A human monoclonal antibody targeting cytotoxic T lymphocyte associated protein 4 (ctla4)、Immunoglobulin G1-kappa, anti-(homo sapiens CTLA4 (cytotoxic tlymphocyte-associated protein 4, cd152))、Zalifrelimab (USAN/INN)

+ [3]

靶点

CTLA4

作用方式

调节剂

作用机制

CTLA4调节剂(细胞毒性T淋巴细胞相关抗原4调节剂)

治疗领域

肿瘤呼吸系统疾病泌尿生殖系统疾病+ [3]

在研适应症

宫颈癌转移性软组织肉瘤复发性宫颈癌+ [11]

非在研适应症

晚期宫颈癌血管肉瘤局部晚期恶性实体瘤+ [1]

原研机构

在研机构

+ [3]

非在研机构

贝达药业股份有限公司

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)终止

特殊审评-

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结构/序列

Sequence Code 12956574L

来源: *****

Sequence Code 12956979H

来源: *****

关联

项与泽弗利单抗相关的临床试验

NCT06782555

/ Recruiting临床1/2期

A Phase 1/2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies

The purpose of this Phase 1/2 study is to test the overall safety, tolerability, and effectiveness of the combination investigational drugs evofosfamide, zalifrelimab, and balstilimab in treating advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, and human papilloma virus (HPV)-negative squamous cell carcinoma of the head and neck (SCCHN).

开始日期2025-01-08

申办/合作机构

Immunogenesis, Inc.初创企业

[+1]

NCT05375903

/ Active, not recruiting临床1期

A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC

This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.

开始日期2022-06-01

申办/合作机构

UroGen Pharma Ltd.

NCT04943848

/ Recruiting临床1期IIT

A Phase I Clinical Trial of Neo-antigen Heat Shock Protein Vaccine (rHSC-DIPGVax) in Combination With Checkpoint Blockade for the Treatment of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffuse Midline Glioma in Childhood

This is a phase I, open label, plus expansion clinical trial evaluating the safety and tolerability of rHSC-DIPGVax in combination with BALSTILIMAB and ZALIFRELIMAB. rHSC-DIPGVax is an off-the-shelf neo-antigen heat shock protein containing 16 peptides reflecting neo-epitopes found in the majority of DIPG and DMG tumors. Newly diagnosed patients with DIPG and DMG who have completed radiation six to ten weeks prior to enrollment are eligible.

开始日期2022-01-10

申办/合作机构

Ann & Robert H. Lurie Children's Hospital of Chicago

[+3]

100 项与泽弗利单抗相关的临床结果

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100 项与泽弗利单抗相关的转化医学

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100 项与泽弗利单抗相关的专利（医药）

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项与泽弗利单抗相关的文献（医药）

2022-07-01·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Abscobal Effect of Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer

Letter

作者: Özdemir, Nuriye ; Aslan, Volkan ; Özet, Ahmet ; Sütcüoğlu, Osman ; Yazıcı, Ozan

2022-04-01·Medical oncology (Northwood, London, England)4区 · 医学

Balstilimab and other immunotherapy for recurrent and metastatic cervical cancer

4区 · 医学

Review

作者: Bose, Chinmoy K

Recurrent and metastatic cervical cancer is generally treated by cisplatin, paclitaxel, and bevacizumab with limited benefit this constituting an unmet need. Immune checkpoint inhibitors, namely the inhibitors of programmed death 1 and programmed death ligand 1 have been proved to be efficacious in the treatment of patients with advanced cervical cancer. Recently, a PD-1 inhibitor, pembrolizumab was approved for such cancer. However, there is much scope of improvement of current outcome. Dual blockade of cytotoxic T lymphocyte-associated protein 4 and PD-1 is an attractive therapeutic approach. It is used in other cancers and is currently proposed for cancer cervix also. Search is on for single or combined regimen showing efficacy in multiple pathological conditions of cancer cervix irrespective presence of PD-L1 in malignant tissue. An effort to meet such unmet need has culminated in inventing new immune checkpoint inhibitors namely PD-1 inhibitor, AGEN2034 (Balstilimab) and CTLA-4 inhibitor, AGEN1884 (Zalifrelimab).They have shown meaningful and durable activity as single-agent therapy in previously treated patients with persistent R/M CC in a large phase II trial (NCT03104699) in PD-L1 + and PD-L1- tumour. Responses were found both in squamous cell carcinoma & adenocarcinoma cell types. Balstilimab plus zalifrelimab combination (NCT03495882) produced improved clinical benefit over monotherapy as evidenced by higher relative response rates and longer response duration, as well as a manageable safety profile. Interesting development of this combination and other immunotherapies in R/M CC are discussed in this ensuing review.

