Phase II Trial of a Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Background:
Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.
Objective:
To test TriAdeno and N-803 in people with early-stage prostate cancer.
Eligibility:
People aged 18 years and older with early-stage low- or medium-risk prostate cancer.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.
TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.
Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.
Blood tests, imaging scans, and other tests will be repeated during the study.
A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.
Participants will have follow-up phone calls for 5 years....

开始日期2026-08-17

申办/合作机构

National Cancer Institute

NCT07686380

/ Not yet recruiting临床2期IIT

Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy

Background:
Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.
Objective:
To test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.
Eligibility:
People aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.
N-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.
Participants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.
The drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.
Participants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.
Follow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.

开始日期2026-08-17

申办/合作机构

National Cancer Institute

NCT05642195

/ Suspended临床1/2期IIT

Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Background:
Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back.
Objective:
To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC.
Eligibility:
Adults aged 18 years or older with no sign of disease after surgery for NSCLC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans.
Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit:
The study vaccine is given as 2-4 small shots under the skin of the thigh or arm.
N-803 is given as a shot under the skin of the abdomen.
Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study.
Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment.
Follow-up visits will continue for up to 5 years.

开始日期2026-08-17

申办/合作机构

National Cancer Institute

100 项与诺格白介素α-因奇西普相关的临床结果

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100 项与诺格白介素α-因奇西普相关的转化医学

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100 项与诺格白介素α-因奇西普相关的专利（医药）

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398

项与诺格白介素α-因奇西普相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

作者: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Zhao, Angela ; Lotan, Yair

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

2026-12-31·Emerging Microbes & Infections

Neuraminidase-inhibiting antibodies boosted by H1N1pdm infection cross-react differently with H5N1 of clades 2.3.4.4b and 2.3.2.1a

Article

作者: Aziz, Dinah Binte ; Tan, Yee-Joo ; Chan, Yee Teng ; Liew, Kong Yen ; Tan, Chee Wah ; Tambyah, Paul

Antibodies against neuraminidase (NA) are an independent correlate of protection and the antigenic relatedness between H1N1pdm and H5N1 NAs suggests that seasonal influenza infection may provide cross-reactive immunity. In this study, recent H1N1pdm infection elicited modest NA-inhibiting (NAI) antibody responses against contemporary A/Victoria/4897/2022 (H1N1pdm) but strong responses against older A/California/7/2009 (H1N1pdm). Convalescent sera exhibited significantly higher cross-reactive NAI against clade 2.3.4.4b H5N1 (A/Texas/37/2024) than non-flu A patients, whereas H3N2 infection did not elicit such cross-reactivity. NAI titres were comparable between N1-California and N1-Texas but lower against N1-Victoria, indicating greater antigenic similarity between N1-California and N1-Texas. This was supported by stronger inhibition of N1-Texas by N1-California sheep antiserum compared with N1-Victoria sheep antiserum. Surprisingly, H1N1pdm-infected patients exhibited very low NAI against clade 2.3.2.1a H5N1 (N1-Bangladesh; GMT of 171 vs GMT 1159 for N1-Texas). Mouse antisera demonstrated reduced reciprocal inhibition between N1-Texas and N1-Bangladesh, consistent with their antigenic divergence. When four residues in N1-Bangladesh were substituted with their corresponding residues in N1-Texas, N1-Bangladesh antiserum showed reduced NAI, while N1-Texas antisera showed increased inhibition compared with wild-type N1-Bangladesh. This suggests that these amino acid differences are partially responsible for their antigenic divergence. Importantly, longitudinal analysis revealed that boosted cross-reactive NAI responses waned by day 90 post-infection, highlighting their limited durability. Together, these findings demonstrate that seasonal H1N1pdm infection can transiently boost cross-reactive NAI antibodies against clade 2.3.4.4b H5N1, but antigenic divergence in clade 2.3.2.1a limits cross-reactivity. As such, the impact of pre-existing antibody during an H5N1 outbreak is dependent on the infecting clade.

