更新于：2024-06-24
Cusatuzumab
更新于：2024-06-24
概要
基本信息
原研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评孤儿药 (欧盟) |
序列信息
Sequence Code 616721570H
来源: *****
Sequence Code 616721571L
来源: *****
关联
9
项与 Cusatuzumab 相关的临床试验Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy
The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?
开始日期2024-05-01 |
申办/合作机构 |
A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).
开始日期2021-05-06 |
申办/合作机构 |
A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination with Azacitidine Compared with Azacitidine Alone in Patients with Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and who are not candidates for Hematopoietic Stem Cell Transplantation (HSCT)
开始日期2020-04-24 |
100 项与 Cusatuzumab 相关的临床结果
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100 项与 Cusatuzumab 相关的转化医学
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100 项与 Cusatuzumab 相关的专利（医药）
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23
项与 Cusatuzumab 相关的文献（医药）2023-11-01·The Lancet. Haematology
Cusatuzumab plus azacitidine in newly diagnosed acute myeloid leukaemia ineligible for intensive chemotherapy (CULMINATE): part one of a randomised, phase 2, dose optimisation study
Article
作者: Wei, Andrew H ; Doronin, Vadim ; Johnson, Amy J ; Xiu, Liang ; Gyan, Emmanuel ; Hamad, Nada ; Vey, Norbert ; Özcan, Muhit ; Nottage, Kerri ; Langlois, Angélique ; Demirkan, Fatih ; Ofran, Yishai ; Hultberg, Anna ; Herrera, Pilar ; Martinelli, Giovanni ; Müller, Rouven ; Jacobs, Julie ; Trudel, Géralyn C ; Samoilova, Olga ; Fogliatto, Laura M ; Pabst, Thomas ; Papayannidis, Cristina ; Arnan, Montserrat ; Guttke, Christina ; Ma, Xuewen ; Tolbert, Jaszianne A
BACKGROUND:
Cusatuzumab, a high-affinity anti-CD70 antibody, has shown preliminary activity as a treatment for acute myeloid leukaemia when combined with azacitidine. We aimed to determine the optimum dose for future trials of cusatuzumab in combination with azacitidine in patients with previously untreated acute myeloid leukaemia who are not eligible for intensive chemotherapy.
METHODS:
In this randomised, phase 2, open-label, dose-optimisation study we enrolled adult patients aged 18 years or older with newly diagnosed acute myeloid leukaemia not eligible for intensive chemotherapy, and with Eastern Cooperative Oncology Group scores of 0-2, from 40 hospitals and centres across seven countries. In part one of the trial, participants were randomly allocated 1:1 to 10 mg/kg or 20 mg/kg intravenous cusatuzumab on days 3 and 17, combined with subcutaneous or intravenous azacitidine 75 mg/m2 on days 1-7 in 28-day cycles. The primary efficacy outcome was the rate of complete remission in the intention-to-treat group. The two dose cohorts were evaluated independently without between-cohort statistical comparison. Safety analyses were performed in all patients who received one dose of study drug. Part two of the trial was planned to be a single-arm expansion to evaluate cusatuzumab plus azacitidine at the cusatuzumab dose level selected in part one (primary hypothesis ≥35% rate of complete remission vs null hypothesis of 20%); however, changes in the acute myeloid leukaemia treatment landscape during this trial made it unlikely that enrolment to part two of the study would be clinically feasible, so the study stopped at the end of part one. The trial was registered at ClinicalTrials.gov, NCT04023526.
