This early phase I trial tests the safety and how well N-803 works in treating patients with synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) that is growing, spreading, or getting worse (progressive) after being treated with adoptive cellular therapy (ACT) using T-cell receptor therapy (T-CRT). Synovial sarcoma is a rare, slow-growing cancer that affects the soft tissues, like muscles or ligaments near the joints. Myxoid/round cell liposarcoma is a rare type of soft tissue sarcoma cancer that originates from fat cells usually in the arms and legs. N-803 is a type of immunotherapy-a treatment that helps patients' own immune system fight cancer, and it is made up of a natural protein called interleukin-15 (IL-15) that is important for growing and activating immune cells. Studies have shown that patients can progress after initially responding to TCR-T, so this trial will use N-803 to stimulate rare persisting cells (cells that survive treatment and cause treatment failure and disease relapse) to make them work better at attacking the cancer. Adoptive cell therapy is a type of therapy that uses a patient's own immune cells to fight cancer. T-cell receptor therapy is a type of ACT that can recognize better recognize and bind to protein in cancer cells. Giving N-803 may be safe and tolerable in patients with SS or MRCL.

开始日期2026-09-02

申办/合作机构

Northwestern University

[+1]

NCT07355205

/ Not yet recruiting临床2期IIT

A Phase II, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)

This is an open-label, single center, one cohort, non-randomized, phase II study. The aim of the study is to evaluate the efficacy and safety of the combination of nivolumab and ipilimumab with nogapendekin alfa inbakicept in patients with stage IV or recurrent non-small cell lung cancer (NSCLC). It is hypothesized that the study treatment will be safe and well tolerated and will improve progression-free survival when compared to a historical study which treated advanced NSCLC patients with nivolumab plus ipilimumab. Patients will be treated in cycles lasting 6 weeks with two to three different chemotherapy drugs to up to 24 months.

开始日期2026-03-31

申办/合作机构

Washington University School of Medicine

[+2]

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2026-03-04

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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322

项与诺格白介素α-因奇西普相关的文献（医药）

2026-05-01·Biomaterials advances

A novel ROS switcher potentiates the type-I photodynamic effect of sodium zinc chlorophyllin against Pseudomonas aeruginosa in diabetic wounds

Article

作者: Yuan, Cai ; Wang, Guodong ; Chen, Hongjie ; Huang, Mingdong ; Wu, Lusheng

Skin wound infections present a serious threat to human health, with bacterial infections in diabetic wounds being particularly challenging due to impaired healing. Gram-negative bacteria are common pathogens in diabetic wound infections and often exhibit high resistance to conventional treatments, necessitating prolonged and costly therapies. Photodynamic antibacterial therapy (PACT) is regarded as a non-invasive and effective approach, with minimal risk of inducing resistance. Sodium zinc chlorophyllin (ZnChl), a water-soluble metalloporphyrin photosensitizer, offers multiple advantages such as low cost, high safety, and the ability to promote wound healing. However, its bactericidal efficacy against Gram-negative bacteria is limited under the hypoxic conditions typically found in diabetic wounds. Herein, we report a strategy to develop an efficient chlorophyll-based photosensitizer operating via an oxygen-independent Type I mechanism by combining ZnChl with inorganic salts (NaI, KBr, or KI). This approach significantly improved antibacterial performance, particularly with NaI or KI. Upon 630 nm light irradiation, low concentrations of KI (5 mM) markedly enhanced the bactericidal effect of ZnChl (50 μM), reducing the survival of three Gram-negative bacterial strains by 3 logs (99.9%). Interestingly, we further discovered that KI acts as a "reactive oxygen species (ROS) converter," shifting the photodynamic mechanism of ZnChl from a mixed Type I/Type II mode to a dominant Type I mechanism, generating highly reactive hydroxyl radicals (OH). Moreover, the ZnChl-KI combination demonstrated significant therapeutic efficacy in treating Pseudomonas aeruginosa-infected diabetic wounds without inducing apparent toxicity in rats. This work provides a foundation for developing efficient and economical Type I photosensitizers for the treatment of bacterial infections in diabetic wounds.

