预约演示
更新于：2025-03-12
ELA-026
更新于：2025-03-12
概要
基本信息
药物类型 单克隆抗体 |
别名 fully human IgG1 monoclonal antibody directed against human signal regulatory protein (SIRP)alpha, SIRPbeta1, and SIRPgamma(Electra Therapeutics)、myeloid and T cell depletor (Electra Therapeutics)、ELA 026 + [1] |
作用机制 SIRPα调节剂(信号调节蛋白α调节剂)、SIRPβ1 modulators(signal regulatory protein beta 1 modulators)、SIRPγ modulators(signal regulatory protein gamma modulators) |
在研适应症 |
非在研适应症- |
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段临床2/3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、快速通道 (美国) |
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关联
3
项与 ELA-026 相关的临床试验NCT05416307
A Multipart, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.
开始日期2022-05-19 |
申办/合作机构 |
NCT05556863
A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ELA026 Following Intravenous and/or Subcutaneous Administration of Single and Multiple Doses in Healthy Adults
ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.
开始日期2021-10-18 |
申办/合作机构 |
EUCTR2021-001387-20-ES
A Phase 1b, Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Adults and Adolescents with Secondary Hemophagocytic Lymphohistiocytosis (sHLH).
开始日期2021-10-11 |
申办/合作机构 |
100 项与 ELA-026 相关的临床结果
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100 项与 ELA-026 相关的转化医学
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100 项与 ELA-026 相关的专利（医药）
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15
项与 ELA-026 相关的新闻（医药）2024-12-15
·药明康德
▎药明康德内容团队编辑
本期看点
1. 用于治疗继发性噬血细胞性淋巴组织细胞增生症（sHLH）的单克隆抗体疗法ELA026在1b期研究中的表现亮眼，用药后第4周时的总缓解率（ORR）为100%（12/12）。
2. RNA干扰（RNAi）药物ARO-CFB用于治疗补体介导疾病，在一项1/2a期临床研究中使正常健康受试者中目标蛋白的水平平均降低90%，且持续时间超过3个月。
3. 6个月内使用1-2次血浆激肽释放酶单克隆抗体抑制剂navenibart在早期临床试验中使遗传性血管性水肿（HAE）患者的每月发作率降低了90%-95%。
药明康德内容团队整理
ELA026：公布1b期临床试验的新数据
Electra Therapeutics公司公布了其单克隆抗体疗法ELA026用于治疗继发性噬血细胞性淋巴组织细胞增生症的1b期研究结果。sHLH是一种罕见的、危及生命的高炎症性疾病，目前尚无批准的治疗方法。它可以由癌症、感染、自身免疫性疾病或免疫疗法引发。sHLH与严重的炎症反应有关，患者需要立即干预。如果不进行治疗，患者可能会出现多器官衰竭和死亡。sHLH与病程早期的高死亡率相关，使用可用疗法的恶性肿瘤相关HLH（mHLH）患者在两个月时的死亡率约为50%。ELA026靶向髓系细胞和T淋巴细胞表面的SIRP-α/β1/γ，髓系细胞和T淋巴细胞是诱发sHLH细胞因子风暴和高炎症反应的主要病理免疫细胞。以SIRP为靶点选择性地清除致病性免疫细胞具有在免疫学、炎症和癌症领域广泛应用的潜力。
此次公布的研究结果表明，对于mHLH患者，在接受ELA026作为一线治疗的患者中，第4周时的ORR为100%（12/12），出院率为100%(11/11)，2个月生存率为92%（11/12）。安全性方面，ELA026的耐受性良好，不良事件可控。
ARO-CFB：公布1/2a期临床试验的中期数据
Arrowhead Pharmaceuticals公司公布了其靶向补体因子B（CFB）的在研RNAi药物ARO-CFB用于治疗补体介导疾病的1/2a期临床研究的中期结果。ARO-CFB旨在减少肝脏中CFB的表达，CFB在放大补体替代通路活化过程中起着重要的调节作用。ARO-CFB正被开发为补体介导的肾脏疾病的潜在治疗药物，如免疫球蛋白A肾病（IgAN）。此外，ARO-CFB还有望用于涉及补体激活的非肾脏疾病的临床治疗。
截至2024年11月15日的数据，ARO-CFB在正常健康受试者中实现了剂量依赖性的循环CFB蛋白水平降低，平均达90%，且持续时间超过3个月。此外，无论是单次还是多次给药，ARO-CFB几乎完全抑制了替代通路的活性。截至目前，ARO-CFB总体耐受性良好，安全性数据支持进一步的临床开发。
Navenibart（STAR-0215）：公布1b/2期临床试验数据
Astria Therapeutics公司公布了其用于治疗遗传性血管性水肿的血浆激肽释放酶单抗抑制剂navenibart的1b/2期临床试验数据。在该研究中，16名患者被分入三个队列接受STAR-0215皮下给药：队列1的4名患者接受了1剂450 mg剂量；队列2的6名患者先接受了1剂600 mg剂量，并在3个月后又接受了1剂300 mg剂量；队列3的6名患者先接受了1剂600 mg剂量，并在1个月后又接受了1剂600 mg剂量。
此次公布的结果显示，在6个月内给药1次或2次navenibart，3个队列患者的平均每月发作率降低了90%-95%，该结果支持每年仅给药2次或4次。此外，使用navenibart后，中度或严重HAE发作减少了约95%-96%，需要使用急救药物的发作减少了91%-94%。队列2和队列3患者6个月内的无发作率为67%。安全性方面，navenibart总体耐受性良好，无严重不良事件，无停药现象。
IO-202：公布1b期临床试验扩展队列的新数据
Immune-Onc Therapeutics公司公布了其1b期扩展队列的最新数据，该队列评估了其抗LILRB4抗体IO-202联用阿扎胞苷（AZA）治疗慢性粒单核细胞白血病（CMML）患者的疗效和安全性。IO-202是一款潜在"first-in-class"的IgG1抗体，可特异性、高亲和力地与LILRB4结合，并通过抗体依赖性细胞毒性和抗体依赖性细胞吞噬作用消除LILRB4阳性细胞。因此，IO-202是一种在血癌、自身免疫性和炎症性疾病方面具有广阔潜力的靶向疗法。
此次公布的结果显示，根据国际工作组2023缓解标准，在接受IO-202与AZA联合治疗的18名疗效可评估的CMML患者中，ORR为66.7%，完全缓解（CR）率为50%。在LILRB4高表达的CMML患者中，ORR为100%，CR率为83.3%。值得注意的是，过往获批疗法的CR率仅为7-17%。
ISB 2001：公布1期临床试验的新数据
Ichnos Glenmark Innovation公司公布了其三特异性抗体ISB 2001用于治疗复发/难治性多发性骨髓瘤（RRMM）的1期研究的新数据。ISB 2001同时靶向MM细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。
