GBM AGILE: Global Adaptive Trial Master Protocol: an International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent GBM

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

开始日期2019-07-30

申办/合作机构

朴莱雷斯集团

[+5]

NCT03364400 / Active, not recruiting临床1期

A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors

This study is an an open-label Phase I trial of VT1021 in patients with advanced solid tumors. Patients must have recurrent or advanced cancer (i.e., solid tumors) for which standard therapy offers no curative potential.

开始日期2017-11-28

申办/合作机构

Vigeo Therapeutics, Inc.

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项与 Vigeo Therapeutics, Inc. 相关的文献（医药）

2023-06-01·Journal of Clinical Oncology

Immune profiling in patients with glioblastoma treated with VT1021 in a phase I/II expansion study.

作者: Watnick, Randolph ; Fyfe, Susanne ; Watnick, Jing ; Vincent, Melanie ; Li, Wendy ; Peereboom, David M. ; Wang, Suming ; Chen, Jian Jennifer ; Mahoney, James ; Cieslewicz, Michael

2021 Background: The cyclic peptide VT1021 is a first-in-class therapeutic agent that has been shown to inhibit tumor growth via stimulation of thrombospondin-1 (TSP-1) and reprogramming the immune tumor microenvironment (TME) in preclinical models. Subsequently, VT1021 has been tested in a phase I/II clinical study in solid tumors (NCT03364400) and has advanced to a phase II/III clinical study in glioblastoma (NCT03970447). VT1021 has demonstrated promising single-agent clinical activity against recurrent glioblastoma (rGBM) in a phase I/II expansion study. Among 22 evaluable subjects with rGBM, 3 had complete response (CR), 1 had partial response (PR), and 6 had stable disease (SD) with an average study duration of over 120 days. One subject has been on VT1021 treatment for > 900 days with no measurable lesion left. The overall disease control rate (DCR) was 45%. Here, we sought to examine the peripheral immune cell profile(s) in response to VT1021 and explore the association between these profiles and clinical responses in rGBM subjects. Methods: In the phase I/II expansion study, 22 evaluable rGBM subjects received VT1021 at a dose of 11.8 mg/kg (twice per week intravenously) until disease progression. Peripheral blood samples were collected from all evaluable subjects; immune cell profiles were analyzed by flow cytometry. Results: The immune profiles following VT1021 treatment on day 1 did not vary significantly among rGBM subjects, regardless of response. Intriguingly, after long-term VT1021 treatment (day 53), our analysis of the immune profiles revealed beneficial and sustained changes in three cytotoxic T Cell (CTL) parameters and PD-L1+ MDSCs that correlated with response. Specifically, CR/PR subjects showed a 20% increase in total CTLs (Pre 33.79% vs. 6hr 40.42%), a 66% increase in proliferating CTLs (Pre 1.37% vs. 6hr 2.28%) and a 63% increase in CTL/Treg ratio (Pre 7.85 vs. 6hr 12.81) on day 53 of VT1021 treatment. In contrast, SD and PD subjects exhibited no change or decrease in these three CTL parameters, respectively. We also observed that CR/PR subjects experienced a sustained decrease in PD-L1+ MDSCs after VT1021 treatment (day 1 Pre 95.96% vs. day 53 Pre 92.66% and day 53 6hr 88.06%). Conversely, the sustained decrease of PD-L1+ MDSCs after VT1021 treatment was not observed in SD and PD subjects. Conclusions: Here we report that the durable responses of peripheral immune cells to VT1021 may be associated with better clinical outcomes in rGBM subjects. These findings are consistent with the MOA of TSP-1 to reprogram the TME by stimulating immune and inflammatory cell functions. While the interpretation of our data is limited by the lack of a control arm and the small sample size, the results provide a signal and warrant continued analysis of these parameters in the ongoing phase II/III trial.

2019-05-20·Journal of Clinical Oncology

A phase I open label study evaluating VT1021 in patients with advanced solid tumors.

作者: Moore, Kathleen N. ; Guttendorf, Robert ; Berk, Gregory Ivan ; Patnaik, Amita ; Watnick, Jing ; Liu, Joyce F. ; Harb, Wael A. ; Patel, Manish R. ; Zheng, Lei ; Wang, Suming ; Bullock, Andrea J. ; Kerstein, Kathy ; Juric, Dejan ; Mahalingam, Devalingam ; Cieslewicz, Michael

