This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.

开始日期2020-01-28

申办/合作机构

Lokon Pharma AB

[+1]

NCT03555149

/ Terminated临床1/2期

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

开始日期2018-09-27

申办/合作机构

Hoffmann-La Roche Ltd.

NCT03225989

/ Completed临床1/2期

Phase I/II Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer

This Phase I/II trial evaluates LOAd703 in patients with cancer (pancreatic, biliary, colorectal or ovarian) together with their standard of care chemotherapy or using gemcitabine immune-conditioning. LOAd703 is administered by intratumoral image-guided injections. Maximum 50 patients can be enrolled.
LOAd703 is an immunostimulatory gene therapy using an selection replication competent adenovirus as a gene vehicle. The virus is derived from serotype 5 adenovirus with the fiber from serotype 35. It expresses the transgenes trimerized membrane-bound isoleucine zipper (TMZ) TMZ-CD40L and 41BBL under control of a cytomegalovirus (CMV) promoter.

开始日期2018-03-01

申办/合作机构

Lokon Pharma AB

[+1]

100 项与 Delolimogene mupadenorepvec 相关的临床结果

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100 项与 Delolimogene mupadenorepvec 相关的转化医学

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100 项与 Delolimogene mupadenorepvec 相关的专利（医药）

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项与 Delolimogene mupadenorepvec 相关的文献（医药）

2024-04-01·The Lancet. Oncology

LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): results from arm 1 of a non-randomised, single-centre, phase 1/2 study

Article

作者: Musher, Benjamin L ; Leen, Ann M ; Sandin, Linda C ; Patel, Kalpesh ; Ullenhag, Gustav J ; Othman, Mohamed ; Jing, James ; Jawaid, Salmaan ; Hilsenbeck, Susan G ; Wu, Mengfen ; Wenthe, Jessica ; Loskog, Angelica S I ; Rowinsky, Eric K ; Eriksson, Emma ; Grilley, Bambi ; Brisco, Amanda ; Smaglo, Brandon G ; Abidi, Wasif ; Brenner, Malcolm K ; Leja-Jarblad, Justyna

BACKGROUND:

Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, activates cytotoxic T cells, and induces tumour regression in preclinical models. The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma.

METHODS:

LOKON001 was a non-randomised, phase 1/2 study conducted at the Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA, and consisted of two arms conducted sequentially; the results of arm 1 are presented here. In arm 1, patients 18 years or older with previously treated or treatment-naive unresectable or metastatic pancreatic ductal adenocarcinoma were treated with standard 28-day cycles of intravenous nab-paclitaxel 125 mg/m² plus gemcitabine 1000 mg/m² (up to 12 cycles) and intratumoural injections of LOAd703 every 2 weeks. Patients were assigned using Bayesian optimal interval design to receive 500 μL of LOAd703 at 5 × 10¹⁰ (dose 1), 1 × 10¹¹ (dose 2), or 5 × 10¹¹ (dose 3) viral particles per injection, injected endoscopically or percutaneously into the pancreatic tumour or a metastasis for six injections. The primary endpoints were safety and treatment-emergent immune response in patients who received at least one dose of LOAd703, and antitumour activity was a secondary endpoint. This study was registered with ClinicalTrials.gov, NCT02705196, arm 2 is ongoing and open to new participants.

FINDINGS:

Between Dec 2, 2016, and Oct 17, 2019, 23 patients were assessed for eligibility, leading to 22 patients being enrolled. One patient withdrew consent, resulting in 21 patients (13 [62%] men and eight [38%] women) assigned to a dose group (three to dose 1, four to dose 2, and 14 to dose 3). 21 patients were evaluable for safety. Median follow-up time was 6 months (IQR 4-10), and data cutoff was Jan 5, 2023. The most common treatment-emergent adverse events overall were anaemia (96 [8%] of 1237 events), lymphopenia (86 [7%] events), hyperglycaemia (70 [6%] events), leukopenia (63 [5%] events), hypertension (62 [5%] events), and hypoalbuminaemia (61 [5%] events). The most common adverse events attributed to LOAd703 were fever (14 [67%] of 21 patients), fatigue (eight [38%]), chills (seven [33%]), and elevated liver enzymes (alanine aminotransferase in five [24%], alkaline phosphatase in four [19%], and aspartate aminotransferase in four [19%]), all of which were grade 1-2, except for a transient grade 3 aminotransferase elevation occurring at dose 3. A maximum tolerated dose was not reached, thereby establishing dose 3 as the highest-evaluated safe dose when combined with nab-paclitaxel plus gemcitabine. Proportions of CD8⁺ effector memory cells and adenovirus-specific T cells increased after LOAd703 injections in 15 (94%) of 16 patients for whom T-cell assays could be performed. Eight (44%, 95% CI 25-66) of 18 patients evaluable for activity had an objective response.

