更新于：2024-11-14
Vilamakitug
更新于：2024-11-14
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最高研发阶段临床2期 |
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关联
7
项与 Vilamakitug 相关的临床试验Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with Methotrexate for the Treatment of Rheumatoid Arthritis
Approximately 108 subjects will be randomized in 2 arms in 2:1 ratio to receive weekly subcutaneous injections of either 400mg Natrunix + MTX weekly or placebo + MTX weekly for 14 weeks. At the week 14 visit subjects in both arms will undergo a safety follow up visit OR begin receiving biweekly subcutaneous injections of 400mg Natrunix for 14 weeks as part of an Open Label Extension (OLE).
The study will last for a maximum of 33 weeks, including: a screening period of up to 4 weeks, a 14-week double-blinded treatment phase followed by a 14-week open label extension phase and one-week follow-up.
The study will last for a maximum of 33 weeks, including: a screening period of up to 4 weeks, a 14-week double-blinded treatment phase followed by a 14-week open label extension phase and one-week follow-up.
开始日期2024-09-15 |
申办/合作机构 |
Phase II, Double Blind, Placebo Controlled, Randomized Study Examining Natrunix in Combination With Standard of Care in HLA-B27 Positive Subjects With Axial Spondyloarthritis
Double-blind, placebo-controlled, randomized trial of Natrunix in combination with Standard of Care in patients with Axial Spondyloarthritis
开始日期2024-08-15 |
申办/合作机构 |
Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis
Phase II, Double-Blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination with MTX (+Folate) for the Treatment of Rheumatoid Arthritis
开始日期2023-07-24 |
申办/合作机构 |
100 项与 Vilamakitug 相关的临床结果
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100 项与 Vilamakitug 相关的转化医学
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100 项与 Vilamakitug 相关的专利（医药）
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17
项与 Vilamakitug 相关的新闻（医药）2024-06-23
·药明康德
▎药明康德内容团队编辑
本期看点
1. CD19靶向候选CAR-T细胞疗法GLPG5101在1项早期临床试验中治疗5例套细胞淋巴瘤（MCL）患者，客观缓解率（ORR）和完全缓解率（CRR）均为100%。
2. 靶向信号调节蛋白（SIRP）的抗体疗法ELA026治疗初治恶性肿瘤相关噬血细胞性淋巴组织细胞增多症（mHLH）的总缓解率达100%，并提高了此类患者的两个月生存率。
3. 抗体疗法Natrunix联用化疗治疗晚期胰腺癌，在早期临床试验中延长了患者的生存期并改善了化疗的耐受性。
药明康德内容团队整理
GLPG5101：公布1/2期临床试验数据
Galapagos公司公布了其CD19靶向候选CAR-T细胞疗法GLPG5101治疗复发/难治性非霍奇金淋巴瘤（NHL）的1/2期临床试验ATALANTA-1的新数据。该细胞疗法从制备到回输到患者体内的中位时间仅需7天。
截至2023年12月20日的数据，在研究的第一部分，中位随访时间为13.1个月，接受GLPG5101治疗的16例可评估患者的ORR为87.5%（14/16），CRR为75%（12/16）。71%的患者在数据截止时保持缓解。在研究的第二部分，中位随访时间为4.2个月，15例可评估患者的ORR和CRR均为93.3%（14/15）。100%的患者在数据截止时保持持续缓解。合并两部分的研究结果后根据肿瘤类型进行划分，弥漫性大B细胞淋巴瘤（DLBCL）患者的ORR为78%（7/9），CRR为56%（5/9）；滤泡性淋巴瘤（FL）或边缘区淋巴瘤（MZL）患者的ORR和CRR均为94%（16/17）；套细胞淋巴瘤患者的ORR和CRR均为100%（5/5）。
安全性方面，大多数治疗伴发不良事件为1/2级，在研究的第一部分观察到2例3级细胞因子释放综合征（CRS），在研究的第二部分观察到1例3级免疫效应细胞相关神经毒性综合征（ICANS）。
ELA026：公布1b期临床试验的新数据
