更新于：2024-11-01
Briquilimab
更新于：2024-11-01
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评罕见儿科疾病 (美国)、孤儿药 (欧盟)、快速通道 (美国) |
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序列信息
Sequence Code 682557638L
来源: *****
Sequence Code 682558090H
来源: *****
关联
12
项与 Briquilimab 相关的临床试验A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Briquilimab in Participants with Allergic Asthma
Study JSP-CP-012 is designed as a proof of concept, parallel-group, single dose, double blind, placebo-controlled study using an allergen challenge model. A single dose proof of concept approach at a dose level shown to be biologically active should inform the impact of briquilimab on allergic asthma as compared to placebo while minimizing exposure to participants, in a new indication.
开始日期2024-09-16 |
申办/合作机构 |
A Phase 1b/2a, Dose Escalation Study of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Sympomatic Despite Treatment With, Or Who Cannot Tolerate Omalizumab - JSP-CP-011
开始日期2024-03-20 |
申办/合作机构 |
A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines
This is an open-label, single ascending dose Phase 1b/2a trial to determine the safety and tolerability and assess the preliminary efficacy of briquilimab in adult participants with Cold Urticaria (ColdU) or Symptomatic Dermographism (SD), who remain symptomatic despite treatment with H1 antihistamines. The trial will explore two ascending dose levels which will be tested in two sequential cohorts.
开始日期2024-03-18 |
申办/合作机构 |
100 项与 Briquilimab 相关的临床结果
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100 项与 Briquilimab 相关的转化医学
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100 项与 Briquilimab 相关的专利（医药）
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5
项与 Briquilimab 相关的文献（医药）2024-09-01·Transplantation and Cellular Therapy
Pharmacokinetics of Briquilimab as a Conditioning Agent for Hematopoietic Stem Cell Transplantation in Patients With Severe Combined Immunodeficiency, Myelodysplastic Syndrome, or Acute Myeloid Leukemia
Article
作者: Pang, Wendy W ; Gobburu, Jogarao V S ; Long-Boyle, Janel R ; Jung, Dawoon
2022-10-01·CPT: Pharmacometrics & Systems Pharmacology
Physiologically‐based pharmacokinetic modeling of immunoglobulin and antibody coadministration in patients with primary human immunodeficiency
Article
作者: Kakkar, Tarundeep ; Salerno, Sara N. ; Deng, Rong
2019-05-09·Blood
Anti-human CD117 antibody-mediated bone marrow niche clearance in nonhuman primates and humanized NSG mice
Letter
作者: Prohaska, Susan S. ; Weissman, Irving L. ; Poyser, Jessica ; Shizuru, Judith A. ; Czechowicz, Agnieszka ; Hollis, Roger ; Tate, Keri ; Kohn, Donald B. ; Pang, Wendy W. ; Chhabra, Akanksha ; Le, Alan ; Kelly, Benjamin V. ; Kwon, Hye-Sook ; Logan, Aaron C.
