This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants.

开始日期2024-05-31

申办/合作机构

Delta-Fly Pharma, Inc.

JPRN-jRCT2031210452 / Recruiting临床1期

A Phase I Study of NS-917 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

开始日期2022-02-17

申办/合作机构-

NCT03926624 / Recruiting临床3期

Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth Salvage

Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens:
Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles.
Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.

开始日期2019-11-22

申办/合作机构

Delta-Fly Pharma, Inc.

100 项与 Radgocitabine 相关的临床结果

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100 项与 Radgocitabine 相关的转化医学

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100 项与 Radgocitabine 相关的专利（医药）

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项与 Radgocitabine 相关的文献（医药）

2023-07-01·European journal of pharmacology

A polyethylene glycol-conjugate of deoxycytidine analog, DFP-14927, produces potential antitumor effects on pancreatic tumor-xenograft murine models via inducing G2/M arrest

Article

作者: Ando, Hidenori ; Ishida, Tatsuhiro ; Eshima, Kiyoshi

A deoxycytidine analog is a potential agent for the treatment of several cancers, which includes poorly prognostic pancreatic cancer. We previously developed deoxycytidine analog DFP-10917, and long-term/low-dose infusions of this analog has produced antitumor effects in leukemia cancer- and ovarian cancer-xenograft models. DFP-10917 is now undergoing clinical Phase III study in the United States for the treatment of patients with relapsed or refractory acute myeloid leukemia. PEG-drug conjugation has become a promising technique to improve the pharmacokinetic and pharmacodynamic properties of anti-cancer drugs. In the present study, we synthesized a novel PEG-drug conjugate of DFP-10917, referred to hereafter as DFP-14927, using a 4-armed CTPEG system to endow the DFP-10917 drug with favorable long-circulating properties that maximize its utility and antitumor efficacy. Intravenous injection of the synthesized DFP-14927 returned encouraging antitumor effects in a Panc-1 human pancreatic tumor- and a BxPC-3 human pancreatic tumor-xenograft models. These effects were comparable to that of free DFP-10917 as well as to that of gemcitabine, which is considered a standard in the treatment of pancreatic cancer. In vitro studies revealed that DFP-14927 inhibits cell division on human pancreatic cancer cell lines via arrest of the G2/M phase in the cell cycle, which is consistent with the effects of free DFP-10917. Intravenous administration of the newly synthesized DFP-14927 has induced G2/M arrest in human pancreatic tumor-xenograft murine models, which represents an improvement in the pharmacokinetics of DFP-10917. DFP-14927 could be an alternative for patients who cannot accept prolonged or continuous infusions of DFP-10917.

2021-12-01·Journal of experimental & clinical cancer research : CR1区 · 医学

Differences between intrinsic and acquired nucleoside analogue resistance in acute myeloid leukaemia cells

1区 · 医学

ArticleOA

作者: Costa, Rui ; McLaughlin, Katie-May ; Schneider, Constanze ; Farmand, Samira ; Rothenburger, Tamara ; Ferreirós, Nerea ; Xiong, Yong ; Temple, Joshua ; Keppler, Oliver T ; Schreiber, Yannick ; Geisslinger, Gerd ; Michaelis, Martin ; Rothweiler, Florian ; Wratil, Paul R ; Digianantonio, Katie ; Cinatl, Jindrich ; Thomas, Dominique ; Wass, Mark N ; Oellerich, Thomas ; Bojkova, Denisa ; Knecht, Kirsten ; Baldauf, Hanna-Mari ; Pflantz, Tamara ; Bilen, Berna

Abstract:

Background:

SAMHD1 mediates resistance to anti-cancer nucleoside analogues, including cytarabine, decitabine, and nelarabine that are commonly used for the treatment of leukaemia, through cleavage of their triphosphorylated forms. Hence, SAMHD1 inhibitors are promising candidates for the sensitisation of leukaemia cells to nucleoside analogue-based therapy. Here, we investigated the effects of the cytosine analogue CNDAC, which has been proposed to be a SAMHD1 inhibitor, in the context of SAMHD1.