Electra Therapeutics公司公布了其靶向信号调节蛋白（SIRP）的单克隆抗体ELA026治疗继发性噬血细胞性淋巴组织细胞增生症（sHLH）的1b期研究的最新临床数据。ELA026靶向细胞表面的SIRP，能够靶向清除血液循环中驱动炎症的髓系细胞和T细胞，并且不破坏SIRPα/CD47免疫检查点功能。该疗法旨在治疗伴有异常髓系和T细胞活性的重度炎性疾病。
此次公布的结果显示，ELA026在sHLH患者中具有良好的安全性，不良事件可控。在已完成入组的队列1和2中（n=12），ELA026在第4周时的总缓解率为75%，在8例未接受过治疗的mHLH（sHLH的一种亚型）患者中，总缓解率为100%，两个月时的生存率为88%。此类患者在自然史研究中的两个月时的死亡率约为50%。
Natrunix：公布1/2期临床试验数据
XBiotech公司公布了其靶向白细胞介素-1α（IL-1α）的抗体疗法Natrunix联用化疗治疗晚期胰腺癌的1/2期多中心研究的数据。除了能够作为一种抗癌疗法，该公司认为Natrunix还有望改善化疗的耐受性。该研究中采用的化疗方案为ONIVYDE（ON）+5-氟尿嘧啶（5FU）+亚叶酸（LV）。
此次公布的结果显示，与安慰剂+化疗组相比，Natrunix+化疗组在24周的治疗周期内发生任何类型的不良事件的数量（297例对比336例）、发生重大不良事件的患者比例（9/33对比12/32）和住院天数（80天对比120天）均明显减少。此外，接受Natrunix+化疗组患者的生存期得到了延长，接受治疗第330天时有8例患者存活，而安慰剂+化疗组没有患者存活超过330天。
▲患者的生存曲线（图片来源：参考资料[9]）
Petrelintide：公布1b期临床试验数据
Zealand Pharma公司公布了其在研长效、潜在“best-in-class”减重疗法petrelintide的1b期试验第二部分的顶线结果。Petrelintide（ZP8396）是一种适合每周一次皮下注射的长效胰淀素类似物，具有中性pH下的化学和物理稳定性。胰淀素在胰腺β细胞中产生，并与胰岛素一起分泌以响应摄入的营养物质。目前的临床或临床前数据表明，petrelintide有潜力实现与GLP-1受体激动剂相当的体重减轻，但具有更好的耐受性，为患者提供更好的用药体验和体重减轻，同时保留患者的肌肉质量。
此次公布的结果显示，患者在接受16周高剂量petrelintide治疗后，体重较基线平均减少了8.6%，而安慰剂组仅为1.7%。安全性方面，petrelintide显示良好的耐受性，没有出现严重的不良事件。所有胃肠道（GI）不良事件均为轻度，除了一名受试者在第三次治疗后因中度恶心和呕吐而停止治疗。值得注意的是，没有其他受试者因不良事件停止治疗或报告呕吐，只有两例轻度腹泻报告。恶心在活性组中报告比例为16.7-33.3%，在安慰剂组为16.7%。少数参与者报告了注射部位反应，均为轻度。未观察到患者产生抗药抗体。新闻稿指出，该积极结果支持petrelintide作为GLP-1受体激动剂类药物之外，在体重管理上的另一选择。
Amezalpat（TPST-1120）：公布1b/2期临床试验的新数据
Tempest Therapeutics公司公布了其在研口服、选择性小分子PPAR⍺拮抗剂amezalpat（TPST-1120）在一项全球随机的1b/2期临床试验中获得的积极结果。临床前数据显示，amezalpat可直接杀死肿瘤细胞，并靶向肿瘤微环境中的抑制性免疫通路。这两种类型中的靶向细胞皆依赖脂肪酸代谢，该代谢过程由PPARα转录因子调节。在一项针对接受过多次治疗的晚期实体瘤患者的1期临床试验中，amezalpat单药治疗和与PD-1抑制剂nivolumab联合应用均导致肿瘤缩小及生物标志物的变化。
此次公布的结果显示，与标准治疗方案相比，amezalpat与标准治疗方案（抗PD-L1抗体atezolizumab和抗VEGF抗体bevacizumab）联用，在无法切除或转移性肝细胞癌（HCC）患者的一线治疗中，显著提高患者的中位总生存期（OS）达6个月（21个月对比15个月）。此外，按照RECIST v1.1标准评估，amezalpat组的确认客观缓解率（cORR）为30%，对照组为13.3%。安全性方面，amezalpat的耐受性良好，两组之间的安全数据相当。
▲Amezalpat试验的OS结果（图片来源：参考资料[29]）
MB-106：公布1/2期临床试验数据
Mustang Bio公司公布了其在研、可通过门诊给药、靶向CD20的自体CAR-T细胞疗法MB-106治疗华氏巨球蛋白血症（WM）的1/2期临床试验最新数据。该试验中的所有十例患者均曾接受过布鲁顿酪氨酸激酶抑制剂（BTKi）的治疗，并且在接受BTKi治疗期间病情持续恶化。患者之前接受过中位9线疗法，只有一例患者在接受MB-106治疗后开始接受额外的抗WM治疗。
总体而言，接受MB-106治疗的患者中有90%（9/10）对治疗产生应答，包括3名患者达完全缓解（CR）、2名达非常好的部分缓解和4名部分缓解。此外，1例患者的病情稳定。其中一名获得CR的患者已持续缓解31个月，该患者的免疫球蛋白M（IgM）水平在接受MB-106治疗后迅速降至正常范围，此后一直保持正常。
安全性方面，9例患者发生了CRS（5例患者为1级，4例患者为2级），一例患者经历了1级ICANS。尽管剂量增加，但并未观察到3级或4级CRS或2、3或4级ICANS。
NX-594：公布1a/b期临床试验数据
Nurix Therapeutics公司公布了其在研口服BTK降解剂NX-5948治疗复发难治性慢性淋巴细胞白血病（CLL）的1a/b期临床试验的积极数据。NX-5948是一种生物利用度高、可穿越血脑屏障的口服BTK小分子降解剂。
▲NX-5948的疗效结果（图片来源：参考资料[5]）
此次公布的结果显示，NX-594在复发难治性CLL患者身上引起了快速、深度的缓解，ORR达69.2%，这些患者之前曾接受大量治疗并带有BTK抑制剂耐药突变。最早在第一次肿瘤扫描（8周）时就观察到患者出现缓解，许多患者在治疗时间延长后缓解加深。截至4月17日数据截止，所有缓解仍在持续。
▲一例患者接受NX-5948治疗24周内，脑脊液中的恶性肿瘤细胞消除（图片来源：参考资料[5]）
▲一例曾接受过11线疗法的患者在接受NX-5948治疗后肿瘤持久消退（图片来源：参考资料[2]）
此外，一例在进入研究时伴有中枢神经系统受累的CLL患者在接受NX-5948治疗的24周内消除了脑脊液（CSF）中的恶性肿瘤细胞，并在36周时达到接近CR的标准。还有一例曾接受过11线疗法的患者在接受NX-5948治疗后肿瘤持久消退已超过6个月。安全性方面，NX-5948在所有评估剂量下均耐受性良好，最常见的治疗不良事件为紫癜/挫伤、血小板减少和中性粒细胞减少。Nurix预计在2025年启动NX-5948的关键临床试验。