TPS3158 Background: VT1021 is a cyclic pentapeptide that functions as a potent inducer of thrombospondin-1 (Tsp-1) expression in the tumor microenvironment (TME). By triggering the production of Tsp-1, VT1021 reprograms the TME from one that is immune-suppressive and tumor-promoting, to one that activates the adaptive immune system and is tumor-inhibiting. Tsp-1 reprograms the TME to: (i) induce apoptosis in tumor cells that express CD36 on their cell surface, (ii) convert macrophages from M2 to M1 polarization, which promotes phagocytosis and blunts immunosuppression and (iii) inhibit angiogenesis. Preclinical studies have shown robust anti-tumor activities of VT1021 in animal models of ovarian, pancreatic and breast cancer, including complete tumor regression and reprogramming of the immune TME. These observations led to the initiation of the first-in-human study of VT1021. Methods: This study is a first-in-human, Phase 1, open-label, multicenter, dose escalation (Part 1) study with dose expansion (Part 2) in advanced solid tumors. The primary objectives are to assess the safety and tolerability of VT1021, to assess dose-limiting toxicities (DLT), and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Secondary objectives include the evaluation of pharmacokinetics (PK) and pharmacodynamic (PD) effects of VT1021 in tumor and tumor microenvironment, and assessment of preliminary antitumor activity. VT1021 is administered intravenously twice weekly. DLTs will be assessed in the first cycle (Days 1-28) of the dose escalation cohort and are defined as grade 3 adverse events related to VT1021. In Part 1 of the study, 24-30 patients will be enrolled to determine the MTD and RP2D for expansion. In Part 2 of the study, 80-100 patients will be enrolled, grouped into cohorts based on disease subtypes (ovarian, pancreatic, Triple-negative breast cancers, and glioblastoma). Blood samples and biopsy samples from patients will be collected to assess PK properties and PD responses systemically as well as in the TME. No formal statistical hypothesis testing will be conducted in this study. This study is currently open for enrollment in the US. Clinical trial information: NCT03364400.

Assessing CD36 and CD47 expression levels in solid tumor indications to stratify patients for VT1021 treatment

作者: Cieslewicz, Michael ; Watnick, Jing ; Watnick, Randolph ; Zota, Victor ; Vincent, Melanie ; WANG, SUMING ; Chen, Jian ; Clossey, Donna ; Mahoney, James

Abstract

Cancer is one of the leading causes of death worldwide. While there are a multitude of cancer treatments, both approved and in clinical trials, there is still a critical need for therapies that are developed for more targeted populations. Despite the development of novel cancer biomarkers and target therapies currently in use, most cancer patients do not have a specific biomarker directly associated with effective treatment options. We have developed VT1021, a cyclic peptide that induces the expression of thrombospondin-1 (TSP-1) in myeloid derived suppressor cells (MDSCs) recruited to the tumor microenvironment (TME). TSP-1 reprograms the TME via binding to CD36 and CD47 to induce tumor and endothelial cell apoptosis as well as reprogramming of the tumor immune microenvironment (TIME). VT1021 has finished a Phase I trial and is currently being tested in a Phase II/III clinical study in glioblastoma (GBM). In this report, we analyzed the expression signature of CD36 and CD47, the major receptors for TSP-1, in patients' tumor cells from the VT1021 Phase I trial and identified that this signature could be used to stratify patients and predict response to VT1021 treatment. We also found that CD36 and CD47 were elevated in multiple solid tumor indications through tissue microarray (TMA), providing further evidence to support using CD36 and CD47 as biomarkers in other types of cancer. Finally, we validated the CD36 and CD47 expression signatures, using annotated clinical data from the National Cancer Institute (NCI) Genomic Data Commons (GDC) Data Portal. Our studies identified CD36 and CD47 as dual biomarkers that can be used as patient stratifying tools and prognostic biomarkers for multiple cancer indications. Patients with dual high levels of CD36 and CD47 expression in tumor cells would benefit the most from the VT1021 treatment.

项与 Vigeo Therapeutics, Inc. 相关的新闻（医药）

2023-07-13

·BioSpace

Vigeo Therapeutics Provides Clinical Update on VT1021 Treatment of GBM Expansion Patient

CAMBRIDGE, Mass., July 13, 2023 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, is pleased to announce that a complete response patient (CR) in Glioblastoma (GBM) cohort from first in human study VT1021-01 (NCT03364400) has now completed 3 full years of dosing with VT1021. When joining the study in July of 2020 the patient had a recurrent case of GBM. After multiple cycles of dosing with VT1021, the tumor was no longer detectable. Now, after 3 years of dosing the tumor continues to be undetectable on regular MRI scans. "The Vigeo Team continues to be encouraged at how well this patient has responded to VT1021 therapy" said Jing Watnick, COO of Vigeo Therapeutics, "Vigeo is currently testing the potential of VT1021 therapy in both newly diagnosed and recurrent GBM patients as part of an ongoing phase II/III clinical study (NCT03970447)." VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 blocks the CD47 immune checkpoint and engages CD36 to induce tumor cell apoptosis, inhibit angiogenesis, activate cytotoxic T cells (CTL), and reprogram macrophages from the M2 to M1 phenotype. Vigeo recently reported the outcome of a GBM cohort of recurrent subjects treated with VT1021 as a single agent in which a group of 22 evaluable subjects with rGBM, 3 had a complete response (CR), 1 had a partial response (PR), and 6 had stable disease (SD) with an average study duration of over 120 days. Historically, rGBM patients have a response rate of less than 5% and a median progression free survival of 48 days. About VT1021 Vigeo's lead asset, VT1021, is a first-in-class dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis in tumors and endothelial cells, and increases the M1:M2 macrophage ratio. VT1021 achieves these biological effects via stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that that are associated with poor response to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are more susceptible to attack from the body's immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. About Vigeo Therapeutics Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline being led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. VT1021 has been investigated as a single agent in a Phase I/II clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently undertaking late-stage clinical studies. For more information visit vigeotx.com