Methods:

CNDAC was tested in 13 acute myeloid leukaemia (AML) cell lines, in 26 acute lymphoblastic leukaemia (ALL) cell lines, ten AML sublines adapted to various antileukaemic drugs, 24 single cell-derived clonal AML sublines, and primary leukaemic blasts from 24 AML patients. Moreover, 24 CNDAC-resistant sublines of the AML cell lines HL-60 and PL-21 were established. The SAMHD1 gene was disrupted using CRISPR/Cas9 and SAMHD1 depleted using RNAi, and the viral Vpx protein. Forced DCK expression was achieved by lentiviral transduction. SAMHD1 promoter methylation was determined by PCR after treatment of genomic DNA with the methylation-sensitive HpaII endonuclease. Nucleoside (analogue) triphosphate levels were determined by LC-MS/MS. CNDAC interaction with SAMHD1 was analysed by an enzymatic assay and by crystallisation.

Results:

Although the cytosine analogue CNDAC was anticipated to inhibit SAMHD1, SAMHD1 mediated intrinsic CNDAC resistance in leukaemia cells. Accordingly, SAMHD1 depletion increased CNDAC triphosphate (CNDAC-TP) levels and CNDAC toxicity. Enzymatic assays and crystallisation studies confirmed CNDAC-TP to be a SAMHD1 substrate. In 24 CNDAC-adapted acute myeloid leukaemia (AML) sublines, resistance was driven by DCK (catalyses initial nucleoside phosphorylation) loss. CNDAC-adapted sublines displayed cross-resistance only to other DCK substrates (e.g. cytarabine, decitabine). Cell lines adapted to drugs not affected by DCK or SAMHD1 remained CNDAC sensitive. In cytarabine-adapted AML cells, increased SAMHD1 and reduced DCK levels contributed to cytarabine and CNDAC resistance.

Conclusion:

Intrinsic and acquired resistance to CNDAC and related nucleoside analogues are driven by different mechanisms. The lack of cross-resistance between SAMHD1/ DCK substrates and non-substrates provides scope for next-line therapies after treatment failure.

2019-12-01·Molecular cancer therapeutics2区 · 医学

CNDAC-Induced DNA Double-Strand Breaks Cause Aberrant Mitosis Prior to Cell Death

2区 · 医学

Article

作者: Liu, Chaomei ; Wood, Richard D. ; Hittelman, Walter N. ; Liu, Xiaojun ; Takata, Kei-ichi ; Nowak, Billie ; Jiang, Yingjun ; Plunkett, William

Abstract:

Incorporation of the clinically active deoxycytidine analogue 2′-C-cyano-2′-deoxy-1-β-D-arabino-pentofuranosyl-cytosine (CNDAC) into DNA generates single-strand breaks that are subsequently converted to double-strand breaks (DSB). Here, we investigated the cellular manifestations of these breaks that link these mechanisms to cell death, and we further tested the relevance of DNA repair pathways in protection of cells against CNDAC damage. The present investigations demonstrate that following exposure to CNDAC and a wash into drug-free medium, chromosomal aberrations, DNA strand breaks, and multinucleate cells arose. These portended loss of viability and were dependent upon exposure time, CNDAC concentration, and passage through mitosis. Following a pulse incubation with CNDAC, live cell imaging using GFP-tagged histone H2B as a marker demonstrated a normal rate of progression to mitosis, but a concentration-dependent delay in passage to a second mitosis. Progression through mitosis was also delayed and accompanied by formation of multinucleate cells. CNDAC-treated cells lacking XPF-ERCC1 nuclease function showed a 16-fold increase in chromosome aberrations. Chromosomal damage in Rad51D-mutant cells (homologous recombination repair deficient) were even more severely affected with extensive aberrations. Rodent or human Polq (POLQ) mutant cells, defective in Pol θ–mediated alternative end joining, did not show enhanced cellular sensitivity to CNDAC. These findings are consistent with formation of DSBs in the second S-phase following exposure, resulting in chromosome aberrations, aberrant mitoses, and subsequent apoptosis.