SL-172154：公布1b期临床试验数据
Shattuck Labs公布了其在研疗法SL-172154在1b期剂量扩展临床试验的最新中期数据。SL-172154（SIRPα-Fc-CD40L）是一款在研重定向检查点激动剂（ARC）融合蛋白，旨在同时抑制CD47/SIRPα检查点的相互作用并激活CD40共刺激受体，以增强晚期癌症患者的抗肿瘤免疫反应。
此次公布的结果显示，SL-172154与阿扎胞苷（AZA）联用作为高风险骨髓增生异常综合征（HR-MDS）和TP53突变（TP53m）急性髓性白血病（AML）患者的一线疗法时，患者的ORR分别达67%与43%，CRR分别为42%与29%。截至2024年4月23日，SL-172154表现出可控的安全性。输液相关反应（IRRs）是SL-172154治疗过程中最常见的不良事件。
KT-333：公布1期临床试验的新数据
Kymera Therapeutics公布了其在研药物KT-333的1期临床试验的更新数据。KT-333是一种潜在“first-in-class”、强效、高选择性的STAT3靶向小分子降解剂。根据新闻稿，KT-333是靶向未成药转录因子的首个进入临床阶段的降解剂。
▲KT-333试验临床结果摘要（图片来源：参考资料[3]）
此次公布的结果显示，KT-333完成初步临床概念验证，在多种血液恶性肿瘤中展示了抗肿瘤活性。其中，两名经典霍奇金淋巴瘤患者达到CR，1名STAT3突变的NK细胞淋巴瘤患者达到CR。安全性方面，KT-333耐受性良好，主要不良事件为1级和2级，包括口腔炎和疲劳。
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参考资料（可上下滑动查看）
[1] Shattuck Labs Announces Updated Positive Interim Data from the Phase 1B Dose Expansion Clinical Trial of SL-172154 in Combination with Azacitidine (AZA) in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) Patients. Retrieved June 21, 2024 from https://www.globenewswire.com/news-release/2024/06/14/2898850/0/en/Shattuck-Labs-Announces-Updated-Positive-Interim-Data-from-the-Phase-1B-Dose-Expansion-Clinical-Trial-of-SL-172154-in-Combination-with-Azacitidine-AZA-in-Frontline-Higher-Risk-Myel.html
[2] Kymera Therapeutics Presents New Clinical Data from the Ongoing Phase 1 Trial of STAT3 Degrader KT-333 at EHA Annual Meeting. Retrieved June 21, 2024 from https://www.globenewswire.com/news-release/2024/06/14/2898896/0/en/Kymera-Therapeutics-Presents-New-Clinical-Data-from-the-Ongoing-Phase-1-Trial-of-STAT3-Degrader-KT-333-at-EHA-Annual-Meeting.html
[3] Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of KT-333, a Targeted Protein Degrader of STAT3, in Patients with Relapsed or Refractory Hematologic and Solid Tumor Cancers. Retrieved June 21, 2024 from https://www.kymeratx.com/wp-content/uploads/2024/06/Kymera-Therapeutics-EHA-KT-333-Poster_June-2024.pdf
[4] Nurix Therapeutics Presents Positive Results from Ongoing Clinical Trial of NX-5948 in Patients with Relapsed Refractory Chronic Lymphocytic Leukemia (CLL) at the European Hematology Association Congress (EHA2024). Retrieved June 21, 2024 from https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-positive-results-ongoing-clinical
[5] EHA2024 Presentation. Retrieved June 21, 2024 from https://ir.nurixtx.com/static-files/e77e9b9c-2e5f-4409-b819-6a5bc02dce47
[6] Galapagos presents encouraging new data for CD19 CAR-T candidate GLPG5101 in non-Hodgkin lymphoma at EHA 2024. Retrieved June 21, 2024 from https://www.globenewswire.com/news-release/2024/06/14/2899182/0/en/Galapagos-presents-encouraging-new-data-for-CD19-CAR-T-candidate-GLPG5101-in-non-Hodgkin-lymphoma-at-EHA-2024.html