2026-03-01·Molecular therapy. Oncology

Efficiently targeting neuroblastoma with the combination of anti-ROR1 CAR NK cells and N-803 in vitro and in vivo in NB xenografts

作者: Cripe, Timothy P. ; Cairo, Mitchell S. ; Liao, Yanling ; Riddell, Stanley ; Ayello, Janet ; Chu, Yaya ; Ozkaynak, Mehmet F. ; Tian, Meijuan ; Ayala-Cuesta, Jessica ; Klose, Kayleigh ; Luo, Wen ; Lee, Dean A. ; Foley, Keira ; Nayyar, Gaurav ; Behbehani, Gregory K. ; Mendelowitz, Alyssa S.

[This corrects the article DOI: 10.1016/j.omton.2024.200820.].

2026-02-12·Zhonghua er ke za zhi = Chinese journal of pediatrics

[Analysis of viral nucleic acid negativity and neuraminidase inhibitor use in children with severe influenza].

Article

作者: Li, Z ; Liu, Y C ; Fang, B L ; Li, K C ; Qian, S Y ; Liu, G

Objectives: To determine the time to influenza virus nucleic acid clearance and the treatment duration of neuraminidase inhibitors (NAI) in children with severe influenza admitted to the pediatric intensive care unit (PICU) following NAI initiation. This study further aimed to identify factors associated with delayed viral clearance and to evaluate the appropriateness of different NAI discontinuation strategies. Methods: In this retrospective cohort study, we analyzed the clinical data of 79 children with severe influenza admitted to the PICU of Beijing Children's Hospital between November 2019 and July 2024. Inclusion criteria were continuous NAI administration for ≥72 h after admission, and serial nasopharyngeal swab tests for influenza virus nucleic acid performed at 3 to 5 d intervals following NAI initiation until clearance or discharge. Collected data included demographic characteristics, serial nucleic acid test results, body temperature, NAI treatment duration, and in-hospital mortality were collected. Children were stratified into three groups based on time from NAI initiation to viral nucleic acid clearance:≤5 d, 6-10 d, and >10 d, the latter 2 of which belong to the delayed clearance group. They were also categorized according to clinical status at NAI discontinuation: the fever group (fever present, nucleic acid negative), the necleic acid-positive group (afebrile, nucleic acid positive) and the double-negative group (afebrile, nucleic acid negative). Select the appropriate statistical test from among the Chi-square test, Kruskal-Wallis H test, or Mann-Whitney U test to compare between-group differences in the following variables: duration of NA use, co-infection rate, proportion of patients with fever after 5 days of NA use, pediatric risk of mortality III score (PRISM III) at 48 h after NA discontinuation, pediatric sequential organ failure assessment score (pSOFA) , and in-hospital mortality rate. Results: Of the 79 children with severe influenza, 43 (54%) were male and 36 (46%) female. The age was 4.6 (2.3,7.7) years. Patients were categorized into the ≤5 d (30 cases), 6-10 d (34 cases), and >10 d (15 cases) groups. The overall proportion of delayed clearance was 62% (49/79). The >10 d group demonstrated a significantly longer duration of NAI therapy, higher co-infection rate, and a greater proportion of patients with persistent fever after 5 d of treatment compared to the other groups (all P<0.05). The ≤5 d group had the lowest incidence of lymphopenia detected on days 4 and 5 after PICU admission (χ²=6.08, P<0.05). No significant differences were observed among the fever (11 cases), nucleic acid-positive (26 cases), and double-negative (42 cases) groups regarding in-hospital mortality, PRISM Ⅲ, or pSOFA at 48 h after NAI discontinuation (P>0.05). Conclusions: A considerable proportion of children with severe influenza in the PICU experienced delayed viral clearance after NAI initiation, which was associated with a longer treatment course, particularly in those requiring >10 d for clearance Discontinuation of NAI upon achieving virological clearance or defervescence may be considered, but this strategy requires careful clinical judgment tailored to the individual patient.