项与 Radgocitabine 相关的新闻（医药）

2024-04-14

·药明康德

完全缓解率达83%的联合疗法；疾病控制率近95%的肺癌免疫联合疗法 | 一周盘点

▎药明康德内容团队编辑本期看点1. 个体化治疗性癌症疫苗GNOS-PV02联用PD-1抑制剂与PD-1抑制剂单药相比，在一项早期临床试验中使晚期肝癌患者的总缓解率（ORR）近翻倍，患者的中位总生存期（mOS）获大幅延长。2. 癌症疫苗PDC*lung01联用PD-1抑制剂一线治疗转移性非小细胞肺癌（NSCLC），在一项1/2期临床试验中的疾病控制率（DCR）高达94.7%。3. CD47抑制剂evorpacept联用利妥昔单抗和来那度胺治疗惰性和侵袭性复发/难治性B细胞非霍奇金淋巴瘤（B-NHL），在一项1/2期临床试验中的ORR为94%，完全缓解（CR）率为83%。4. 长效IL-2超级激动剂MDNA11治疗晚期实体肿瘤，使1例转移性胰腺导管腺癌（PDAC）患者在基线时存在的所有病变完全消退。药明康德内容团队整理GNOS-PV02：公布1/2期临床试验数据Geneos Therapeutics公司公布其个体化治疗性癌症疫苗GNOS-PV02的1/2期临床试验全部入组患者的安全性、免疫原性和疗效数据。这项试验中使用的癌症疫苗是一款DNA质粒递送的新抗原疫苗。该公司通过对每例患者的肿瘤进行测序，发现基于每个患者独特的肿瘤突变产生的新抗原，然后将表达这些新抗原的DNA序列导入到DNA质粒中。这种基于DNA的个体化治疗性癌症疫苗可能包含多达40种新抗原。此次公布的结果显示，该试验达到了安全性和免疫原性的主要终点，以及基于缓解率的疗效次要终点。在36名晚期肝癌患者中，有11名（30.6%）对该疫苗与PD-1抑制剂Keytruda联合疗法产生缓解，这大约是过去对照药物缓解率的两倍。其中3例患者达到了CR，8例患者达到了部分缓解（PR）。数据截止时，患者的mOS为19.9个月，而先前报道的Keytruda和其他PD-1抑制剂单药用于二线治疗时的mOS范围为12.9-15.1个月。▲GNOS-PV02治疗晚期肝癌患者的临床结果（图片来源：参考资料[28]）此外，免疫学分析证实，在14名可评估的患者中，100%的患者出现了对疫苗编码的新抗原的新T细胞反应。单细胞测序分析显示，这些T细胞克隆中的绝大多数是CD8 T效应记忆细胞，这是诱导抗肿瘤细胞毒性的关键细胞。PDC*lung01：公布1/2期临床试验的新数据 PDC*line Pharma公司公布了其用于NSCLC患者的现货型治疗性癌症疫苗候选药物PDC*lung01单药或与抗PD-1治疗联用的1/2期临床试验中最后一批患者的中期数据。浆细胞样树突状细胞（PDC）系是一种有效的专业抗原呈递细胞系，能够激发和增强患者的抗肿瘤细胞毒性CD8+ T细胞，并能与抗PD-1治疗协同作用。PDC*lung01是由7种活性组分组成的细胞悬液，装载着多种肿瘤抗原。此次公布的数据显示，中位随访时间为12.5个月时，在19例可评估的患者中，高剂量PDC*lung01与pembrolizumab联用一线治疗IV期（转移性）NSCLC患者的DCR为94.7%，ORR为63.2%，获得缓解的患者均为PR。患者的中位无进展生存期（mPFS）为10.9个月，中位缓解持续时间为9.49个月。Evorpacept（ALX148）：公布1/2期临床试验数据ALX Oncology公布了其CD47抑制剂evorpacept（ALX148）联用利妥昔单抗和来那度胺治疗惰性和侵袭性复发/难治性B细胞非霍奇金淋巴瘤的1/2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。截至目前，evorpacept已在500多名受试者中使用，并在与各种抗癌抗体联用时，在一系列血液和实体恶性肿瘤中显示出良好的活性和耐受性。该研究中，20名惰性和2名侵袭性复发/难治性B-NHL患者接受了evorpacept联用利妥昔单抗和来那度胺的治疗，该组合疗法的耐受性良好，安全性与利妥昔单抗联用来那度胺相似，未报告剂量限制性毒性。接受evorpacept联用利妥昔单抗和来那度胺的患者的最佳ORR为94%，83%的患者实现了CR。与之相比，在先前的一项3期基准试验中，接受利妥昔单抗联用来那度胺的此类患者的ORR为78%，CR率为34%。MDNA11：公布1/2期临床试验的新数据 Medicenna Therapeutics公司公布了其下一代长效IL-2超级激动剂MDNA11治疗晚期实体瘤的新临床结果。MDNA11具有优秀的CD122（IL-2受体β）结合作用，而没有CD25（IL-2受体α）亲和力，从而能优先刺激癌症杀伤效应T细胞和NK细胞。此次公布的结果显示，MDNA11的耐受性良好，没有报告剂量限制毒性和血管渗漏综合征。截至2024年3月22日的数据，14例患者中有4例达到了PR，3例达到了疾病稳定（SD），ORR为29%，DCR为50%。MDNA11已使3名转移性黑色素瘤患者获得了6个月至18个月的持久SD，并且这些患者的肿瘤有缩小。第66周时，1例转移性胰腺导管腺癌患者在基线时存在的所有病变均完全消退。一例双检查点抑制剂治疗后进展的黑色素瘤患者的靶病灶在第28周时完全消退，非靶病灶在第36周持续缩小。Autogene cevumeran（BNT122，RO7198457）：公布1期临床试验的新数据 BioNTech公司在2024年美国癌症研究协会（AACR）年会上，公布了其针对胰腺导管腺癌的个体化癌症疫苗autogene cevumeran的临床试验随访成果。Autogene cevumeran是基于BioNTech的iNeST癌症疫苗技术平台生成的个体化新抗原疫苗，它可以编码数十种新抗原，旨在激发人体针对肿瘤细胞产生更为全面的免疫反应，防止肿瘤细胞逃避免疫系统的攻击。此前公布的结果显示，16名接受过手术治疗的患者在atezolizumab治疗后接受了autogene cevumeran治疗。在这16人中，8人（50%）产生了T细胞免疫反应，由疫苗诱导产生了大量新抗原特异性的T细胞——其中一半的T细胞可以靶向一种以上的新抗原。▲去年5月所公布autogene cevumeran与抗PD-L1抗体atezolizumab和化疗联用，治疗PDAC患者的疗效结果（图片来源：参考资料[27]）此次公布的分析表明，患者在接种PDAC癌症疫苗3年后，体内的T细胞免疫应答持续激活，并且患者的无复发生存期（RFS）得到了持续的延长。