[7] Editas Medicine Announces New Safety And Efficacy Data From The EdiTHAL Trial Of Reni-Cel In 7 Patients With Transfusion-Dependent Beta Thalassemia, Presented At The European Hematology Association (EHA) Annual Congress. Retrieved June 21, 2024 from https://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-announces-new-safety-and-efficacy-data-edithal
[8] Editas Medicine Reports New Safety And Efficacy Data From The RUBY Trial Of Reni-Cel In 18 Patients With Sickle Cell Disease, Presented At The European Hematology Association (EHA) Annual Congress. Retrieved June 21, 2024 from https://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-reports-new-safety-and-efficacy-data-ruby-trial
[9] XBiotech Results from Randomized Double-Blinded Phase 1/2 Study Suggest Potential Breakthrough Treatment for Advanced Pancreatic Cancer. Retrieved June 21, 2024 from https://www.globenewswire.com/news-release/2024/06/18/2900654/35550/en/XBiotech-Results-from-Randomized-Double-Blinded-Phase-1-2-Study-Suggest-Potential-Breakthrough-Treatment-for-Advanced-Pancreatic-Cancer.html
[10] Zealand Pharma announces positive topline results from the Phase 1b 16-week multiple ascending dose clinical trial with long-acting amylin analog petrelintide. Retrieved June 21, 2024 from https://www.globenewswire.com/news-release/2024/06/20/2901879/0/en/Zealand-Pharma-announces-positive-topline-results-from-the-Phase-1b-16-week-multiple-ascending-dose-clinical-trial-with-long-acting-amylin-analog-petrelintide.html
[11] Spyre Therapeutics Announces First Participants Dosed in Phase 1 Trial of SPY001, its Novel Half-life Extended anti-α4β7 Antibody, for the Treatment of Inflammatory Bowel Disease. Retrieved June 21, 2024, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-first-participants-dosed-in-phase-1-trial-of-spy001-its-novel-half-life-extended-anti-47-antibody-for-the-treatment-of-inflammatory-bowel-disease-302174975.html
[12] Taysha Gene Therapies Announces Positive Clinical Data Across Adult and Pediatric Patients from Low Dose Cohort in Ongoing REVEAL Phase 1/2 Trials Evaluating TSHA-102 in Rett Syndrome. Retrieved June 21, 2024, from https://ir.tayshagtx.com/news-releases/news-release-details/taysha-gene-therapies-announces-positive-clinical-data-across/
[13] Assembly Biosciences Doses First Participant in Phase 1b Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 for the Treatment of Chronic Hepatitis B Virus Infection. Retrieved June 21, 2024, from https://www.globenewswire.com/news-release/2024/06/18/2900341/16259/en/Assembly-Biosciences-Doses-First-Participant-in-Phase-1b-Clinical-Trial-Evaluating-Next-Generation-Capsid-Assembly-Modulator-Candidate-ABI-4334-for-the-Treatment-of-Chronic-Hepatit.html
[14] Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants. Retrieved June 21, 2024, from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-initiation-phase-1-study-aficamten
