A Phase II Study With a Safety Run-In of the Addition of N-803, a Novel IL-15 Super-Agonist, to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma

The study participant is being asked to take part in this research study because the participant has been diagnosed with neuroblastoma that did not fully respond to previous treatment (refractory), or it has returned after treatment (relapsed).
Primary Aims
* To evaluate if the administration of N-803 in combination with irinotecan, temozolomide, hu14-18K322A, and GM-CSF in patients with relapsed/refractory neuroblastoma is feasible and tolerable
* To determine if the response rate of N-803 with irinotecan, temozolomide, hu14.18K322A and GM-CSF in patients with relapsed/refractory neuroblastoma is superior to the combination of irinotecan, temozolomide, hu14.18K322A, and GM-CSF
Secondary Aims
* To describe the toxicity profile of N-803 administered with irinotecan, temozolomide, hu14.18K322A and GM-CSF
* To evaluate and compare the progression free survival (PFS) and overall survival (OS) of and between patients receiving irinotecan, temozolomide, hu14.18K322A and GM-CSF with and without N-803

开始日期2025-12-01

申办/合作机构

St. Jude Children's Research Hospital, Inc.

NCT06161545

/ Recruiting临床2期IIT

A Phase II Sequential Window of Opportunity Trial of Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma

Background:
Squamous cell carcinoma is a type of cancer that can cause tumors on the head and neck (HNSCC). Even with treatment, less than 50% of people with certain types of HNSCC survive for 5 years.
Objective:
To test a new drug treatment (N-803 and pembrolizumab, with or without PD-L1 t-haNK cells) in people with HNSCC. These drugs may help the immune system to fight cancer.
Eligibility:
People aged 18 years and older who have HNSCC that is not linked to human papillomavirus infection. They must not yet have received any treatment and be scheduled for surgery to remove the tumors.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They will have a biopsy: A sample of tissue will be removed from the tumor.
Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm (intravenous infusion). N-803 is injected under the skin of the abdomen. All participants will receive these 2 treatments on day 1. They will have follow-up visits on days 8 and 15.
Some participants will also receive PD-L1 t-haNK cells by intravenous infusion. These are cells that attack cancer cells. These participants will receive this treatment on days 1, 5, 8, 12, and 15.
All participants will have a clinic visit on day 21. They will have a second biopsy.
Follow-up visits will occur on days 49 and 105. Visits will continue by phone or email every 9 weeks for 2 years....

开始日期2025-09-22

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2025-09-22

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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105

项与诺格白介素α-因奇西普相关的文献（医药）

2025-08-19·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Therapeutic CD8⁺ T cell tissue retention and immunomodulation during ART interruption fail to prevent SIV rebound.

Article

作者: Viox, Elise G ; Samer, Sadia ; Deleage, Claire ; Kuri-Cervantes, Leticia ; Betts, Michael R ; Paiardini, Mirko ; Safrit, Jeffrey T ; Pampena, M Betina ; Davenport, Miles P ; Regan, James ; Docken, Steffen ; Bar, Katharine J ; Wu, Vincent H ; Keele, Brandon F ; Nguyen, Kevin

A primary obstacle for HIV elimination is the long-term viral reservoir in lymphoid tissues (LT) that can cause rebound viremia if therapy is stopped. Cytotoxic CD8⁺ T cells are critical for control of HIV and Simian immunodeficiency virus (SIV) viremia; however, CD8⁺ T cells that migrate to LT are primarily noncytotoxic, calling into question whether these cells could reduce the viral reservoir on antiretroviral therapy (ART) or control viral replication when therapy is halted. To determine whether CD8⁺ T cells can inhibit viral replication when retained in LT, we inhibited lymphocyte egress from LTs in ART-treated SIV-infected rhesus macaques (RMs) during analytic treatment interruption (ATI) using the S1PR modulator FTY720 alone or in combination with anti-PD1 antibody (αPD1) and the IL-15 receptor superagonist N-803 to increase cytolytic function. FTY720 retained migrating CD4⁺ and CD8⁺ T cells in LT, whereas cytotoxic CD8⁺ T cells remained in the vasculature. After ATI and viral rebound, activated SIV-specific CD8⁺ T cells increased in frequency in LT of FTY720-treated RMs but failed to become cytotoxic or control plasma viremia compared to controls, even when combined with αPD1 and N-803. These findings indicate that LT-localized CD8⁺ T cells alone may be insufficient to delay or prevent plasma viral rebound during ATI.