这一结果印证了该癌症疫苗的免疫持久性。DOC1021：公布1期临床试验的中期数据Diakonos Oncology公司公布了其树突状细胞疫苗DOC1021用于治疗多形性胶质母细胞瘤（GBM）患者的1期开放标签试验的中期分析结果。该公司的树突状细胞疫苗由患者自身的免疫细胞与从肿瘤样本中提取的RNA和蛋白质结合制成。这种独特的方法可以靶向完整的癌症抗原谱，而无需进行任何基因修饰。通过利用天然的免疫信号通路，这种策略使免疫系统能将癌细胞视同病毒感染的细胞一样进行识别和清除。此次公布结果时，GBM患者的mOS期尚未达到，但有望大幅超过接受标准治疗（SOC）患者12.7个月的预期mOS。平均随访时间为12.9个月时，16名新确诊的GBM患者中有12名仍然存活，且未发生可归因的严重不良事件。2021年10月入组的首例GBM患者已存活了两年多。尽管接受的治疗剂量不到预计治疗剂量的25%，接下来入组的4名患者中的每一位都存活了15个月以上，其中两名在20.3个月和17.5个月时仍然存活。MGMT未甲基化GBM患者目前的12个月生存率为88%，而接受SOC的MGMT未甲基化GBM患者的12个月生存率仅为53%。OBX-115：公布1期临床试验的新数据 Obsidian Therapeutics公司公布了其肿瘤浸润淋巴细胞（TIL）疗法OBX-115用于晚期或转移性黑色素瘤患者的1期临床试验的最新进展，包括25周的中期研究随访安全性数据和最新的详细疗效数据。OBX-115是一种新型工程化的TIL疗法，该TIL具有表达于细胞膜上受调节的白介素-15（IL-15）蛋白，因此患者在接受OBX-115治疗时不需要同时接受传统TIL治疗方案中要求的高剂量IL-2。临床前数据显示，与未经改造的TIL疗法相比，OBX-115具有增强的持久性与效力，动物模型的肿瘤控制得到改善，因此具潜力改善不同类型实体瘤患者的临床结果。此次公布的结果显示，OBX-115的耐受性良好，与使用高剂量IL-2的非工程化TIL疗法具有差异化的安全性，未报告剂量限制性毒性和≥4级的非血液学事件。OBX-115诱导了深入且持久的缓解，ORR为50%，其中CR率为33%，mPFS尚未达到，6个月无进展生存率为67%。此外，所有患者在接受治疗后肿瘤负荷有所减轻，疾病控制时间≥12周。TILT-123：公布1期临床试验的初步数据 TILT Biotherapeutics公司公布了其溶瘤病毒疗法TILT-123联合Keytruda治疗铂类耐药或难治性卵巢癌的1期临床试验的安全性和有效性数据。TILT-123是一种溶瘤腺病毒，不但能够在肿瘤内部复制、裂解肿瘤并且释放肿瘤相关抗原，还可以产生免疫刺激细胞因子TNFα和IL-2。该病毒的另一个优势是它不会在正常细胞中繁殖，而且可以使用肿瘤内注射或者静脉注射给药。TILT-123在临床前癌症模型中表现出100%的缓解率。这项研究中，患者接受了瘤内或腹膜内注射TILT-123联合静脉注射Keytruda的治疗。结果显示，71%可评估患者的疾病得到了控制，其中一名粘液腺癌患者获得了长期PR。注射和未注射的肿瘤都出现了肿瘤体积缩小和显著的免疫调节，这表明该疗法有可能导致全身性的缓解。ELVN-001：公布1期临床试验数据 Enliven Therapeutics公司公布了其小分子激酶抑制剂ELVN-001治疗复发/难治性或对现有酪氨酸激酶抑制剂（TKI）不耐受的慢性髓系白血病（CML）患者的1期临床试验的积极数据。ELVN-001是一种强效、高选择性、潜在“best-in-class”的小分子激酶抑制剂，专门针对CML患者的致癌驱动因子BCR-ABL融合蛋白。ELVN-001还具有针对耐药性最强的BCR-ABL1耐药突变体T315I和其他已知耐药突变体的活性。截至2024年3月18日的数据，ELVN-001的耐受性良好，未报告≥3级治疗相关的非血液学毒性反应。治疗12周时，既往接受过asciminib和/或对TKI耐药的患者的初始累积主要分子缓解（MMR）率为44%（7/16），与已获批的BCR-ABL1酪氨酸激酶抑制剂在1期临床试验中的数据相比具有优势。在可评估的患者中，所有患者在12周时BCR-ABL1融合蛋白的转录水平都有改善或保持稳定。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency. 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Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/07/2858841/0/en/Three-year-Phase-1-Follow-Up-Data-for-mRNA-based-Individualized-Immunotherapy-Candidate-Show-Persistence-of-Immune-Response-and-Delayed-Tumor-Recurrence-in-Some-Patients-with-Resec.html[4] AACR 2024: PDC*line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine. Retrieved April 9, 2024, from https://www.businesswire.com/news/home/20240408470952/en[5] ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer. 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Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/08/2859553/0/en/Kineta-Reports-Initial-Clinical-Response-Data-at-AACR-2024-of-its-Ongoing-Phase-1-2-VISTA-101-Clinical-Trial.html[10] ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”). Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2860415/0/en/ALX-Oncology-Reports-Encouraging-Clinical-Data-of-Evorpacept-in-Combination-with-Standard-of-Care-in-an-Ongoing-Phase-1-2-Clinical-Trial-in-Patients-with-Relapsed-or-Refractory-B-c.html[11] Alkermes Announces Positive Topline Results From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia. Retrieved April 9, 2024, from https://www.prnewswire.com/news-releases/alkermes-announces-positive-topline-results-from-phase-1b-study-of-alks-2680-demonstrating-improved-wakefulness-in-patients-with-narcolepsy-type-2-and-idiopathic-hypersomnia-302111041.html[12] Molecular Templates Presents Interim Data from MT-6402 Phase I Study in Patients with PD-L1+ Solid Tumors at the 2024 American Association for Cancer Research (AACR) Annual Meeting; Monotherapy Activity in Checkpoint-Experienced Head and Neck Cancer Patients Observed Through Novel Immuno-oncology Mechanism. 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Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2860391/0/en/Medicenna-Presents-Updated-Results-of-Single-Agent-MDNA11-Anti-tumor-Activity-from-Dose-Escalation-and-Ongoing-Dose-Expansion-of-the-Phase-1-2-ABILITY-1-Study-at-the-2024-Annual-Me.html[15] Corvus Pharmaceuticals Announces Initiation of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2860339/0/en/Corvus-Pharmaceuticals-Announces-Initiation-of-Placebo-Controlled-Phase-1-Clinical-Trial-of-Soquelitinib-for-Atopic-Dermatitis.html[16] Diakonos Oncology’s Unique Dendritic Cell Vaccine (DOC1021) Improves Survival Compared to Standard of Care in Phase 1 Trial for Glioblastoma. Retrieved April 9, 2024, from https://www.diakonosoncology.com/blog/diakonos-oncologys-unique-dendritic-cell-vaccine-doc1021-improves-survival-compared-to-standard-of-care-in-phase-1-trial-for-glioblastoma/[17] Vanqua Bio Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating VQ-101, its Small Molecule GCase Activator for GBA-Parkinson’s Disease and Related Disorders. Retrieved April 9, 2024, from https://www.globenewswire.com/news-release/2024/04/09/2859875/0/en/Vanqua-Bio-Announces-First-Patient-Dosed-in-Phase-1-Clinical-Trial-Evaluating-VQ-101-its-Small-Molecule-GCase-Activator-for-GBA-Parkinson-s-Disease-and-Related-Disorders.html[18] Obsidian Therapeutics Presents Positive 25-Week Median Study Follow-Up Safety and Efficacy Data from First-in-Human Study of OBX-115 in Advanced Melanoma at the American Association for Cancer Research Annual Meeting. Retrieved April 9, 2024, from https://www.businesswire.com/news/home/20240409687216/en/[20] Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an Allogeneic Regulatory T-Cell Therapy to Treat Autoimmune Diseases. Retrieved April 11, 2024, from