截至2024年10月1日的数据，20名可评估疗效患者的ORR为75%（5/20），CR/严格的CR（sCR）率为20%。在接受活性剂量（0.05 mg/kg和更高剂量）治疗的18例患者中，ORR为83%，CR/sCR率为22%。安全性方面，在每周皮下注射剂量为1.2 mg/kg时未观察到剂量限制性毒性（DLT），大多数是轻度的细胞因子释放综合征（CRS），未报告神经毒性，也没有患者因不良事件而停药。
NX-5948：公布1a/1b期临床试验的新数据
Nurix Therapeutics公司公布了其布鲁顿酪氨酸激酶（BTK）降解剂NX-5948用于治疗复发或难治性慢性淋巴细胞白血病或小淋巴细胞淋巴瘤（CLL/SLL）的1a/1b期临床试验的新数据。NX-5948是一种口服、可穿越血脑屏障的小分子BTK蛋白降解剂。
截至2024年10月10日的数据，首次疾病评估时（治疗后第8周）49名疗效可评估的CLL/SLL患者的客观缓解率为75.5%，该数据在至少进行两次疾病评估（治疗后第16周时）的患者中增加至84.2%。无论患者既往治疗、基线突变、高危分子特征或中枢神经系统（CNS）受累如何，均观察到缓解。13名患者的缓解持续时间超过6个月，5名患者在治疗一年后仍在接受治疗并保持缓解。此外，NX-5948在所有评估的剂量中均具有良好的耐受性。
Enzomenib（DSP-5336）：公布1/2期临床试验的新数据
Sumitomo Pharma America公司公布了其在研口服小分子enzomenib用于治疗复发/难治性急性白血病的1/2期临床试验的新数据。Enzomenib可抑制menin与MLL蛋白的相互作用，并能降低白血病相关基因HOXA9和MEIS1的表达，增加带有MLL重排和NPM1突变的人类急性白血病细胞系中分化基因CD11b的表达。
此次公布的结果显示，在23例KMT2A重排患者中，客观缓解率为65.2%，达到CR加部分血液学恢复的完全缓解（CRh）的患者比例为30.4%。在接受300 mg每日两次（BID）治疗的15名KMT2A重排患者中，客观缓解率为73.3%，达到CR加CRh的比例为40%。在接受200 mg BID或300 mg BID治疗的17名NPM1突变患者中，客观缓解率为58.8%，达到CR加CRh的比例为47.1%。Enzomenib的耐受性良好，药物相关不良事件的总体发生率较低，没有报告DLT。10.7%的患者患上了分化综合征，但未导致患者死亡，也不需要永久停用enzomenib。
Evorpacept：公布1b/2期联合治疗试验数据
ALX Oncology公司公布了其CD47抑制剂evorpacept联用HER2靶向双特异性抗体zanidatamab治疗此前接受过大量治疗的HER2阳性和HER2低表达转移性乳腺癌患者的1b/2期临床试验数据。Evorpacept是一种下一代CD47阻断疗法，它将高亲和性CD47结合结构域与经特殊处理的Fc结构域相结合，因此无法激活Fc受体，有望降低CD47靶向抗体因激活Fc受体可能产生的毒副作用。此外，与其它抗CD47抗体相比，evorpacept的分子量更小，更容易渗透到实体瘤中，从而提高疗效。
此次公布的结果显示，evorpacept联用zanidatamab对经中央实验室评估确认为HER2阳性的患者（n=9）显示出最强的抗肿瘤活性。这些患者经确认的客观缓解率为55.6%，中位无进展生存期（PFS）为7.4个月。总体而言，队列1（HER2阳性的转移性乳腺癌患者）患者（n=21）的经确认的客观缓解率为33.3%，中位PFS为3.6个月，中位缓解持续时间（DOR）尚未达到。在队列2（HER2低表达的转移性乳腺癌患者）的患者（n=15）中也观察到了一定的缓解，经确认的客观缓解率为20.0%，中位PFS为1.9个月，中位DOR为5.5个月。
MDNA11：公布1/2期临床试验的新数据
Medicenna Therapeutics公司公布了正在进行的1/2期ABILITY-1研究的最新临床数据，该研究旨在评估其下一代长效IL-2超级激动剂MDNA11单药或联用PD-1抑制剂帕博利珠单抗治疗晚期实体瘤的疗效和安全性。MDNA11是一种通过静脉注射给药的长效“增强β而非α”的IL-2超级细胞因子（IL-2 Superkine），它能够优先激活负责杀伤癌细胞的免疫效应细胞（CD8阳性T细胞和自然杀伤细胞，即NK细胞），同时最小化或不刺激具有免疫抑制作用的调节性T细胞（Tregs）。
此次公布的结果显示，MDNA11单药治疗和联用帕博利珠单抗的疾病控制率（DCR）分别为55%（1例CR、4例部分缓解和6例疾病稳定）和78%（1例CR、1例部分缓解和5例疾病稳定）。1名70岁的晚期化疗难治性肛门癌患者在接受MDNA11联用帕博利珠单抗治疗时，在8周内达到了CR。单药治疗组中两名免疫检查点抑制剂耐药患者的所有肿瘤完全消失，1名获得CR的黑色素瘤患者在第63周时依然没有复发，1名微卫星不稳定性高（MSI-H）的胰腺癌患者在肝脏中实现了靶病灶和非靶转移灶的完全消除，在研究期间实现了20个月的持久缓解，并已持续停止抗癌治疗达11个月。
VGA039：公布1期临床试验的中期数据
Star Therapeutics公司公布了其在研单克隆抗体VGA039用于治疗血管性血友病（Von Willebrand Disease，VWD）的1期单剂量递增（SAD）研究的中期数据。VGA039靶向蛋白质S，旨在恢复血液凝固的平衡，有望作为一种适用于多种出血性疾病的通用止血疗法。
此次公布的数据显示，在3名高年出血率（ABR）VWD患者中，皮下注射VGA039与ABR的显著降低相关，单次注射使患者的ABR降低了75%-88%，且治疗浓度保持了约4周。该降幅与已获批准的VWD预防疗法在临床试验中观察到的降幅一致，但这些疗法需要每周进行多次静脉注射。在安全性可评估的7名患者中，VGA039安全且耐受性良好，未观察到注射部位反应。
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参考资料（可上下滑动查看）
[1] Nurix Therapeutics Presents New Positive Data from Phase 1a/1b Clinical Trial of NX-5948 in Chronic Lymphocytic Leukemia at the 66th American Society of Hematology Annual Meeting. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2994129/0/en/Nurix-Therapeutics-Presents-New-Positive-Data-from-Phase-1a-1b-Clinical-Trial-of-NX-5948-in-Chronic-Lymphocytic-Leukemia-at-the-66th-American-Society-of-Hematology-Annual-Meeting.html
[2] Ichnos Glenmark Innovation (IGI) Presents First Clinical Data from Phase 1 Study of Trispecific TREAT™ Antibody, ISB 2001, Showing High Overall Response Rate (ORR) with Durable Responses and Favorable Safety Profile in Patients with Heavily Pretreated Multiple Myeloma. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994146/0/en/Ichnos-Glenmark-Innovation-IGI-Presents-First-Clinical-Data-from-Phase-1-Study-of-Trispecific-TREAT-Antibody-ISB-2001-Showing-High-Overall-Response-Rate-ORR-with-Durable-Responses-.html