2025-07-08·JCI Insight

Impact of the IL-15 superagonist N-803 on lymphatic reservoirs of HIV

Article

作者: Miller, Jeffrey S ; Wieking, Garritt ; Beilman, Gregory J ; Schacker, Timothy W ; Reichel, Jarrett ; Safrit, Jeffrey T ; Baker, Jason V ; Deeks, Steven G ; Khoruts, Alexander ; Klatt, Nichole R ; Vaughn, Byron P ; Soon-Shiong, Patrick ; Anderson, Jodi ; Chipman, Jeffrey G ; Batres, Rodolfo ; Davis, Zachary B ; Cromarty, Ross ; Eilkhani, Elnaz ; Escandón, Kevin ; Eaton, Anne ; Hinderlie, Peter ; Basting, Christopher M ; Rhein, Joshua

BACKGROUNDNK cell function is impaired in people with HIV (PWH), hindering their potential to reduce the lymphoid tissue (LT) reservoir. The IL-15 superagonist N-803 has been shown to enhance NK and T cell function and thus may reduce viral reservoirs.METHODSTo determine the impact of N-803 on LTs, we conducted a clinical trial where 10 PWH on effective antiretroviral therapy (ART) were given 3 subcutaneous 6 mcg/kg doses of N-803. We obtained PBMCs and lymph node (LN) and gut biopsies at baseline and after the last N-803 dose.RESULTSWe found a nonstatistically significant approximately 0.50 median log reduction in the frequency of viral RNA+ (vRNA+) and vDNA+ cells/g in the 6 participants with baseline and posttreatment LN biopsies. In the ileum, we observed reductions of vRNA+ cells in 8/10 participants and vDNA+ cells in all participants. We also found significant inverse correlations between NK cell proliferation and the frequency of vRNA+ cells and between NKG2A expression on NK cells and the frequency of vRNA+ cells.CONCLUSIONOur findings suggest N-803 may reduce the HIV reservoir in LTs of PWH on ART, an effect likely mediated by enhanced NK cell function. Controlled studies assessing the impact of NK cell therapy on HIV LTs are needed.TRIAL REGISTRATIONClinicalTrials.gov NCT04808908.FUNDINGNIH grants 5UM1AI126611, UL1TR002494, R01 AI147912, R35 CA283892, and UM1AI164561.

2025-05-01·Journal for ImmunoTherapy of Cancer

Combination of a therapeutic cancer vaccine targeting the endogenous retroviral envelope protein ERVMER34-1 with immune-oncology agents facilitates expansion of neoepitope-specific T cells and promotes tumor control

Article

作者: Donahue, Renee N ; Maldonado, Maria Del Mar ; Palena, Claudia ; Schlom, Jeffrey ; Iida, Masafumi ; Hamilton, Duane H ; Gulley, James L ; Gracia-Hernandez, Maria ; Le, Loc Huu

Background:

Endogenous retroviruses (ERVs) are remnants of retrovirus germline infections that occurred over the course of evolution and constitute between 5% and 8% of the human genome. While ERVs tend to be epigenetically silenced in normal adult human tissues, they are often overexpressed in carcinomas and may represent novel immunotherapeutic targets. This study characterizes the ERV envelope protein ERVMER34-1 as a target for a therapeutic cancer vaccine.

Methods:

The expression of ERVMER34-1 in multiple healthy adult and cancer tissues was assessed, as was its immunogenicity, to ascertain whether specific T cells could lyse human carcinoma cell lines expressing ERVMER34-1. Furthermore, the ability of a rationally designed ERVMER34-1-targeted therapeutic vaccine to induce tumor clearance in two murine carcinoma models expressing ERVMER34-1 was examined either as a monotherapy or in combination with anti-programmed cell death protein-1/programmed death-ligand 1 monoclonal antibody (mAb) or the interleukin-15 superagonist N-803.