101
项与 Briquilimab 相关的新闻（医药）2024-10-24
REDWOOD CITY, Calif., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, is presenting data from preclinical studies evaluating briquilimab at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, taking place October 24-28, 2024, in Boston, Massachusetts. “We are pleased to present promising preclinical results from multiple studies at ACAAI this year,” said Wendy Pang, M.D., Ph.D., Senior Vice President, Research and Translational Medicine. “Both the in-vitro data and the non-human primate data generated in these studies provide further support for the pharmacodynamics of briquilimab, particularly its ability to bind c-Kit and drive mast cell depletion with relatively high potency.” Details of the presentations are as follows: Abstract Title: Briquilimab is Well-Tolerated and Effectively Depletes Tissue Resident Mast Cells in Non-Human PrimatesAbstract ID: 8271ePoster ID: R056 Presentation Date / Time: Friday, October 25, 2024; 3:45 p.m. - 4:00 p.m. EDTLocation: Exhibit Hall A Abstract Title: Briquilimab Potently Inhibits Stem Cell Factor (SCF)/c-Kit Signaling, and Mast Cell (MC) Degranulation and SurvivalAbstract ID: 8282ePoster ID: R058 Presentation Date / Time: Friday, October 25, 2024; 4:15 p.m. - 4:30 p.m. EDTLocation: Exhibit Hall A Abstract Title: Briquilimab Potently Blocks Stem Cell Factor (SCF)/c-Kit Signaling in Primary Human Mast CellsAbstract ID: 8298ePoster ID: R059 Presentation Date / Time: Friday, October 25, 2024; 4:30 p.m. - 4:45 p.m. EDTLocation: Exhibit Hall A Copies of the presentations will be available on the ACAAI website as well as the Events & News – Events page on the Jasper Therapeutics IR website. About BriquilimabBriquilimab is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU and is initiating a clinical study in patients with asthma. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU, and as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD). About JasperJasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria, asthma and lower to intermediate risk MDS and as a conditioning agent for stem cell transplants for rare diseases such as SCD, FA and SCID. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU and as a conditioning agent in SCID, AML, MDS, FA, and SCD. For more information, please visit us at www.jaspertx.com. Forward-Looking StatementsCertain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, and asthma and its ability to bind c-Kit and drive mast cell depletion with relatively high potency; and Jasper’s presentation at ACAAI. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that prior test, study and trial results may not be replicated in continuing or future studies and trials; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: Joyce Allaire (investors)LifeSci Advisors617-435-6602jallaire@lifesciadvisors.com Alex Gray (investors)Jasper Therapeutics650-549-1454 agray@jaspertx.com Lauren Walker (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com
免疫疗法细胞疗法AACR会议
2024-10-23