[15] Mozart Therapeutics Doses First Cohort of Participants in Phase 1a/b Clinical Trial of MTX-101, in Development for Treatment of Autoimmune Diseases. Retrieved June 21, 2024, from https://www.prnewswire.com/news-releases/mozart-therapeutics-doses-first-cohort-of-participants-in-phase-1ab-clinical-trial-of-mtx101-in-development-for-treatment-of-autoimmune-diseases-302173782.html
[16] Zymeworks Announces FDA Clearance Of Investigational New Drug Application For ZW171, A Novel 2+1 T-Cell Targeting Bispecific Antibody For Mesothelin-Expressing Cancers. Retrieved June 21, 2024, from https://ir.zymeworks.com/news-releases/news-release-details/zymeworks-announces-fda-clearance-investigational-new-drug
[17] Ryvu Therapeutics presents clinical and preclinical data on RVU120 at the 2024 European Hematology Association Congress. Retrieved June 21, 2024, from https://www.prnewswire.com/news-releases/ryvu-therapeutics-presents-clinical-and-preclinical-data-on-rvu120-at-the-2024-european-hematology-association-congress-302173184.html
[18] Sumitomo Pharma Presents New Clinical Data on DSP-5336 at the European Hematology Association 2024 Congress. Retrieved June 21, 2024, from https://www.prnewswire.com/news-releases/sumitomo-pharma-presents-new-clinical-data-on-dsp-5336-at-the-european-hematology-association-2024-congress-302173004.html
[19] Zura Bio Presents Data for the Tibulizumab (ZB-106) Program at EULAR 2024. Retrieved June 21, 2024, from https://www.businesswire.com/news/home/20240614812438/en
[20] Immune-Onc Therapeutics to Present Additional Positive Interim Data from IO-202 Phase 1b Expansion Cohort in Patients with Chronic Myelomonocytic Leukemia (CMML) at 2024 European Hematology Association (EHA) Annual Congress. Retrieved June 21, 2024, from https://www.businesswire.com/news/home/20240614920813/en
[21] Cabaletta Bio Reports Positive Initial Clinical Data from Phase 1/2 RESET-Myositis™ and RESET-SLE™ Trials of CABA-201. Retrieved June 21, 2024, from https://www.globenewswire.com/news-release/2024/06/14/2898772/0/en/Cabaletta-Bio-Reports-Positive-Initial-Clinical-Data-from-Phase-1-2-RESET-Myositis-and-RESET-SLE-Trials-of-CABA-201.html
[22] ORYZON Presents Preliminary Data From Ongoing Phase Ib FRIDA Trial with Iadademstat Plus Gilteritinib in Relapsed/Refractory FLT3-mut AML Patients at EHA-2024. Retrieved June 21, 2024, from https://www.globenewswire.com/news-release/2024/06/14/2898942/0/en/ORYZON-Presents-Preliminary-Data-From-Ongoing-Phase-Ib-FRIDA-Trial-with-Iadademstat-Plus-Gilteritinib-in-Relapsed-Refractory-FLT3-mut-AML-Patients-at-EHA-2024.html
[23] Enlivex Announces Positive Interim Data Readout from a Phase I/II Trial Evaluating Allocetra in End-Stage Knee Osteoarthritis. Retrieved June 21, 2024, from https://www.globenewswire.com/news-release/2024/06/17/2899579/0/en/Enlivex-Announces-Positive-Interim-Data-Readout-from-a-Phase-I-II-Trial-Evaluating-Allocetra-in-End-Stage-Knee-Osteoarthritis.html