INTERPRETATION:

Combining LOAd703 with nab-paclitaxel plus gemcitabine in patients with advanced pancreatic ductal adenocarcinoma was feasible and safe. To build upon this novel chemoimmunotherapeutic approach, arm 2 of LOKON001, which combines LOAd703, nab-paclitaxel plus gemcitabine, and atezolizumab, is ongoing.

FUNDING:

Lokon Pharma, the Swedish Cancer Society, and the Swedish Research Council.

2020-12-01·Cancer gene therapy2区 · 医学

Immunostimulatory oncolytic virotherapy for multiple myeloma targeting 4-1BB and/or CD40

2区 · 医学

Article

作者: Hellström, Ann-Charlotte ; Wenthe, Jessica ; Wiklund, Helena Jernberg ; Loskog, Angelica ; Naseri, Sedigheh ; Eriksson, Emma

Abstract:

Multiple myeloma (MM) is a plasma cell malignancy that is characterized by immune dysregulation. MM is commonly treated with immunomodulating agents, but still remains incurable. Herein, we proposed and evaluated immunostimulatory Lokon oncolytic adenoviruses (LOAd) for MM treatment. LOAd viruses are serotype 5/35 chimera, which enables infection of hematopoietic cells. Oncolysis is restricted to cells with a dysregulated retinoblastoma protein pathway, which is frequently observed in MM. Further, LOAd viruses are armed with human immunostimulatory transgenes: trimerized membrane-bound CD40L (LOAd700, LOAd703) and 4-1BBL (LOAd703). LOAd viruses were assessed in a panel of MM cell lines (ANBL-6, L363, LP-1, OPM-2, RPMI-8226, and U266-84). All cells were sensitive to infection, leading to viral replication and cell killing as analyzed by quantitative PCR and viability assay. Transgene expression was verified post infection with flow cytometry. Cell phenotypes were further altered with a downregulation of markers connected to MM progression (ICAM-1, CD70, CXCL10, CCL2, and sIL-2Rα) and an upregulation of the death receptor Fas. In a co-culture of immune and MM cells, LOAd viruses promoted activation of cytotoxic T cells as seen by higher CD69, CD107a, and IFNγ expression. This was most prominent with LOAd703. In conclusion, LOAd viruses are of interest for MM therapy.

2017-10-01·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

Shaping the Tumor Stroma and Sparking Immune Activation by CD40 and 4-1BB Signaling Induced by an Armed Oncolytic Virus

1区 · 医学

Article

作者: Leja-Jarblad, Justyna ; Alemany, Ramon ; Milenova, Ioanna ; Moreno, Raphael ; Eriksson, Emma ; Dimberg, Anna ; Ullenhag, Gustav ; Loskog, Angelica ; Wenthe, Jessica ; Ståhle, Magnus

Abstract:

Purpose: Pancreatic cancer is a severe indication with short expected survival despite surgery and/or combination chemotherapeutics. Checkpoint blockade antibodies are approved for several cancer indications, but pancreatic cancer has remained refractory. However, there are clinical data suggesting that stimulation of the CD40 pathway may be of interest for these patients. Oncolytic viruses armed with immunostimulatory genes represent an interesting approach. Herein, we present LOAd703, a designed adenovirus armed with trimerized CD40L and 4-1BBL that activates the CD40 and 4-1BB pathways, respectively. As many cells in the tumor stroma, including stellate cells and the infiltrating immune cells, express CD40 and some 4-1BB, we hypothesize that LOAd703 activates immunity and simultaneously modulates the biology of the tumor stroma.Experimental Design: Tumor, stellate, endothelial, and immune cells were infected by LOAd703 and investigated by flow cytometry, proteomics, and functional analyses.Results: LOAd703-infected pancreatic cell lines were killed by oncolysis, and the virus was more effective than standard-of-care gemcitabine. In in vivo xenograft models, LOAd703 efficiently reduced established tumors and could be combined with gemcitabine for additional effect. Infected stellate and tumor cells reduced factors that promote tumor growth (Spp-1, Gal-3, HGF, TGFβ and collagen type I), while chemokines were increased. Molecules involved in lymphocyte migration were upregulated on infected endothelial cells. Dendritic cells were robustly stimulated by LOAd703 to produce costimulators, cytokines and chemokines, and such DCs potently expanded both antigen-specific T cells and NK cells.Conclusions: LOAd703 is a potent immune activator that modulates the stroma to support antitumor responses. Clin Cancer Res; 23(19); 5846–57. ©2017 AACR.