Jasper Therapeutics Announces Further Expansion of Clinical Program in Chronic Spontaneous Urticaria
REDWOOD CITY, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that it is commencing an open-label extension study in chronic urticarias that will roll over patients from the BEACON and SPOTLIGHT studies upon completion of their initial follow up period. Additionally, Jasper also announced it has obtained regulatory clearance in the US and in the EU to further expand the BEACON study in CSU by adding a 360mg single-dose cohort (n=4), and that enrollment in this cohort has commenced. Jasper continues to plan to report initial data from all doses of the BEACON study up through 240mg in CSU during the week of January 6th, 2025. Data from the newly added 360mg single-dose cohort is expected to be reported in the first half of 2025. “I am very pleased with the ability of our clinical and regulatory teams to efficiently advance our clinical development plan in support of generating a robust data set in chronic urticaria,” said Ronald Martell, President and Chief Executive Officer of Jasper. “The addition of the 360mg single-dose cohort in the BEACON study in CSU will allow us to evaluate another potential loading dose leveraging the ongoing clinical trial, and the rollover extension study will allow us to gather longer-term safety and efficacy data at therapeutic doses for patients in both BEACON and SPOTLIGHT. The expanded breadth of clinical data provided in CSU and CindU should further support optimal biologic dosing in our registrational studies, planned to commence in the second half of 2025.” About Briquilimab Briquilimab is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU and is initiating a clinical study in patients with asthma. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU, and as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD). About Jasper Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria, asthma and lower to intermediate risk MDS and as a conditioning agent for stem cell transplants for rare diseases such as SCD, FA and SCID. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU and as a conditioning agent in SCID, AML, MDS, FA, and SCD. For more information, please visit us at www.jaspertx.com. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, and asthma; the expected number of participants in the 360mg single-dose cohort; Jasper’s expected timing for presenting initial data from all doses of the BEACON study up through the 240mg dose cohort in CSU and from the 360mg single-dose cohort; Jasper’s expectations regarding the commencement and timing of registrational studies; and Jasper’s expectation that the expanded clinical data should further support optimal biologic dosing in its registrational studies. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that prior test, study and trial results may not be replicated in continuing or future studies and trials; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts:Alex Gray (investors)Jasper Therapeutics650-549-1454 agray@jaspertx.com Joyce Allaire (investors)LifeSci Advisors617-435-6602jallaire@lifesciadvisors.com Lauren Walker (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com