免疫疗法临床研究临床结果

2023-06-11

·药明康德

实现90%靶病灶控制的快速生产非病毒CAR-T疗法、明星PROTAC疗法结果亮眼… | 一周盘点

▎药明康德内容团队编辑本期看点1. 强生（Johnson & Johnson）旗下的杨森（Janssen）公司公布用于治疗复发或难治性多发性骨髓瘤的双特异性抗体talquetamab积极长期随访数据，与Darzalex Faspro联用，总缓解率（ORR）超过70%，12个月时的总生存率超过90%。2. 通过气溶胶形式给药的基因疗法4D-710具有治疗囊性纤维化的潜力，在超过90%的肺气道细胞中观察到了靶标蛋白广泛且一致的表达。3. 用于治疗晚期转移性去势抵抗性前列腺癌（mCRPC）的PROTAC蛋白降解剂ARV-766早期临床结果亮眼。4. Allogene Therapeutics公司公布CAR-T细胞疗法ALLO-501A的早期临床新数据，2名复发性/难治性大B细胞淋巴瘤患者已维持完全缓解（CR）超过30个月。5. 耐化疗的转基因自体γδT细胞疗法INB-200用于治疗新诊断的多形性胶质母细胞瘤，在早期研究中使100%患者的中位无进展生存期（PFS）超过了历史上此类患者的中位PFS。6. 能够在非病毒基因递送后实现隔天回输的UltraCAR-T细胞疗法PRGN-3005公布积极早期数据，在中位治疗线数≥8线晚期铂类耐药卵巢癌患者中，90%的单个靶病灶稳定或达到了部分缓解（PR）。药明康德内容团队整理Talquetamab：公布1/2期临床试验的长期随访数据杨森公司公布了其双特异性抗体talquetamab用于治疗复发或难治性多发性骨髓瘤的关键临床试验的积极长期随访数据。Talquetamab是一款在研、皮下注射、潜在“first-in-class”的双特异性抗体，同时靶向GPRC5D与CD3分子。其中GPRC5D是表达在多发性骨髓瘤细胞上的靶标，其表达不会随着时间而减少，而CD3则是T细胞受体，与活化T细胞有关。2022年12月，杨森公司向美国FDA递交了talquetamab的生物制品许可申请（BLA）。此次公布的数据显示，talquetamab单药或与Darzalex Faspro联用，在多发性骨髓瘤患者中均展现出良好的安全性和有效性。在talquetamab单药研究中，两种剂量的ORR相似。中位随访时间为12.7个月时，0.8 mg/kg每两周一次（Q2W）剂量组的ORR为71.7%，60.7%的患者达到了非常好的部分缓解（VGPR），CR率为9%，12个月时的总生存率为77.4%，无进展生存率为54.4%。中位随访时间为18.8个月时，0.4 mg/kg每周一次（QW）剂量组的ORR为74.1%，59.4%的患者达到了VGPR或更好，CR率为9.8%，12个月时的总生存率为76.4%，无进展生存率为34.9%。在talquetamab联用Darzalex Faspro的研究中，中位随访时间为15个月时，0.8 mg/kg Q2W剂量组的ORR为84%，74%的患者达到了VGPR或更好，CR率为16%，12个月时的总生存率为91.5%，无进展生存率为67.4%。中位随访时间为16.8个月时，0.4 mg/kg QW剂量组的ORR为71.4%，57.1%的患者达到了VGPR或更好，CR率为14.3%，12个月时的总生存率为92.3%，无进展生存率为77.4%。此外，talquetamab的安全性在临床上是可控的，在长期随访中没有观察到新的安全信号。4D-710：公布1/2期临床试验的新数据4D Molecular Therapeutics公司公布了其基因疗法4D-710治疗肺囊性纤维化的1/2期临床试验的新数据。4D-710是一种由治疗性载体A101和优化的CFTR∆R转基因组成的候选疗法。A101载体能够通过气溶胶形式把疗法递送至整个肺部，在气道细胞中实现高效的基因转导和基因表达，且对人类预先存在的抗体具有抵抗力。此次公布的数据显示，3名不符合或不耐受现有CFTR调节剂的肺囊性纤维化患者的生活质量都有显著的改善，肺功能稳定或得到了改善。支气管镜样本结果显示，CFTR蛋白在92-99%的肺气道细胞中被广泛且一致地表达，其水平明显高于用于对照的正常肺组织样本。ARV-766：公布1/2期临床试验的中期数据Arvinas公司公布了其在研PROTAC蛋白降解剂ARV-766用于治疗晚期mCRPC的1/2期临床试验的积极结果。ARV-766旨在降解雄激素受体（AR）的所有临床相关耐药驱动点突变，包括L702H——一种与阿比特龙和其他AR通路新型激素药物（NHA）耐药相关的突变。此次公布的数据显示，ARV-766耐受性良好，并且在接受过多线治疗、NHA治疗后、所有患者群体中显示出潜在疗效，42%的AR配体结合域（LBD）突变患者实现了前列腺特异性抗原（PSA）减少≥50%（PSA50），在AR L702H突变患者中，60%（3/5）达到了PSA50，在同时发生T878/H875/L702突变的患者中，所有3名患者均达到了PSA50。在4名可评估的AR LBD突变患者中，1名达到确认的PR，1名达到未确认的PR。ALLO-501A：公布1期临床试验的新数据Allogene Therapeutics公司公布了其在研“现货型”CAR-T疗法ALLO-501A的1期临床试验的新数据。ALL-501A是一种经基因工程改造、靶向CD19的AlloCAR-T产品。ALLO-501A通过TALEN基因编辑技术破坏TRAC与CD52基因，以减少移植物抗宿主疾病（GvHD）产生的风险。此外，经由基因工程改造的ALL-501A也让病患得以使用ALLO-647进行辅助治疗。ALLO-647是一种抗CD52的单克隆抗体，可以协助病患进行选择性与暂时性的宿主淋巴细胞清除，以在病患体内建立一个更有利于ALL-501A细胞生长的免疫环境。此前，美国FDA授予ALL-501A再生医学先进疗法认定（RMAT），用于治疗复发性/难治性大B细胞淋巴瘤。截至2023年4月20日，使用单剂量ALL-501A联用FCA90淋巴细胞去除方案（氟达拉滨/环磷酰胺/90 mg ALLO-647）的复发性/难治性大B细胞淋巴瘤患者的ORR为67%（8/12），CR率为58%（7/12），6个月时的CR率为42%，2名患者已保持CR超过30个月，1名患者已保持CR超过24个月。安全性方面，未观察到剂量限制毒性（DLT），免疫效应细胞相关神经毒性综合征（ICANS）或移植物抗宿主病。INB-200：公布1期临床试验数据IN8bio公司公布其耐化疗的转基因自体γδT细胞疗法INB-200用于治疗新诊断的多形性胶质母细胞瘤的积极早期数据。INB-200是一种强大的协同治疗方法，能在患者接受化疗时持续存在，并保持其识别、参与和杀死癌细胞的自然能力。此次公布的结果显示，100%（8/8）接受INB-200治疗的患者已超过历史上此类患者的中位PFS，2名接受3剂INB-200的患者已分别保持23.5个月和19.4个月的疾病无进展。此外，INB-200继续表现出可控的安全性，重复给药没有导致毒性特征的变化。PRGN-3005：公布1b期临床试验数据Precigen公司公布了其在研UltraCAR-T细胞疗法PRGN-3005在晚期铂类耐药卵巢癌患者中的安全性和有效性结果。PRGN-3005是利用Precigen的变革性UltraCAR-T治疗平台所开发，一种使用非病毒基因递送系统制造的自体CAR-T细胞疗法，该系统共表达嵌合抗原受体、膜结合白细胞介素-15（mbIL15）和终止开关，使PRGN-3005具有更好的精度和控制。此外，UltraCAR-T平台无需离体扩增缩短了制造时间，使PRGN-3005能够在非病毒基因递送后实现隔天回输。此次公布的结果显示，在中位治疗线数≥8线的晚期（III/IV）复发性铂耐药卵巢癌、输卵管癌和原发性腹膜癌患者中，接受静脉输注PRGN-3005前进行清淋治疗（lymphodepletion）的策略显示出积极的疗效信号，67%（6/9）患者的肿瘤负荷降低，第35天时，89%（8/9）的患者的CA125有降低，90%的单个靶病灶稳定或达到了PR。此外，PRGN-3005耐受性良好，治疗相关不良事件发生率低，无剂量限制性毒性，无神经毒性，细胞因子释放综合征不超过2级。SNK01：公布1/2a期临床试验数据NKGen Biotech公司公布了其自体自然杀伤细胞（NK）细胞疗法SNK4联用化疗治疗非小细胞肺癌（NSCLC）的积极数据。