2026-08-01·UROLOGIC CLINICS OF NORTH AMERICA

Emerging Intravesical Therapies for Non–Muscle-Invasive Bladder Cancer

Review

作者: Bukavina, Laura ; Isali, Ilaha ; Wang, Betty ; Calaway, Adam

Non-Muscle-Invasive Bladder Cancer poses significant therapeutic challenges due to high recurrence and progression rates. While intravesical Bacillus Calmette-Guérin (BCG) has long been the standard, limitations in efficacy, global shortages, and patient-specific contraindications to radical cystectomy have fueled the development of novel bladder-sparing therapies. Recent advances include UGN-102 for low-grade/intermediate-risk disease and multiple FDA-approved agents-nadofaragene firadenovec, TAR-200, and nogapendekin alfa inbakicept-for BCG-unresponsive disease. Ongoing trials of TAR-210, cretostimogene, and other combination regimens promise to further expand options. Comparative studies and real-world evidence will be critical to define optimal sequencing, benchmark outcomes against radical cystectomy, and address quality-of-life considerations.

414

项与诺格白介素α-因奇西普相关的新闻（医药）

2026-08-11

·优在生物

JITC | 美国国立癌症研究所免疫肿瘤中心James L Gulley团队报道三联免疫方案改善错配修复完整前列腺癌疗效

点击上方 [优在生物] 关注我们导语转移性去势抵抗性前列腺癌（mCRPC）晚期治疗手段有限，常规PD-1/PD-L1单药免疫治疗应答率极低，仅错配修复缺陷人群可稳定获益。绝大多数患者为pMMR分型，现有免疫方案难以产生持久肿瘤缓解。当前免疫单药、双药组合均无法同步完成肿瘤抗原激活、肿瘤微环境抑制、效应免疫细胞扩增三重任务，缺少分层临床试验对比不同联用策略的疗效与外周免疫动态变化，可用于预判应答的外周标志物体系尚未建立。 2026年7月24日，美国国立癌症研究所免疫肿瘤中心James L Gulley团队在Journal for ImmunoTherapy of Cancer发表题为Durable responses to triplet immunotherapy targeting TGF-β, PD-L1, and tumor antigen, with an IL-15 receptor superagonist的多中心I期QuEST1临床研究。