Results:

The ERVMER34-1 protein was shown to be overexpressed in 232/376 of human carcinomas analyzed while being absent in most healthy adult tissues. High levels of ERVMER34-1 RNA expression associate with decreased survival in uveal melanoma, adenoid cystic, and head and neck carcinomas. ERVMER34-1-specific T cells were detected in peripheral blood mononuclear cells (PBMCs) of patients with cancer but not healthy donors following an overnight stimulation. However, reactive T cells are readily expanded from both healthy donor and patient with cancer PBMCs following a 7- day in vitro stimulation. Furthermore, ERVMER34-1-specific T cells selectively kill human carcinoma cell lines expressing ERVMER34-1. A novel, rationally designed, therapeutic cancer vaccine targeting ERVMER34-1 mediated tumor control in established syngeneic murine tumors expressing the full-length ERVMER34-1 protein. When combined with checkpoint blockade, the vaccine promoted expansion of neoepitope-reactive T cells whose function was further enhanced when combined with N-803. This expansion of neoepitope-reactive T cells was associated with tumor control.

Conclusions:

This study reveals the potential of a vaccine that targets the retroviral envelope protein ERVMER34-1 and supports its continued development toward clinical testing as a new class of therapeutic cancer vaccine.

235

项与诺格白介素α-因奇西普相关的新闻（医药）

2025-09-10

·FiercePharma

J&J's 'practice-changing' bladder cancer therapy Inlexzo lands FDA nod

With an 82% complete response rate seen in trials, Johnson & Johnson has touted high market hopes for the med. The FDA has signed off on Johnson & Johnson’s highly anticipated bladder cancer drug Inlexzo, marking an advance in the ability to care for patients who otherwise face bladder removal and limited treatment options.Inlexzo, previously called TAR-200, can now treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.The drug-releasing system combo allows for extended release of the chemotherapy gemcitabine directly to patients' bladders through an intravesical system that can be placed in minutes in an outpatient setting, with no general anesthesia needed, J&J said in a Sept. 9 release.Before the approval, the typical treatment route for NMIBC patients who don’t respond to standard-of-care BCG therapy was a radical cystectomy to remove the entire bladder. It's a life-altering and risky procedure that's not appropriate for many patients. J&J’s offering, meanwhile, provides a “potentially practice-changing” treatment, the company said.“We are proud of the science that has brought us to this historic moment,” John Reed, M.D., Ph.D., head of R&D at J&J Innovative Medicine, said in a statement. “As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients.”J&J picked up the asset from Taris Biomedical in 2019 with hopes to “give patients with bladder cancer a renewed sense of hope and belief,” Jennifer Taubert, J&J's head of Innovative Medicine, commented. “In an area that has seen little progress for more than 40 years, Inlexzo delivers a first-of-its-kind breakthrough innovation with a bright future ahead.” In a phase 2b study, 82% of Inlexzo-treated patients experienced a complete response without the need for reinduction, with 51% maintaining the response for at least one year. The complete response rate is the highest recorded among currently available therapies, Mark Wildgust, Ph.D., vice president of oncology global medical affairs for J&J Innovative Medicine, said in an interview with Fierce Pharma earlier this year.With its high complete response rate and its convenience factor, J&J believes Inlexzo will set itself apart from other bladder cancer offerings such as Merck’s Keytruda, Ferring Pharmaceuticals’ gene therapy Adstiladrin and ImmunityBio’s immunotherapy Anktiva, which is used alongside the BCG vaccine. The company has high hopes for the drug’s market potential.“In all the research that we have done, I have absolutely no reason to believe that they will use anything else but us once they fail BCG,” the president of J&J’s solid tumor business, Biljana Naumovic, told Fierce Pharma in April. She acknowledged, however, that the drug won’t reach that level of market dominance right away. J&J has already set up a patient support program and a Care Navigator offering educational resources at no cost to patients. Inlexzo is being further studied across patients with MIBC and those with NMIBC in four ongoing clinical trials.