323

项与诺格白介素α-因奇西普相关的新闻（医药）

2026-02-26

·BioSpace

ImmunityBio Completes Enrollment in Pivotal Randomized Trial Evaluating ANKTIVA® Plus BCG Versus BCG Alone in BCG-Naïve Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Study fully enrolled ahead of schedule, with 366 of 366 BCG-naïve NMIBC patients randomized to receive BCG alone or ANKTIVA plus BCG Interim analysis requested by the FDA demonstrated a statistically significant improvement in duration of complete response with ANKTIVA plus BCG, with no significant safety signals observed Company anticipates submitting a biologics license application (BLA) to the U.S. FDA by Q4 2026 Expanded access program (EAP) of recombinant BCG is ongoing, with 580 patients currently enrolled throughout the U.S. CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio ( NASDAQ: IBRX ), a commercial-stage immunotherapy company, today announced completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA ® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. The QUILT 2.005 trial (NCT02138734), which completed enrollment ahead of schedule, includes 366 patients randomized to receive either BCG alone, the current standard-of-care for NMIBC CIS, or ANKTIVA in combination with BCG. An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated that treatment with ANKTIVA plus BCG resulted in a statistically significant improvement in the duration of complete response compared with BCG alone, with no significant safety concerns reported. The interim analysis demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. Despite the limited sample size of the interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455). 1 “The interim results from this randomized study are encouraging and suggest that ANKTIVA plus BCG may improve the durability of response in patients with BCG-naïve NMIBC,” said Dr. Christopher Pieczonka, Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the trial. “Given the historical limitations of BCG alone, continued evaluation of this combination has the potential to inform future treatment strategies and potentially change the current standard-of-care recommendations for NMIBC. Importantly, no new or worsening safety signals have been observed to date, which is encouraging when considered alongside prior studies evaluating BCG in combination with checkpoint inhibitors in this disease setting.” Additional study results are expected to be available in the fourth quarter of 2026. Based on these data, ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026. “We are encouraged by these interim results and await the final unblinding of the completed trial,” said Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “If approved, ANKTIVA plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS, building on the therapy’s existing approval in the BCG-unresponsive setting.” In parallel, ImmunityBio continues to address the ongoing shortage of TICE ® BCG through its Expanded Access Program (EAP) for recombinant BCG (NCT06810141), which is progressing and supporting patient access. The Company has requested consultation with the FDA regarding the potential approval of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including for patients with BCG-naïve disease. About ANKTIVA ® (nogapendekin alfa inbakicept-pmln) The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA ® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA ® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA ® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA ® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA ® at Anktiva.com . References: Reddy S, et al. QUILT-2.005: A comparison of intravesical Bacillus Calmette-Guérin (BCG) in combination with the IL-15 superagonist N-803 versus BCG alone in patients with BCG-naïve NMIBC. Presented at AUA Annual Meeting 2024; May 3–6, 2024; San Antonio, TX. 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 superagonist, 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 plus BCG in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS); the potential for ANKTIVA plus BCG to improve durability of complete response compared to BCG alone; the timing, availability, and results of additional data from the QUILT 2.005 trial; the Company’s anticipated submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) by the fourth quarter of 2026; the potential for FDA approval of ANKTIVA in the BCG-naïve setting; the potential for ANKTIVA plus BCG to change the standard of care for NMIBC; the progress and potential regulatory outcome of the Company’s Expanded Access Program for recombinant BCG; the potential approval of recombinant BCG as an alternative supply source; and the broader capabilities and expected benefits of the Company’s Cancer BioShield™ platform. 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 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