该研究设置三组递进免疫联用队列，对比疫苗+双功能融合蛋白、联合IL-15超激动剂、再加IDO抑制剂的疗效差异，三联方案实现29%PSA持久缓解率，外周NK与CD8细胞显著扩增。IL-15受体超激动剂NAI是提升pMMR前列腺癌免疫应答的核心增效组分。该I期分层数据为晚期前列腺癌多靶点免疫联合开发提供循证支撑。正文研究人员首先设计自适应分层I期临床试验QuEST1，设定三组递进给药队列，BN-Brachyury疫苗作为通用抗原启动手段，bintrafusp alfa双功能融合蛋白统一用于抑制PD-L1与TGF-β通路。2.1队列仅采用两种药物联用，2.2队列增加NA（nogapendekin alfa inbakicept）IL-15超激动剂，2.3队列叠加IDO抑制剂依帕司他。试验预设每队列13例初治mCRPC患者，达到≥2例客观应答方可开启扩展队列，全程统一给药周期、影像学复查与PSA评估标准。研究同步收集基线、第2周、第10周外周血单个核细胞，完成流式免疫分型、bulk转录组与细胞因子定量，用于各组免疫特征横向对比。为验证IL-15超激动剂带来的免疫改变差异，研究对比2.1与2.2队列外周免疫动态变化。给药两周后，2.2队列总淋巴细胞、成熟NK细胞、NKp46阳性活化NK细胞扩增幅度显著高于2.1队列，效应细胞/抑制细胞比值同步大幅提升，CD8/Treg、NK/MDSC比值存在统计学差异。转录通路富集结果显示，仅2.2队列NK细胞杀伤、T细胞细胞毒性相关通路显著上调，血清颗粒酶B、IFN-γ水平同步升高。NAI可特异性扩增外周活化NK与CD8阳性效应T细胞，重塑机体抗肿瘤免疫平衡。抗原特异性T细胞检测显示两组均可诱导Brachyury、MUC1特异性多功能T细胞，但扩增幅度不具备明显组间差异，提示疫苗带来的抗原应答不受NAI干预。研究进一步整合三组临床疗效、安全性与应答人群免疫基线数据，完成最终分层分析。2.1队列仅1例实现持久PSA缓解，无扩展队列开启资格；2.2队列24例可评估患者中7例获得≥30%持续PSA下降，含2例RECIST实体瘤部分缓解，中位缓解时长13.8个月，仅1例为dMMR分型，其余均为难治pMMR患者；2.3队列因3级重度皮肤毒性提前终止入组，无临床应答。应答患者基线存在更高4-1BB阳性T细胞占比、更低髓系抑制细胞水平，治疗第10周IFN-γ增幅显著优于无应答人群。外周活化NK细胞持续扩增、基线高效应免疫细胞比例可作为三联方案疗效预判标志物。综合疗效、安全、多组学数据，完整阐明“肿瘤疫苗+双通路免疫抑制+IL-15激动剂”三重协同抗肿瘤机制。接受联合免疫治疗的前列腺癌患者试验方案总结总的来说，这项自适应I期QuEST1临床研究设置三组递进免疫联合队列，证实BN-Brachyury疫苗联合bintrafusp alfa基础上加入NAIIL-15超激动剂，可显著提升pMMR转移性去势抵抗性前列腺癌持久缓解率，叠加IDO抑制剂会增加重度皮肤毒性且无疗效增益。外周NK、CD8效应细胞扩增水平与基线免疫特征可预判治疗应答。该研究首次在大样本pMMR前列腺癌人群验证三联协同免疫方案的临床活性，明确IL-15超激动剂的免疫增效核心作用，为难治晚期前列腺癌多靶点免疫联合新药研发、外周预后标志物筛选提供I期临床依据。论文链接： https://jitc.bmj.com/content/14/7/e015336 END 内容为【优在生物】公众号原创，转载请写明来源于【优在生物】版权声明：本公众号标注原创的文章系作者个人学习心得，若有版权争议或标注差错，请联系我们。免责声明：本文内容仅供学术交流参考，不构成任何建议或承诺，优在生物不对因使用本文信息导致的任何后果负责。