[3] Immune-Onc Therapeutics Presents Updated Data from Phase 1b Study of IO-202 Highlighting Promising Efficacy and Safety Data in CMML Patients at 2024 American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2024, from https://www.immune-onc.com/pr-posts/immune-onc-therapeutics-presents-updated-data-from-phase-1b-study-of-io-202-highlighting-promising-efficacy-and-safety-data-in-cmml-patients-at-2024-american-society-of-hematology-ash-annual-meeting
[4] Electra Therapeutics Presents Positive Clinical Results from Completed Phase 1b Study of ELA026 in Secondary Hemophagocytic Lymphohistiocytosis (sHLH) in an Oral Session at ASH 2024. Retrieved December 12, 2024, from https://electra-therapeutics.com/electra-therapeutics-presents-positive-clinical-results-from-completed-phase-1b-study-of-ela026-in-secondary-hemophagocytic-lymphohistiocytosis-shlh-in-an-oral-session-at-ash-2024/
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[6] Sumitomo Pharma America Presents New Data on Nuvisertib and Enzomenib at the 2024 American Society of Hematology Annual Meeting. Retrieved December 12, 2024, from https://www.prnewswire.com/news-releases/sumitomo-pharma-america-presents-new-data-on-nuvisertib-and-enzomenib-at-the-2024-american-society-of-hematology-annual-meeting-302326146.html
[7] Arvinas and Pfizer Announce Initial Phase 1b Data from the TACTIVE-U Sub-Study of Vepdegestrant in Combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994631/0/en/index.html
[8] ALX Oncology Announces New Data Demonstrating Evorpacept in Combination with Zanidatamab Generates Promising Antitumor Activity in Advanced Breast Cancer. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994624/0/en/index.html
[9] Arrowhead Pharmaceuticals Presents Interim Clinical Data on ARO-CFB for the Treatment of Complement Mediated Diseases. Retrieved December 12, 2024, from https://arrowheadpharma.com/news-press/arrowhead-pharmaceuticals-presents-interim-clinical-data-on-aro-cfb-for-the-treatment-of-complement-mediated-diseases/
[10] Astria Therapeutics Announces Positive Final Results from Target Enrollment in the ALPHA-STAR Phase 1b/2 Trial of Navenibart for HAE. Retrieved December 12, 2024, from https://ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-positive-final-results-target
[11] C4 Therapeutics Presents Cemsidomide Phase 1 Data at the American Society for Hematology (ASH) Annual Meeting that Demonstrated Potential to Become Best-in-Class IKZF1/3 Degrader. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/08/2993401/0/en/C4-Therapeutics-Presents-Cemsidomide-Phase-1-Data-at-the-American-Society-for-Hematology-ASH-Annual-Meeting-that-Demonstrated-Potential-to-Become-Best-in-Class-IKZF1-3-Degrader.html
[12] Medicenna Provides Clinical Update and Announces First Complete Responder in MDNA11 in Combination with KEYTRUDA® (pembrolizumab) Combination Dose Escalation Arm of the ABILITY-1 Study. Retrieved December 12, 2024, from https://ir.medicenna.com/news-releases/news-release-details/medicenna-provides-clinical-update-and-announces-first-complete
[13] Disc Medicine Presents Positive Updated Results from Phase 1b Trial in Patients with Myelofibrosis (MF) and Anemia in an Oral Presentation at the 66th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2993429/0/en/Disc-Medicine-Presents-Positive-Updated-Results-from-Phase-1b-Trial-in-Patients-with-Myelofibrosis-MF-and-Anemia-in-an-Oral-Presentation-at-the-66th-American-Society-of-Hematology-.html
[14] Rigel Highlights Initial Data from Ongoing Phase 1b Study Evaluating R289 in LR-MDS at the 66th ASH Annual Meeting and Exposition. Retrieved December 12, 2024, from https://www.prnewswire.com/news-releases/rigel-highlights-initial-data-from-ongoing-phase-1b-study-evaluating-r289-in-lr-mds-at-the-66th-ash-annual-meeting-and-exposition-302325895.html