临床结果临床2期免疫疗法疫苗上市批准

2025-08-28

·药明康德

100%疾病控制率！潜在重磅疗法组合积极试验结果公布；诺和诺德达成5.5亿美元RNA疗法合作

100%疾病控制率！潜在重磅疗法组合积极试验结果公布 ImmunityBio近日公布一项探索性研究的最新结果。该研究评估其免疫增强方案用于治疗5例复发性胶质母细胞瘤（GBM）患者的疗效与安全性。该方案包含IL-15激动剂Anktiva（nogapendekin alfa inbakicept，旨在增强自然杀伤细胞活性）、NK细胞疗法（PD-L1 t-haNK）以及Optune Gio肿瘤电场治疗装置。分析显示，在接受治疗的5名患者中，3名患者获得缓解，其中2名接近完全缓解，另2名至今维持疾病稳定，患者的整体疾病控制率（DCR）达100%。新闻稿指出，对于复发性GBM二线患者而言，这一无需化疗方案的积极试验结果极具意义。基于这一初步发现，ImmunityBio计划启动一项随机对照临床试验，专门针对在标准治疗后仍出现疾病复发的二线GBM患者。 Anktiva是一款IL-15超级激动剂。该疗法在2019年获FDA授予突破性疗法认定，用于与卡介苗（BCG）联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。2024年4月，美国FDA批准Anktiva与BCG联合使用，用于治疗对BCG无应答且伴有原位癌的非肌层浸润性膀胱癌成年患者，这些患者伴或不伴有乳头状肿瘤。值得一提的是，行业媒体Evaluate曾将这款疗法列为2024年有望获批的10款潜在重磅疗法之一。诺和诺德达成5.5亿美元RNA疗法合作 Replicate Bioscience今日宣布与诺和诺德（Novo Nordisk）达成一项为期多年的研究合作。此次合作将结合诺和诺德在治疗和药物开发方面的深厚经验，以及Replicate创新的自我复制RNA（srRNA）平台，共同开发用于治疗肥胖、2型糖尿病及其他心脏代谢疾病的新型候选疗法。根据协议，双方将在特定心脏代谢疾病靶点上展开合作，诺和诺德将获得Replicate srRNA平台的全球独家许可，用于开发和商业化相关项目。Replicate将获得研究经费，并有资格从诺和诺德处获得高达5.5亿美元的资金支持，包括预付款和潜在里程碑付款等款项。 Replicate拥有完善的srRNA专有技术，可根据需求定制蛋白表达特征。相比其他RNA技术，其平台在体内表现出更高水平的蛋白表达、更持久的效果以及更灵活的调控能力。Replicate正通过其创新的srRNA技术克服传统RNA疗法的不足，在生物活性、免疫反应强度及治疗指数方面展现出提升潜力。目前，公司研发的临床阶段狂犬病疫苗RBI-4000已在1期试验中显示出在低于其他RNA疫苗剂量下实现保护性免疫水平的成果。参考资料： [1] Replicate Bioscience Announces Partnership with Novo Nordisk to Unlock Self-Replicating RNA Therapies for Obesity and Diabetes. Retrieved August 28, 2025 from https://www.prnewswire.com/news-releases/replicate-bioscience-announces-partnership-with-novo-nordisk-to-unlock-self-replicating-rna-therapies-for-obesity-and-diabetes-302540245.html [2] Initial Data Shows 100% Disease Control in 5 Out of 5 Patients With Recurrent Glioblastoma With Two Patients in Near Complete Response Treated With ImmunityBio’s ANKTIVA®, NK Cell Therapy Plus Optune Gio® Device. Retrieved August 28, 2025 from https://www.businesswire.com/news/home/20250826147574/en/Initial-Data-Shows-100-Disease-Control-in-5-Out-of-5-Patients-With-Recurrent-Glioblastoma-With-Two-Patients-in-Near-Complete-Response-Treated-With-ImmunityBios-ANKTIVA-NK-Cell-Therapy-Plus-Optune-Gio-Device 免责声明：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：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1期突破性疗法临床2期临床结果