2026-08-11

·今日头条

马斯克、埃里森、黄仁勋等科技巨头为何集体关注癌症？

世界上最具影响力的一批科技企业家，正把目光投向癌症。马斯克关注罕见肿瘤新药，甲骨文创始人拉里·埃里森描绘AI驱动的个体化癌症疫苗，黄仁勋执掌的英伟达投资AI制药，Facebook早期创业者肖恩·帕克则把资金直接投入癌症免疫治疗。（来源：ChatGPT）他们不是肿瘤医生，也不能代替临床研究。但他们带来的资金、算力、工程能力和全球影响力，正在帮助医学界挑战一些过去进展缓慢、成本高昂的问题。对患者而言，真正值得关注的，不只是“大佬说了什么”，而是这些力量能否让新药发现更快、临床研究更高效，让更多缺少治疗选择的患者看到新的可能。 01 马斯克关注的，不只是一颗药 2024年10月，马斯克在美国匹兹堡的一场公开活动中，讲述了朋友母亲的治疗经历。据他描述，这位患者原本被告知生命可能只剩几个月，后来在临床研究中使用Welireg，肿瘤出现显著缓解。马斯克由此称，这款药能够“解决脑癌” ，并认为一些可能改变患者命运的新药，应该更快被看见、更快到达真正需要它们的人身边。马斯克在匹兹堡讲述朋友母亲的治疗经历（来源：STAT News） Welireg中文通用名为贝组替凡，是一种HIF-2α抑制剂。它的重要性在于，研究人员从一种罕见遗传病VHL出发，逐步弄清肿瘤如何利用缺氧信号生长，最终把这些生物学发现转化为可以口服的精准治疗药物。对于部分过去需要反复接受手术的VHL相关肿瘤患者，这类药物提供了新的治疗可能。此后，贝组替凡的研究和应用范围又逐步扩展到肾细胞癌等领域。当然，马斯克将这个案例概括为“一颗药解决脑癌”，并不严谨。 Welireg最初获批治疗的是VHL相关肾细胞癌、胰腺神经内分泌肿瘤和中枢神经系统血管母细胞瘤。其中，中枢神经系统血管母细胞瘤通常属于良性血管性肿瘤，不能简单等同于公众理解的恶性“脑癌”。一个患者获得显著缓解，也不能证明药物适用于所有脑肿瘤。肿瘤缩小、完全缓解和长期治愈，同样不是一回事。但这段话背后的积极信号不应被忽视：一种源于罕见病研究的新机制药物，正在沿着精准医学的路径进入更多肿瘤领域；一位科技企业家的关注，也让更多人看见了罕见肿瘤、新药研发和药物可及性问题。 02 埃里森的“48小时”，背后是一条正在成形的技术链 2025年1月，美国公布“星际之门”AI基础设施项目时，甲骨文创始人拉里·埃里森谈到了癌症。他描绘的路径是：通过血液寻找肿瘤释放的微小信号，利用AI辅助发现癌症；对肿瘤进行基因测序后，再根据每位患者特有的肿瘤突变，设计个体化mRNA癌症疫苗，并通过自动化系统在约48小时内完成制备。埃里森在白宫公布“星际之门”的发布会上发言（来源：Wikimedia Commons）这并不是毫无科学基础的想象。过去，这些能力分别存在于不同的研究领域：液体活检负责寻找血液中的癌症信号；基因测序负责解析肿瘤突变；AI帮助预测值得攻击的肿瘤新抗原；mRNA平台负责把这些信息转化为疫苗。如今，它们正在被连接起来。这正是“48小时”最值得期待的地方。它不意味着48小时治愈癌症，而是意味着AI和自动化技术有可能大幅压缩部分疫苗设计与生产流程，让高度个体化的治疗不再完全依赖漫长的人工操作。目前，个体化癌症疫苗仍在多种癌症中接受临床验证，距离普遍应用还有安全性、有效性、生产质量、成本和监管等多道关卡。但方向已经比过去清晰：未来的癌症治疗，可能不只是根据癌种选择药物，还可能根据每位患者肿瘤中的独特突变，为其定制一套免疫攻击方案。 03 黄仁勋押注的，是AI改变新药研发速度科技企业对癌症的关注，也不只停留在公开演讲中。 2023年7月，英伟达向AI制药公司Recursion投资5000万美元。双方计划利用Recursion积累的生物与化学数据，结合英伟达的算力和AI模型，寻找新的药物靶点与候选分子。黄仁勋当时表示，生成式AI可能成为发现新药和新疗法的革命性工具。黄仁勋与Recursion董事会主席讨论AI驱动药物发现（来源：NVIDIA）此后，Recursion与另一家AI制药企业Exscientia合并。目前，其研发管线包含晚期实体瘤、淋巴瘤、B细胞恶性肿瘤和乳腺癌等多个方向。需要说明的是，这是英伟达公司的投资，并非黄仁勋个人出资；相关候选药物也不能被简单称为“英伟达研发的抗癌药”。英伟达主要提供资金、计算平台和AI模型能力。