项与 Delolimogene mupadenorepvec 相关的新闻（医药）

2025-02-21

·ioncology

年度盘点丨李恩孝教授：继往开来——2024年胰腺癌领域重磅研究进展

点击蓝字关注我们年度盘点微专辑扫描二维码可查看更多内容编者按春风十里，春景初盛。回首2024年，胰腺癌领域的研究百花齐放，成果斐然。新年伊始，《肿瘤瞭望消化时讯》特邀西安交通大学第一附属医院李恩孝教授为我们梳理过去一年胰腺癌领域的诊疗进展，并展望未来的发展方向。李恩孝教授西安交通大学第一附属医院肿瘤内科学科带头人主任医师，教授，医学博士，博士研究生导师陕西省抗癌协会肿瘤生物治疗专业委员会主委 CSCO理事 CSCO胆道肿瘤专委会副主委、胰腺癌专业委员会委员、 GP-NET专委会常委、中西医结合专委会常委国家卫健委能力建设和继续教育肿瘤学专委会委员中国康复医学会肿瘤康复专委会常委中国老年医学学会肿瘤学分会副会长 CACA肿瘤分子靶向治疗专业委员会，NET专业委员会常委中国研究型医院协会精准医学与肿瘤MDT专业委员会副主委中国医疗保健国际交流促进会消化肿瘤综合诊疗学分会, NET专委会副主委《现代肿瘤医学》《中国肿瘤临床与康复》编委胰腺癌具有高致死率、起病隐匿、进展迅速和预后极差的特点。目前，胰腺癌的5年生存率仅为7%~10%。据GLOBOCAN 2022年的统计数据显示，我国胰腺癌的发病率排名第十，死亡病例为11万，死亡率位居肿瘤相关死亡原因第六位[1]。尽管胰腺癌的基础转化研究和临床研究面临严峻挑战，但多项研究为这一“癌王”的治疗带来了新的希望。指南领航，优化精准治疗策略 2024年美国国家综合癌症网络（NCCN）胰腺癌指南2025.V1版重磅发布[2]，重点更新了精准治疗策略、一线治疗方案及局晚期/转移性疾病的治疗推荐。指南特别强调了使用二代测序（NGS）检测临床上可操作的和/或新出现的突变，以加强靶向治疗的应用。其中包括基因融合（ALK、NRG1、NTRK、ROS1，FGFR2和RET）、基因突变（BRAF、BRCA、KRAS和PALB2）、基因扩增（HER2）、微卫星不稳定性（MSI）、错配修复缺陷（dMMR）及肿瘤突变负荷（TMB）。通过全面的基因组分析，可为患者提供更精准的个体化治疗方案，预测治疗效果并评估预后。多点开花，基于化疗排兵布阵新辅助治疗新辅助治疗在胰腺癌治疗中的地位日益凸显。如何制定有效的治疗方案，以实现肿瘤降期、提高R0切除率、建立药敏平台并改善患者预后，一直是临床探索的重点。 2024 ASCO GI大会公布的Ⅱ期NEO-Nal-IRI研究结果显示[3]，NALIRIFOX方案（伊立替康脂质体+奥沙利铂+5-氟尿嘧啶/亚叶酸钙）用于可切除及临界可切除胰腺癌患者新辅助治疗的客观缓解率（ORR）为45%，疾病控制率（DCR）为73%，R0切除率为90%，且安全性可控。这一结果为胰腺癌的新辅助治疗奠定了良好的基础。一线治疗一线治疗是胰腺癌患者长期生存的关键。2023 ASCO GI大会公布的Ⅲ期NAPOLI-3研究结果显示[4]，NALIRIFOX（伊立替康脂质体+奥沙利铂+5-氟尿嘧啶/亚叶酸钙）对比Gem+NabP（白蛋白紫杉醇+吉西他滨）在无进展生存期（PFS）和总生存期（OS）方面均显示出显著获益。2024 ASCO大会进一步公布了随访29.5个月后的数据[5]，NALIRIFOX组的OS获益持续优于Gem+NabP组，两组12个月和18个月的OS率分别为45.6% vs. 39.6%和26.6% vs. 20.0%（图1）。此外，在临床试验中，NALIRIFOX组腹泻不良发生率较低，且患者耐受性良好。图1. OS获益结果一线治疗中老年胰腺癌患者约占三分之一，但其治疗方案一直缺乏高质量的循证医学证据。2024 ASCO大会公布的Ⅱ期GIANT研究评估了吉西他滨+白蛋白紫杉醇（AG）+5-FU对比亚叶酸钙联合脂质体伊立替康（nal-IRI+5-FU/LV）一线治疗老年转移性胰腺肿瘤的疗效。结果显示[6]，两组患者的OS和PFS获益均无显著差异，且安全性相当。这一研究为老年胰腺癌患者的一线治疗提供了重要参考。二线治疗一线治疗失败后，胰腺癌患者的二线治疗选择有限。目前，多项基于伊立替康脂质体的二线治疗方案正在探索中。 2024 ESMO大会公布的一项Ⅱ期研究显示[7]，伊立替康脂质体联合替吉奥（S-1）用于一线含吉西他滨化疗失败的患者，中位OS为10.3个月，中位PFS为5.7个月，ORR为20.4%，DCR为79.6%，且安全性可控，表现显著的临床获益，同时S-1作为一种口服氟尿嘧啶类药物，可以替代静脉滴注，减轻患者的住院负担和不便。 