2025-08-28

·PRNewswire

FDA Tightens Survival Standards as Cancer Drug Pipeline Hits $866B Market Milestone

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 28, 2025 /PRNewswire/ -- Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY), ImmunityBio, Inc. (NASDAQ: IBRX), Agenus Inc. (NASDAQ: AGEN), Sutro Biopharma, Inc. (NASDAQ: STRO), and Castle Biosciences, Inc. (NASDAQ: CSTL). Major pharmaceutical companies have committed in the range of $20 billion in recent partnerships to advance next-generation immunotherapies, while venture capital investors continue backing innovative oncology startups despite economic headwinds. The timing couldn't be more strategic, as there are several companies demonstrating robust survival data and regulatory alignment now commanding premium valuations as big pharma races to replace expiring patents with breakthrough platforms. Oncolytics Biotech Inc. (NASDAQ: ONCY) has reached a pivotal inflection point, advancing toward what could become a registration-enabling trial for its breakthrough immunotherapy, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Recently, the company confirmed active discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters, positioning Oncolytics for potential initiation of trial activities by Q4 2025. This regulatory engagement represents a critical milestone, transitioning from proof-of-concept research to regulatory-stage development in one of oncology's most challenging therapeutic areas. The strategic emphasis on mPDAC builds on compelling survival data and addresses a massive unmet medical need. Pelareorep functions as a systemically delivered oncolytic virus that transforms immunologically "cold" tumors into "hot" targets responsive to immune-based treatments. Clinical data reveals pelareorep combinations achieved a remarkable 21.9% two-year overall survival rate in first-line pancreatic cancer patients, substantially outperforming the 9.2% historical benchmark established by standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This outcome carries particular weight given checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumor types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The mechanism behind these outcomes involves pelareorep's dual action profile. The virus selectively replicates within cancer cells and activates broad immune responses against tumor tissue. Translational studies from GOBLET and AWARE-1 trials demonstrate how treatment elevates PD-L1 expression, amplifies interferon signaling, and mobilizes tumor-infiltrating lymphocytes throughout the bloodstream. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME - all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." These mechanistic insights, combined with survival data from over 1,100 patients across multiple clinical programs, have shaped management's focus on pancreatic cancer as the lead indication for regulatory advancement. Leadership changes reflect Oncolytics' execution-oriented approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly assumed the CEO role in June 2025, while Aromando joined a few weeks later to oversee business development initiatives. The company has also eliminated its At-the-Market and Equity Line facilities, signaling confidence in current cash resources to reach key development milestones. Regulatory momentum supports accelerated development timelines. Pelareorep maintains both Fast Track and Orphan Drug designations from the FDA specifically for pancreatic cancer, acknowledging both therapeutic promise and critical patient need. These designations facilitate expedited review processes and can enhance partnership attractiveness with major pharmaceutical companies. The broader market context highlights the commercial opportunity. Pancreatic cancer maintains among the lowest survival rates of common malignancies, with five-year survival below 14%. While immunotherapies have revolutionized treatment across multiple cancer types, mPDAC has remained largely resistant to immune-based approaches, creating substantial unmet need for effective therapeutic combinations. During July, Oncolytics conducted a key opinion leader event featuring gastrointestinal oncology specialists who analyzed patient survival outcomes and biomarker validation studies. Expert feedback reinforced that pelareorep's immune activation mechanism addresses fundamental treatment gaps in first-line mPDAC therapy. Current FDA discussions center on study design parameters that could support regulatory submission for commercial approval. Should the agency accept Oncolytics' proposed framework emphasizing overall survival endpoints, the resulting trial would provide definitive evidence of pelareorep's clinical and commercial viability in pancreatic cancer treatment. Oncolytics anticipates sharing updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With robust survival data, established regulatory plans, and experienced leadership driving strategic execution, the company appears well-positioned to advance pelareorep through its most critical development phase. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: ImmunityBio, Inc. (NASDAQ: IBRX) achieved groundbreaking results in its pilot study for recurrent glioblastoma, reporting 100% disease control in all five patients treated with its investigational immune-boosting regimen combining ANKTIVA, NK cell therapy, and Optune Gio Tumor Treating Fields. Three of the five patients responded to treatment, with two achieving near complete responses while the remaining two maintained stable disease in this chemotherapy-free approach. ANKTIVA treatment increased absolute lymphocyte count in all five patients who had experienced lymphopenia after standard radiation and chemotherapy. "Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "There is compelling evidence that ANKTIVA's mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand." Based on these preliminary findings, ImmunityBio is initiating a randomized Phase 2 trial targeting second-line glioblastoma patients with recurring disease following standard care. The company also announced a new Phase 2 study to assess ANKTIVA in patients with long COVID, expanding its clinical research beyond cancer applications. Agenus Inc. (NASDAQ: AGEN) reported significant progress in the second quarter of 2025 as it is advancing its botensilimab (BOT) and balstilimab (BAL) immunotherapy combination, which delivered 42% two-year survival in refractory MSS colorectal cancer. "Our team is committed to advancing BOT/BAL to deliver meaningful benefits to patients with treatment-resistant cancers, and we are working with regulatory agencies to expedite access through a streamlined Phase 3 trial," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "With significant clinical progress, strategic partnerships, and prudent financial management, we are well-positioned to execute our vision of transforming cancer care." Agenus secured regulatory alignment for its Phase 3 BATTMAN trial initiation in Q4 2025 and expects a $91 million capital infusion from Zydus Lifesciences collaboration upon closing, and anticipates several significant milestones in the second half of 2025, including the global BATTMAN Phase 3 trial launch and new BOT/BAL clinical data presentations at major oncology congresses. Sutro Biopharma, Inc. (NASDAQ: STRO) delivered exceptional revenue growth in the second quarter of 2025, reporting $63.7 million compared to $25.7 million in Q2 2024, driven primarily by the Astellas collaboration and recognition of previously deferred revenue from Ipsen's decision not to advance the STRO-003 program. "Over the past several months, we've generated compelling preclinical data across our entire pipeline, further supporting our candidates' best-in-class potential as well as highlighting the unique capabilities of our platform technology," said Jane Chung, CEO of Sutro. "As we look to the second half of the year, we are well capitalized to meet our top priority of pipeline execution which we believe is critical to increasing shareholder value and we continue to look for ways to implement operating efficiencies and further extend our cash runway." Sutro's pipeline includes STRO-006, an integrin beta-6 ADC expected to enter clinical development in 2026, and a dual-payload ADC platform with an IND filing anticipated in 2027. The oncology company pioneering site-specific antibody drug conjugates maintained a strong cash position of $205.1 million and reduced operating expenses while preparing to initiate clinical trials for STRO-004, its next-generation Tissue Factor-targeting exatecan ADC, in the second half of 2025. Castle Biosciences, Inc. (NASDAQ: CSTL) announced the publication of new evidence supporting the use of its DecisionDx-SCC test in guiding treatment pathway decisions for NCCN high-risk cutaneous squamous cell carcinoma patients. A new validation study demonstrates that DecisionDx-SCC significantly outperforms current staging systems in predicting risk of local recurrence and metastasis, while a clinician survey confirms test results align with treatment decision-making thresholds for adjuvant radiation therapy and surveillance imaging. "These new data indicate that DecisionDx-SCC test results provide individualized risk predictions that doctors can use to guide risk-aligned escalation or de-escalation of care in their NCCN high-risk SCC patients," said Dr. Désirée Ratner, Mohs micrographic surgeon and clinical professor of dermatology at the NYU Grossman School of Medicine. "The ability of the test to reliably identify those patients with NCCN high-risk SCC at risk of developing local recurrence or metastasis is not only practice-changing for physicians who treat SCC, but also life-changing for their patients." The 40-gene expression profile test uses a patient's tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis and stratify patients into Class 1 (low), Class 2A (higher), or Class 2B (highest) risk categories. Castle Biosciences continues expanding clinical evidence for its genomic tests, with DecisionDx-SCC now validated for predicting local recurrence in addition to metastatic risk and likelihood of benefit from adjuvant radiation therapy. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. 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临床结果免疫疗法临床3期孤儿药