临床结果免疫疗法临床2期上市批准

2026-02-25

·PRNewswire

Immuno-Oncology Investments Accelerate as Pipeline Catalysts Multiply in 2026

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 25, 2026 /PRNewswire/ -- Equity Insider News Commentary, The immuno-oncology market is forecast to grow from $65.22 billion in 2025 to $170.19 billion by 2032, fueled by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines[1]. Five companies positioned at the forefront of this expansion include Oncolytics Biotech (NASDAQ: ONCY), ImmunityBio (NASDAQ: IBRX), CRISPR Therapeutics (NASDAQ: CRSP), BioNTech (NASDAQ: BNTX), and Novocure (NASDAQ: NVCR). The broader oncology market is projected to nearly triple from $279.98 billion to $748.17 billion by 2035, with North America commanding a 43% market share[2]. Targeted therapy remains the fastest-growing segment within the $335.2 billion cancer drugs market projected for 2033, as personalized medicine reshapes treatment paradigms[3]. Oncolytics Biotech Inc. (NASDAQ: ONCY) recently announced its decision to focus on registrational programs in anal and colorectal cancer, concluding enrollment in the GOBLET gastrointestinal study after generating sufficient clinical and translational data to chart a clear path toward FDA approval. The promising efficacy signal in GOBLET Cohort 4 has defined a clear registrational path for pelareorep in second-line and later squamous cell anal cancer, a setting where available therapies offer only limited benefit to patients. Oncolytics expects to meet with the FDA in mid-April to align on study design, and believes a clinical trial of well under 100 subjects will be sufficient to secure approval in this rare cancer indication. With sufficient cash on hand to execute near-term milestones, the company expects to avoid immediate material dilution, redirecting capital from the GOBLET cohorts toward its highest-conviction registration programs. "GOBLET has done its job successfully. We now know where pelareorep can make the greatest impact for patients and where we can pursue approval most efficiently," said Jared Kelly, CEO of Oncolytics Biotech. "Our disciplined strategy is to run registrational or registration-enabling studies with ruthless efficiency that can create maximum shareholder value without unnecessary dilution." The registration push builds on pelareorep's recent Fast Track Designation from the FDA for second-line KRAS-mutant microsatellite-stable (MSS) metastatic colorectal cancer. Clinical data showed pelareorep combined with standard chemotherapy and Avastin® achieved a 33% response rate versus roughly 10% with chemotherapy and Avastin®, while median overall survival reached 27 months versus 11.2 months with standard treatment. KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat populations, with limited options after first-line treatment fails. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually. The company plans to launch a controlled study with the first clinical site activating in March and interim data expected by year-end 2026. Pelareorep is also delivering strong results in anal cancer, where third-line patients achieved a 29% response rate with the median duration of response lasting around 17 months in a setting with no FDA-approved treatments. In second-line or later patients, the 30% response rate more than doubled the benchmark for the FDA-approved immunotherapy. The company continues strengthening its leadership, having recently appointed John McAdory as EVP of Strategy and Operations and Yujun Wu as Head of Biostatistics. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments: ImmunityBio (NASDAQ: IBRX) recently announced a partnership with Accord Healthcare to expand European access to ANKTIVA for bladder cancer patients across 33 countries. ANKTIVA achieved a 71% complete response rate in BCG-unresponsive non-muscle invasive bladder cancer, with approvals spanning the U.S., EU, UK, and Saudi Arabia. "Our partnership with Accord marks a significant step in our European growth strategy and our mission to redefine cancer care," said Richard Adcock, President and CEO of ImmunityBio. The company continues to advance its IL-15 receptor agonist platform. CRISPR Therapeutics (NASDAQ: CRSP) provided a business update reporting encouraging clinical data from its allogeneic CAR-T candidate, zugocabtagene geleucel (zugo-cel), in both autoimmune disease and oncology indications. CASGEVY generated $116 million in full-year 2025 revenue, with patient initiations increasing nearly three-fold year-over-year. "We made meaningful advances across multiple clinical and preclinical programs, including encouraging data from zugo-cel in autoimmune disease and oncology, continued global uptake of CASGEVY, and important developments across our in vivo liver editing portfolio," said Samarth Kulkarni, Ph.D., Chairman and CEO of CRISPR Therapeutics. The company is building a differentiated oncology platform with its allogeneic CAR-T approach, which could enable off-the-shelf cancer therapies without patient-specific manufacturing. BioNTech (NASDAQ: BNTX) outlined its 2026 strategy at the J.P. Morgan Healthcare Conference, detailing plans to initiate six additional Phase 3 clinical trials this year. The company now has more than 25 ongoing Phase 2 or 3 oncology trials spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. "We see 2026 as a year when science translates into tangible results," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. The company held approximately 17.2 billion euros in cash as of December 2025, positioning it to fund at least 17 late-stage data readouts expected by 2030. Novocure (NASDAQ: NVCR) received FDA approval for its Optune Pax system in locally advanced pancreatic cancer, the first new treatment approved for this indication in approximately 30 years. The Phase 3 PANOVA-3 trial demonstrated a statistically significant improvement in overall survival. "Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells," said Frank Leonard, CEO, Novocure. The Tumor Treating Fields platform is also approved in certain countries for glioblastoma and malignant pleural mesothelioma, with additional pipeline candidates in development. Article Source: CONTACT: EQUITY INSIDER [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. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES: Logo - 21% more press release views with Request a Demo