2022-03-01·Journal of clinical oncology : official journal of the American Society of Clinical Oncology1区 · 医学

Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study

1区 · 医学

Article

作者: Doger de Speville Uribe, Bernard ; Monk, Bradley J. ; Bagameri, Andrea ; Bulat, Iurie ; Ancukiewicz, Marek ; Neffa, Maryna ; Wang, Edward W. ; Meniawy, Tarek M. ; Ortuzar Feliu, Waldo ; Hegg, Roberto ; Huang, Marilyn ; Melkadze, Tamar ; Lugowska, Iwona ; Kryzhanivska, Anna ; O'Malley, David M.

PURPOSE:

Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte–associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882 ) evaluated the combination of balstilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy.

PATIENTS AND METHODS:

Patients were intravenously dosed with balstilimab 3 mg/kg once every 2 weeks and zalifrelimab 1 mg/kg once every 6 weeks, for up to 24 months. The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). Secondary end points included duration of response, safety and tolerability, and survival.

RESULTS:

In total, 155 women (median age, 50 years [range, 24-76 years]) were enrolled and treated with balstilimab plus zalifrelimab; 125 patients had measurable disease at baseline and one prior line of platinum-based therapy in the advanced setting, and these patients constituted the efficacy-evaluable population. The median follow-up was 21 months. The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders, with median duration of response not reached (86.5%, 75.5%, and 64.2% at 6, 9, and 12 months, respectively). The ORRs were 32.8% and 9.1% in patients with programmed death ligand-1–positive and programmed death ligand-1–negative tumors, respectively. For patients with squamous cell carcinoma, the ORR was 32.6%. The overall disease control rate was 52% (95% CI, 43.3 to 60.6). Hypothyroidism (14.2%) and hyperthyroidism (7.1%) were the most common immune-mediated adverse events.

CONCLUSION:

Promising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte–associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing.