https://www.prnewswire.com/news-releases/tr1x-announces-fda-clearance-of-first-investigational-new-drug-application-for-trx103-an-allogeneic-regulatory-t-cell-therapy-to-treat-autoimmune-diseases-302112587.html[21] ViGeneron Announces First Patient Dosed in Phase 1b Clinical Trial of VG901 For the Intravitreal Treatment of Retinitis Pigmentosa. Retrieved April 11, 2024, from https://vigeneron.com/press/vigeneron-announces-first-patient-dosed-in-phase-1b-clinical-trial-of-vg901-for-the-intravitreal-treatment-of-retinitis-pigmentosa/[22] TILT Biotherapeutics Presents Clinical Data on TILT-123 in Combination with KEYTRUDA® (pembrolizumab) for Ovarian Cancer at AACR 2024. Retrieved April 11, 2024, from https://www.globenewswire.com/news-release/2024/04/10/2860497/0/en/TILT-Biotherapeutics-Presents-Clinical-Data-on-TILT-123-in-Combination-with-KEYTRUDA-pembrolizumab-for-Ovarian-Cancer-at-AACR-2024.html[23] Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia. Retrieved April 11, 2024, from https://ir.enliventherapeutics.com/news-releases/news-release-details/enliven-therapeutics-announces-positive-proof-concept-data-phase[24] Possible New Hope for Metastatic Cancer Patients: Food and Drug Administration Grants Approval for Clinical Trials For Lamassu's Groundbreaking Cancer Treatment Protocol. Retrieved April 11, 2024, from https://www.prnewswire.com/news-releases/possible-new-hope-for-metastatic-cancer-patients-food-and-drug-administration-grants-approval-for-clinical-trials-for-lamassus-groundbreaking-cancer-treatment-protocol-302114390.html[25] MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients. Retrieved April 11, 2024, from https://www.businesswire.com/news/home/20240411126658/en[26] Boundless Bio Announces First Patient Dosed in First-in-Human Phase 1/2 Clinical Trial of BBI-825 in Cancer Patients with Resistance Gene Amplifications. Retrieved April 11, 2024, from https://www.businesswire.com/news/home/20240410633469/en[27] Rojas et al., (2023). Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature, https://doi-org.libproxy1.nus.edu.sg/10.1038/s41586-023-06063-y[28] Yarchoan M, Gane EJ, Marron TU, Perales-Linares R, Yan J, Cooch N, Shu DH, Fertig EJ, Kagohara LT, Bartha G, Northcott J, Lyle J, Rochestie S, Peters J, Connor JT, Jaffee EM, Csiki I, Weiner DB, Perales-Puchalt A, Sardesai NY. Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial. Nat Med. 2024 Apr 7. doi: 10.1038/s41591-024-02894-y. Epub ahead of print. PMID: 38584166.[29] Silence Therapeutics Announces JAMA Publication of Additional Phase 1 Data for Zerlasiran in Subjects with Elevated Lipoprotein(a). Retrieved April 11, 2024, from https://www.businesswire.com/news/home/20240408451903/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