真正的新药仍然要经历实验室验证、动物研究和Ⅰ、Ⅱ、Ⅲ期临床试验。传统新药研发需要从大量靶点和分子中反复筛选。 AI的价值不是凭空创造“神药”，而是帮助研究人员更快提出值得验证的候选答案，把更多时间和资源集中到真正有希望的方向。换句话说，AI不能取消验证，却可能让验证开始得更早。 04 肖恩·帕克，把互联网财富投入实体瘤免疫治疗 Facebook首任总裁肖恩·帕克，是另一个更直接的案例。 2016年，他投入2.5亿美元成立帕克癌症免疫治疗研究所。2025年，该研究所又参与创立Dispatch Bio，并与ARCH Venture Partners共同领投2.16亿美元A轮融资。 Dispatch Bio正在开发一种名为Flare的免疫治疗平台。这一技术试图把人工设计的抗原送入肿瘤细胞，让免疫系统更容易识别和攻击肿瘤，同时改变实体瘤内部抑制免疫反应的环境。之所以值得关注，是因为实体瘤一直是细胞治疗和免疫治疗最难攻克的领域之一。血液肿瘤中的部分成功经验，并不能直接复制到肺癌、胰腺癌、乳腺癌等实体瘤。当然，Dispatch Bio仍处于早期开发阶段。“广谱实体瘤治疗”是研发目标，不是已经在患者身上得到证明的疗效。但2.16亿美元融资至少说明，科技资本愿意为高风险、长周期、可能带来重大突破的方向提供资源。很多前沿疗法只有获得这样的长期支持，才有机会从实验室走向临床。 05 为什么科技大佬纷纷关注癌症？首先，癌症仍然存在巨大的未满足医疗需求。它影响无数患者和家庭，也最容易让公众理解技术进步的现实意义。其次，癌症并不是一种疾病，而是一大类高度复杂、个体差异显著的疾病。肿瘤研究会产生海量的基因、病理、影像和临床数据，这恰好是AI、云计算和芯片企业擅长处理的领域。再次，肿瘤精准治疗与科技行业熟悉的“个性化”逻辑高度相似：根据每位患者的肿瘤特征，匹配不同药物、疫苗或细胞治疗。更重要的是，科技企业带来的不只有钱。它们擅长建设大规模计算平台、连接不同学科、改造工作流程，并把实验室中需要大量人工完成的环节自动化。这些能力有可能改变药物发现、患者筛选、临床试验和治疗生产的效率。 06 越令人振奋的技术，越需要准确表达科技资本进入癌症领域值得欢迎，但影响力越大，表达就越需要谨慎。华裔医学创业者陈颂雄旗下的ImmunityBio，开发出了免疫治疗药Anktiva。 2024年，这款药获得美国食品药品监督管理局（FDA）批准，与BCG（卡介苗）联合用于一种特定的BCG治疗无效、高危非肌层浸润性膀胱癌。这是一项真实的新药进展。但陈颂雄后来宣称Anktiva可能治疗“所有癌症”，甚至用于癌症预防。 2026年，FDA发出警告，认为这些表述超出了现有证据，也可能让公众误以为它是一针即可使用的广谱癌症疫苗。这个案例并不否定药物本身的价值。它提醒我们：即使企业家本人是医生，即使药物已经获批，也必须讲清具体癌种、适用人群、联合方案和给药方式。愿景可以宏大，面向患者的信息必须准确。 07 患者真正应该关注什么？科技大佬进入癌症领域，带来的不只是新闻热度。他们带来了资金、算力、工程思维和跨学科合作，也让一些过去因研发周期太长、风险太高而缺少资源的方向，获得继续向前的机会。这些进展值得关注，也值得期待。但真正影响患者治疗决策的，始终不是投资者的名字，而是某项技术已经走到了哪个阶段。看到名人谈抗癌，可以先问这几个问题：说的是哪一种癌症、哪一类患者？依据是个人故事、动物实验，还是人体临床试验？研究处于临床前、Ⅰ期、Ⅱ期还是Ⅲ期？所谓“有效”，是肿瘤缩小、延缓复发，还是延长生存？这是技术设想、公司融资、候选药物，还是已经获批的治疗？全球癌症研究发展很快。新药、临床试验和治疗策略，又分散在不同国家、医疗机构和研究体系中。跨境医疗咨询与服务的价值，正是帮助患者跨越语言和信息壁垒，看懂一项国际进展的真实意义，了解相关医疗机构、专家资源和临床试验，并判断它是否真正与自己的病情相关。我们乐见更多科技力量进入癌症领域。因为每一笔长期投入、每一次跨学科合作，都可能让新的治疗方法更早抵达临床。而越接近希望，患者越需要专业、准确、克制的信息，分清哪些已经可以讨论，哪些仍需等待，哪些可能真正与自己有关。科技人物可以描绘未来，资本可以加速研究。但最终让未来成为现实的，仍然是科学、临床证据，以及无数研究者和患者共同走过的验证之路。 #肿瘤治疗# #癌症# #马斯克# #黄仁勋# #科技#