免疫疗法细胞疗法临床申请
2024-10-20
·药明康德
▎药明康德内容团队编辑
本期看点
1. 新型IL-15受体激动剂NKTR-255联用嵌合抗原受体（CAR）-T细胞疗法治疗复发或难治性B细胞急性淋巴细胞白血病（B-ALL），患者12个月时的无进展生存率是单独使用CAR-T细胞疗法历史对照组的两倍（67%对比38%）。
2. 单抗疗法briquilimab在针对慢性诱发性荨麻疹（CIndU）患者开展的1b/2a期研究中表现亮眼，93%的患者在接受治疗后6周达成缓解。
3. 首个进入人体临床试验的工程化B细胞疗法ISP-001的初步结果积极，首位接受治疗的1型黏多糖贮积症（MPS I）患者已停止使用标准疗法。
药明康德内容团队整理
NKTR-255：公布1期联合治疗试验数据
Nektar Therapeutics公司公布了一项1期研究的首个临床数据，该研究评估了其新型IL-15受体激动剂NKTR-255联用靶向CD19和CD22的自体双特异性CAR-T细胞疗法治疗复发或难治性B细胞急性淋巴细胞白血病患者的效果。NKTR-255是一种聚合物偶联人IL-15，它能保持与IL-15受体α亚基的结合亲和力，并降低清除率，从而提供持续的药效学作用。NKTR-255具有增强免疫治疗效果的潜力。
此次公布的结果显示，NKTR-255联用CAR-T细胞疗法治疗复发或难治性B-ALL患者的疗效良好。9名患者中有8名获得了完全缓解（CR），伴有或不伴有血液学恢复，所有患者均未检测到微小残留病（MRD）。此外，与仅接受相同CAR-T细胞疗法的历史对照组相比，NKTR-255联用CAR-T细胞疗法组患者的12个月无复发生存率更高（67%对比38%）。历史对照组患者的中位无复发生存期（RFS）为3.9个月，联合治疗组患者接受随访超过14个月，中位RFS尚未达到。安全性方面，未观察到与NKTR-255相关的剂量限制性毒性。联合治疗组中观察到的毒性与单独使用CAR-T细胞治疗后观察到的毒性相似。
Briquilimab：公布1b/2a期临床试验数据
Jasper Therapeutics公司公布了其候选单抗briquilimab用于治疗慢性诱发性荨麻疹的1b/2a期研究SPOTLIGHT的初步数据。Briquilimab是一种非糖基化单克隆抗体，可通过靶向细胞表面受体c-Kit（也称为CD117）以避免与干细胞因子结合，从而阻断肥大细胞中的关键生存信号，造成细胞凋亡与耗竭，从而消除肥大细胞驱动疾病（如慢性荨麻疹）中炎症反应的潜在来源。
此次公布的结果显示，CIndU患者在接受briquilimab皮下注射后1周便观察到CR，且93%的患者在接受治疗后6周达成缓解。120毫克剂量组中，12名患者中有10名（83%）达到了CR，1名达成部分缓解（PR）。40毫克组中，1名患者达成CR，2名患者达成PR。该公司已获得监管批准在SPOTLIGHT研究中招募患者接受更高剂量药物的治疗。
ISP-001：公布1期临床试验中首例患者的数据
Immusoft公司公布了首位接受其工程化B细胞疗法ISP-001治疗的1型黏多糖贮积症患者的积极结果。根据新闻稿，ISP-001是首个进入人体临床试验的工程化B细胞疗法。该疗法使用非病毒载体将表达α-L-艾杜糖苷酶的转基因引入B细胞中，能够让经过改造的B细胞长期大量生产治疗性蛋白，从而改善患者症状。
此次公布的临床试验结果显示，首位接受ISP-001治疗的患者在接受治疗3-8个月后，尿液中的多糖疾病生物标志物水平降低到正常范围内。这名患者脑脊液中的硫酸乙酰肝素（HS）水平在接受治疗6个月时降低25%。这是FDA认可的一个与MPS I疾病活动相关的替代终点。生物标志物之外，这名患者的6分钟行走检测表现提高30%，并且肩部活动范围在6个月时得到改善。关节僵硬是MPS I的症状之一。在接受治疗8个月后，该患者停止使用标准酶替代疗法（ERT）。随后的一个月里，患者的6分钟行走检测表现仍然获得改善，不过幅度比6个月时有所下降，肩部活动范围的改善得到维持。安全性方面，ISP-001的耐受性良好。截至2024年9月19日，尚未报告任何不良事件。
WVE-006：公布1b/2a期临床试验数据
Wave Life Sciences公司公布了其在研RNA编辑候选疗法WVE-006用于治疗α-1抗胰蛋白酶缺乏症（AATD）的1b/2a期临床试验RestorAATion-2的积极结果。AATD是一种可影响肺和肝脏功能的遗传疾病，患者除了缺乏具有正常功能的α-1抗胰蛋白酶（AAT），其突变型AAT蛋白的积累也会损害肝脏和肺部。WVE-006是一款通过PN化学修饰和GalNAc偶联，以皮下注射方式给药的潜在“first-in-class”RNA编辑寡核苷酸疗法。WVE-006的设计旨在修复SERPINA1等位基因编码mRNA中的单碱基突变，从而恢复血液中的功能性野生型AAT蛋白，同时减少异常AAT蛋白的存在，以潜在治疗AATD相关的肺病和/或肝病。
此次公布的结果显示，WVE-006能够成功编辑AATD患者的基因。基线时未能检测到患者体内的AAT蛋白，而在试验第15天时，患者的平均总AAT蛋白水平达到10.8微摩尔，达到了监管机构批准AAT增强疗法的标准。此外，早在试验第3天，患者的总AAT和M-AAT蛋白水平即较基线增加，并持续到第57天。根据新闻稿，WVE-006是首个进入临床开发的RNA编辑疗法，该试验结果是RNA编辑疗法在人体当中完成的首次机制验证。
BB-301：公布1b/2a期临床试验中前两例患者的数据
Benitec Biopharma公司公布了其开发用于治疗眼咽肌营养不良（OPMD）的沉默和取代基因疗法BB-301在早期临床试验中的前两例患者的积极数据。该疗法利用一种新型的、经过改良的AAV9载体，表达一种独特的、单一的双功能构建体，从而能够促进密码子优化的PABPN1基因和两个针对PABPN1突变体siRNA的共同表达。这两个siRNA被塑造成微RNA骨架，以抑制有缺陷的PABPN1突变体的表达，同时允许表达经过密码子优化的PABPN1基因，用PABPN1蛋白的功能性版本取代突变体。
两名患者接受了最低剂量的BB-301治疗，未报告值得注意的不良事件。此次公布的结果显示，1号患者和2号患者分别在接受BB-301治疗9个月和6个月后，吞咽功能得到了持久且有临床意义的改善。其中，在基线时症状更轻的2号患者的悉尼吞咽问卷评分已达到了临床定义的正常水平。新闻稿指出，这是使用新型基因疗法成功改善OPMD患者吞咽功能的首次报道。
SR-02：IND申请获得FDA许可