该试验中的患者在接受过酪氨酸激酶抑制剂后进展，均为肺腺癌患者。该研究中，ORR为25%（3/12），疾病控制率（DCR）为100%，其中35%为PR，75%为疾病稳定（SD），中位PFS为143天。DF1001：公布1期临床试验数据Dragonfly Therapeutics公司公布了其潜在“first-in-class”的三特异性NK细胞接合疗法（TriNKET）DF1001用于治疗晚期实体肿瘤的积极早期数据。DF1001靶向HER2，可驱动实体瘤中的先天性和适应性免疫系统的激活。此次公布的结果显示，DF1001已在先前接受过多线（最多达16线）治疗的转移性乳腺癌（MBC），结直肠癌（CRC），NSCLC和胃食管癌患者中表现出抗肿瘤活性。在平均接受过6线治疗的MBC患者（其中大多数为HER2低表达）中，25%达到了临床缓解。AFM24：公布1/2期临床试验的新数据Affimed公司公布了其先天细胞接合剂（innate cell engager，ICE）疗法AFM24用于治疗NSCLC的早期临床结果。该疗法靶向EGFR和CD16A。此次公布的研究结果显示，15名先前接受过多线治疗的患者中有2名达到了PR，5名达到了SD，ORR为13%，DCR为47%。所有SD患者至少维持了3.5个月无进展，其中1名SD患者持续稳定超过了8个月。此外，AFM24单药治疗继续显示出良好的安全性。BNT316/ONC-392：公布1/2期临床试验数据BioNTech公司和OncoC4公司公布了其联合开发的下一代抗CTLA-4单克隆抗体候选药物BNT316/ONC-392的积极早期临床数据。BNT316/ONC-392旨作为一系列实体瘤的单一或联合疗法，目前正处于临床开发的后期阶段。此次公布的数据显示，在27名转移性PD-（L）1耐药的NSCLC患者中，可评估患者的ORR为29.6%，DCR为70.4%，包括1名CR、7名PR和11名SD的患者。该候选疗法具有良好的耐受性，安全性可控。在10名患者（30%）中观察到3-4级的免疫相关不良事件（irAE），这被认为低于类似药物的报告。VT1021：公布1/2期临床试验的新数据Vigeo Therapeutics公司公布了其衍生自PSAP的小分子肽药物VT1021在复发性胶质母细胞瘤患者中的单药活性。VT1021通过与髓源性抑制细胞（MDSC）结合，诱导肿瘤微环境中血栓形成素-1（Tsp-1）的表达。Tsp-1能够阻断CD47免疫检查点并参与CD36诱导肿瘤细胞凋亡，抑制血管生成，激活细胞毒性T细胞（CTL），并把诱导肿瘤生长的M2巨噬细胞重编程为抑制肿瘤生长的M1巨噬细胞。此次公布的结果显示，在22名可评估的患者中，3名达到CR，1名达到PR，6名达到SD，平均研究持续时间超过120天。1名受试者持续接受VT1021治疗，已参与研究近3年，目前没有剩余的可测量病变。从历史上看，这类患者的缓解率低于5%，中位无进展生存期为48天。ATRC-101：公布1b期临床试验数据Atreca公司公布了其靶向肿瘤特异性核糖核蛋白复合物（RNP）的单克隆抗体ATRC-101作为单一疗法，或联用帕博利珠单抗治疗晚期实体瘤患者的1b期临床试验的数据。结果显示，ATRC-101在多种肿瘤类型中观察到临床活性。在高靶点表达的患者中，DCR为59%（10/17)，53%的患者达到SD，6%的患者达到PR。此外，研究人员在这类患者中观察到了更长的PFS。ATRC-101继续保持良好耐受性。IO-202：公布1期临床试验数据Immune-Onc Therapeutics公司公布了其在研抗LILRB4抗体IO-202的早期临床试验数据。该公司此前的研究显示，LILRB4在急性髓系白血病（AML）的免疫抑制和肿瘤浸润中发挥了作用，LILRB4可抑制抗原呈递细胞激活，导致免疫耐受。针对实体瘤的临床前数据表明，IO-202在体外研究中能够增强树突状细胞功能并激活T细胞，且能在体内研究模型中抑制肿瘤生长。在此次针对复发或难治性急性髓系白血病（AML）和慢性髓系单核细胞白血病（CMML）患者的1期试验中，IO-202的耐受性良好，在单药治疗和联合治疗中均表现出令人鼓舞的临床反应。在单药治疗队列中，1名CMML患者表现出超过一年的临床益处，1名AML患者达到了PR。在联合治疗队列中，1名LILRB4表达高的AML患者达到了CR，并持续缓解超过10个月。此外，5名CMML患者中有3名获得了临床益处，包括最佳骨髓缓解（Optimal Marrow Response）。BI-1910：IND申请获得FDA许可BI-1910是BioInvent International公司开发的靶向抗肿瘤坏死因子受体2（TNFR2）的单克隆抗体，IND申请已获得FDA的批准。该候选疗法单药和与帕博利珠单抗联用的1/2a期临床试验将在美国和欧洲展开，首先在肝细胞癌（HCC）和非小细胞肺癌患者中进行探索性的队列研究。PIPE-791：IND申请获得FDA许可PIPE-791是Pipeline Therapeutics公司开发的一种有效的、选择性的、脑渗透性小分子LPA1受体拮抗剂，主要适应症为多发性硬化（MS）。PIPE-791已在体外和体内模型中显示出活性，并在支持IND申请的临床前研究中耐受性良好。该公司有望在2023年下半年开始招募健康受试者。IFx-Hu2.0：公布1b期临床试验数据Morphogenesis公司公布了其新型个体化癌症疫苗IFx-Hu2.0在对免疫检查点抑制剂（ICI）表现出原发耐药的晚期Merkel细胞癌、皮肤鳞状细胞癌患者中的早期临床结果。结果显示，ICI原发耐药的患者在接受IFx-Hu2.0后，有71%（5/7）在再次接受ICI治疗后产生了客观且持久的抗肿瘤反应，并且该候选疗法的安全性良好。ELI-002：公布1期临床试验的中期数据Elicio Therapeutics公司公布了其在研治疗性癌症免疫疗法ELI-002治疗具高复发风险胰腺癌和结直肠癌患者的积极临床试验数据，这些患者携带KRAS G12D和G12R突变。ELI-002由AMP修饰的KRAS突变体（mKRAS）肽段，和一种AMP修饰的免疫刺激寡核苷酸佐剂ELI-004组成，经皮下给药靶向淋巴结。它能产生RAS特异性杀伤性T细胞，以攻击术后残留肿瘤细胞，有望延长癌症患者缓解并可预防未来复发。此疫苗可覆盖99%携带KRAS基因突变的肿瘤。此次公布的数据显示，77%患者的肿瘤生物标志物减少，32%患者的生物标志物实现了完全清除，ELI-002在87%患者中诱发了强有力的mKRAS特异性T细胞反应。安全性方面，ELI-002显示出良好的耐受性，没有剂量限制性毒性或细胞因子释放综合征。大家都在看▲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，填写业务需求信息参考资料（可上下滑动查看）[1] BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO. Retrieved June 5, 2023, from https://www.globenewswire.com/news-release/2023/06/02/2681039/0/en/BioNTech-and-OncoC4-Present-Positive-Phase-1-2-Data-for-Antibody-Candidate-BNT316-ONC-392-in-Hard-to-Treat-NSCLC-at-ASCO.html[2] Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-101, a Conditionally Active VISTA-blocking Antibody, for the Treatment of Advanced Solid Tumors. Retrieved June 5, 2023, from https://investors.senseibio.com/news-releases/news-release-details/sensei-biotherapeutics-announces-first-patient-dosed-phase-12-0[3] Bluejay Therapeutics