FINDINGS:
103 patients were enrolled between Aug 30, 2019, and Feb 25, 2020, and randomly assigned to either cusatuzumab 10 mg/kg (n=51) or 20 mg/kg (n=52). Median follow-up was 7·2 months (IQR 10·7 months). 57 of 103 (55%) patients were male and 46 (45%) patients were female, 78 (76%) were White, one (1%) was Asian, and 24 (23%) did not report their race. In the 10 mg/kg group, complete remission rate was 12% (six of 51 patients; 95% CI 6-23) and in the 20 mg/kg group was 27% (14 of 52; 17-40). Grade 3 or worse treatment-emergent adverse events (TEAEs) were similar between the cusatuzumab 10 mg/kg (n=51) and 20 mg/kg (n=51) cohorts and included thrombocytopenia (24 patients [47%] vs 29 [57%]), anaemia (24 [47%] vs 17 [33%]), and neutropenia (20 [39%] in both cohorts). Serious TEAEs were also similar in the two cohorts (44 [86%] vs 40 [78%]). Treatment-related TEAEs leading to death were reported in both groups (three patients [6%] in the 10 mg/kg group vs one patient [2%] in the 20 mg/kg group); the reported causes of death were pneumonia (n=2) and septic shock (n=2).
INTERPRETATION:
Although part one of this study was not designed to formally compare the two dose cohorts for efficacy, the totality of clinical data for cusatuzumab studies performed to date indicate that cusatuzumab 20 mg/kg plus azacitidine represents the optimal dose for further studies. A phase 1b study investigating the triple combination of cusatuzumab with venetoclax and azacitidine is underway (NCT04150887).
FUNDING:
Janssen Research & Development and argenx.
2023-10-01·Cell death and differentiation
METTL3 inhibition induced by M2 macrophage-derived extracellular vesicles drives anti-PD-1 therapy resistance via M6A-CD70-mediated immune suppression in thyroid cancer.
Article
作者: Gao, Ming ; Ruan, Xianhui ; Zheng, Xiangqian ; Ning, Junya ; Zhang, Wei ; Hao, Jie ; Huang, Yue ; Hou, Xiukun ; Shi, Yi
The treatment options for advanced papillary thyroid cancer (PTC) and anaplastic thyroid cancer (ATC) refractory to standard therapies are limited. Although anti-PD-1 therapy has a manageable safety profile and has been effective in a small percentage of patients with advanced PTC and refractory ATC, the majority of the patients either do not respond or develop resistance to anti-PD-1 therapy. N6-methyladenosine (m6A) modification is a critical determinant of the complexity of the tumor microenvironment (TME). However, it is unclear whether and how m6A modification in tumor cells shapes the immune landscape of PTC and ATC. In this study, we performed bulk and single cell RNA sequencing analysis of PTC and ATC tissues, and found that low METTL3 expression not only correlated to poor response to immune checkpoint blockade (ICB) but was also associated with increased TNF family-related ligand-receptor interactions in the immunosuppressive Tregs and exhausted T cells. Furthermore, overexpression of METTL3 in PTC and ATC cells enhanced the efficacy of anti-PD-1 therapy in a peripheral blood mononuclear cell humanized NCG (huPBMC-NCG) mouse model. Mechanistically, M2 macrophage-derived extracellular vesicles (M2 EVs) inhibited METTL3 expression in PTC and ATC cells via miR-21-5p. Downregulation of METTL3 promoted demethylation of CD70 mRNA, which prevented YTHDF2-mediated degradation of the transcripts. The stabilization of CD70 mRNA, and the subsequent upregulation in CD70 protein levels increased the abundance of the immunosuppressive Tregs and terminally exhausted T cells, thereby inducing resistance to anti-PD-1 therapy. Furthermore, blocking CD70 using cusatuzumab, a high-affinity monoclonal antibody, reversed the anti-PD-1 therapy resistance induced by M2 EVs in vivo. Finally, we demonstrated that METTL3 expression negatively correlated with CD70 expression and M2 macrophages and Tregs infiltration in PTC and ATC tissues. Our findings provide new insights into developing novel therapies for advanced PTC and ATC.