[15] OnKure Announces Encouraging Preliminary Safety, Tolerability, and Pharmacokinetic (PK) Data from its First-In-Human PIKture-01 Trial of OKI-219. Retrieved December 12, 2024, from https://investors.onkuretherapeutics.com/news-releases/news-release-details/onkure-announces-encouraging-preliminary-safety-tolerability-and
[16] Prelude Therapeutics Presents Preliminary Results of Phase 1 Dose-escalation Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib in Patients with Relapsed/Refractory Lymphoid Malignancies. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/11/2995306/0/en/Prelude-Therapeutics-Presents-Preliminary-Results-of-Phase-1-Dose-escalation-Study-of-PRT2527-as-Monotherapy-and-in-Combination-with-Zanubrutinib-in-Patients-with-Relapsed-Refracto.html
[17] Enterome’s Immunotherapy EO2463 Shows Early Clinical Response in Newly Diagnosed Follicular Lymphoma Suggesting a Potential Alternative to ‘Watchful Waiting’. Retrieved December 12, 2024, from https://www.enterome.com/news-events/enteromes-immunotherapy-eo2463-shows-early-clinical-response-in-newly-diagnosed-follicular-lymphoma-suggesting-a-potential-alternative-to-watchful-waiting/
[18] CatalYm’s Visugromab Phase 1/2a Data Demonstrating Clinical Proof-of-Concept for Reversing Resistance to Checkpoint Inhibitors through GDF-15 Neutralization Published in Nature. Retrieved December 12, 2024, from https://www.catalym.com/catalyms-visugromab-phase-1-2a-data-demonstrating-clinical-proof-of-concept-for-reversing-resistance-to-checkpoint-inhibitors-through-gdf-15-neutralization-published-in-nature/
[19] Opna Bio Announces Interim Data from Phase 1 Combination Study of OPN-2853 with Ruxolitinib in Patients with Advanced Myelofibrosis. Retrieved December 12, 2024, from https://www.opnabio.com/opna-bio-announces-interim-data-from-phase-1-combination-study-of-opn-2853-with-ruxolitinib-in-patients-with-advanced-myelofibrosis/
[20] Recursion Reports Interim Phase 1 Clinical Data for REC-617 Monotherapy, a Potential Best-in-Class CDK7 Inhibitor, With Encouraging Patient Response and Favorable Tolerability. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2994128/0/en/Recursion-Reports-Interim-Phase-1-Clinical-Data-for-REC-617-Monotherapy-a-Potential-Best-in-Class-CDK7-Inhibitor-With-Encouraging-Patient-Response-and-Favorable-Tolerability.html
[21] Galapagos Announces Encouraging New Results from Ongoing Phase 1/2 Study of CD19 CAR T-Cell Therapy, GLPG5101, in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/07/2993348/0/en/Galapagos-Announces-Encouraging-New-Results-from-Ongoing-Phase-1-2-Study-of-CD19-CAR-T-Cell-Therapy-GLPG5101-in-Patients-with-Relapsed-Refractory-Non-Hodgkin-Lymphoma.html
[22] Poseida Therapeutics Highlights Positive Interim Phase 1 Results for P-BCMA-ALLO1 and Preclinical Data for Dual CAR-T P-CD19CD20-ALLO1 at the 66th American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2024, from https://www.prnewswire.com/news-releases/poseida-therapeutics-highlights-positive-interim-phase-1-results-for-p-bcma-allo1-and-preclinical-data-for-dual-car-t-p-cd19cd20-allo1-at-the-66th-american-society-of-hematology-ash-annual-meeting-302325606.html
[23] Lyell Presents Positive Initial Clinical Data from the Phase 1-2 Clinical Trial of IMPT-314 for the Treatment of B-cell Lymphoma at the 2024 ASH Annual Meeting. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994158/0/en/Lyell-Presents-Positive-Initial-Clinical-Data-from-the-Phase-1-2-Clinical-Trial-of-IMPT-314-for-the-Treatment-of-B-cell-Lymphoma-at-the-2024-ASH-Annual-Meeting.html