Advances in Hepatitis B and D Trials: Successfully Completes BJT-778 Phase 1a Study and Begins Phase 1b Trial Enrollment. Retrieved June 5, 2023, from https://bluejaytx.com/bluejay-therapeutics-advances-in-hepatitis-b-and-d-trials-successfully-completes-bjt-778-phase-1a-study-and-begins-phase-1b-trial-enrollment/[4] OnQuality Announces FDA Clearance of IND Application for OQL051, for the Prophylaxis of Chemotherapy-Induced Diarrhea. Retrieved June 5, 2023, from https://www.prnewswire.com/news-releases/onquality-announces-fda-clearance-of-ind-application-for-oql051-for-the-prophylaxis-of-chemotherapy-induced-diarrhea-301844368.html[5] Emergex Announces Positive Phase I Trial Data for DengueTcP™, Its Novel T Cell-Priming Immune Set-Point Candidate. Retrieved June 5, 2023, from https://www.globenewswire.com/news-release/2023/06/06/2683139/0/en/Emergex-Announces-Positive-Phase-I-Trial-Data-for-DengueTcP-Its-Novel-T-Cell-Priming-Immune-Set-Point-Candidate.html[6] ZielBio to Present Interim Findings from its Phase 1/2, First-in-Human Trial of ZB131 at 2023 ASCO Annual Meeting. Retrieved June 5, 2023, from https://www.prnewswire.com/news-releases/zielbio-to-present-interim-findings-from-its-phase-12-first-in-human-trial-of-zb131-at-2023-asco-annual-meeting-301840821.html[7] Panbela Announces Poster Presentation at Immunology of Diabetes Society Meeting:Evaluating the Potential of CPP-1X (Eflornithine) in Recent Onset Type 1 Diabetes. Retrieved June 5, 2023, from https://panbela.com/wp-content/uploads/2023/05/PBLA-PR-IDS-POSTER-PRES-01JUN2023.pdf[8] Treos Bio Announces Presentation of Final Results from Phase 1b Study of PolyPEPI1018 Immunotherapy for Late-Stage Metastatic Colorectal Cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2682035/0/en/Treos-Bio-Announces-Presentation-of-Final-Results-from-Phase-1b-Study-of-PolyPEPI1018-Immunotherapy-for-Late-Stage-Metastatic-Colorectal-Cancer-at-2023-American-Society-of-Clinical.html[9] Oncoinvent Presents 15-Month Safety and Efficacy Data from Ongoing RAD-18-002 Phase 1/2A Trial of Radspherin® in Colorectal Cancer Patients at the 2023 ASCO Annual Meeting. Retrieved June 5, 2023, from https://www.businesswire.com/news/home/20230605005033/en[10] Portage Biotech Reports Updated Interim Data for Lead iNKT Engager, PORT-2, in a Phase 1/2 Trial for the Treatment of Advanced Melanoma and Metastatic Non-Small Cell Lung Cancer at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2681880/0/en/Portage-Biotech-Reports-Updated-Interim-Data-for-Lead-iNKT-Engager-PORT-2-in-a-Phase-1-2-Trial-for-the-Treatment-of-Advanced-Melanoma-and-Metastatic-Non-Small-Cell-Lung-Cancer-at-t.html[11] NexImmune Presents Initial Positive Data from the NEXI-001 Phase 1 Trial for Relapsed/Refractory Post Allo-HSCT AML at the American Society of Clinical Oncology 2023 Annual Meeting. Retrieved June 5, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2681928/0/en/NexImmune-Presents-Initial-Positive-Data-from-the-NEXI-001-Phase-1-Trial-for-Relapsed-Refractory-Post-Allo-HSCT-AML-at-the-American-Society-of-Clinical-Oncology-2023-Annual-Meeting.html[12] Pipeline Therapeutics Receives IND Clearance from FDA to Initiate Phase 1 Study of PIPE-791. Retrieved June 8, 2023, from https://www.businesswire.com/news/home/20230608005323/en[13] Arvinas Announces Interim Data from the ARV-766 Phase 1/2 Dose Escalation and Expansion Trial Showing Promising Signals of Efficacy in Late-line mCRPC, Including in Patients with AR L702H Mutations. Retrieved June 8, 2023, from