2023-03-01·Cancer science
Cusatuzumab plus azacitidine in Japanese patients with newly diagnosed acute myeloid leukemia ineligible for intensive treatment
Article
作者: Hatayama, Tomoyoshi ; Shirahase, Toru ; Ikezoe, Takayuki ; Yamauchi, Takahiro ; Aida, Kensuke ; Usuki, Kensuke
Abstract:
We present the results of a phase 1 study that evaluated the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary disease response to cusatuzumab, a novel anti‐CD70 monoclonal antibody, in combination with azacitidine, in newly diagnosed acute myeloid leukemia Japanese participants who were not candidates for intensive treatment. In this multicenter, single‐arm study, six participants were enrolled and treated. Only in cycle 1, participants received cusatuzumab monotherapy on day 14. Subsequently, cusatuzumab was administered intravenously on days 3 and 17 at 20 mg/kg in combination with azacitidine (75 mg/m2) on days 1‐7 of each 28‐day cycle. All six participants had at least one treatment‐emergent adverse event, and the most common treatment‐emergent adverse events (all grades) were leukopenia (four participants [66.7%]) and constipation (three participants [50.0%]). No dose‐limiting toxicity was observed during the study period. The combination of cusatuzumab and azacitidine is generally well tolerated in Japanese participants, and further exploration of this combination is warranted.
23
项与 Cusatuzumab 相关的新闻（医药）2023-05-26
PRO1160 first patient dosed in the US
China NMPA clearance for PRO1184 (rinatabart sesutecan, Rina-S) and PRO1160 to initiate clinical trials
Rina-S preliminary clinical data is encouraging
SUZHOU, China and WOODINVILLE, Wash., May 26, 2023 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that dosing in the Phase 1/2 first-in-human trial of PRO1160 (NCT05721222) has initiated in the US, and the company received approval from National Medical Products Administration (NMPA) to initiate the PRO1160 trial in China. The company also received NMPA approval to initiate the Rina-S Phase 1/2 first-in-human trial in China. Preliminary results from the on-going trial (NCT05579366) demonstrate a promising clinical profile, with anti-tumor activity observed at tolerable dose levels.
"We continue to advance our next-generation antibody-drug conjugate (ADC) programs in our mission to bring new and better treatment options to patients with advanced cancers." said Naomi Hunder, MD, CMO of ProfoundBio. "Rina-S and PRO1160 have the potential to be best-in-class therapies; both leverage our novel hydrophilic linker and exatecan payload, designed to reduce off-target toxicities and improve anti-tumor activity through better exposure and stronger bystander activity. We are gratified to have enthusiastic support from global investigators as we gain experience with these novel agents to address high unmet needs."
About rinatabart sesutecan (PRO1184)
Rina-S is an ADC comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload with ProfoundBio's novel, proprietary hydrophilic linker. The Phase 1/2 study will evaluate the safety, activity, and pharmacokinetics of Rina-S in patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma. This first-in-human study is actively enrolling with multiple clinical trial sites across the United States and China.
About PRO1160
PRO1160 is an ADC comprising a CD70-directed antibody conjugated to the exatecan payload with ProfoundBio's novel, proprietary hydrophilic linker. The Phase 1/2 study will evaluate the safety, activity, and pharmacokinetics of PRO1160 in patients with metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma, or advanced non-Hodgkin lymphoma. In preclinical studies, PRO1160 demonstrated the potential to be a first- and best-in-class CD70-directed ADC. The first-in-human study is actively enrolling with multiple clinical trial sites across the United States.
About ProfoundBio
ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple drug candidates targeting solid tumors and hematological malignancies that are in discovery, preclinical, and clinical development stages. ProfoundBio has operations in both the US and China.
For more information, please visit .