[24] Synthekine Presents Positive Initial Results from Phase 1 Clinical Trial of CD19 CAR-T (SYNCAR-001) and Orthogonal IL-2 (STK-009) Combination Therapy for Treatment of Hematologic Malignancies at ASH 2024 Annual Meeting. Retrieved December 12, 2024, from https://www.synthekine.com/news/synthekine-presents-positive-initial-results-from-phase-1-clinical-trial-of-cd19-car-t-syncar-001-and-orthogonal-il-2-stk-009-combination-therapy-for-treatment-of-hematologic-malignancies-at-ash-2/
[25] AAVantgarde presents safety data of the LUCE-1 study of AAVB-081 for RP related to Usher 1B. Retrieved December 12, 2024, from https://www.aavantgarde.com/en/news/aavantgarde-presents-safety-data-of-the-luce-1-study-of-aavb-081-for-rp-related-to-usher-1b/
[26] Neurona Therapeutics Presents Positive Clinical Update: New Data from NRTX-1001 Cell Therapy Trial in Drug-resistant Epilepsy Announced at 2024 Annual Meeting of the American Epilepsy Society. Retrieved December 12, 2024, from https://www.neuronatherapeutics.com/news/press-releases/120624/
[27] IN8bio Reports Continued Progression-Free Survival in Phase 1 Investigator-Sponsored Trial of INB-100 Allogeneic Gamma-Delta T Cells for Leukemias at the 2024 American Society of Hematology Annual Meeting. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994365/0/en/IN8bio-Reports-Continued-Progression-Free-Survival-in-Phase-1-Investigator-Sponsored-Trial-of-INB-100-Allogeneic-Gamma-Delta-T-Cells-for-Leukemias-at-the-2024-American-Society-of-H.html
[28] Sonnet BioTherapeutics Announces Topline Safety Data Following Successful Completion of SON-1010 Monotherapy Dose Escalation in Phase 1 SB101 Trial. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2993772/0/en/Sonnet-BioTherapeutics-Announces-Topline-Safety-Data-Following-Successful-Completion-of-SON-1010-Monotherapy-Dose-Escalation-in-Phase-1-SB101-Trial.html
[29] CRISPR Therapeutics Presents Data at the 2024 American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2993974/0/en/CRISPR-Therapeutics-Presents-Data-at-the-2024-American-Society-of-Hematology-ASH-Annual-Meeting.html
[30] Monte Rosa Therapeutics Provides Development Progress Update for Ongoing MRT-2359 Phase 1/2 Study in Patients with MYC-driven Solid Tumors. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/05/2992220/0/en/Monte-Rosa-Therapeutics-Provides-Development-Progress-Update-for-Ongoing-MRT-2359-Phase-1-2-Study-in-Patients-with-MYC-driven-Solid-Tumors.html
[31] Olema Oncology Announces FDA Clearance of Investigational New Drug Application for OP-3136, a Potent KAT6 Inhibitor. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2993612/0/en/Olema-Oncology-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-OP-3136-a-Potent-KAT6-Inhibitor.html
[32] Theratechnologies Announces Preliminary Tolerability and Efficacy Data from Phase 1b, Dose-Ranging Trial of Sudocetaxel Zendusortide in Patients with Advanced Ovarian Cancer. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2993661/0/en/Theratechnologies-Announces-Preliminary-Tolerability-and-Efficacy-Data-from-Phase-1b-Dose-Ranging-Trial-of-Sudocetaxel-Zendusortide-in-Patients-with-Advanced-Ovarian-Cancer.html
[33] Artelo Biosciences Announces Presentation of Phase 1 Data with ART27.13 in Cancer-Related Anorexia. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2993818/0/en/Artelo-Biosciences-Announces-Presentation-of-Phase-1-Data-with-ART27-13-in-Cancer-Related-Anorexia.html
[34] Silence Therapeutics Presents Promising Phase 1 Data in Polycythemia Vera Patients at the American Society of Hematology (ASH) Annual Meeting. Retrieved December 12, 2024, from https://silence-therapeutics.com/investors/press-releases/press-releases-details/2024/Silence-Therapeutics-Presents-Promising-Phase-1-Data-in-Polycythemia-Vera-Patients-at-the-American-Society-of-Hematology-ASH-Annual-Meeting/default.aspx