https://www.globenewswire.com/news-release/2023/06/08/2684609/0/en/Arvinas-Announces-Interim-Data-from-the-ARV-766-Phase-1-2-Dose-Escalation-and-Expansion-Trial-Showing-Promising-Signals-of-Efficacy-in-Late-line-mCRPC-Including-in-Patients-with-AR.html[14] Immune-Onc Therapeutics Presents IO-202 Phase 1 Data in Patients with Relapsed or Refractory AML and CMML at the EHA Annual Meeting 2023. Retrieved June 8, 2023, from https://www.businesswire.com/news/home/20230607005899/en[15] 4DMT Presents Positive Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial in Patients with Cystic Fibrosis at the ECFS 46th Annual Meeting. Retrieved June 8, 2023, from https://ir.4dmoleculartherapeutics.com/news-releases/news-release-details/4dmt-presents-positive-interim-data-aerosolized-4d-710-phase-12[16] Repare Therapeutics Reports Proof of Concept for Lunresertib (RP-6306) in Clinic, Initial Monotherapy Data from Phase 1 MYTHIC Clinical Trial and Early Insights from Ongoing Combination Trials. Retrieved June 8, 2023, from https://www.businesswire.com/news/home/20230607005685/en/[17] BioInvent Announces Additional Efficacy Data from Intravenous Part of Phase 1/2 Trial with BI-1206 in Solid Tumors. Retrieved June 8, 2023, from https://www.accesswire.com/759774/BioInvent-Announces-Additional-Efficacy-Data-from-Intravenous-Part-of-Phase-12-Trial-with-BI-1206-in-Solid-Tumors[18] Oncternal Therapeutics Announces First Patient Dosed in Phase 1/2 Study of ROR1 targeting autologous CAR T, ONCT-808, in patients with relapsed or refractory aggressive B-cell lymphoma. Retrieved June 8, 2023, from https://investor.oncternal.com/news-releases/news-release-details/oncternal-therapeutics-announces-first-patient-dosed-phase-12[19] BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO. Retrieved June 8, 2023, from https://www.globenewswire.com/news-release/2023/06/02/2681039/0/en/BioNTech-and-OncoC4-Present-Positive-Phase-1-2-Data-for-Antibody-Candidate-BNT316-ONC-392-in-Hard-to-Treat-NSCLC-at-ASCO.html[20] Vigeo Therapeutics will present New Clinical and Immune Profiling Data from Ph I/II Expansion study in GBM Patients in ASCO Poster Oral Session. Retrieved June 8, 2023, from https://www.prnewswire.com/news-releases/vigeo-therapeutics-will-present-new-clinical-and-immune-profiling-data-from-ph-iii-expansion-study-in-gbm-patients-in-asco-poster-oral-session-301840335.html[21] Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 8, 2023, from https://ir.replimune.com/news-releases/news-release-details/replimune-presents-rp1-data-ignyte-anti-pd1-failed-melanoma[22] Allogene Therapeutics Presents Updated ALLO-501/501A Phase 1 Data in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 8, 2023, from https://www.globenewswire.com/news-release/2023/06/03/2681518/0/en/Allogene-Therapeutics-Presents-Updated-ALLO-501-501A-Phase-1-Data-in-Large-B-Cell-Lymphoma-at-the-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting.html[23] AFFIMED PRESENTS AFM24 MONOTHERAPY DATA IN NON-SMALL CELL LUNG CANCER AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY AND PROVIDES STRATEGIC UPDATE ON AFM24 DEVELOPMENT PLAN. Retrieved June 8, 2023, from https://www.affimed.com/affimed-presents-afm24-monotherapy-data-in-non-small-cell-lung-cancer-at-the-annual-meeting-of-the-american-society-of-clinical-oncology-and-provides-strategic-update-on-afm24-development-plan-2/[24] Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma. Retrieved June 8, 2023, from