[24] Cessation Therapeutics Announces Oral Presentation of Preliminary Findings from First-in-Human Study of Anti-Fentanyl Monoclonal Antibody, CSX-1004. Retrieved June 21, 2024, from https://www.businesswire.com/news/home/20240619579616/en
[25] Innate Pharma Shares Updated Results From the Sanofi Developed Blood Cancer Phase 1/2 SAR443579/IPH6101 Trial. Retrieved June 21, 2024, from https://www.businesswire.com/news/home/20240616126553/en
[26] Tempest Unveils New Survival Data for Amezalpat (TPST-1120) in Randomized First-Line HCC Study Demonstrating a Six-Month Improvement over Control Arm. Retrieved June 21, 2024, from https://ir.tempesttx.com/news-releases/news-release-details/tempest-unveils-new-survival-data-amezalpat-tpst-1120-randomized
[27] Escend Announces Poster Presentation at the Annual Meeting of the European Hematology Association (EHS) from an Investigator-Initiated Phase I/II study evaluating ES-3000 in Myelodysplastic Syndrome (MDS). Retrieved June 21, 2024, from https://www.prnewswire.com/news-releases/escend-announces-poster-presentation-at-the-annual-meeting-of-the-european-hematology-association-ehs-from-an-investigator-initiated-phase-iii-study-evaluating-es-3000-in-myelodysplastic-syndrome-mds-302177666.html
[28] Tubulis Doses First Patient in Phase I/IIa Trial Investigating ADC Candidate TUB-040 in Ovarian Cancer and Lung Adenocarcinoma. Retrieved June 21, 2024, from https://www.businesswire.com/news/home/20240620456143/en/
[29] Amezalpat (TPST-1120) Randomized 1L HCC Data Updat. Retrieved June 20, 2024 https://ir.tempesttx.com/static-files/8ba2d665-884e-47f7-89c2-adbba73378b2
[30] Mustang Bio Announces Favorable Efficacy and Safety Data from Complete Waldenstrom Macroglobulinemia Cohort of Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR-T Therapy. Retrieved June 18, 2024 from https://ir.mustangbio.com/news-events/press-releases/detail/180/mustang-bio-announces-favorable-efficacy-and-safety-data
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细胞疗法临床结果免疫疗法临床2期
2024-06-19
June 18, 2024 -- XBiotech (NASDAQ: XBIT) announced today data from its Phase 1/Phase 2 randomized, double-blind, placebo-controlled multi-center study for advanced pancreatic cancer. Known as 1-BETTER, the study examined Natrunix (anti-interleukin-1alpha) antibody in combination with an established chemotherapy regimen (ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV), a regimen that is already widely used for treating pancreatic cancer but is associated with difficult toxicities and less then ideal survival outcomes. Natrunix was being evaluated as an anti-cancer agent for use in cytotoxic chemotherapy combinations where the Company believes it might potentially also improve tolerability of the chemotherapy.
