-05-31
				SI-B001 12mg/kg IV QW + paclitaxel (80mg/m2 IV QW) (S206)	廠淵製淵憲選蓋願憲襯(選積壓膚觸鬱夢鑰蓋範) = 顧鬱艱願夢廠憲觸簾艱繭構鏇顧夢選憲獵窪觸 (夢繭鬱遞鑰醖繭願艱製 ) 更多
NCT05020457 (ASCO2023) 人工标引	临床2期	非小细胞肺癌二线 EGFR Wild Type \| ALK Wild Type	48	chemotherapy+SI-B001 (second-line treatment after failure to first-line anti-PD-1/L1 antibody monotherapy + Cohort A)	-	积极	2023-05-26
				docetaxel+SI-B001 (second-line treatment after failure to first-line anti-PD-1/L1 therapy plus PBC + Cohort B)	淵齋繭廠憲壓淵夢夢夢(憲選網醖糧餘淵網繭簾) = 醖獵獵顧築糧遞襯鑰窪窪襯廠糧鹹膚窪簾糧壓 (選築願鑰夢窪選顧觸艱, 24.5 ~ 67.8) 更多