https://www.prnewswire.com/news-releases/janssen-presents-longer-term-talquetamab-follow-up-data-showing-overall-response-rates-of-more-than-70-percent-in-heavily-pretreated-patients-with-multiple-myeloma-301841822.html[25] IN8bio Announces Positive INB-200 Phase 1 Data Update in Glioblastoma at the 2023 ASCO Annual Meeting. Retrieved June 8, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2681908/0/en/IN8bio-Announces-Positive-INB-200-Phase-1-Data-Update-in-Glioblastoma-at-the-2023-ASCO-Annual-Meeting.html[26] NKGen Biotech Announces SNK01 Preclinical and Phase I/IIa Clinical Data Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 9, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2681899/0/en/NKGen-Biotech-Announces-SNK01-Preclinical-and-Phase-I-IIa-Clinical-Data-Presented-at-the-2023-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting.html[27] Atreca Presents Data from Ongoing Phase 1b Study of ATRC-101 in Patients with Select Advanced Solid Tumors during Oral Abstract Session at the ASCO 2023 Annual Meeting. Retrieved June 9, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2681923/0/en/Atreca-Presents-Data-from-Ongoing-Phase-1b-Study-of-ATRC-101-in-Patients-with-Select-Advanced-Solid-Tumors-during-Oral-Abstract-Session-at-the-ASCO-2023-Annual-Meeting.html[28] Morphogenesis, Inc. and CohBar, Inc. Announce Positive Results from Phase 1b Trial of IFx-Hu2.0, a Novel Personalized Cancer Vaccine, in Checkpoint Inhibitor Resistant Advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) . Retrieved June 9, 2023, from https://www.globenewswire.com/news-release/2023/06/05/2681931/0/en/Morphogenesis-Inc-and-CohBar-Inc-Announce-Positive-Results-from-Phase-1b-Trial-of-IFx-Hu2-0-a-Novel-Personalized-Cancer-Vaccine-in-Checkpoint-Inhibitor-Resistant-Advanced-Merkel-Ce.html[29] Dragonfly Therapeutics Announces the Presentation of Phase 1 DF1001 TriNKET® Dose Escalation Results at ASCO 2023 Annual Meeting . Retrieved June 9, 2023, from https://www.prnewswire.com/news-releases/dragonfly-therapeutics-announces-the-presentation-of-phase-1-df1001-trinket-dose-escalation-results-at-asco-2023-annual-meeting-301842406.html[30] Vigeo Therapeutics will present New Clinical and Immune Profiling Data from Ph I/II Expansion study in GBM Patients in ASCO Poster Oral Session. Retrieved June 9, 2023, from https://www.prnewswire.com/news-releases/vigeo-therapeutics-will-present-new-clinical-and-immune-profiling-data-from-ph-iii-expansion-study-in-gbm-patients-in-asco-poster-oral-session-301840335.html[31] Elicio Therapeutics Announces Positive Interim Data from the Phase 1 Study of an Investigational Therapeutic Cancer Immunotherapy, ELI-002, in Patients with High Relapse Risk Pancreatic and Colorectal Cancer at the ASCO Annual Meeting. Retrieved June 9, 2023, from https://www.globenewswire.com/news-release/2023/06/03/2681519/0/en/Elicio-Therapeutics-Announces-Positive-Interim-Data-from-the-Phase-1-Study-of-an-Investigational-Therapeutic-Cancer-Immunotherapy-ELI-002-in-Patients-with-High-Relapse-Risk-Pancrea.html[32] Precigen Announces Positive Phase 1 Data for Off-the-Shelf PRGN-2009 AdenoVerse™ Immunotherapy Alone and in Combination with an Investigational Checkpoint Inhibitor in Patients with Recurrent/Metastatic HPV-associated Cancers. . Retrieved June 9, 2023, from https://www.prnewswire.com/news-releases/precigen-announces-positive-phase-1-data-for-off-the-shelf-prgn-2009-adenoverse-immunotherapy-alone-and-in-combination-with-an-investigational-checkpoint-inhibitor-in-patients-with-recurrentmetastatic-hpv-associated-cancers-301841791.html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