2026-08-10

·BioSpace

ImmunityBio Appoints Dr. Jim Yong Kim, Former World Bank President and Global Health Leader, as Vice Chairman

Dr. Kim will advise on international partnerships and global access initiatives through the newly formed Office of the Executive Chairman CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced that Dr. Jim Yong Kim has joined the company as Vice Chairman. Dr. Kim will serve in a newly created Office of the Executive Chairman, where he will focus on strengthening the company's international and global relationships. He will report to Executive Chairman and Founder Dr. Patrick Soon-Shiong. The Office of the Executive Chairman will bring together senior leaders to support Dr. Soon-Shiong on strategy, partnerships, and initiatives intended to advance ImmunityBio’s scientific and clinical programs globally. In his role, Dr. Kim will focus on relationships with governments, health ministries, multilateral institutions, and global health partners, with the goal of supporting access to the company’s immunotherapy platform, clinical programs, and approved therapies where authorized in markets outside the United States. Dr. Kim brings decades of leadership at the intersection of medicine, public health, development, and global finance. He served as the twelfth president of the World Bank Group from 2012 to 2019, where he set the institution's goals to end extreme poverty by 2030 and to lift up the poorest 40 percent of people in developing countries. During his tenure, the World Bank launched the Pandemic Emergency Financing Facility, one of the first financial instruments built to move money quickly to stop outbreaks before they spread. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In 1987, Dr. Kim co-founded Partners In Health with Dr. Paul Farmer and others, and helped build treatment programs for drug resistant tuberculosis, HIV, and AIDS in some of the poorest communities in Haiti, Peru, and beyond. From 2003 to 2005, he led the World Health Organization's HIV/AIDS department, where he directed the "3 by 5" initiative, the first global target for AIDS treatment, which expanded access to antiretroviral medicines across the developing world. He has also served as president of Dartmouth College and held professorships at Harvard Medical School and the Harvard T.H. Chan School of Public Health. A physician and anthropologist, he is a recipient of a MacArthur Fellowship and was named one of TIME magazine's 100 Most Influential People. He currently serves as Vice Chairman and Senior Advisor at Global Infrastructure Partners, a part of Blackrock, where he supports the work of the emerging markets team. He also serves as the Chancellor of the University of Global Health Equity in Rwanda. “Dr. Kim has spent his life working to bring care to people and communities that too often face the greatest barriers to access,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “Our mission is to harness the power of the immune system to address some of the world’s most challenging diseases. Dr. Kim’s experience across global health, development finance, governments, and multilateral institutions will be invaluable as we work to build the partnerships that can help advance our science, support clinical development, and expand access to our approved therapies around the world.” “I have spent my career focused on ensuring that scientific and medical advances reach the people who need them most,” said Dr. Jim Yong Kim. “ImmunityBio is pursuing an ambitious vision grounded in immunology, innovation, and global impact that has the potential to improve countless lives. I am excited to work with Dr. Soon-Shiong and the team to build partnerships across governments, health system, and international institutions that can help accelerate research, broaden access and bring the benefits of these advances to patients around the world.” About ImmunityBio ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield ™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 receptor agonist, ANKTIVA ® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical development, therapeutic potential, safety, efficacy, and regulatory pathway of ANKTIVA; the anticipated clinical benefits of ANKTIVA and its potential to address some of the world’s most challenging diseases, Dr. Kim’s ability to help the Company advance its science, support clinical development, and expand access to its approved therapies around the world as well as to build partnerships across governments, health system, and international institutions that can help accelerate research and broaden to patients around the world. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management, and are subject to significant risks and uncertainties. Actual results may differ materially from those expressed or implied by such forward-looking statements due to a variety of factors, including, but not limited to: risks related to clinical trial design, enrollment, timing, interim analyses, and final data outcomes; the possibility that interim results may not be predictive of final trial results; regulatory risks, including the timing and outcome of interactions with the FDA and other regulatory authorities, and the risk that a BLA may not be submitted when anticipated or, if submitted, may not be approved or may require additional data or studies; risks related to safety signals or adverse events that may arise during continued evaluation; the Company’s ability to manufacture sufficient quantities of ANKTIVA and recombinant BCG to support clinical development and potential commercialization; risks associated with product supply, including ongoing BCG shortages; competitive developments; changes in standard-of-care treatment; market acceptance; reimbursement; and intellectual property protection. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, as well as its Form 10-Q filed with the SEC on August 4, 2026 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio, Inc. +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

高管变更免疫疗法

100 项与诺格白介素α-因奇西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12888	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性非小细胞肺癌	沙特阿拉伯	ImmunityBio, Inc.	2026-04-21
原位癌	欧盟	ImmunityBio, Inc.	2026-02-16
原位癌	冰岛	ImmunityBio, Inc.	2026-02-16
原位癌	列支敦士登	ImmunityBio, Inc.	2026-02-16
原位癌	挪威	ImmunityBio, Inc.	2026-02-16
非肌层浸润性膀胱尿路上皮癌	沙特阿拉伯	ImmunityBio, Inc.	2026-01-14
淋巴细胞减少	美国	ImmunityBio, Inc.	2025-06-02
非肌层浸润性膀胱肿瘤	美国	Altor BioScience Corp.	2024-04-22