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

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适应症	国家/地区	公司	日期
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

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
新冠肺炎后遗症	临床2期	美国	ImmunityBio, Inc.	2025-08-01
前列腺腺癌	临床2期	-	ImmunityBio, Inc.	2025-05-15
铂耐药性卵巢癌	临床2期	美国	ImmunityBio, Inc.	2024-11-06
复发性铂耐药性卵巢癌	临床2期	美国	ImmunityBio, Inc.	2024-11-06
多形性胶质母细胞瘤	临床2期	美国	ImmunityBio, Inc.	2024-08-07
头颈癌转移	临床2期	美国	ImmunityBio, Inc.	2024-02-16
复发性头颈癌	临床2期	美国	ImmunityBio, Inc.	2024-02-16
复发性头颈部鳞状细胞癌	临床2期	美国	ImmunityBio, Inc.	2024-02-16

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临床结果

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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


NEWS 人工标引	N/A	复发性胶质母细胞瘤	5	Anktiva	壓製簾夢鹽簾願鬱憲構(窪顧壓積鑰廠膚糧願廠) = 夢鹽製繭遞蓋簾鹽網繭繭範鏇壓窪範遞糧觸築 (願鹽齋鹽窪襯觸鑰觸憲 )	积极	2025-08-29
NCT04390399 (QUILT-88, ASCO2025)	临床2期	转移性胰腺癌 ALC \| CA19-9	84	N-803 and PD-L1 t-haNK chemo-immunotherapy	簾繭選鏇壓觸範鹹齋鹹(顧餘網顧衊鹹夢鏇壓遞) = Grade 3 or higher TEAEs occurred in 95% of patients and were largely chemotherapy-associated 齋鹹範廠鹹壓鬱築醖淵 (襯鑰憲鹽遞艱範壓鹹製 )	积极	2025-05-30
				Low-dose SBRT and low-dose chemotherapy
NCT03022825 (QUILT-3.032, Company_Website \| Literature) 人工标引	临床2/3期	非肌层浸润性膀胱肿瘤	180	ANKTIVA®ANKTIVA® plus BCG (CIS with or without Papillary)	壓積衊鹹蓋範簾繭蓋窪(夢廠網憲顧廠衊積構鑰) = 醖繭糧觸餘鬱艱憲艱壓廠齋襯鹹願膚願網醖遞 (鏇廠鏇憲鹹廠醖願築獵 ) 更多	积极	2025-04-28
				ANKTIVA® Plus BCG (Papillary without CIS)	鏇獵願夢遞醖簾糧蓋鬱(艱廠製鹽鏇構願鹽壓繭) = 簾顧襯網鹹窪淵鹹鬱夢顧夢膚選夢遞糧鑰餘遞 (繭積餘網糧觸繭廠繭鹹 ) 更多
NCT03381586 (CTgov)	临床1期	-	20	ALT-803 (Group A)	願選網夢淵獵簾製餘獵(壓憲齋廠網襯糧鹹鏇齋) = 廠窪簾齋淵鑰製廠構淵窪憲憲襯壓襯襯遞範膚 (範築獵鹽艱艱簾憲鑰獵, 0.813) 更多	-	2025-03-24
				ALT-803 (Group B)	願選網夢淵獵簾製餘獵(壓憲齋廠網襯糧鹹鏇齋) = 餘願醖顧築衊範遞製蓋窪憲憲襯壓襯襯遞範膚 (範築獵鹽艱艱簾憲鑰獵, 0.095) 更多