2024 ESMO大会公布的另一项Ⅰ/Ⅱ期研究进一步比较了伊立替康脂质体联合S-1与联合5-FU/LV二线治疗吉西他滨化疗后的晚期胰腺癌患者的疗效。结果显示[8]，S-1组对比5-FU/LV组在OS方面具有获益趋势，且不良反应发生率更低。因此，当前伊立替康脂质体联合氟尿嘧啶/亚叶酸方案仍是最佳选择，其他联合方案仍需进一步探索。曙光初现，靶向治疗迎来“破局” 目前，胰腺癌最主要的四个驱动基因突变包括KRAS、TP53、SMAD4和CDKN2A已被证实在众多胰腺癌患者中存在突变。长期以来，KRAS一直被认为是不可成药靶点。但近年来越来越多的靶向药物及方案在胰腺癌临床研究显示出希望。 KRAS 2024 ASCO GI大会公布了KRAS G12C抑制剂glecirasib在胰腺癌和其他实体肿瘤患者中的初步活性和安全性结果。数据显示[9]，在28例胰腺癌患者中，ORR为46.4%，DCR为96.4%，中位DOR为4.1个月，中位PFS为5.5个月。安全性方面，患者耐受性良好，不良事件可控，未出现因治疗相关不良事件导致的死亡或治疗终止。针对KRAS G12D突变的药物研究也取得了初步成果。2023 ESMO大会公布了KRAS G12D抑制剂HRS-4642的Ⅰ期临床研究数据，其中1例胰腺癌患者获益显著[10]。此外，后续，Ⅰ/Ⅰb期RMC-9805-001研究结果显示[11]，新型口服KRAS G12D选择性共价抑制剂RMC-9805在KRAS G12D突变胰腺癌患者的后线治疗中ORR为30%，DCR为80%（图2）。尽管这些结果来自早期临床研究，但未来对其后续研究结果充满期待。图2. RMC-9805-001研究结果 RAS 同样，针对泛RAS抑制剂的研究也显示出潜力。Ⅰb期临床研究数据显示[12]，泛RAS抑制剂RMC-6236单药二线治疗KRAS G12X或任何RAS突变胰腺癌患者中位PFS分别为8.5个月和7.6个月，中位OS均为14.5个月，且安全性良好。目前，RMC-6236的Ⅲ期研究正在筹备中，未来值得期待。 HER2 HER2靶向ADC药物在胰腺癌领域的研究也备受关注。2024 ASCO大会公布的Ⅱ期DESTINY-PanTumor02研究显示[13]，胰腺癌患者的ORR为4.0%，中位PFS为3.2个月，这表明T-DXd在HER2表达的胰腺癌患者中显示出一定的抗肿瘤活性，但因纳入人群有限，特别是在IHC 3+组中，所以其疗效仍需进一步验证。 CLDN18.2 CLDN18.2是潜在的胰腺癌治疗靶点。2024 ASCO大会公布了一项Ⅰ期临床研究中抗CLDN18.2/CD3双特异性抗体IBI389在晚期胰腺癌患者中的安全性和有效性初步结果[14]。数据显示，在27例胰腺癌患者中，ORR为29.6%，DCR为70.4%，且安全性可控。这一结果为CLDN18.2靶点在胰腺癌中的应用提供了新的方向。此外，另一款针对CLDN18.2靶点的ADC药物ATG-022也正在临床研究中[15]，目前尚未有后续数据公布。创新引领，解锁免疫治疗新策略 2024年The Lancet Oncology首次公布Ⅰ/Ⅱa期LOKON001研究第1组的结果显示[16]，溶瘤腺病毒LOAd703+白蛋白结合型紫杉醇+吉西他滨用于既往治疗或未接受过治疗的不可切除或转移性胰腺癌患者，ORR为44%。不良反应多为1~2级，整体安全性良好。这一研究为溶瘤病毒联合化疗的临床应用提供了初步证据。 2024年Nature Medicine发表的一项Ⅰ期研究评估了新型淋巴结靶向性mKRAS特异性两亲疫苗ELI-002 2P在胰腺癌和结直肠癌患者中的安全性、耐受性、推荐的Ⅱ期剂量（RP2D）以及初步的抗肿瘤活性[17]。数据显示，中位无复发生存期（RFS）为16.3个月（图3），中位OS为16.3个月（图4）。研究结果证明了ELI-002 2P疫苗在治疗KRAS突变型肿瘤中的安全性和免疫原性，且可有效缓解结直肠癌和胰腺癌患者的肿瘤复发，增加患者生存率。这些结果为KRAS突变肿瘤的免疫治疗提供了新的策略，并为未来的Ⅱ期研究奠定了基础。图3. RFS获益结果图4. OS获益结果攻坚克难，齐心探索结硕果胰腺癌术后复发率高达70%以上，如何早期发现复发并采取干预措施是临床上的重大挑战。对此李恩孝教授所在团队通过基于循环肿瘤DNA（ctDNA）的微小残留病灶（MRD）检测对胰腺癌患者展开了前瞻性研究，通过ctDNA动态监测用于患者术前和术后的风险分层和指导疾病监测及辅助治疗决策。