未上市

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适应症	最高研发状态	国家/地区	公司	日期
社区获得性肺炎	临床3期	-	ImmunityBio, Inc.	2026-04-15
急性呼吸窘迫综合征	临床3期	-	ImmunityBio, Inc.	2026-04-15
脓毒症	临床3期	-	ImmunityBio, Inc.	2026-04-15
脓毒性休克	临床3期	-	ImmunityBio, Inc.	2026-04-15
肺癌	临床3期	美国	ImmunityBio, Inc.	2022-07-27
晚期非小细胞肺癌	临床3期	美国	ImmunityBio, Inc.	2018-05-18
膀胱癌	临床3期	美国	ImmunityBio, Inc.	2017-06-02
HPV阳性的口咽鳞状细胞癌	临床2期	-	ImmunityBio, Inc.	2026-07-22
HPV16阳性口咽癌	临床2期	-	ImmunityBio, Inc.	2026-07-22
复发性胶质母细胞瘤	临床2期	-	ImmunityBio, Inc.	2026-07-22

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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


NCT02782546 (CTgov)	临床2期	急性髓性白血病 \| 难治性急性髓细胞白血病	60	G-CSF+ALT-803+Tacrolimus+mycophenolate mofetil+CIML NK cell infusion (Recipient)	襯獵蓋廠鹽製繭鹽鏇製 = 窪壓構廠衊淵網廠觸繭醖艱餘鹹觸餘築壓網遞 (鑰衊醖齋廠觸糧獵製製, 蓋獵窪顧繭鬱製艱壓淵 ~ 願淵壓鏇鬱糧廠選廠積) 更多	-	2026-06-01
				Leukapheresis (Donor)	夢壓齋製淵製膚遞鏇廠(蓋願獵簾膚簾積觸觸範) = 窪夢憲積選醖顧衊遞壓製鹽製餘簾構鏇製獵顧 (夢膚齋選窪夢壓醖製選, 積鹽顧願築憲製衊壓壓 ~ 鏇糧鑰醖淵廠齋窪顧積) 更多
NCT03520686 (QUILT-2.023, ASCO2026)	临床3期	非小细胞肺癌一线 PD-L1 TPS	98	CPI+NAI	簾積築醖築製蓋範糧艱(遞憲鏇糧憲鏇夢選艱襯) = 選蓋壓夢糧壓製鏇艱鬱醖繭糧鏇觸夢衊選鹹艱 (鑰夢糧夢簾衊糧遞鹽鏇 ) 更多	积极	2026-05-29
				CPI	簾積築醖築製蓋範糧艱(遞憲鏇糧憲鏇夢選艱襯) = 鏇餘艱憲遞積遞衊選鏇醖繭糧鏇觸夢衊選鹹艱 (鑰夢糧夢簾衊糧遞鹽鏇 ) 更多
NCT03022825 (QUILT-3.032, ASCO2026)	临床3期	非肌层浸润性膀胱肿瘤	173	nogapendekin alfa inbakicept-pmln + BCG (NAI+BCG)	製艱網簾製醖衊選獵鏇(鏇鏇衊窪簾餘鬱範衊顧) = 築餘構鹹選夢鹹獵遞衊蓋艱繭觸艱醖壓蓋鏇糧 (繭繭築範顧齋鬱築鏇糧 ) 更多	积极	2026-05-29
				pembrolizumab (PEMBRO)	製艱網簾製醖衊選獵鏇(鏇鏇衊窪簾餘鬱範衊顧) = 繭餘鬱遞艱蓋衊獵窪簾蓋艱繭觸艱醖壓蓋鏇糧 (繭繭築範顧齋鬱築鏇糧 ) 更多
NCT05419011 (TRIAD5-Plus, Pubmed \| Front Immunol)	临床2期	遗传性非息肉病性结直肠癌 Lynch syndrome	158	Tri-Ad5	選糧願醖齋繭窪蓋獵積(繭範窪醖憲餘衊鹽願選) = 壓壓鑰繭鹽願鏇齋廠製衊鏇襯製築衊艱繭淵製 (鬱鹹獵憲遞襯壓構醖鹹 )	积极	2026-05-19