[35] AC Immune Reports Interim Safety Data from Phase 1b/2 ABATE Trial of ACI-24.060 in Down syndrome. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994352/0/en/AC-Immune-Reports-Interim-Safety-Data-from-Phase-1b-2-ABATE-Trial-of-ACI-24-060-in-Down-syndrome.html
[36] Affimed Reports Promising Phase 1 Efficacy and Safety Data for AFM28 in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/09/2994033/0/en/Affimed-Reports-Promising-Phase-1-Efficacy-and-Safety-Data-for-AFM28-in-Relapsed-Refractory-Acute-Myeloid-Leukemia-R-R-AML.html
[37] PS3-08: Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated with First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. Retrieved December 10, 2024, from https://sabcs.org/Portals/0/Documents/Formatted_Abstracts%2011-27%20Without%20Embargoed.pdf?ver=qjVzk5LPNjOteEIvNEYJFw%3d%3d
[38] Olema Oncology Presents Updated Clinical Results for Palazestrant in Combination with Ribociclib at the San Antonio Breast Cancer Symposium. Retrieved December 12, 2024, from https://ir.olema.com/news-releases/news-release-details/olema-oncology-presents-updated-clinical-results-palazestrant
[39] Astria Therapeutics Announces FDA Clearance of IND Application for STAR-0310, a Monoclonal Antibody OX40 Antagonist for the Treatment of Atopic Dermatitis. Retrieved December 12, 2024, from https://ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-fda-clearance-ind-application-0
[40] Aptose Clinical Data Featured in Poster Presentation at the 2024 ASH Annual Meeting Support Tuspetinib Triple Drug Therapy for Newly Diagnosed AML. Retrieved December 12, 2024, from https://www.aptose.com/news-media/press-releases/detail/304/aptose-clinical-data-featured-in-poster-presentation-at-the
[41] Biomea Fusion Announces Preliminary Data from Ongoing COVALENT-103 Study of Investigational Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia. Retrieved December 12, 2024, from https://investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-announces-preliminary-data-ongoing-covalent-103
[42] NextCure Announces Acceptance of IND Application for LNCB74. Retrieved December 12, 2024, from https://www.globenewswire.com/news-release/2024/12/10/2994522/0/en/NextCure-Announces-Acceptance-of-IND-Application-for-LNCB74.html
[43] PureTech Founded Entity Seaport Therapeutics Presents Additional Data from Phase 1 Study of SPT-300 at ACNP Annual Meeting 2024. Retrieved December 12, 2024, from https://news.puretechhealth.com/news-releases/news-release-details/puretech-founded-entity-seaport-therapeutics-presents-additional
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免疫疗法临床结果临床2期
2024-12-10
ELA026 demonstrated 100% overall response rate, improved survival, and a favorable safety profile in malignancy-associated HLH (mHLH), the most common type of sHLH with the poorest prognosis.
Company is advancing ELA026 as a frontline treatment for patients with sHLH and plans to initiate a global pivotal study in 2025.
SOUTH SAN FRANCISCO, CA, USA I December 09, 2024 I
Electra Therapeutics
, Inc., a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, announced the presentation of positive results from the completed Phase 1b study of ELA026 for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH). ELA026 is a first-in-class monoclonal antibody that targets SIRP-α/β1/γ on the cell surface of myeloid cells and T lymphocytes, the principal pathological immune cells that induce the cytokine storm and hyperinflammation in sHLH. Targeting SIRP to selectively deplete pathogenic immune cells has potential for broad therapeutic applications in immunology, inflammation and cancer. The results of the ELA026 study in sHLH are being presented today at 2:45 PM PST in an oral session at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA.