项与泽弗利单抗相关的新闻（医药）

2025-03-09

·药明康德

快速持久降解目标蛋白超80%的小分子疗法；有望使患者停止激素替代治疗的创新生物器官疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 小分子蛋白降解剂BHV-1300的1期临床试验结果积极，目标IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。 2. 创新生物混合器官Cell Pouch获批一项新的IND申请，它与自体甲状腺细胞疗法相结合，旨在恢复自然的甲状腺功能，使患者无需使用甲状腺激素替代药物或免疫抑制疗法。 3. 巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎，在一项1/2期临床试验中使患者报告的疼痛平均减少47.0%，关节功能改善46%。药明康德内容团队整理 BHV-1300：公布1期临床试验的新数据 Biohaven公司公布了其皮下给药的在研小分子蛋白降解剂BHV-1300的1期临床试验的新结果。BHV-1300在选择性清除目标IgG（IgG1、IgG2和IgG4）方面具有独特优势，同时保留IgG3水平。IgG3在对抗细菌、寄生虫和病毒中发挥关键作用。BHV-1300的设计目标是避免与其他IgG降低方法相关的广泛免疫抑制，同时在治疗自身免疫性疾病的过程中允许免疫系统对潜在感染做出反应。在为期四周的1期研究中，每周皮下注射1000 mg剂量的BHV-1300可使总IgG快速、深度和持续地降低，降幅最高达84%，中位降幅为80%。在每次给药后的数小时内，患者的IgG就会逐渐降低，并且与基线值相比，在四周内持续降低。BHV-1300在高达2000 mg的皮下给药剂量下安全性和耐受性良好。大多数不良事件轻微，可自行消退，没有因与研究药物相关的不良事件而停药，也没有严重的不良事件。 ▲BHV-1300的作用方式和1期临床试验结果（图片来源：参考资料[7]） Cell Pouch：IND申请获得FDA许可 Sernova Biotherapeutics公司宣布，美国FDA已批准其IND申请，允许在因结节性甲状腺疾病接受甲状腺手术的患者中评估Cell Pouch与自体移植甲状腺细胞的联合疗法。Sernova公司的Cell Pouch是一种创新的生物混合器官，由非生物材料与活体组织结合而成，旨在恢复或增强受损器官的功能。Cell Pouch与自体甲状腺细胞疗法相结合，旨在通过提供一种稳定、长期的生理解决方案，恢复自然甲状腺功能，而无需使用甲状腺激素替代药物或免疫抑制疗法。临床前研究表明，在没有免疫抑制的情况下，将甲状腺组织重新植入预先血管化的Cell Pouch中，成功地将两种主要的甲状腺激素——甲状腺素（T4）和三碘甲状腺原氨酸（T3）恢复到甲状腺切除术前水平，而无需激素补充。放射性同位素成像和组织学分析证实，植入后5个月内Cell Pouch内存在健康、功能性的甲状腺组织。 Allocetra：公布1/2期临床试验的中期数据 Enlivex Therapeutics公司公布了其巨噬细胞疗法Allocetra治疗中度至重度膝骨关节炎的1/2期临床试验的中期数据。败血症、骨关节炎、银屑病关节炎等疾病会使巨噬细胞失去平衡状态。这些非稳态巨噬细胞在很大程度上导致了相应疾病的严重性。Allocetra是一种通用、现货型细胞疗法，通过对巨噬细胞进行重编程，旨在恢复其稳态（homeostasis），进而治疗疾病。Allocetra提供创新的免疫调节机制，具潜力作为单药或组合疗法治疗这些具未竟医疗需求的疾病。此次公布的结果显示，治疗后第6个月，患者报告的疼痛平均显著减少了47.0%（P=0.0001），关节功能改善了46%。此外，83%接受治疗的患者在6个月时仍被认为对治疗有应答。这表明Allocetra作为骨关节炎的潜在突破性治疗方法，具有良好的持久性和持续疗效。安全性方面，没有报告严重的不良事件。 PER-001：公布1/2a期临床试验数据 Perfuse Therapeutics公司公布了其玻璃体内植入疗法PER-001在青光眼患者中的首次人体1/2a期试验的24周数据。PER-001是一种新型的小分子长效内皮素受体拮抗剂。内皮素是人体内最强的血管收缩剂，在青光眼中上调，并通过其在视网膜血管和神经视网膜细胞中的受体参与炎症和细胞死亡。PER-001是一种生物可降解的植入疗法，通过一次性25号注射器注入眼球玻璃体腔中。该疗法被设计为每6个月给药一次，能够持续释放药物。 24周的数据表明，PER-001具有良好的耐受性，仅有一例药物相关不良事件（轻微且短暂的玻璃体飞蚊症），没有严重药物相关不良事件或眼内炎症报告。接受PER-001治疗的患者从第1周开始，视神经头血流量较基线平均增加了至少10%，并持续至第24周。第24周时，光学相干断层扫描（OCT）显示，PER-001治疗组患者的视野平均偏差改善了1 dB/年，视网膜神经纤维层厚度平均增加了3微米。相比之下，假手术对照组患者的视野平均偏差下降了0.63 dB/年，OCT视网膜神经纤维层厚度减少了1.3微米。这些结果表明，PER-001在青光眼患者中不仅安全性良好，还显示出显著的功能和结构改善，为其作为青光眼治疗的潜在疗法提供了概念验证。 RPESC-RPE-4W：公布1/2a期临床试验数据 Luxa Biotechnology公司公布了一项1/2a期临床试验的数据，该试验评估了其专有的视网膜色素上皮（RPE）细胞疗法RPESC-RPE-4W在干性年龄相关性黄斑变性（AMD）患者中的应用。RPESC-RPE-4W是一种基于成人RPE干细胞的疗法，旨在通过替换受损的RPE细胞来恢复视力功能。干性AMD是一种导致中心视力模糊或丧失的退行性眼病，目前尚无有效治疗方法。在1/2a期试验的最低剂量组中，6名干性AMD患者被分为视力较差组和视力较好组。视力较差组的3名患者在12个月的随访中，平均在ETDRS视力表上获得了21.67个字母的改善，视力较好组的3名患者在3个月时，平均改善了3.3个字母。 VXA-G1.1-NN：公布1b期临床试验数据 Vaxart公司宣布，其第一代口服诺如病毒候选疫苗VXA-G1.1-NN在老年人群（55-80岁）中的1b期临床试验完整数据已发表在学术期刊Science Translational Medicine上。VXA-G1.1-NN是一种口服疫苗片剂，将表达诺如病毒GI.1主要衣壳蛋白VP1的非复制性腺病毒载体递送到小肠，旨在预防由诺如病毒引起的急性胃肠炎。该试验评估了VXA-G1.1-NN在55-65岁和66-80岁两个健康老年人群中的安全性和免疫原性。受试者以2：1的比例随机接受疫苗或安慰剂，并在第28天进行加强接种。63名志愿者完成了研究，安全性及免疫原性评估持续至第390天。免疫原性结果显示，与安慰剂相比，疫苗在所有三个剂量组中均诱导了强效且持久的血清抗体反应，第29天和第57天的血清抗VP1 IgA水平显著增加，且抗VP1 IgG水平也显著高于接种前水平，呈剂量依赖性增加。口服疫苗还刺激了唾液和鼻腔中强烈且持久的IgA反应。安全性方面，疫苗在老年人群中表现出良好的安全性和耐受性，未发生与疫苗相关的3级不良事件。最常见的不良反应为头痛（14%）和不适/疲劳（16%），与安慰剂组的发生率相似。 APG990：公布1期临床试验的中期数据 Apogee Therapeutics公司公布了其新型半衰期延长的OX40L单克隆抗体APG990的首个人体试验的积极中期结果。