疫苗免疫疗法临床结果

2024-04-08

·BioSpace

Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax

TOKUSHIMA, Japan--(BUSINESS WIRE)-- Following to the previous information on March 11th, 2024, we are excited to share our latest development status. We are pleased to announce the protocol for the Phase I/II clinical trial of DFP-10917 combined with Venetoclax (VTX) in patients with acute myeloid leukemia (AML) with prior VTX involved one regimen, which was submitted to the FDA in US on March 8 has been approved by the FDA in US dated April 8, 2024. Accordingly, we can start the Phase I/II combo-study very soon. The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML. This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML. The interim analysis of the Phase III trial of DFP-10917 monotherapy in patients with recurrent or refractory AML is under follow-up for a number of long-term survivors that have a significant impact on the overall survival (OS) analysis. Please take notice of our own innovative approach for miserable cancer patients and contact with us. View source version on businesswire.com: Contacts Inquiries Scott Frank Vice President for Business Development Delta-Fly Pharma, Inc. Head office: Tokushima 771-0117, Japan Phone: +81-3-6231-1278 E-mail: sfrank1206@delta-flypharma.co.jp Home page: Source: Delta-Fly Pharma Inc. View this news release online at:

临床申请临床3期

2024-03-11

·BioSpace

Delta-Fly Pharma Inc.: FDA submission of the protocol of the Phase I/II study of DFP-10917 combined with Venetoclax (VTX) in the AML patients pretreated by VTX involved one regimen