				Tri-Ad5 + NAI	選糧願醖齋繭窪蓋獵積(繭範窪醖憲餘衊鹽願選) = 製淵餘獵夢蓋遞鏇憲獵衊鏇襯製築衊艱繭淵製 (鬱鹹獵憲遞襯壓構醖鹹 )
NCT06745908 (ResQ201A, ESMO_ELCC2026)	临床3期	-	462	NAI+tislelizumab+docetaxel	顧艱壓蓋鹽選壓鹹觸網(觸襯糧醖膚餘淵簾淵積) = 艱簾廠淵網顧鑰鏇膚餘築齋壓夢襯觸鬱淵夢餘 (淵齋蓋憲廠願膚觸廠網 ) 更多	积极	2026-03-25
				docetaxel	顧艱壓蓋鹽選壓鹹觸網(觸襯糧醖膚餘淵簾淵積) = 範壓蓋遞鬱廠廠積選窪築齋壓夢襯觸鬱淵夢餘 (淵齋蓋憲廠願膚觸廠網 ) 更多
NCT02523469 (CTgov)	临床1/2期	转移性非小细胞肺癌	67	ALT-803+Nivolumab (Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg)	襯鏇夢製顧鑰築壓衊蓋 = 選廠窪齋艱範廠積膚願餘築齋醖選襯積獵繭網 (鑰壓製齋獵積鏇顧醖願, 製廠製衊構窪願蓋夢鹹 ~ 膚範範憲襯膚選糧蓋窪) 更多	-	2026-02-17
				ALT-803+Nivolumab (Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg)	襯鏇夢製顧鑰築壓衊蓋 = 鑰願襯糧遞構蓋獵襯鏇餘築齋醖選襯積獵繭網 (鑰壓製齋獵積鏇顧醖願, 膚獵鏇顧襯簾餘觸窪齋 ~ 鹹鹹鹹膚積遞襯簾鏇繭) 更多
NCT04491955 (Pubmed \| Oncologist)	临床1/2期	转移性结直肠癌 pMMR	32	CV-301 + N-803 + bintrafusp alfa + PDS01ADC	築醖繭壓艱襯鏇積觸範(願壓遞積醖鹽鹽窪鑰遞) = 蓋淵襯夢衊鹽憲觸膚簾網窪顧築鹽範艱齋艱窪 (網蓋鏇願醖衊窪餘艱獵 ) 更多	不佳	2026-02-05
NCT03228667 (QUILT-3.055, Company_Website) 人工标引	临床2期	非小细胞肺癌二线	-	ANKTIVA + CPI (NSCLC)	憲夢窪願窪糧簾襯蓋蓋(壓窪壓繭築製鑰艱鏇夢) = 衊衊顧遞襯願餘餘選獵獵鏇構廠鬱衊製獵艱顧 (願膚遞衊網獵蓋選蓋積 )	积极	2026-01-13
				ANKTIVA + CPI (NSCLC + Responders)	廠壓鏇鹹顧繭廠選構襯(艱顧築願衊顧積糧衊艱) = 鹹製淵壓選鏇觸遞製窪鑰鬱製製製選壓顧鏇觸 (窪膚願遞淵鹹醖衊艱製 )
NCT03520686 (QUILT-2.023, Company_Website) 人工标引	临床3期	转移性非小细胞肺癌 \| 晚期非小细胞肺癌一线	-	ANKTIVA + CPI	衊鏇選顧選觸廠餘鬱壓(糧積淵壓繭憲製淵醖鬱): P-Value = 0.0065	积极	2026-01-13
				CPI
NCT03022825 (QUILT-3.032, Pubmed \| J Urol)	临床2期	-	54	NAI plus BCG (BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer)	製築遞顧蓋簾製鑰鏇艱(膚構膚鑰淵鬱觸艱積積) = 鹹憲獵觸壓襯鏇壓餘窪鹽壓網顧廠範淵網獵憲 (顧觸構醖齋觸襯膚淵簾, 46.6 ~ 68.2) 更多	积极	2026-01-01