APG990是一种皮下注射疗法，靶向炎症通路中位于IL-13上游的OX40L，从而对1型、2型和3型炎症通路产生广泛影响。此次公布的结果显示，APG990的半衰期约为60天，可支持每3个月或6个月一次的维持给药方案。在所有5个剂量组（最高剂量为1200 mg）中，APG990均表现出良好的耐受性。Apogee公司还开发了APG279，即APG777（一种深度抑制2型炎症的药物）与APG990的联合制剂，旨在实现单次注射2 mL联合制剂，每年仅需给药2-4次的治疗方案，为患者提供更有效的治疗选择，同时最大限度地减少其他可用疗法的副作用。 BL-001：公布1期临床试验数据 Bloom Science公司公布了其在研口服疗法BL-001在一项涉及32名健康成年人（体重从正常到超重）的1期试验中的疗效和安全性结果。BL-001是一种潜在“first-in-class”、口服给药的活生物治疗产品（LBP），旨在模拟生酮饮食的治疗效果。临床前数据表明，BL-001在癫痫模型中复制了生酮饮食的治疗效果，并进一步展示了其对γ-氨基丁酸（GABA）和其他关键生物能途径的调节作用，以抑制癫痫发作的关键驱动因素——过度兴奋性。 BL-001在28天的治疗期内在体重减轻方面的整体治疗效果具有统计学显著性（p=0.0424）。超重组（BMI≥25）中接受BL-001治疗的受试者与所有接受安慰剂的受试者相比，体重的百分比变化具有统计学意义（p=0.0007）。此外，BL-001治疗的超重和正常体重个体之间的体重百分比变化也具有统计学意义（p=0.0003），体重减轻最高为4.9%。80%在BL-001治疗期间体重减轻的受试者在最后一次给药两周后仍保持体重减轻，其中接受最高剂量的所有超重受试者的体重继续下降，在两周随访期结束时体重减少了3.4%。此外，BL-001治疗组观察到了剂量依赖性的变化，包括尿酮、食欲降低和体重减轻，而安慰剂组未观察到这些变化。靶向生物标志物分析显示，与食欲控制、代谢调节和消化相关的关键代谢激素发生了具有统计学意义的变化。更大规模的代谢组学分析还揭示了循环酮体的统计学显著变化，这些发现进一步支持了BL-001的潜在生酮和减肥效果。 ▲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] Perfuse Therapeutics Announces Positive Visual, Structural and Safety Data from a Ph1/2a Trial of PER-001 in Glaucoma Patients at the American Glaucoma Society Meeting. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-visual-structural-and-safety-data-from-a-ph12a-trial-of-per-001-in-glaucoma-patients-at-the-american-glaucoma-society-meeting-302387598.html [2] Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035709/0/en/Sernova-Biotherapeutics-Receives-FDA-Clearance-for-IND-Application-for-its-Cell-Pouch-Bio-hybrid-Organ-with-Autograft-Thyroid-Cells-in-Patients-with-Hypothyroidism.html [3] Enlivex Therapeutics Announces Investor Webinar to Discuss Positive Interim Data from Phase I/II Allocetra™ Trial in Knee Osteoarthritis. Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/04/3036995/0/en/Enlivex-Therapeutics-Announces-Investor-Webinar-to-Discuss-Positive-Interim-Data-from-Phase-I-II-Allocetra-Trial-in-Knee-Osteoarthritis.html [4] Bloom Science Reports Positive Data from Phase 1 Trial of BL-001 Demonstrating Statistically Significant, Durable Weight Loss in Overweight Individuals. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bloom-science-reports-positive-data-from-phase-1-trial-of-bl-001-demonstrating-statistically-significant-durable-weight-loss-in-overweight-individuals-302391446.html [5] Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html [6] Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-initiation-of-phase-1-clinical-study-evaluating-nbi-1140675-a-second-generation-vmat2-inhibitor-in-healthy-adults-302392294.html [7] Biohaven Reports Positive Degrader Data Achieving > 80% Sustained Reductions in Total IgG with Potential First-in-Class BHV-1300. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/biohaven-reports-positive-degrader-data-achieving--80-sustained-reductions-in-total-igg-with-potential-first-in-class-bhv-1300-302389515.html [8] Adiso Therapeutics Announces Data Publication of Two Phase 1 Studies of First-in-Class Neutrophil Modulator ADS051 in the American Journal of Gastroenterology. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/adiso-therapeutics-announces-data-publication-of-two-phase-1-studies-of-first-in-class-neutrophil-modulator-ads051-in-the-american-journal-of-gastroenterology-302393958.html [9] Apogee Therapeutics Announces Positive Interim Phase 1 Results from the APG990 Healthy Volunteer Trial, Unlocking Potential Maintenance Dosing Every Three and Six Months for APG279 (APG777 + APG990). Retrieved March 7, 2025, from https://www.globenewswire.com/news-release/2025/03/03/3035377/0/en/Apogee-Therapeutics-Announces-Positive-Interim-Phase-1-Results-from-the-APG990-Healthy-Volunteer-Trial-Unlocking-Potential-Maintenance-Dosing-Every-Three-and-Six-Months-for-APG279-.html [10] Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study. Retrieved March 7, 2025, from https://acadia.com/en-us/media/news-releases/acadia-pharmaceuticals-and-saniona-announce-initial-positive [11] Actio Biosciences Announces First Participant Dosed in Phase 1 Clinical Trial of ABS-0871, a Novel TRPV4 Inhibitor, for the Treatment of Charcot Marie Tooth Disease 2C. Retrieved March 7, 2025, from https://actiobiosciences.com/actio-biosciences-announces-first-participant-dosed-in-phase-1-clinical-trial-of-abs-0871-a-novel-trpv4-inhibitor-for-the-treatment-of-charcot-marie-tooth-disease-2c/ [12] Contineum Therapeutics Initiates Patient Dosing in Phase 1b Positron Emission Tomography (PET) Trial of PIPE-791. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20241216396391/en/Contineum-Therapeutics-Initiates-Patient-Dosing-in-Phase-1b-Positron-Emission-Tomography-PET-Trial-of-PIPE-791 [13] Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study. Retrieved March 7, 2025, from https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-enrollment-in-third-safety-cohort-in-ph-762-phase-1b-dose-escalation-study/ [14] Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT001, a Novel Multi-Targeting, Half-Life Extended Bispecific Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Skin Diseases. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/bambusa-therapeutics-announces-first-subject-dosed-in-phase-1-clinical-trial-of-bbt001-a-novel-multi-targeting-half-life-extended-bispecific-antibody-for-the-treatment-of-atopic-dermatitis-and-other-inflammatory-skin-diseases-302388661.html [15] Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference. Retrieved March 7, 2025, from https://www.businesswire.com/news/home/20250306998366/en/Luxa-Biotechnology-Presents-Clinical-Data-from-First-in-Human-Retinal-Pigment-Epithelium-Cell-Therapy-Trial-for-Dry-Age-Related-Macular-Degeneration-at-the-77th-Annual-Wills-Eye-Conference [16] ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors. Retrieved March 7, 2025, from https://www.prnewswire.com/news-releases/immunogenesis-doses-first-patient-in-phase-12-clinical-trial-of-imgs-101-in-combination-with-balstilimab-anti-pd-1-and-zalifrelimab-anti-ctla-4-in-relapsed-or-refractory-advanced-prostate-pancreatic-and-hpv--head--neck-t-302393719.html [17] Vaxart Announces Publication Demonstrating the Immunogenicity and Safety of its First-Generation Oral Pill Norovirus Vaccine Candidate in Elderly Adults. Retrieved March 7, 2025, from https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-publication-demonstrating-immunogenicity-and 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