免疫疗法临床3期临床结果高管变更快速通道

2026-02-25

·药时空

打爆空头，PD-1挑战者今年5倍了

创新药公司如何打爆空头？Immunity Bio正在“手把手”教你如何做到。拥有已商业化IL-15超级激动剂ANKTIVA的Immunity Bio（IBRX）在2026年以来经历了暴涨，从年初的2美元/股上涨至如今的11.55美元/股，年内累计涨幅高达483.33%。过去一年这家公司是被空头最喜爱的生物科技标的之一，但1月21日有报道指出IBRX反弹已经让空头们账面浮亏4.92亿美元，如今看来这一数字只会更多。 IBRX到底经历了什么又或是做出了什么改变，让自身市值实现大反转，如今公司的市值已经来到了118.75亿美元，这显然是一个值得细品的课题。 01 一扫2025阴霾，2026疯狂输出 IBRX近两年核心价值在于IL-15激动剂ANKTIVA在非肌层浸润性膀胱癌（NMIBC）和转移性非小细胞肺癌（NSCLC）两大适应症赛道。 2025年公司价值受到压制主要基于几个方面： 1）早在2024年4月FDA批准了ANKTIVA获批了联合卡介苗（BCG）用于BCG无应答的非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS），但商业化早期放量不及预期，上市首年仅取得3000万美元出头的收入，显著低于同适应症药物的上市放量速度，这一困境与BCG在美国短缺有关（IBRX已与印度血清研究所合作解决BCG供给替代问题）； 2）早在2024Q1提交乳头状NMIBC（无CIS）的sBLA，2025年收到FDA完整回复函（CRL）或需要额外数据； 3）2025年9月FDA强生批准BCG无应答、携带CIS的成人NMIBC患者，对ANKTIVA形成显著竞争压力； 4）ANKTIVA收入迟迟未能放大对公司经营造成巨大压力，2025年前三季度单季收入分别为1651万美元、2642万美元、3206万美元，但单季归母净亏损仍达1.3亿美元、9257万美元和6727万美元，同时公司现金储备显得捉襟见肘（2025Q2现金只剩1.54亿美元，融资压力高企）；而在2025底至2026年开年，什么催化使得IBRX彻底反转？ 1）全球审批全面开花&商业化渐入佳境：开年以来ANKTIVA在沙特批准了NMIBC、NSCLC两大适应症，以及欧盟也批准了首个NMIBC适应症，配合公司在2025Q4继续环比增长放量，ANKTIVA商业化趋势向好； 2）临床进展：更早线的BCG初治NMIBC的III期临床试验进展顺利，预计2026年上半年完成入组并读出结果（在最后一例患者入组结束后6个月即可提交sBLA）。另外，ANKTIVA有望获得NCCN更新拓展至乳头状NMIBC； 3）联合药物BCG受限得到解决：印度血清研究所采用不锈钢罐大规模生产替代传统工艺，生产周期从数月缩短至数周且质量更稳定。上述催化涉及ANKTIVA欧洲、中东市场扩围，沙特率先批准二线转移性NSCLC对美欧后续审批有一定先行意义，BCG初治NMIBC和乳头状NMIBC均在短中期内有望进入商业化（市场较现在翻数倍），以及商业化掣肘阴霾正在消散。 02 NMIBC吃饱，NSCLC开跑那么问题来了，ANKTIVA目前在NMIBC和后线NSCLC能有多大的市场潜力？ NMIBC并不算一个小适应症，而ANKTIVA等新疗法年费用较高（≥25万美元），仅高危BCG无应答患者人群并可支撑单一创新药物在美国实现15亿美元-25亿美元峰值销售。在NMIBC领域，ANKTIVA目前面临几大创新药物同台竞技，其中带来巨大威胁的竞品分别是强生的TAR-200和CGON的Cretostimogene。