同时，李恩孝教授所在团队针对局部晚期胰腺癌患者开展了一项Ⅱ期临床研究，旨在探索索凡替尼联合AG方案用于此类患者转化治疗的疗效和安全性。目前，初步研究结果已在2024美国胰腺大会和欧洲胰腺大会等国际会议上以壁报形式发表。数据显示，截至2024年12月共纳入25例患者，其中24例可评估患者的ORR为45%，DCR为87.5%，83%患者实现了肿瘤退缩。在完成术前治疗的20例患者中65%达到切除标准，40%实现了R0切除，安全性总体可控。目前，PFS和OS等长期指标仍在随访中，研究结果值得期待。任重道远，未来曙光在前胰腺癌的治疗仍然面临诸多挑战，但近年来在靶向治疗、免疫治疗和细胞治疗等领域的研究进展为我们带来了新的希望。未来可从以下几个方面进一步突破：第一，通过基础研究深入探索包括NTRK、ROS1、SMAD4、BRCA、BRAF、KRAS等关键驱动基因的可成药性是关键。第二，探索联合治疗策略是提升疗效的重要方向。需进一步优化基于细胞毒性药物的联合治疗方案，如索凡替尼联合AG方案在转化治疗中已显示出潜力。第三，免疫治疗仍然是未来研究的重要方向。其中溶瘤病毒和癌症疫苗等新策略可为克服“免疫荒漠”胰腺癌提供新的思路。胰腺癌的治疗之路任重道远，期待未来更多研究成果的涌现，为患者带来新的希望。参考文献（上下滑动可查看） [1] Siegel RL, Miller KD, Fuchs HE, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. [2] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), Pancreatic Adenocarcinoma, Version 1.2025, November 20, 2024. [3] Thomas J. Georgel, et al. ASCO GI 2024. Poster 655. [4] Wainberg ZA, et al. Lancet. 2023;402(10409):1272-81. [5] 2024 ASCO. Abstract 4136. [6] 2024 ASCO. Abstract 4003. [7] Hiroshi Imaoka, et al. 2024 ESMO 1521P. [8] Anne M. Gehrels, et al. 2024 ESMO LBA63 [9] 2024 ASCO GI.Abstract：604. [10] 2023 ESMO. Abstract LBA33. [11] Revolution Medicines Presents Initial Data from RMC-9805 Monotherapy Study in Patients with Advanced Pancreatic Ductal Adenocarcinoma. Retrieved October 25, 2024 from https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-presents-initial-data-rmc-9805-monotherapy. [12]https://www.globenewswire.com/en/news-release/2024/10/23/2967583/0/en/Revolution-Medicines-Presents-Updated-Data-from-RMC-6236-Monotherapy-Study-in-Patients-with-Advanced-Pancreatic-Ductal-Adenocarcinoma.html. [13] Meric-Bernstam F, et al.J Clin Oncol. 2024;42(1):47-58. [14] Musher, Benjamin L et al. The Lancet Oncology. 2024; 25(4):488 - 500. [15] Pant S, et al. Nat Med. 2024;30(2):531-542. [16] 2024 ASCO. Abstract 4011. [17] 2024 ASCO. Abstract 2526. （来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