SOURCE ProfoundBio
临床申请抗体药物偶联物临床研究
2023-05-04
关注并星标CPHI制药在线CD70，又称TNFRSF7，是肿瘤坏死因子(TNF)超家族的成员之一，是一种Ⅱ型跨膜蛋白，与受体CD27作用后可促进T细胞和B细胞活化、增殖及分化，在调控免疫应答过程中发挥重要的作用。 正常情况下，CD70主要表达于活化的淋巴细胞。病理情况下，CD70高表达于多种肿瘤细胞（包括血液恶性肿瘤和实体瘤），可导致免疫功能耗竭，诱导免疫逃逸，与肿瘤的发生发展及预后密切相关，可作为恶性肿瘤早期诊断的新型生物标志物、临床治疗及监测疾病预后的新靶点。 此外，德克萨斯大学MD安德森癌症中心的研究人员发现CD70在EGFR突变的非小细胞肺癌（NSCLC）耐药癌细胞上呈现高度表达，这意味着CD70或将成为一种新的治疗靶点，用于消除常用的EGFR酪氨酸激酶抑制剂(TKI)治疗后仍然存在的耐药癌细胞。 目前，全球已有多家企业布局CD70靶点，详见下表。整体来看，在研CD70靶向药进展较慢，最快的处于2期临床，适应症包括恶性血液肿瘤和实体瘤（尤其是肾细胞癌），药物类型主要为单抗、抗体偶联药物（ADC）和嵌合抗原受体T细胞疗法（CAR-T）。 值得一提的是，我国药企也积极布局CD70靶点。其中宜明昂科、普方生物、博锐生物和重庆精准生物等积极搞自主研发，百济神州、和新码生物依靠"Licensen-in"方式引进CD70靶向药。 • cusatuzumab是Argenx公司基于其强大的美洲驼免疫系统的SIMPLE抗体平台开发的一种CD70靶向单抗，旨在靶向阻断CD70，通过补体依赖性细胞毒性作用、增强抗体依赖性细胞介导的吞噬作用、增强抗体依赖性细胞介导的细胞毒性作用，杀死表达CD70的癌细胞，恢复对实体瘤的免疫监测。 在针对初治急性骨髓性白血病（AML）患者的1/2期临床试验中，cusatuzumab与阿扎胞苷（azacitidine）联合使用，与阿扎胞苷单独使用的历史数据相比，有更高的完全缓解率（67%）。2019年ASH年会上公布的cusatuzumab治疗AML和高风险骨髓增生异常综合征（MSD）的1/2期临床试验结果表明：cusatuzumab达到高达92%的总缓解率和42%的完全缓解率。 2018年12月，强生斥资16亿美元获得cusatuzumab的授权。但基于对cusatuzumab现有临床数据的审查，以及对AML护理标准不断发展的考虑，2021年强生终止与argenx公司就cusatuzumab达成的合作许可协议。2023年3月，OncoVerity公司又从argenx公司获得开发cusatuzumab的全球权益，并完成了3000万美元的A轮融资。 • SEA-CD70是Seagen公司开发的一款CD70靶向单抗。2019年11月，百济神州与Seagen公司达成合作协议，获得SEA-CD70在亚洲（除日本）以及其他一些地区的权益。2021年6月，SEA-CD70在国内获批临床，用于治疗复发/难治性MSD和AML。 • IMM40H是一款具有细胞毒作用（ADCC）加强活性的人源化 IgG1 CD70单抗。体内药效研究证明，IMM40H对多种肿瘤具有显著抑瘤活性，较低剂量 2-3 次治疗即可全部清除皮下肿瘤；体外实验研究结果表明，与cusatuzumab analogue相比，IMM40H 具有更强的CD70亲和力，这使其能够更有效地阻断CD70与CD27的相互作用。2022年9月，IMM40H在国内启动1期临床。 • BR108是一款靶向CD70的创新型ADCC增强型单抗。临床前研究表明，BR108与CD70具有很高的亲和力，可通过抗体依赖性细胞介导的ADCC、抗体依赖的细胞介导的吞噬作用（ADCP）、补体依赖的细胞毒 性作用（CDC）杀伤多种CD70阳性肿瘤细胞。此外，BR108还可阻断CD70与其受体CD27的相互作用，解除免疫抑制的肿瘤微环境。在体内药效和毒理研究中，BR108展现了较好的抗肿瘤活性和良好的安全性。2023年1月，BR108在国内获批临床，用于治疗复发/难治性血液系统恶性肿瘤。 • ARX305是一款人源化抗CD70单克隆抗体共价结合2个微管抑制剂AS269而成的ADC。相较于传统ADC药物，ARX305偶联稳定，血液中稳定性高，在多个CD70表达肿瘤模型中显示良好的抑瘤效果；同时，ARX305在动物模型上表现出良好的安全性特征。2019年10月，新码生物与Ambrx达成合作，获得后者ARX305在中国的开发和商业化授权。 • PRO1160是一种ADC，由一种新型的针对CD70的专有抗体通过ProfoundBio专有的ADC平台技术，与exatecan有效载荷偶联组成。PRO1160在实体瘤和淋巴瘤的临床前模型中产生了强大的抗肿瘤作用，同时在大鼠中保持了与亲本mAb相似的PK特征，并在一项非人灵长类动物安全性试验中具有良好的耐受性。 临床前研究数据展示PRO1160具有宽泛的治疗窗口，有望成为同类最 佳ADC疗法的潜力。目前，PRO1160正在进行一项1期临床，旨在评估其在转移性肾细胞癌、转移性或复发性鼻咽癌和晚期非霍奇金淋巴瘤患者中的安全性、活性和药代动力学特点。 • BMS-936561是Medarex/BMS开发的一种CD70靶向ADC，抗体通过蛋白酶敏感型linker与MGBA相连。在临床前研究中，低剂量MDX-1203在PXDX模型中已表现出强有效的抗肿瘤活性，对淋巴瘤和肾细胞癌（RCC）模型疗效良好且毒副作用较低。 • ALLO-316是一款靶向CD70的同种异体CAR-T疗法，由一种靶向CD70的全人源单链抗体、一种基于利妥昔单抗的关闭开关，以及4-1BB和CD3ζ信号域组成。目前，ALLO-316正在进行一项1期TRAVERSE试验，旨在评估ALLO-316在晚期或转移性透明细胞RCC患者中的安全性、耐受性和活性。2022年3月，ALLO-316被FDA授予快速通道资格（FTD），用于治疗晚期或转移性透明细胞肾细胞癌（RCC）患者。 • C-4-29细胞制剂是BCMA/CD70双靶向CAR-T产品，在探索性临床试验中显示具有良好的安全性和有效性，作为靶向多发性骨髓瘤的首 个多靶点产品，有望在临床上进一步降低肿瘤的复发风险。目前，C-4-29细胞制剂已先后在国内获批两项临床试验，适应症为18岁及以上的复发/难治性多发性骨髓瘤和CD70表达阳性的晚期肾细胞癌。 • CTX130是一种健康供体衍生的基因编辑的异体CAR-T研究性疗法，靶向CD70。目前，CTX130正在进行两个独立的1期单臂、多中心、开放标签临床试验，旨在评估CTX130在成年患者中的几个剂量水平的安全性和有效性，COBALT-LYM试验针对复发或难治的T或B细胞恶性肿瘤，COBALT-RCC试验则针对复发或难治性肾细胞癌。2022年9月，CTX130被FDA授予再生医学高级疗法（RMAT）认证，针对皮肤T细胞淋巴瘤（CTCL），真菌病和塞扎里综合征（MF/SS）。 此外，目前已有企业开始研发CD70靶向CAR-NK细胞疗法。2021年5月，CRISPR Therapeutics和Nkarta达成战略合作，共同开发和商业化靶向CD70和未知靶点的两款CAR-NK细胞疗法。 然而，CD70靶向药的开发并不顺利。CD70靶向ADC，如安进的AMG 172和BMS的MDX-1203均已停止，Seagen的ADC药物SGN-75和SGN-CD70也均因毒性原因停止了临床试验。 总结 免疫疗法是近年来肿瘤药物研发的热门领域。CD70作为免疫治疗潜力靶点，是国内外药企积极布局的热门方向，多款在研药物已显现出治疗恶性血液肿瘤和肾细胞癌等实体瘤的潜力。而且，CD70靶向药药物类型多样，涉及单抗、ADC和CAR-T，我国药企重庆精准生物还研发出了BCMA/CD70双靶向CAR-T疗法。此外，最新研究发现，CD70还有可能成为EGFR突变，并已经发生获得性EGFR TKI耐药性肿瘤的干预靶标之一。然而，CD70靶向药的开发仍充满挑战，AMG 172等多款药物研发停止。智药研习社近期直播报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~
免疫疗法细胞疗法引进/卖出抗体药物偶联物临床1期
2023-03-28
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OncoVerity licenses Cusatuzumab, a first-in-class anti-CD70 antibody, from argenx
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Max Colao, MBA appointed as Chief Executive Officer and Dr. Clay Smith as Chief Medical Officer
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OncoVerity closes $30M Series A financing
AURORA, CO, USA I March 27, 2023 I
OncoVerity, a pioneer in applying advanced multiomic, data driven patient stratification to the development of human therapeutics in oncology, has secured worldwide licensing rights to cusatuzumab from argenx and received $30M in funding from argenx and a joint venture of UCHealth and University License Equity Holdings, Inc. on the University of Colorado Anschutz Medical Campus for its continued development. Cusatuzumab is a first-in-class anti-CD70 antibody that has generated promising results in early acute myeloid leukemia (AML) human studies. OncoVerity will optimize cusatuzumab’s continued development in AML and explore its application in other cancers.