The Phase 1b study was an open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of ELA026, assess the pharmacodynamic (PD) and pharmacokinetic (PK) profile, and identify a dose regimen for further evaluation in a Phase 2/3 study (
NCT05416307
). The Phase 1b study demonstrated that for sHLH patients with the poorest prognosis, those with malignancy-associated HLH (mHLH), treatment with ELA026 in frontline settings achieved 100% overall response rate by week 4 and 100% hospital discharge, as well as 92% survival at two months. Various PD and HLH-related biomarkers showed that ELA026 rapidly attenuated inflammation, which correlated with clinical responses.
“ELA026 has shown potential to be a transformative treatment for sHLH, a life-threatening disease with no approved therapies. Compared with available treatment, which may include chemotherapy and single cytokine-directed therapies, ELA026 may offer a safer, more effective approach to address the overwhelming immune reaction in sHLH. The Phase 1b study results showing rapid PD and biomarker effects and improved survival at two months are particularly promising,” said Swaminathan P. Iyer, MD, Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. “There is a growing appreciation that controlling the cytokine storm early in the sHLH disease course is necessary to prevent multiorgan failure and allow for proper treatment of the underlying cancer. It is clear that overcoming this critical early period of hyperinflammation in sHLH provide significant clinical benefits for patients.”
“We are highly encouraged by these compelling results for sHLH patients, and Electra is working to advance ELA026 into a pivotal study as rapidly as possible. Through rigor and resolve, our team has pioneered a drug development program targeting SIRP, going from a novel idea to pivotal study readiness in five years,” said Kathy Dong, PharmD, MBA, President and CEO of Electra Therapeutics. “We have demonstrated the therapeutic value of selectively depleting pathological immune cells to modulate inflammation and look forward to applying this novel approach with ELA026 and our pipeline to expand to other diseases with high unmet need.”
Phase 1b Study Results Presented in Oral Session at ASH
The oral presentation at the ASH Annual Meeting, entitled “ELA026, a monoclonal antibody targeting signal regulatory protein-α/β1/γ rapidly controls inflammation and improves 2-month survival in treatment-naïve malignancy-associated hemophagocytic lymphohistiocytosis,” is being presented by the lead author, Abhishek Maiti, MD, Assistant Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center. This presentation was featured in the section “Granulocytes, Monocytes, and Macrophages: From Inflammation to Hemophagocytic Lymphohistiocytosis.” The clinical results presented for ELA026 described the analysis of 12 mHLH patients treated in frontline settings in the completed Phase 1b clinical study. Highlights of the Phase 1b results are as follows:
“Because sHLH is a complex, rapidly progressing disease with limited development precedents, advancing ELA026 required a focused approach that our Electra team boldly took on, in collaboration with leading researchers and clinicians. It is gratifying to see the positive Phase 1b results for ELA026 and the potential to improve outcomes for sHLH patients who face this life-threatening condition,” said Kim‑Hien Dao, DO, PhD, Chief Medical Officer at Electra. “We have a clear path forward based on recent alignment with the US FDA on the pivotal study design and are moving towards initiating a global Phase 2/3 study in 2025 to address the significant disease burden in sHLH.”
About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening hyperinflammatory disease for which there is no approved treatment. It can be triggered by cancer, infection, autoimmune disease, or immunotherapy. sHLH is associated with a severe inflammatory response for which patients require immediate intervention. Without treatment, patients may experience multiorgan failure and death. sHLH is associated with high mortality early in the disease course, with malignancy-associated HLH (mHLH) patients having a mortality rate of approximately 50% at two months with available therapies.
3
About Electra Therapeutics
Electra Therapeutics
is a clinical stage biotechnology company developing therapies against novel targets for immune disorders and cancer. The company’s lead product candidate, ELA026, is a first-in-class monoclonal antibody that targets signal regulatory proteins (SIRP) on the cell surface of myeloid cells and T lymphocytes, and selectively depletes pathological immune cells. This novel approach has potential therapeutic benefit across numerous diseases. ELA026 is in clinical development for secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory condition for which there is no approved treatment. The company is pursuing other disease indications for ELA026, as well as additional development candidates, including an antibody with selectivity for activated T lymphocytes for broad application in immunology and inflammation. For more information, please visit
www.electra-therapeutics.com
and follow us on
LinkedIn
.
1
Lorenz F, et al. Leuk Lymphoma. 2018 Aug;59(8):1840-1850.
2
Abdelhay A, et al. Ann Hematol. 2023 Jul;102(7):1705-1711.
3
Löfstedt A, et al. Blood. 2024 Jan 18;143(3):233-242.
SOURCE:
Electra Therapeutics
临床结果临床1期免疫疗法AACR会议ASCO会议
2024-11-05
SOUTH SAN FRANCISCO, Calif.--(
BUSINESS WIRE
)--
Electra Therapeutics, Inc.
, a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, announced today that clinical data for its lead drug candidate, ELA026, has been selected for presentation in an oral session at the American Society of Hematology (ASH) annual meeting being held in San Diego on December 7-10, 2024.