ASCO会议CSCO会议临床结果

2025-01-21

·癌度

《癌度早报2025年1月21日》

一、新药快讯 1、塔戈利单抗新适应症获批，用于一线治疗鼻咽癌 2025年1月20日，药监局官方网站数据显示，PD-L1抑制剂塔戈利单抗获批新的适应症，用于联合吉西他滨和顺铂一线治疗复发性或转移性鼻咽癌。本次获批是基于一项三期临床试验，相比化疗，塔戈利单抗联合化疗一线治疗鼻咽癌让疾病进展或死亡风险降低了53%，治疗应答率也获得了提升，中位总生存时间也获得了相应的延长。 2、94%胰腺癌患者病情获得有效控制，新型融瘤病毒疗法获得快速通道认证近日，一款名为LOAd703的新型融瘤病毒疗法获得快速通道认定，用于治疗胰腺癌。在临床前模型中，这款融瘤病毒能选择性裂解癌细胞，激活细胞毒性T细胞并诱导肿瘤消退。在相应的人体临床试验中，这款融瘤病毒用于18名可评估疗效的患者，44%的患者病灶缩小超过30%，94%的患者病情获得控制。 3、口服免疫肿瘤学候选药物R-5780获批开展临床试验近日，美国食品药品监督管理局FDA已经接受R-5780开展临床试验新药申请，这是一款口服抗癌药，能够利用肠道调节的免疫通路增强免疫系统对癌细胞的攻击能力，研究表明，R-5780能够增强免疫检查点抑制剂的治疗效果。目前这款药的临床试验针对的是晚期黑色素瘤、基底细胞癌或鳞状细胞癌。不管之前是否使用过免疫治疗。二、新药快讯 1、前列腺癌疫苗新进展，80%患者病情获得有效控制基于最近的一项临床试验，一款名为Poly-ICLC的个性化癌症疫苗治疗获得了非常积极的初步疗效，患者的耐受性也良好。这款疫苗可以直接注射到肿瘤部位或注射到肌肉，协助患者的免疫系统对抗癌细胞。10名患者中的8名在随访一年的时间里，前列腺特异性抗原PSA低于参考值，也就是大多数患者用药后病情获得了有效控制。目前围绕这款疫苗还有多项临床试验开展。