OncoVerity is also announcing the appointment of Max Colao, MBA as Chief Executive Officer, and Dr. Clay Smith as Chief Medical Officer.
"We are thrilled to welcome Max and Clay to the OncoVerity leadership team. Together with Max’s extensive commercial leadership experience and Clay’s proven track record in research and development, we are confident that will drive growth and expansion as we enter the next phase of development,” said Arjen Lemmen, Vice President, Corporate Development and Strategy at argenx, and OncoVerity Board Member.
Mr. Colao has over 30 years of biotechnology leadership experience. In his most recent position, he served as the Chief Commercial Officer of Aurinia, where he built out the commercial team through launch. Prior to that, Mr. Colao held senior roles of increasing responsibility at Alexion, where he led the US commercial operations and built out the new business units in launching several rare disease therapies. He also spent over 20 years at Amgen, where he launched multiple therapies in the areas of hematology, oncology, and autoimmune disorders supporting Amgen’s growth from small to large biotech.
Dr. Smith joins OncoVerity with more than 30 years of experience in oncology research, clinical care and clinical trials. He was previously Professor and Associate Chief of the Hematology Division at the University of Colorado. He was also the Director at UCHealth Blood Disorders and Cell Therapies Center. With the support of the University of Colorado Anschutz Medical Campus and UCHealth, Dr. Smith and his team pioneered the clinical and single cell multiomics infrastructure necessary to support, de-risk, and accelerate the development of this innovative therapy. Throughout his career, Dr. Smith has published over 150 scientific articles.
“I am excited to lead OncoVerity to its next phase of development and believe that the licensing of cusatuzumab and new funding demonstrate our commitment to advance novel cancer therapies in areas of high unmet need,” said Max Colao. “OncoVerity’s differentiated approach and talented team put us in a strong position to answer unresolved disease and therapeutic questions in oncology. I’m grateful for the contributions of the University of Colorado and argenx in establishing OncoVerity and look forward to making significant progress on behalf of cancer patients around the world.”
“OncoVerity is an example of a unique partnership that bridges the best in research, healthcare delivery, and the use of advanced multiomic data science-driven drug development to bring cutting edge treatments to patients in the areas of greatest unmet medical need,” said Kimberly Muller, Executive Director, CU Innovations, Anschutz Medical Campus, General Partner, CU Healthcare Innovation Fund, and Board Member of OncoVerity.
"This is a very exciting time to be joining OncoVerity as we start this journey to advance cancer research and develop targeted therapies that can make a real difference in the lives of patients," said Dr. Clay Smith. "I am particularly enthusiastic about the potential for our work on cusatuzumab for the treatment of AML, a disease where despite many advances in the treatment paradigm there remains a significant opportunity to develop effective therapies that meaningfully prolong survival.”
About Cusatuzumab
Cusatuzumab is a monoclonal antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors
(Silence K. et al. mAbs 2014; 6 (2):523-532)
. Cusatuzumab is currently being evaluated in patients with hematologic malignancies, including a Phase 2 trial in combination with azacitidine and a Phase 1b trial in combination with azacitidine and venetoclax in patients with newly diagnosed AML.