细胞疗法免疫疗法临床结果基因疗法蛋白降解靶向嵌合体

2023-06-02

·BioSpace

Vigeo Therapeutics will present New Clinical and Immune Profiling Data from Ph I/II Expansion study in GBM Patients in ASCO Poster Oral Session

CAMBRIDGE, Mass., June 2, 2023 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, today announced new data from its Phase I/II expansion study evaluating single-agent activity of VT1021 in patients with recurrent glioblastoma (rGBM). The data will be presented by Dr. David Peereboom of Cleveland Clinic in a poster discussion session tomorrow, June 3, 2023, from 4:30 – 6:00 PM at the American Society of Clinical Oncology (ASCO) annual meeting being held June 2 – June 6, 2023 in Chicago, IL. VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 blocks the CD47 immune checkpoint and engages CD36 to induce tumor cell apoptosis, inhibit angiogenesis, activate cytotoxic T cells (CTL), and reprogram macrophages from the M2 to M1 phenotype. In a phase I/II clinical study in solid tumors (NCT03364400) VT1021 demonstrated promising single-agent clinical activity against recurrent glioblastoma. Among 22 evaluable subjects with rGBM, 3 had a complete response (CR), 1 had a partial response (PR), and 6 had stable disease (SD) with an average study duration of over 120 days. One subject continues to receive VT1021 treatment and has been on study for almost 3 years with no remaining measurable lesion. Historically, rGBM patients have a response rate of less than 5% and a median progression free survival of 48 days. Confirming the role of VT1021 in altering the tumor microenvironment, immune profiling of the GBM patients on the study showed beneficial and sustained changes in CTL parameters and PD-L1+ MDSCs that correlated with response. Specifically, CR/PR subjects showed decreases in PDL1+ MDSCs along with an increase in total CTLs, proliferating CTLs, and CTL/Treg ratio. In contrast, SD and PD subjects exhibited no change or decrease in these three CTL parameters. "The demonstration of the effect of VT1021 on the tumor immune microenvironment and the correlation with clinical outcome are encouraging signs in the development of new therapies for GBM patients" said Dr. David Peereboom of Cleveland Clinic. "To further advance VT1021 as a therapy for GBM, Vigeo is studying the potential of VT1021 in both newly diagnosed and recurrent subjects in an ongoing phase II/III clinical study (NCT03970447)" said Dr. Jing Watnick, COO and co-founder of Vigeo Therapeutics. Presentation Title: Immune profiling in patients with glioblastoma treated with VT1021 in a phase I/II expansion study. Date & Time: Saturday June 3, 2023 from 4:30PM – 6:00 PM Abstract Session: Central Nervous System Tumors Abstract: 409504 Location: Board # 378 Presenter: David M. Peereboom, MD Professor of Medicine, Cleveland Clinic About VT1021 Vigeo's lead asset, VT1021, is a first-in-class dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis in tumors and endothelial cells, and increases the M1:M2 macrophage ratio. VT1021 achieves these biological effects via stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that that are associated with poor response to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are more susceptible to attack from the body's immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. About Vigeo Therapeutics Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline being led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. VT1021 has been investigated as a single agent in a Phase I/II clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently undertaking late-stage clinical studies. For more information visit vigeotx.com

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Paxalisib ( Akt x PI3K family x mTOR )	复发性胶质母细胞瘤更多	临床3期
VT-1021 ( THBS1 )	复发性胶质母细胞瘤更多	临床3期
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