以数据更新最多的BCG无应答NMIBC（伴CIS）适应症为例，三款产品有各自的优势： 1）各自研究的完全缓解率来看，TAR-200的CR率高达82%（存在耐药导致CR率下滑风险），而Cretostimogene和ANKTIVA分别为76%和62%； 2）从治疗持续时间角度看，ANKTIVA拥有更坚实的长期随访证据，QUILT-3.032研究患者中位CR持续时间超53个月，部分患者>4年无复发；而TAR-200尚未提供三年期随访数据，数据显示mDOR约25.8个月，同样Cretostimogene也并未能提供3年期随访数据； 3）给药方式层面，TAR-200的总给药时间（15 - 45分钟），显著短于cretostimogene（约2小时）和ANKTIVA（与BCG序贯膀胱灌注，好处是符合过往医生习惯，2个小时以上）其他疗法，不过TAR-200必须由泌尿科医生操作； 4）时间先发角度，目前ANKTIVA已经来到上市第二年并已经获得医保J-Code，强生TAR-200在2025Q3获批（管理层预计要获得J-Code后才可快速放量），而Cretostimogene预计2026年下半年获准，古根海姆认为2030年之前ANKTIVA、TAR-200占有相当市场地位。 NSCLC方面，ANKTIVA目前罪最快的寻求批准路径是PD‑1±化疗一线失败的2–3线NSCLC患者，这类患者主要治疗方式是“多西他赛±抗血管生成药或ADC”，存在大量未满足需求。在QUILT‑3.055研究中：Anktiva+PD‑1联合方案的中位总生存期（mOS）为14.1个月，显著长于历史上多西他赛等化疗7–10个月的标准。在PD-1耐药后的2-3线NSCLC人群，由于治疗时间短、其他药物竞争有限，海外机构给到对应峰值为5-10亿美元。不过Immunity Bio在上个月公布了QUILT-2.023研究结果（联合PD-1治疗一线NSCLC，但后续因一线治疗变化停止入组）：绝对淋巴细胞计数（ALC）比基线显著且持续增加（p=0.0065），确立了ANKTIVA作为淋巴细胞刺激剂的贡献，后续不排除公司开展新三期继续进军一线市场。 03 IL-15的广谱性故事 ANKTIVA作为IL-15激动剂，其治疗广谱性具备很强的想象力（IL-15是NK细胞和CD8+T细胞增殖活化的关键细胞因子，几乎所有实体瘤均存在免疫逃逸，均可从免疫激活中获益），并且可以根据不同肿瘤进行不同类型注射（皮下/膀胱）。目前除了NMIBC、NSCLC外，Immunity Bio在多个瘤种进行临床探索，横跨实体瘤和血液瘤，展现出极强的治疗广谱性。以在“难治”的胶质母细胞瘤（GBM）为例，ANKTIVA联合CAR-NK细胞疗法治疗治疗二线复发或进展的GBM患者QUILT-3.078研究显示：在可评估的14例患者中，从疾病复发时间起已观察到的最长生存期达12个月，随访仍持续进行。值得注意的是，在既往二线及以上GBM中，传统疗法mOS一般仅6-9个月，且反复复发患者预后极差。另外QUILT-3.078研究入组患者存在严重淋巴细胞减少，但经过ANKTIVA组合疗法单周期治疗后内平均绝对淋巴细胞计数（ALC）即显著升高，代表ANKTIVA能有效逆转免疫抑制，增强NK与CD8+T细胞参与肿瘤杀伤。理论上，ANKTIVA在GBM这类冷肿瘤上依旧具备免疫激活/逆转免疫抑制的疗效，其可拓展瘤种可以覆盖大量目前PD-1无效的难治性肿瘤，可以成为一个“免疫治疗的万金油”。结语：虽然有泛瘤种的故事在支撑，ANKTIVA目前在NMIBC和NSCLC的表现并未展现出Immunity Bio匹配百亿美金市值的基本面，或许更多是市场对未来预期的情绪溢价，但Immunity Bio股价反转打爆空头的这波操作，仍然值得细细品味。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