About Acute Myeloid Leukemia
Despite the advancements in medical research, there is still a significant lack of effective therapies to treat Acute Myeloid Leukemia (AML). The five-year survival rate for AML patients remains the lowest of all blood malignancies (5-20%), and relapse is common. AML is a heterogeneous disease, which means that it can differ in its genetic and molecular characteristics from one patient to another. This makes it difficult to develop effective treatments that can target all types of AML. Innovative therapies and targeted treatment approaches that can improve the survival rates, reduce toxicity, and target specific subtypes of AML are urgently needed to address this unmet need.
About OncoVerity
OncoVerity is pioneering the use of a unique clinical and single cell multiomics database to better the lives of patients battling cancer. OncoVerity’s approach leverages the University of Colorado Anschutz Medical Campus and UCHealth infrastructure of single cell analysis capabilities for multiple types of -omic technologies including genomics, transcriptomics, and proteomics, alongside one of the most comprehensive and highly curated AML patient databases to gain insights to tumor characteristics and therapeutic response Cusatuzumab is expected to be the first of many novel therapeutics that will benefit from the OncoVerity platform and differentiated approach to oncology drug development. In collaboration with world-renowned hematologists specializing in acute myeloid leukemia (AML), OncoVerity aims to develop cusatuzumab by truly understanding and acting upon the heterogeneous characteristics of AML.
SOURCE:
OncoVerity
高管变更引进/卖出临床2期临床1期
100 项与 Cusatuzumab 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 成人急性髓性白血病 | 临床2期 | 中国 | 2022-01-30 | |
| 慢性粒单核细胞白血病 | 临床2期 | 澳大利亚 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 巴西 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 法国 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 德国 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 意大利 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 俄罗斯 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 沙特阿拉伯 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 西班牙 | 2021-05-06 | |
| 慢性粒单核细胞白血病 | 临床2期 | 瑞士 | 2021-05-06 |
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临床结果
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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2期 | 52 | (cohort where patients received at least two treatment cycles) | 鏇願製繭鹹蓋餘願構簾(構糧衊網襯壓範鑰遞膚) = 淵夢製醖繭糧窪壓簾鑰 選鑰選觸獵窪壓餘廠鹽 (鑰膚憲窪繭廠選蓋齋範 ) 更多 | 积极 | 2021-01-08 | ||
(20 mg/kg) | 鏇願製繭鹹蓋餘願構簾(構糧衊網襯壓範鑰遞膚) = 顧鏇願壓淵願遞醖憲齋 選鑰選觸獵窪壓餘廠鹽 (鑰膚憲窪繭廠選蓋齋範 ) 更多 | ||||||
临床1/2期 | 12 | 蓋選糧選壓糧淵艱壓廠(壓遞憲衊構鬱窪簾觸鑰) = cusatuzumab treatment substantially reduced LSCs 顧繭襯構襯糧蓋鏇憲築 (醖鹹鏇衊鏇觸顧顧膚餘 ) | - | 2020-06-29 | |||
临床1/2期 | 急性髓性白血病 一线 | 12 | 艱糧膚築願壓簾鏇簾願(鑰窪窪齋蓋蓋鹹積糧窪) = 窪襯襯糧衊鑰範鹽衊餘 夢鹽選壓艱鏇壓顧獵憲 (醖遞願夢廠構蓋繭窪獵 ) 更多 | 积极 | 2018-11-29 | ||
N/A | - | 願獵廠窪觸鬱觸艱淵窪(艱觸餘遞淵觸積鬱願糧) = PR in 2 patients, with another 6 patient showing stable disease 遞憲膚獵糧齋壓顧獵鑰 (醖網積窪艱壓選遞鑰簾 ) 更多 | - | 2017-06-07 | |||
临床1期 | 19 | 醖艱鏇淵憲醖糧獵餘衊(鹹糧構製窪憲構顧積餘) = 16% 鏇艱憲糧顧艱積艱廠廠 (憲願繭遞獵網艱網衊遞 ) 更多 | - | 2014-05-20 |
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