临床申请临床1期细胞疗法免疫疗法临床结果

2025-03-06

·PRNewswire

ImmunoGenesis Doses First Patient in Phase 1/2 Clinical Trial of IMGS-101 in Combination With Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) in Relapsed or Refractory Advanced Prostate, Pancreatic, and HPV(-) Head & Neck Tumors

IMGS-101 is the only known reducer of solid tumor hypoxia, offering the potential to enhance the efficacy of immunotherapy HOUSTON, March 6, 2025 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, today announced the first patient has been dosed in the company's Phase 1/2 clinical trial of its hypoxia reversal agent IMGS-101 (evofosfamide) in combination with Balstilimab (anti-PD-1) and Zalifrelimab (anti-CTLA-4) at The University of Texas MD Anderson Cancer Center in Houston, Texas. Tumor hypoxia (low oxygen levels) is an immunosuppressive factor in solid tumors. By reversing hypoxia, IMGS-101 may improve the efficacy of immunotherapies in cancer types that are otherwise resistant to immune-based treatments. Continue Reading ImmunoGenesis The Phase 1/2, open-label, multicenter study (NCT06782555) consists of a dose escalation and expansion portion to evaluate the safety, pharmacokinetics, and anti-tumor activity of IMGS-101 in combination with Balstilimab and Zalifrelimab in adult patients with locally advanced or metastatic castration-resistant prostate cancer (CRPC), pancreatic cancer, and human papillomavirus-(HPV) negative squamous cell carcinoma of the head and neck (SCCHN). The study is being conducted in collaboration with Agenus, a clinical-stage immuno-oncology company developing the checkpoint inhibitors Balstilimab and Zalifrelimab. "Launching this trial represents a significant milestone in our mission to target key mechanisms of immune resistance," said ImmunoGenesis President and CEO James Barlow. "By targeting and reversing hypoxia, we aim to unlock the immune system's full potential and redefine the therapeutic landscape for these cancers with high unmet medical needs." "This trial marks an exciting step forward in addressing one of the key challenges in cancer immunotherapy," said Dr. Charles Schweizer, Senior Vice President of Clinical Development at ImmunoGenesis. "Hypoxia limits T-cell infiltration and suppresses immune responses, especially in prostate, pancreatic, and head and neck cancers. By reversing hypoxia, IMGS-101 may restore T-cell access to tumors, enhancing the effectiveness of checkpoint inhibitors and potentially transforming outcomes in these hard-to-treat cancers." About ImmunoGenesis ImmunoGenesis is a clinical-stage biotech company dedicated to transforming immuno-oncology by targeting key mechanisms of immune resistance. The company's lead product, IMGS-001, is a cytotoxic, dual-specific PD-L1/PD-L2 antibody currently in a phase 1a/b clinical trial for the treatment of immune-excluded ("cold") tumors, which account for more than half of all cancers. In addition to its lead program, the company is developing a number of novel approaches to overcome immune resistance in cold tumors. ImmunoGenesis designs therapies to address the pathology of these tumors, overcoming immune exclusion to elicit a robust immune response. For more information, visit . About IMGS-101 IMGS-101, also known as Evofosfamide, is a 2-nitroimidazole prodrug of the cytotoxin bromo-isophosphoramide mustard (Br-IPM) originally developed as a hypoxia-activated prodrug. ImmunoGenesis' Founder, Dr. Michael A. Curran from MD Anderson, demonstrated in his lab that IMGS-101 has the unique ability to address one of the most significant immunosuppressive barriers by reversing hypoxia. In pre-clinical models and a Phase 1 clinical study, IMGS-101 restored T-cell function and showed early signs of synergizing with checkpoint inhibitors. ImmunoGenesis is developing IMGS-101 as a hypoxia-reversal agent that can condition tumors to respond to checkpoint inhibition. About Balstilimab Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Balstilimab is being developed by Agenus, Inc. About Zalifrelimab Zalifrelimab is a novel, fully human monoclonal immunoglobulin G1 (IgG1) designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) from interacting with its ligands CD80 and CD86. CTLA-4 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Zalifrelimab is being developed by Agenus, Inc. Disclosure Dr. Curran's financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee. Contact ImmunoGenesis Investors: James Barlow President and CEO [email protected] SOURCE Immunogenesis Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床1期临床结果