Seraxis公司宣布，其新型胰岛替代疗法SR-02的IND申请已获得FDA许可，可开展1/2期临床研究。SR-02由同种异体胰腺内分泌细胞簇组成，当被植入网膜时，可在患者自身的胰腺外形成功能性内分泌胰腺。SR-02能够以临床规模生产，由健康供体胰腺组织进行重编程后产生的专有干细胞系制成。新闻稿指出，SR-02作为一种有潜力功能性治愈需要胰岛素的糖尿病患者的疗法，是FDA许可的首个可用于人体试验的重编程干细胞衍生的候选胰腺产品。
CLN-978：IND申请获得FDA许可
Cullinan Therapeutics公司宣布，美国FDA批准了其新型、高效的CD19 x CD3靶向双特异性T细胞接合器CLN-978的IND申请，其针对中度至重度系统性红斑狼疮（SLE）患者的全球1期临床试验可在美国开展。新闻稿指出，CLN-978是首个在自身免疫疾病领域获得美国FDA授予IND批准的在研CD19靶向T细胞接合器。
CLN-978可在体外和体内引发对表达CD19的靶细胞的定向裂解。CLN-978与CD19的结合亲和力极高，可有效靶向B细胞，包括CD19水平极低的B细胞。CLN-978的分子量小（65 kDa），含有两个单链可变片段，一个与CD19结合，另一个与T细胞上的CD3结合，还有一个与人血清白蛋白结合的单结构域抗体，可延长血清半衰期。CLN-978有望为SLE和类风湿性关节炎等自身免疫疾病患者提供一种方便、现货型、皮下注射的治疗选择。
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[1] Immusoft to Announce Positive Phase 1 Data for First Engineered B Cell Therapy in a Clinical Trial. Retrieved October 15, 2024, from https://www.prnewswire.com/news-releases/immusoft-to-announce-positive-phase-1-data-for-first-engineered-b-cell-therapy-in-a-clinical-trial-302255551.html
[2] Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes. Retrieved October 18, 2024, from https://seraxis.com/wp-content/uploads/2024/10/Seraxis-IND-clearance-PR-FINAL-for-release-15Oct2024.pdf
[3] Nektar Announces Publication in Blood of Phase 1 Data for Novel IL-15 Agonist NKTR-255 in Combination with Autologous CD19-22 CAR-T Cell Therapy in Patients with B-cell Acute Lymphoblastic Leukemia. Retrieved October 18, 2024, from https://ir.nektar.com/news-releases/news-release-details/nektar-announces-publication-blood-phase-1-data-novel-il-15
[4] Jasper Therapeutics Reports Positive Data from SPOTLIGHT Study of Briquilimab in Chronic Inducible Urticaria. Retrieved October 14, 2024 from https://www.globenewswire.com/news-release/2024/10/14/2962446/0/en/Jasper-Therapeutics-Reports-Positive-Data-from-SPOTLIGHT-Study-of-Briquilimab-in-Chronic-Inducible-Urticaria.html
[5] Wave Life Sciences Announces First-Ever Therapeutic RNA Editing in Humans Achieved in RestorAATion-2 Trial of WVE-006 in Alpha-1 Antitrypsin Deficiency. Retrieved October 16, 2024 from https://www.globenewswire.com/news-release/2024/10/16/2964053/0/en/Wave-Life-Sciences-Announces-First-Ever-Therapeutic-RNA-Editing-in-Humans-Achieved-in-RestorAATion-2-Trial-of-WVE-006-in-Alpha-1-Antitrypsin-Deficiency.html
[6] Benitec Biopharma Reports Positive Data from Two Subjects Treated with Low-Dose BB-301 in Phase 1b/2a Study Presented at 29th Annual Congress of the World Muscle Society. Retrieved October 18, 2024, from https://www.globenewswire.com/news-release/2024/10/12/2962249/0/en/Benitec-Biopharma-Reports-Positive-Data-from-Two-Subjects-Treated-with-Low-Dose-BB-301-in-Phase-1b-2a-Study-Presented-at-29th-Annual-Congress-of-the-World-Muscle-Society.html
[7] Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus. Retrieved October 18, 2024, from https://investors.cullinantherapeutics.com/news-releases/news-release-details/cullinan-therapeutics-receives-us-fda-clearance-investigational
[8] SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia. Retrieved October 18, 2024, from https://www.prnewswire.com/news-releases/systimmune-inc-announces-fda-clearance-of-ind-application-for-bl-m11d1-in-relapsedrefractory-acute-myeloid-leukemia-302275098.html