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+ETBX-011+5-fluorouracil+ALT-803+ETBX-021+Nab-paclitaxel+Cyclophosphamide+Avelumab+haNK+Leucovorin+GI-6207+Regorafenib+oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	鹽夢繭憲遞艱膚觸願獵 = 蓋衊觸窪築壓艱構遞構窪築蓋壓鏇廠簾選餘淵 (壓廠鏇構鹽鏇蓋襯醖遞, 觸衊積鹹選壓簾鹹壓鬱 ~ 糧醖鑰顧鏇顧憲膚獵夢) 更多	-	2024-12-11
				Regorafenib (Regorafenib)	願構積糧鬱選鹽醖選鏇(淵選齋廠廠觸膚繭齋鹹) = 積蓋觸獵艱構艱鏇鑰鬱顧顧鏇鑰築觸艱願獵襯 (醖製膚窪淵選選鏇蓋衊, 廠選襯膚選築積範糧衊 ~ 壓構鏇鑰獵顧淵蓋夢鑰) 更多
NCT02099539 (CTgov)	临床1期	复发性多发性骨髓瘤 \| 难治性多发性骨髓瘤	19	N-803 (Cohort 1: N-803 - IV 1 ug/kg)	壓顧選襯醖衊襯窪鏇襯 = 憲廠鹹憲獵鹽鹽獵鹹繭衊範淵鹽衊蓋蓋壓艱夢 (廠艱範蓋膚顧積壓醖鬱, 簾鬱構積醖鬱顧獵遞廠 ~ 獵衊鑰願範顧齋衊鏇觸) 更多	-	2024-09-26
				N-803 (Cohort 2: N-803 - IV 3 ug/kg)	壓顧選襯醖衊襯窪鏇襯 = 製鬱夢築蓋餘鏇窪鹽繭衊範淵鹽衊蓋蓋壓艱夢 (廠艱範蓋膚顧積壓醖鬱, 壓壓繭繭製衊構願範醖 ~ 餘餘願鹽衊醖淵齋遞選) 更多
NCT03493945 (QuEST1, ESMO2024)	临床1/2期	去势抵抗性前列腺癌 dMMR \| pMMR	25	BNVax + BA + Anktiva	築網製窪糧夢窪蓋膚選(製廠淵製夢艱鏇衊衊糧) = 齋齋積鹽鹽獵範製窪積鹹糧網網膚網夢夢憲積 (衊構窪積糧構憲獵鹽夢, 39.9 ~ 83.9) 更多	积极	2024-09-15
NCT03228667 (QUILT 3.055, WCLC2024) 人工标引	临床2期	非小细胞肺癌二线 \| 末线 \| 三线 PDL1+	86	Anktiva 15mcg/knivolumabvolupembrolizumab	齋構蓋窪積鏇夢鹹網衊(鏇糧築繭襯鹽艱衊築夢) = injection site reaction 78 (91%), fatigue 46 (53%), chills 36 (42%). 範襯鬱糧鏇製繭簾選鏇 (選憲醖遞憲衊鹽願衊蓋 )	积极	2024-09-08
				Anktiva + CPI (nivolumab or pembrolizumab)pembrolizumab) (failure of CPI + 3rd line)
NCT04385849 (CTgov)	临床1期	新型冠状病毒感染	1	N-803 (Experimental Arm)	獵壓鹽膚顧鬱艱鏇醖鬱 = 鹽製艱鹹淵廠醖窪網構餘網製糧艱積壓餘膚膚 (築願醖簾憲範築夢淵鹹, 鏇壓積壓繭蓋網築築製 ~ 顧齋構範構範鏇築構製) 更多	-	2024-09-05
				Saline (Placebo Arm)	獵壓鹽膚顧鬱艱鏇醖鬱 = 觸遞選製憲觸遞願獵顧餘網製糧艱積壓餘膚膚 (築願醖簾憲範築夢淵鹹, 壓餘積築窪構齋醖壓窪 ~ 繭製壓鹽顧鹽糧築鹹鹽) 更多
NCT03387085 (QUILT-3.067, CTgov)	临床1/2期	三阴性乳腺癌	9	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+5-fluorouracil+N-803+nab-Paclitaxel+avelumab+Cyclophosphamide+haNK for Infusion+Leucovorin+GI-6207+cisplatin+bevacizumab+Capecitabine	願壓積夢衊夢廠鬱顧蓋 = 遞衊繭願積範繭鬱積願網鏇繭窪範蓋齋築製顧 (廠鹹遞窪壓蓋艱醖衊積, 鑰鹹蓋壓醖膚窪製獵獵 ~ 衊顧選夢壓觸鏇獵鏇範) 更多	-	2024-08-09