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
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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
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

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
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
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
复发性非小细胞肺癌	临床2期	美国	ImmunityBio, Inc.	2026-03-31
新冠肺炎后遗症	临床2期	美国	ImmunityBio, Inc.	2025-09-04
前列腺腺癌	临床2期	-	ImmunityBio, Inc.	2025-05-15
前列腺癌	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

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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


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)	餘齋襯築遞窪鹽齋襯淵 = 鏇鑰顧積繭構繭範簾築艱窪繭衊淵衊壓廠範蓋 (鹽鬱網壓構齋廠壓遞齋, 窪構鹹範簾鹽廠鹹廠夢 ~ 繭觸顧齋製顧積鹹構糧) 更多	-	2026-02-17
				ALT-803+Nivolumab (Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg)	餘齋襯築遞窪鹽齋襯淵 = 構壓餘窪鬱壓願夢構鹹艱窪繭衊淵衊壓廠範蓋 (鹽鬱網壓構齋廠壓遞齋, 製構淵顧壓憲範鏇繭鬱 ~ 鹽蓋範窪簾窪選蓋蓋製) 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	鑰鏇繭簾窪製夢襯遞獵(齋糧淵繭網淵鏇選醖鑰) = 簾簾鏇鬱選襯衊範齋選簾廠獵積鹹鑰衊醖獵淵 (築鏇構簾鏇廠選廠鏇壓 ) 更多	不佳	2026-02-05
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	衊餘鬱壓膚淵糧繭糧鹹(鬱淵齋廠構鬱蓋醖獵糧): P-Value = 0.0065	积极	2026-01-13
				CPI
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)	壓憲廠淵積遞繭網壓鏇(網廠繭積鏇衊鹽觸餘窪) = 艱廠網遞齋簾觸遞選醖積鏇築簾遞壓鹽範齋鏇 (鏇製衊遞積網齋艱糧襯 )	积极	2026-01-13
				ANKTIVA + CPI (NSCLC + Responders)	築蓋廠蓋積蓋壓窪繭蓋(憲網鑰膚淵醖顧衊網壓) = 遞積廠醖廠廠廠廠網製衊醖窪鬱製窪鹹醖廠鹹 (壓構糧簾壓艱鏇艱糧淵 )
NCT03493945 (QuEST1, SITC2025)	临床1/2期	去势抵抗性前列腺癌	37	BNVax+BA+NAI	醖獵獵壓艱壓膚餘網範(範築醖齋觸鏇鹽網製製) = 淵選積網餘築構範膚艱襯繭範網選蓋範齋顧觸 (齋蓋鹹築範鏇簾夢遞壓 )	积极	2025-11-05
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)	淵簾積膚網鏇鏇選製構(窪鏇鹽鹽餘醖壓鹹壓鏇) = 製觸糧製蓋觸積衊艱築獵鏇衊遞構糧衊簾顧獵 (壓製範憲衊夢窪鑰襯齋, 46.6 ~ 68.2) 更多	积极	2025-11-03
NEWS 人工标引	N/A	复发性胶质母细胞瘤	5	Anktiva	襯簾選顧觸鏇繭構網遞(膚襯壓蓋鬱鑰築構選築) = 築積積製鹽齋餘餘膚蓋繭願鏇齋餘醖範築遞鹽 (廠艱鑰製鹽遞膚簾築齋 )	积极	2025-08-29
NCT03493945 (QuEST1, CTgov)	临床1/2期	局部晚期恶性实体瘤 \| 晚期恶性实体瘤	59	castration+M7824+BN-Brachyury (Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A)	鏇願憲壓鹹獵蓋積醖糧 = 憲餘願淵構願窪鹽製選網鏇構餘齋鑰壓鏇觸築 (廠艱簾壓壓蓋獵廠選選, 夢繭醖齋觸繭鏇選觸積 ~ 壓鑰蓋選積窪願鑰獵構) 更多	-	2025-06-08
				N-803+M7824+BN-Brachyury (All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion)	鏇願憲壓鹹獵蓋積醖糧 = 夢蓋壓製壓壓鬱壓積鏇網鏇構餘齋鑰壓鏇觸築 (廠艱簾壓壓蓋獵廠選選, 齋憲構艱膚餘醖鬱鏇積 ~ 選願醖鏇願願範觸廠蓋) 更多
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	衊齋築鏇鹹獵觸襯餘構(鬱鹹鏇淵壓獵淵襯艱廠) = Grade 3 or higher TEAEs occurred in 95% of patients and were largely chemotherapy-associated 築築窪獵顧範築積顧壓 (淵衊築膚顧構夢鹹窪憲 )	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)	淵壓窪鏇衊壓鹹壓製膚(蓋餘夢膚襯齋壓積壓衊) = 願餘糧憲齋製繭蓋醖簾築觸膚衊鹹範鹹鬱築憲 (衊壓醖糧鹽膚醖構餘築 ) 更多	积极	2025-04-28
				ANKTIVA® Plus BCG (Papillary without CIS)	構餘鬱遞築築夢淵鹹簾(鬱艱範簾鏇鏇鬱醖窪夢) = 鏇鏇鹽淵遞鑰製衊觸醖觸積廠簾網範齋醖齋構 (齋製簾鏇淵簾獵顧遞淵 ) 更多