TOKUSHIMA, Japan--(BUSINESS WIRE)-- Following to the previous information on Jan. 30th. in 2024, we are excited to share our latest development status. FDA submission of the protocol of the Phase I/II study of DFP-10917 combined with Venetoclax (VTX) in the AML patients pretreated by VTX involved one regimen have been done on March 8th, 2024. The Phase I/II study of DFP-10917 with VTX in the above AML patients shall be started at Wake Forest and the other hospitals soon after FDA approval. The interim analysis of the Phase III study of DFP-10917 in patients with recurrent or refractory acute myeloid leukemia (R/R AML) at multicenter in the US is undergoing for the reason there are patients with a long-term survival may effect on OS analysis. The invention with the combination of DFP-14927 with VTX in AML was granted in Japan, US, and Taiwan. Please take notice of our own innovative approach for miserable cancer patients and contact with us. View source version on businesswire.com: Contacts Inquires Scott Frank Vice President for Business Development Delta-Fly Pharma, Inc. Head office: Tokushima 771-0117, Japan Phone: +81-3-6231-1278 E-mail: sfrank1206@delta-flypharma.co.jp Home page: Source: Delta-Fly Pharma, Inc. View this news release online at:

临床3期临床1期临床申请

100 项与 Radgocitabine 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11667

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床3期	美国	Delta-Fly Pharma, Inc.	2019-11-22
急性白血病	临床2期	美国	Delta-Fly Pharma, Inc.	2012-10-10
急性淋巴细胞白血病	临床2期	美国	Delta-Fly Pharma, Inc.	2012-10-10
晚期结直肠腺癌	临床2期	美国	Taiho Pharmaceutical Co., Ltd.	2009-01-01
难治性结直肠癌	临床2期	美国	Taiho Pharmaceutical Co., Ltd.	2009-01-01

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临床结果

适应症

分期

评价

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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


NCT01702155 (Pubmed \| Cancer) 人工标引	临床1/2期	急性髓性白血病	-	DFP-10917 (stage 2)	築獵齋齋積膚廠範憲鑰(窪範壓鑰顧膚糧願鬱醖) = 14-day continuous intravenous infusion at a dose of 6 mg/m2 /day 衊製製簾鏇夢醖壓遞繭 (廠蓋簾鹽鑰憲糧鹹鏇壓 )	积极	2019-05-15
NCT01702155 (Pubmed \| Cancer) 人工标引	临床1/2期	急性髓性白血病	-	DFP-10917		积极	2019-05-15
NCT00824161 (Pubmed \| Invest New Drugs) 人工标引	临床2期	结直肠癌	28	DFP-10917	鑰製蓋積範顧齋餘糧壓(鑰廠鑰鑰憲夢築範蓋願) = 膚積繭憲衊糧選襯醖鑰選選艱範選範鹽繭構鬱 (衊壓簾選衊遞簾窪糧鏇 ) 更多	不佳	2018-10-01
NCT01702155 (ASCO2015)	临床1/2期	急性白血病	27	DFP-10917	積繭觸艱鬱窪築襯鹽鏇(獵夢製願製製廠膚夢繭) = 鏇衊鑰憲鏇鑰積齋鑰衊窪鏇餘築糧鹹蓋艱鏇鏇 (餘鏇憲鏇鹹製鹹醖衊範 ) 更多	-	2015-05-20
NCT00824161 (CTgov)	临床2期	难治性结直肠癌 \| 晚期结直肠腺癌	28	TAS-109	餘製鏇襯艱衊願製衊夢(繭壓繭顧餘蓋構遞壓餘) = 築遞顧壓鬱齋齋糧艱遞襯齋鑰鏇願膚艱網蓋製 (膚製廠壓鏇觸壓鑰繭鹽, 膚鹹餘蓋夢夢製範鏇醖 ~ 繭製築觸糧淵醖製積襯) 更多	-	2011-08-17