[9] Circle Pharma announces first patients dosed in Phase 1 clinical trial of first-in-class oral Cyclin A/B RxL inhibitor CID-078 for advanced solid tumors. Retrieved October 18, 2024, from https://circlepharma.com/circle-pharma-announces-first-patients-dosed-in-phase-1-clinical-trial-of-first-in-class-oral-cyclin-a-b-rxl-inhibitor-brcid-078-for-advanced-solid-tumors
[10] Immutep Announces First-in-Human Phase I Study of IMP761 Progresses to Dose Escalation Portion of Trial. Retrieved October 18, 2024, from https://www.globenewswire.com/news-release/2024/10/17/2964816/0/en/Immutep-Announces-First-in-Human-Phase-I-Study-of-IMP761-Progresses-to-Dose-Escalation-Portion-of-Trial.html
[11] Bright Peak Therapeutics Announces Dosing of First Patient in Phase 1/2a Clinical Trial of BPT567, a First-in-Class Bifunctional PD1-IL18 Immunoconjugate. Retrieved October 18, 2024, from https://brightpeaktx.com/bright-peak-therapeutics-announces-dosing-of-first-patient-in-phase-1-2a-clinical-trial-of-bpt567-a-first-in-class-bifunctional-pd1-il18-immunoconjugate/
[12] Athos Announces Positive Topline Phase 1 Data for its AI-Generated, Novel, Oral G9A Inhibitor ATH-063, Demonstrating Selective Expansion and Activation of Potent Anti-Inflammatory Regulatory T Cells. Retrieved October 18, 2024, from https://athostx.com/news-posts/athos-announces-positive-topline-phase-1-data-for-its-ai-generated-novel-oral-g9a-inhibitor-ath-063-demonstrating-selective-expansion-and-activation-of-potent-anti-inflammatory-regulatory-t-cells/
[13] Latigo Biotherapeutics Doses First Participant in Phase 1 Clinical Trial of LTG-305 for Non-Opioid Treatment of Pain. Retrieved October 18, 2024, from https://www.prnewswire.com/news-releases/latigo-biotherapeutics-doses-first-participant-in-phase-1-clinical-trial-of-ltg-305-for-non-opioid-treatment-of-pain-302276944.html
[14] IgGenix Announces First Patient Dosed in Phase 1 Clinical Trial "ACCELERATE Peanut" Evaluating IGNX001 in Peanut Allergy. Retrieved October 18, 2024, from https://www.prnewswire.com/news-releases/iggenix-announces-first-patient-dosed-in-phase-1-clinical-trial-accelerate-peanut-evaluating-ignx001-in-peanut-allergy-302277256.html
[15] Repare Therapeutics Doses First Patient in Phase 1 Clinical Trial of RP-3467, a Polθ ATPase Inhibitor. Retrieved October 18, 2024, from https://ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-doses-first-patient-phase-1-clinical-trial-2
[16] uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial of AMT-162 for the Treatment of SOD1-ALS. Retrieved October 18, 2024, from https://www.globenewswire.com/news-release/2024/10/15/2963063/0/en/uniQure-Announces-Dosing-of-First-Patient-in-Phase-I-II-Clinical-Trial-of-AMT-162-for-the-Treatment-of-SOD1-ALS.html#:~:text=LEXINGTON%2C%20Mass.%20and%20AMSTERDAM%2C%20Oct.%2015%2C%202024%20%28GLOBE,a%20rare%2C%20inherited%20and%20progressive%20motor%20neuron%20disease.