The Phase 1 portion was a dose escalation study in metastatic pancreatic cancer patients to determine if dose limiting toxicities (DLTs) occurred in combination with the ON+5FU+LV regimen in second- or third-line setting. DLTs were not expected with Natrunix and none were seen. The Natrunix dose in the Phase 2 portion was thus the highest dose used in the Phase 1 portion.
Sixty-five subjects were randomized into the Phase 2 study on a 1:1 basis to receive either Natrunix+ ON+5FU+LV (Arm1) or Placebo +ON+5FU+LV (Arm2). There were 33 subjects enrolled into Arm1 and 32 into Arm2. The Phase 2 treatment period was 24-weeks with subjects receiving therapy once every other week for a total of 12 cycles.
Subjects included in the study had confirmed metastatic, unresectable, or recurrent pancreatic adenocarcinoma of exocrine pancreas and were required to have had disease progression after one prior gemcitabine-based therapy or one FOLFIRINOX and gemcitabine containing therapy. All patients were required to have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
The primary endpoint for the Phase 2 study was to assess the safety and tolerability of Natrunix when used with the ON+5FU+LV combination. Overall, there were fewer adverse events (AEs) of any kind during the 24-week treatment period for the Natrunix arm compared to placebo (297 vs 336), with markedly fewer events in specific categories of adverse events during that time. There was a 28% reduction in the number of subjects experiencing significant adverse events (SAEs) in the Natrunix arm (9 out of 33) versus placebo (12 out of 32) that occurred during the 24-week treatment period. Subjects receiving the Natrunix ON+5FU+LV regimen also had about a 33% reduction in hospitalization (80 days versus 120 days) during the 24-week treatment period compared to subjects receiving placebo + ON+5FU+LV combination.
Subjects receiving the Natrunix combination also reported a 22% reduction in fatigue (28 vs 36), 32% improved appetite (19 vs 28) and 41% reduction in pain (17 vs 29) as of the last day of the 24-week treatment period compared to subjects receiving the placebo ON+5FU+LV combination.
Severe diarrhea that can be life -threatening is a significant complication for the ON+5FU+LV regimen. There was a two-fold reduction (9% versus 19%) in the incidence of severe diarrhea during the 24-week treatment regimen for patients receiving the Natrunix + ON+5FU+LV combination compared to placebo + ON+5FU+LV.
Overall Survival (OS), one of the secondary endpoints for the Phase 2 study, was conventionally defined in as time from randomization to death. The sample size for the study included intent-to-treat analysis of 33 subjects randomized into the Natrunix + ON+5FU+LV arm versus 32 subjects in Placebo + ON+5FU+LV arm. A Kaplan-Meier Survival Curve using a product limit comparison method was performed. This data highlights the observation that no subjects in the placebo ON+5FU+LV group (n=32) survived for longer than 330 days, whereas 8 subjects in the Natrunix ON+5FU+LV arm (n=33) were still alive as of day 330. Considering the small sample size, the borderline statistically significant p-value of p = 0.096 suggests prolonged survival for subjects receiving the Natrunix regimen.
The lead investigator for the study, David J. Park, MD Medical Oncologist, Medical Director for the providence St. Jude Crosson Institute, Fullerton, CA stated “Treatment of advanced pancreatic cancer in the second and third line settings presents significant challenges in terms of toxicity as well as efficacy. To observe these trends for reduced toxicity and potential survival benefit is remarkable, particularly given the limited sample size. The potential interaction between reduced toxicity, more time on treatment and improvement in survival makes intuitive sense for clinicians who treat these patients. These findings are extremely important.”
While there was a relatively small number of pancreatic cancer patients enrolled in the Phase 2 portion of the study, in the Company’s opinion, the findings show better outcomes for the Natrunix + ON+5FU+LV group as compared to the control arm. The Company believes that the reduced number of serious and adverse events, the significant reduction in hospitalization, and improved OS during the respective time periods described above for each of these metrics suggest that Natrunix could represent a breakthrough advance for the treatment of pancreatic cancer.