The oral presentation will describe clinical data from a completed Phase 1b study of ELA026 for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory disease for which there is no approved treatment. Specifically, data will highlight results from treatment of malignancy-associated HLH (mHLH), the deadliest type of sHLH, in frontline settings. ELA026 is a first-in-class monoclonal antibody that targets signal regulatory protein (SIRP)-α/β1/γ on the cell surface of myeloid cells and T lymphocytes, the pathological immune cells that induce hyperinflammation in sHLH. The Phase 1b study is an open-label, single-arm, multi-center study designed to evaluate the safety and efficacy of ELA026, assess biomarkers, and identify a dose regimen for further evaluation in a Phase 2/3 study (NCT05416307). The abstract is published on the
ASH website
.
“We are delighted to share the latest results of our clinical study of ELA026 in sHLH with the clinical and research community,” said Kim‑Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. “As we engage with physicians and researchers familiar with sHLH, we are gratified to hear that ELA026 has the potential to address high unmet needs in patients with sHLH who lack effective treatment options. We hypothesize that the selective depletion of pathogenic immune cells may offer a more definitive approach to address the cytokine storm and improve survival in this highly deadly disease and are very encouraged by the data with ELA026.”
Details of the oral presentation are as follows:
Title:
ELA026, a monoclonal antibody targeting signal regulatory protein (SIRP)-α/β1/γ rapidly controls inflammation and improves 2-month survival in treatment-naïve malignancy-associated hemophagocytic lymphohistiocytosis
Presenter:
Abhishek Maiti, MD, Assistant Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center
Session Name:
201. Granulocytes, Monocytes, and Macrophages: From Inflammation to Hemophagocytic Lymphohistiocytosis
Session Date and Time:
Monday, December 9, 2024, 2:45 p.m. PT
Location:
San Diego Convention Center, Room 6DE
Publication Number:
805
About Secondary Hemophagocytic Lymphohistiocytosis
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening hyperinflammatory disease for which there is no approved treatment. It can be triggered by cancer, infection, autoimmune disease, or immunotherapy. sHLH is associated with a severe inflammatory response for which patients require immediate intervention. Without effective treatment, patients may experience multiple organ failure and death. sHLH has a high mortality rate during the first months of diagnosis, with malignancy-associated HLH (mHLH) patients having the poorest outcomes.
About Electra Therapeutics
Electra Therapeutics
is a clinical stage biotechnology company developing therapies against novel targets for immunological diseases and cancer. The company’s lead product candidate, ELA026, is a first-in-class monoclonal antibody that targets SIRP on the cell surface of myeloid cells and T lymphocytes, and selectively depletes pathological immune cells. ELA026 is in clinical development for secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory condition for which there is no approved treatment, as well as additional disease indications. For more information, please visit
www.electra-therapeutics.com
and follow us on
LinkedIn
.
临床1期免疫疗法ASH会议AACR会议
100 项与 ELA-026 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 噬血细胞性淋巴组织细胞增多症 | 临床3期 | 美国 | 2022-05-19 | |
| 噬血细胞性淋巴组织细胞增多症 | 临床3期 | 奥地利 | 2022-05-19 | |
| 噬血细胞性淋巴组织细胞增多症 | 临床3期 | 意大利 | 2022-05-19 | |
| 噬血细胞性淋巴组织细胞增多症 | 临床3期 | 荷兰 | 2022-05-19 | |
| 噬血细胞性淋巴组织细胞增多症 | 临床3期 | 西班牙 | 2022-05-19 | |
| 噬血细胞性淋巴组织细胞增多症 | 临床3期 | 英国 | 2022-05-19 | |
| 炎症 | 临床1期 | 美国 | 2021-10-18 | |
| 炎症 | 临床1期 | 奥地利 | 2021-10-18 |
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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 |
|---|
PipelineReview 人工标引  | 临床1期 | 12 | 鏇簾顧壓廠壓醖鬱遞鏇(遞築觸獵窪餘窪範觸淵) = 選網簾襯襯顧選餘壓鹽 膚窪餘壓鹽蓋衊糧壓蓋 (願顧顧艱夢願夢鏇夢構 ) 更多 | 积极 | 2024-12-10 | ||
临床1期 | 12 | 顧窪獵鹹鏇鬱簾鹹壓淵(築衊願夢鑰獵鑰獵遞糧) = 鬱憲鬱鏇範廠顧夢廠鹹 憲選範鹹餘淵鑰網壓築 (餘獵觸廠製鬱繭醖繭顧 ) 更多 | 积极 | 2024-12-09 | |||
临床1期 | 18 | 築構襯淵網鏇鬱鹹鹹鹽(繭鏇構憲衊獵齋顧獵網) = 網顧餘醖夢窪遞鹽淵廠 簾蓋鏇窪網鏇鑰憲夢觸 (淵廠鑰製鏇簾鏇壓糧餘 ) 更多 | 积极 | 2024-06-17 | |||
临床1期 | 10 | 願構顧鏇鹹壓齋選鏇顧(壓糧齋築顧鑰鬱遞鬱築) = 範願簾顧襯衊艱繭獵窪 積夢鏇網窪醖衊顧願簾 (鹽顧淵願夢鹽鬱選繭鹹 ) 更多 | 积极 | 2023-12-11 |
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