临床3期快速通道疫苗免疫疗法

2023-01-02

·PRNewswire

Propulsion of Pancreatic Cancer Pipeline as Novel and Extensive 170+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of pancreatic cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Pancreatic Cancer drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Eli Lilly and Company, CARsgen Therapeutics, and several others. LAS VEGAS, Jan. 2, 2023 /PRNewswire/ -- DelveInsight's ' Pancreatic Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline pancreatic cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the pancreatic cancer pipeline domain. Key Takeaways from the Pancreatic Cancer Pipeline Report DelveInsight's pancreatic cancer pipeline report depicts a robust space with 150+ active players working to develop 170+ pipeline therapies for pancreatic cancer treatment. Key pancreatic cancer companies such as FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc.Amgen, Biomea Fusion, and others are evaluating pancreatic cancer drugs to improve the treatment landscape. Promising pancreatic cancer pipeline therapies in various stages of development include Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72, PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. In December 2022, Targovax ASA announced that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy. In December 2022, Bluestar Genomics, Inc. announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics' proprietary epigenomic methods for the detection of the disease. In December 2022, iOnctura BV, a clinical-stage biotech developing novel cancer therapies, had been granted €17.5 million ($18.6 million) funding from the European Investment Council's (EIC) accelerator program to develop IOA-289 for pancreatic cancer.The EIC's funding consists of a grant of €2.5 million ($2.7 million) and €15 million ($16 million) of equity investment. In December 2022, In the Phase I/II CodeBreaK 100 trial, the KRAS G12C inhibitor sotorasib achieved meaningful anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer, according to researchers at The University of Texas MD Anderson Cancer Center. The results of the trial, published in the The New England Journal of Medicine, indicate an objective response rate of 21.1% and a median time-to-response of 1.5 months, with 84% of patients experiencing disease control. Median progression-free survival was 4 months, and overall survival was 6.9 months. In December 2022, Oncolytics Biotech® Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation. In December 2022, RemeGen Co., Ltd. announced that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been granted ODD twice for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Panbela Therapeutics, Inc. announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela's application for orphan designation of ivospemin ( SBP-101) in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA). In September 2022, Qualigen Therapeutics, Inc. announced the presentation of two posters on QN-302 at the AACR 8th Special Conference on Pancreatic Cancer. The data presented include information on the compound's safety, tolerability, and efficacy in a pancreatic cancer model. The poster included preclinical toxicology data that showed QN-302 does not produce adverse toxicological reactions in mouse models at therapeutic doses. In in vitro tests, QN-302 inhibits acetylcholinesterase (AChE) by 53% and muscarinic receptor (M2) by 70% at 1 µM. Request a sample and discover the recent advances in pancreatic cancer drugs @ Pancreatic Cancer Pipeline Report The pancreatic cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage pancreatic cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the pancreatic cancer clinical trial landscape. Pancreatic Cancer Overview Pancreatic cancer develops in the pancreas tissues, an abdomen organ located behind the stomach's bottom portion. The pancreas secretes hormones that help control blood sugar and enzymes that aid digestion. Pancreatic cancer is a condition in which malignant (cancer) cells develop in pancreatic tissues. The pancreas can develop tumors in various ways, including malignant and noncancerous tumors. However, the precise causes of pancreatic cancer are unknown. Individuals diagnosed with pancreatic cancer before the tumor develops or spreads have an average life expectancy of pancreatic cancer of 3 to 3.5 years. Pancreatic cancer symptoms may include jaundice, dark urine, weight loss, loss of appetite, fatigue, and others. A pancreatic cancer diagnosis is difficult because symptoms are frequently confused with those of other disorders, such as irritable bowel syndrome. The extent of the cancer determines the treatment of pancreatic cancer options. Pancreatic cancer treatment options may include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Learn more about the diseases and pancreatic cancer diet @ Pancreatic Cancer Tests A snapshot of the Pancreatic Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging pancreatic cancer treatment options @ Pancreatic Cancer Clinical Trials Pancreatic Cancer Therapeutics Assessment The pancreatic cancer pipeline report proffers an integral view of pancreatic cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Pancreatic Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Oral, Parenteral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine Therapeutics Assessment By Mechanism of Action: Connective tissue growth factor inhibitors, Poly(ADP-ribose) polymerase 1 inhibitors, Poly(ADP-ribose) polymerase 2 inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Growth differentiation factor 15 inhibitors, Endothelin B receptor antagonists, Image enhancers Key Pancreatic Cancer Companies: FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc., Amgen, Biomea Fusion, and others. Key Pancreatic Cancer Pipeline Therapies: Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72,PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. Dive deep into rich insights for pancreatic cancer research; visit @ New Treatment for Pancreatic Cancer Table of Contents For further information on pancreatic cancer prevention, reach out @ Pancreatic Cancer Drug Treatment Related Reports Pancreatic Cancer Epidemiology Pancreatic Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted pancreatic cancer epidemiology in the 7MM. Pancreatic Cancer Market Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Advanced Pancreatic Cancer Market Advanced Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key advanced pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, among others. Advanced Pancreatic Cancer Pipeline Advanced Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Metastatic Pancreatic Cancer Market Metastatic Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Metastatic Pancreatic Cancer Pipeline Metastatic Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