2025-01-01

·ioncology

安菊生教授：双免疫治疗在宫颈癌领域的研究进展丨ESMO ASIA 2024

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标” ESMO ASIA 2024微专辑扫描二维码可查看更多内容在2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA 2024）的妇科肿瘤优选口头报告专场，中国医学科学院肿瘤医院安菊生教授汇报了一项吴令英教授担任leading PI的II期研究结果（摘要号372O）。《肿瘤瞭望》在会议现场邀请安菊生教授对这项研究发现予以解读，并分享此次会议的亮点内容。吴令英教授国家癌症中心/中国医学科学院肿瘤医院辽宁医院主任医师、博士生导师北京协和医学院长聘教授国家癌症中心/中国医学科学院肿瘤医院辽宁医院副院长中国临床肿瘤学会(CSCO)副理事长 CSCO妇科肿瘤专家委员会主任委员中国妇幼保健协会妇幼微创专业委员会主任委员国家抗肿瘤药物临床应用监测委员会副主任委员中国临床肿瘤学会临床研究专家委员会副主任委员中国妇幼保健协会常务理事等安菊生教授国家癌症中心中国医学科学院肿瘤医院副主任医师硕士生导师国家癌症中心国家肿瘤质控中心宫颈癌质控专家委员会委员中国抗癌协会近距离放射治疗专业委员会常委 CSCO妇科肿瘤专家委员会委员北京医学奖励基金会妇瘤专业委员会常委全民健康素养促进分会青委会副主委北京医学会妇科肿瘤学会青年委员北京医师协会妇科分会青年委员北京医学会放射肿瘤治疗学分会泛京津冀妇科肿瘤多中心专业协作组委员中国精准放疗实用指南编委会专家复发或转移性宫颈癌的治疗选择有限，根据您在本次会议上汇报的随机II期研究结果，Balstilimab±Zalifrelimab免疫疗法对这种疾病的疗效和安全性如何？安菊生教授我们非常有幸得到ESMO ASIA大会的邀请，对这项研究结果进行首次汇报。这项开放标签、非比较、随机的II期研究纳入局部晚期、不可切除和/或转移性宫颈鳞状细胞癌、腺鳞癌或腺癌患者，要求PD-L1阳性，根据RECIST 1.1标准至少有一个可测量的病灶，ECOG PS为0-1，既往至少接受过一线全身治疗。这项研究包括两个治疗组，74名患者在Balstilimab（PD-1抑制剂）单药组接受治疗，41名患者接受Balstilimab+Zalifrelimab（CTLA-4抑制剂）双免治疗。根据ESMO ASIA展示了疗效和安全性数据，主要治疗终点ORR（客观缓解率）在单药组可以达到25.7%，在双药组为36.6%。根据我们的临床治疗经验和同类药物的研究数据，以上ORR结果还是非常不错的。单药组和双药组的中位无进展生存期（PFS）分别为2.7个月和5.7个月。这两个方案的总体安全性可靠，没有治疗相关死亡病例的报道，绝大多数免疫相关不良反应（AE）的程度非常轻。比较常见的副反应包括骨髓抑制、甲状腺功能异常等，但大多数患者的AE最终都能将至一级，甚至恢复正常。既往KEYNOTE-158等研究证明了PD-1抑制剂单药在宫颈癌二线和后线治疗中的疗效，相比单药免疫治疗，“双免疗法”策略有何特点？安菊生教授宫颈癌免疫治疗的研究从PD-(L)1抑制剂单药治疗开始，其中Ⅱ期KEYNOTE-158研究显示帕博利珠单抗在至少1种治疗方案进展的晚期宫颈癌患者中的ORR为14.3%，但PD-L1阴性患者的ORR为零，PD-L1阳性的ORR达到17.1%。后续又有几项PD-(L)1单药治疗研究的关键性结果公布，包括在本研究中Balstilimab单药治疗的ORR为25.6%。综上，免疫单药治疗的疗效非常有限，ORR一般在20%左右。采用双免治疗可能会起到1+1>2的抗肿瘤作用，比如在我们这项研究中Balstilimab+Zalifrelimab双药免疫治疗的ORR达到36.6%，之前报道CheckMate 358研究中纳武利尤单抗联合伊匹木单抗双药治疗复发或转移性宫颈癌的有效率也都在30%以上，国产卡度尼利单抗（同时靶向PD-1和CTLA-4的双特异性抗体）、艾帕洛利托沃瑞利单抗（PD-1/CTLA-4组合抗体）的临床效果都实现明显提高。然而，除了药效，临床用药过程中还要注意到双免疫治疗的副反应控制，增加了一个免疫检查点抑制剂或靶点，可能意味着治疗的副反应也会升高。在2024 ESMO ASIA妇科肿瘤教育专场，嵌入免疫治疗（Embedding immunotherapy）是讨论主题之一，能否请您针对这一议题分享一些思考。安菊生教授该专场的议题非常好，作专题报告的教授汇报了宫颈癌免疫治疗进展，从后线治疗到一线治疗和更前线的初始治疗，将加入免疫治疗的相关研究一网打尽，进行了特别清晰的梳理。免疫检查点抑制剂在妇科肿瘤领域，尤其是在宫颈癌领域，已经取得了非常大的进展，国内外指南已将免疫检查点抑制剂纳入复发或转移性宫颈癌的治疗推荐，甚至正在变革传统的宫颈癌治疗模式。免疫检查点抑制剂的效果在后线被确定后，研究领域转向更前线的治疗，希望患者在治疗更早期就能从免疫治疗中获益。然而，免疫疗法目前获批的适应症并不是非常多，特别是在宫颈癌一线治疗、初始治疗、同步放化疗方面获批的适应症仍然非常有限，需要更多的探索。参考文献： Jusheng An, et al. Balstilimab (bal) alone or with zalifrelimab (zal) treatment for cervical cancer: an open-label, non-comparative, randomised, phase 2 trial. 2024 ESMO ASIA, 372O. （来源：《肿瘤瞭望》编辑部）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。