XBiotech is pioneering the discovery and development of targeted antibodies based on its True Human™ technology. The company’s mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of truly natural human antibodies for treating serious diseases such as inflammatory conditions like rheumatology, infectious disease, cardiovascular disease and cancer. XBiotech has several candidate products including Natrunix. Cloned from individual donors who possess natural immunity against certain targeted diseases, XBiotech’s pipeline of True Human antibodies are intended to deliver unmatched safety and efficacy. Located just minutes from downtown Austin, the XBiotech campus headquarters includes GMP manufacturing facilities, research and testing laboratories, infectious disease research facilities, and quality control and clinical operations. For more information, visit www.xbiotech.com.
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临床结果临床2期
2024-01-04
AUSTIN, Texas, Jan. 04, 2024 (GLOBE NEWSWIRE) -- XBiotech Inc. today announced that it plans to expand it’s campus headquarters with the construction of a new, state-of-the-art research and development facility. XBiotech has received City of Austin approval to begin excavation for site preparation and groundwork is expected to begin 1st quarter 2024. The new four-story building, to be located close to the existing 46,000 ft2 manufacturing and R&D facility, will provide key infrastructure to support commercialization plans for the company’s Natrunix rheumatology program. The new 46,000+ft2 facility will house clinical and medical operations, commercialization teams, and even incorporate wet laboratories, especially to enable ongoing infectious disease programs. In keeping with XBiotech’s desire to preserve the woodlands nature on the 48 acre campus, a subterranean parking garage is being constructed to minimize footprint and ecological impact of the new structure. John Simard, President and CEO of XBiotech commented, “We are excited to begin construction of what will be a unique and remarkable R&D facility. It will add significant operational capability to our existing manufacturing and R&D operations on the campus, and will create among the most capable biotechnology operations in Texas.” About XBiotechXBiotech is pioneering the discovery and development of targeted antibodies based on its True Human™ technology. The company’s mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of truly natural human antibodies for treating serious diseases such as inflammatory conditions like rheumatology, infectious disease, cardiovascular disease and cancer. XBiotech has several candidate products including Natrunix. Cloned from individual donors who possess natural immunity against certain targeted diseases, XBiotech’s pipeline of True Human antibodies are intended to deliver unmatched safety and efficacy. Located just minutes from downtown Austin, the XBiotech campus headquarters includes GMP manufacturing facilities, research and testing laboratories, infectious disease research facilities, and quality control and clinical operations. For more information, visit www.xbiotech.com. Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Wenyi Weiwwei@xbiotech.comTel. 737-207-4600 Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/968ca9bd-c3d8-4d69-b6a2-e50d09e55be0 https://www.globenewswire.com/NewsRoom/AttachmentNg/e2513789-6111-4068-9277-adc8b9acd0ce
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 中轴性脊柱关节炎 | 临床2期 | - | 2024-08-15 | |
| 类风湿关节炎 | 临床2期 | - | 2022-06-15 | |
| 结直肠癌 | 临床2期 | 法国 | 2022-04-28 | |
| 晚期胰腺腺癌 | 临床2期 | 美国 | 2021-05-27 |
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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 |
|---|
临床1/2期 | 17 | 顧獵淵淵蓋鏇範膚淵願(製願淵壓壓繭繭醖衊製) = None 憲衊願憲選廠糧夢窪襯 (淵餘壓遞壓廠餘觸範築 ) | 积极 | 2024-06-27 | |||
临床1/2期 | 17 | 簾憲鹹鹹顧鬱憲願糧製(積夢窪蓋獵積網獵鏇艱) = 廠窪鬱繭鏇積襯廠獵糧 繭築繭簾鹽選鏇鏇鑰觸 (廠衊構遞壓糧糧蓋壓鏇 ) 更多 | 积极 | 2024-06-20 | |||
临床1/2期 | 晚期胰腺腺癌 二线 | 三线 | 65 | Natrunix+ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV) | 膚築鹽窪鹽獵獵齋憲選(襯遞鹹觸壓觸積窪構築) = This data highlights the observation that no subjects in the placebo ON+5FU+LV group (n=32) survived for longer than 330 days, whereas 8 subjects in the Natrunix ON+5FU+LV arm (n=33) were still alive as of day 330. 遞襯壓製艱襯簾範遞淵 (壓選鹹夢壓築願壓鑰網 ) | 积极 | 2024-06-18 | |
Placebo+ONIVYDE (ON) + 5-Fluorouracil (5FU) + Leucovorin (LV) |
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