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细胞疗法临床结果免疫疗法临床1期
100 项与 Briquilimab 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 |
|---|---|---|---|---|
| 慢性荨麻疹 | 临床2期 | 德国 | 2023-11-29 | |
| 慢性荨麻疹 | 临床2期 | 美国 | 2023-11-29 | |
| β地中海贫血 | 临床2期 | 美国 | 2022-05-12 | |
| 急性髓性白血病 | 临床2期 | 美国 | 2020-07-08 | |
| 重症联合型免疫缺陷 | 临床2期 | 美国 | 2017-03-20 | |
| 镰状细胞血症 | 临床2期 | 美国 | - | |
| 过敏性哮喘 | 临床1期 | 加拿大 | 2024-09-16 | |
| 慢性肉芽肿病 | 临床1期 | 美国 | 2023-01-02 | |
| 骨髓增生异常综合征 | 临床1期 | 美国 | 2020-07-08 | |
| 炎症 | 临床前 | 美国 | - |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | - | - | 齋夢襯製醖鏇餘願範願(艱膚衊選艱觸鬱網鹹夢) = The frequency of apoptotic cells from all three conditions was less than 14% 鏇鏇餘糧簾糧鑰廠遞艱 (艱齋壓鬱繭選築簾築鏇 ) 更多 | - | 2024-05-14 | ||
临床1/2期 | 3 | 夢觸夢窪願醖範顧淵衊(齋築鹹製蓋鑰壓餘選繭) = 襯廠範壓網襯鏇顧壓壓 糧遞選製窪鏇窪構構襯 (築鏇糧壓衊積衊餘觸醖 ) 更多 | - | 2023-12-09 | |||
临床1期 | 29 | 壓構觸鑰糧積窪繭夢網(鹹餘艱壓繭淵鹽餘膚遞) = 衊壓製襯願夢蓋繭繭選 遞鬱願膚蓋獵醖廠選觸 (願衊鬱鹹醖網簾遞顧壓 ) 更多 | - | 2023-04-23 | |||
N/A | - | JSP191 + Flu/TBI | 築糧鹽築遞簾窪鹽顧網(鹽糧顧醖夢觸鹽糧觸鏇) = were elevated in BM plasma in cGVHD 壓願鬱選憲觸範範鹹壓 (醖夢糧齋製衊網顧艱顧 ) 更多 | - | 2023-02-01 | ||
临床1期 | 12 | (簾憲鏇窪齋衊鑰壓觸齋) = 範繭夢簾網壓鏇鑰襯選 鹹鬱憲繭製網襯憲願簾 (齋淵憲壓積繭壓築餘繭 ) 更多 | 积极 | 2023-02-01 | |||
临床1期 | 12 | 選齋觸觸繭鏇窪壓範構(蓋製觸願鑰夢窪構憲壓) = 6 of whom were MRD negative at the latest post-HCT evaluable timepoint 廠觸淵顧膚製觸蓋網壓 (築衊觸醖鏇鏇繭築鏇獵 ) 更多 | 积极 | 2023-02-01 | |||
Fludarabine 30 mg/m2/day | |||||||
临床1/2期 | 2 | (蓋醖蓋鹹齋築鬱築襯構) = 膚構衊廠鬱憲蓋蓋憲積 遞淵膚範蓋糧網鏇憲願 (糧壓襯顧積製顧襯廠壓 ) | 积极 | 2022-09-26 | |||
临床1期 | 24 | (糧衊廠鏇築繭膚鑰艱壓) = 1pt with grade III-IV acute GI GVHD，1pts with secondary graft failure 齋繭製糧網鹹築糧艱鏇 (構構艱艱憲蓋膚鑰壓構 ) | 积极 | 2022-04-26 | |||
临床1期 | 17 | 醖鑰窪鏇願選蓋膚衊製(窪製膚觸憲構鬱醖願顧) = No other grade 2-4 acute GVHD events have been observed 糧齋範鹹構夢網製餘顧 (衊構襯觸繭憲遞糧醖壓 ) 更多 | 积极 | 2022-03-01 |
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