CSCO会议放射疗法免疫疗法临床2期

100 项与泽弗利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11823	-	-	DB15632

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
转移性胰腺癌	临床2期	美国	Agenus, Inc.	2025-01-08
转移性前列腺癌	临床2期	美国	Agenus, Inc.	2025-01-08
转移性头颈部鳞状细胞癌	临床2期	美国	Agenus, Inc.	2025-01-08
胰腺癌	临床2期	西班牙	-	2021-09-25
胰腺导管腺癌	临床2期	西班牙	Nelum Corp.	2021-09-01
血管肉瘤	临床2期	-	Agenus, Inc.	2021-02-01
转移性软组织肉瘤	临床2期	美国	Agenus, Inc.	2020-01-28
复发性宫颈癌	临床2期	美国	Agenus, Inc.	2019-06-01
复发性宫颈癌	临床2期	巴西	Agenus, Inc.	2019-06-01
复发性宫颈癌	临床2期	墨西哥	Agenus, Inc.	2019-06-01

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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


NCT02694822 (CTgov)	临床1/2期	晚期恶性实体瘤 \| 难治性癌症	89	Zalifrelimab (Phase 1: Zalifrelimab Dose 1)	選構觸選築遞積醖選蓋 = 範憲鹹糧淵網製鹹壓淵蓋鹽窪鬱夢糧糧網願廠 (艱鑰窪襯窪夢醖鹽衊壓, 壓構襯簾獵觸餘範艱衊 ~ 築膚範壓構醖襯齋鑰鏇) 更多	-	2025-03-17
NCT02694822 (CTgov)	临床1/2期	晚期恶性实体瘤 \| 难治性癌症	89	Zalifrelimab (Phase 1: Zalifrelimab Dose 2)	選構觸選築遞積醖選蓋 = 顧齋構鹽製廠衊網範壓蓋鹽窪鬱夢糧糧網願廠 (艱鑰窪襯窪夢醖鹽衊壓, 壓醖顧願繭淵範膚鑰鏇 ~ 蓋築鑰構壓淵積鬱膚鹹) 更多	-	2025-03-17
NCT04827953 (NUMANTIA, ESMO_GI2024) 人工标引	临床1/2期	胰腺癌一线	22	NLM-001 + gemcitabine (G)+ nab-paclitaxel (nP)+zalifrelimab	衊顧觸蓋鹽鬱鏇願積構(願醖製築鑰選餘鹽獵願) = 夢壓淵製醖蓋網願顧繭淵憲壓鹽觸願淵鹽選網 (餘範構齋願襯顧選壓憲 ) 更多	积极	2024-06-27
NCT04430036 (CTgov)	临床2期	肌层浸润性膀胱癌	4	AGEN2034+gemcitabine+Cisplatin+AGEN1884	觸獵廠憲鑰醖遞願醖廠 = 壓壓夢夢顧願鹹築繭鏇構餘齋窪製繭壓築衊廠 (壓襯製衊製遞鑰繭鏇夢, 鏇蓋膚積壓製淵鬱廠製 ~ 壓繭蓋簾鬱齋鏇餘鏇願) 更多	-	2024-04-04
NCT04028063 (ASCO 12023 \| ASCO 22023) 人工标引	临床2期	转移性软组织肉瘤	31	doxorubicin+Zalifrelimab+Balstilimab	鏇廠鏇鏇壓網觸積夢鬱(淵膚醖積襯醖衊壓製構) = 壓範網醖遞積鏇鹽醖選鬱壓製範蓋廠鏇製襯範 (鏇繭鹽網網壓築願壓鹽, 31 ~ 72) 更多	积极	2023-05-26
NCT03495882 (Pubmed \| J Urol \| J Clin Oncol) 人工标引	临床2期	晚期宫颈癌二线	155	Zalifrelimab+Balstilimab	夢壓鑰鏇蓋觸糧網簾積(衊網廠築製繭積顧廠襯) = 願醖襯衊願鏇艱窪簾齋齋製鹽廠膚觸簾鹽鏇鑰 (鏇繭製鏇壓網鹹範鹽齋, 18.8 ~ 33.9) 更多	积极	2022-03-01
NCT03495882 (ESMO 12021 \| ESMO 22021) 人工标引	临床2期	复发性宫颈癌二线	155	zalifrelimab+balstilimab	積夢網遞鏇鬱簾淵積願(餘遞夢糧壓顧選鏇鑰積) = 淵鑰築餘艱襯觸淵壓網網願網餘夢積觸遞繭觸 (艱膚憲願顧鹹鏇鹹製積 ) 更多	积极	2021-09-19
NCT03894215 (PRNewswire) 人工标引	临床2期	宫颈癌二线	78	Balstilimab+Zalifrelimab	積遞憲蓋蓋願範齋鑰繭(糧獵鬱鬱範觸壓淵鏇鏇) = 襯衊繭鏇網艱築鑰網範艱憲夢獵願衊餘鬱鹽範 (網願鹽膚遞衊鹽醖蓋襯 ) 更多	积极	2020-02-20
NCT03894215 (PRNewswire) 人工标引	临床2期	宫颈癌二线	78	Balstilimab	積遞憲蓋蓋願範齋鑰繭(糧獵鬱鬱範觸壓淵鏇鏇) = 醖衊遞鹹鑰衊糧製壓鑰艱憲夢獵願衊餘鬱鹽範 (網願鹽膚遞衊鹽醖蓋襯 )	积极	2020-02-20
NCT02694822 (ASCO2018)	临床1期	晚期恶性实体瘤	33	AGEN1884 0.1 mg/kg	鏇廠夢獵獵艱膚窪製網(簾糧淵蓋鹹鏇鏇衊鬱鏇) = reported in 1 patient treated with 3 mg/kg 餘齋淵膚艱糧鹹襯遞蓋 (窪範範簾鑰憲選願顧淵 ) 更多	-	2018-06-01
NCT02694822 (ASCO2018)	临床1期	晚期恶性实体瘤	33	AGEN1884 0.3 mg/kg		-	2018-06-01
NCT02694822 (ASCO2017)	临床1期	晚期恶性实体瘤	11	AGEN1884 0.1 mg/kg	憲選醖構願膚願壓膚壓(遞艱餘鏇壓壓憲艱製襯) = 壓鏇簾構壓蓋鹹憲遞餘醖鏇齋顧鏇鬱窪醖簾餘 (積窪積醖糧壓製醖齋淵 ) 更多	-	2017-05-30
NCT02694822 (ASCO2017)	临床1期	晚期恶性实体瘤	11	AGEN1884 0.3 mg/kg	憲選醖構願膚願壓膚壓(遞艱餘鏇壓壓憲艱製襯) = 醖觸願糧衊繭蓋夢鏇顧醖鏇齋顧鏇鬱窪醖簾餘 (積窪積醖糧壓製醖齋淵 )	-	2017-05-30