快速通道孤儿药临床结果免疫疗法

100 项与 Delolimogene mupadenorepvec 相关的药物交易

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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
黑色素瘤	临床2期	美国	Lokon Pharma AB	2020-01-28
黑色素瘤	临床2期	瑞典	Lokon Pharma AB	2020-01-28
结直肠癌	临床2期	瑞典	Lokon Pharma AB	2018-03-01
卵巢癌	临床2期	瑞典	Lokon Pharma AB	2018-03-01
胰腺腺癌	临床2期	瑞典	Lokon Pharma AB	2018-03-01
不能切除的胆道癌	临床2期	瑞典	Lokon Pharma AB	2018-03-01
胆道癌	临床2期	瑞典	Lokon Pharma AB	2018-03-01
胰腺癌	临床2期	美国	Lokon Pharma AB	2016-11-01
胰腺导管腺癌	临床2期	美国	Lokon Pharma AB	2016-11-01
多发性骨髓瘤	临床前	瑞典	Lokon Pharma AB	2019-08-15

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临床结果

适应症

分期

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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


NCT03225989 (ESMO2024) 人工标引	临床1/2期	晚期恶性实体瘤	41	LOAd703 with standard of care chemotherapy	願積淵製選鑰淵構簾襯(艱餘艱廠壓壓鏇廠蓋顧) = associated with LOAd703 and related procedures were overall transient and of grade 1-2. The most frequent adverse events were pyrexia (76%), chills (39%), and fatigue (34%). However, three patients developed nephrotoxicity possibly related to LOAd703. 衊衊遞願衊壓餘艱壓繭 (齋壓鬱選積鹽壓襯鏇願 )	积极	2024-09-13
NCT04123470 (LOKON003, ESMO2024) 人工标引	临床1/2期	黑色素瘤	24	LOAd703ectoratezolizumab (LOAd703 (1x10^11 VP))	選願遞糧鏇網範遞鏇壓(窪廠鏇簾願糧網壓遞憲) = Most common adverse events with suspected relationship to LOAd703 were pyrexia (n=14 patients), vomiting (n=5), and chills (n=5). 積蓋鏇遞鏇廠襯遞膚遞 (積鹽淵製鏇艱製遞獵壓 ) 更多	积极	2024-09-13
NCT04123470 (LOKON003, ESMO2024) 人工标引	临床1/2期	黑色素瘤	24	LOAd703ectoratezolizumab (LOAd703 (5x10^11 VP))		积极	2024-09-13
NCT02705196 (LOKON001, Pubmed)	临床1/2期	不能切除性胰腺癌	22	LOAd703	艱廠夢鹹網觸憲糧餘鹽(鏇繭艱網網顧鹹積構餘) = 齋窪憲遞遞鬱醖壓繭遞構夢積鹽膚鹹獵糧積醖 (範憲憲製鏇顧選鑰鹽廠 ) 更多	积极	2024-04-01
NCT03225989 (LOKON002, AACR2023) 人工标引	临床1/2期	晚期恶性实体瘤	28	LOAd703	簾醖構壓膚遞觸築艱顧(襯糧選餘鹽夢齋蓋餘選) = 醖鏇淵淵糧膚壓糧淵窪餘網壓艱構鏇築餘積選 (襯範鑰糧網艱鹹鏇觸醖 ) 更多	积极	2023-04-14
NCT02705196 (ASCO2022) 人工标引	临床1/2期	胰腺癌	22	LOAd703+nab-paclitaxel+gemcitabine	構蓋構衊鬱選範鬱範糧(醖窪鹹膚觸餘鹹艱顧遞) = 範繭鏇艱窪夢膚觸顧願壓鹹糧齋獵壓艱範選餘 (構壓齋顧鏇醖餘廠遞製 ) 更多	积极	2022-06-02