A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With LA-HNSCC

This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) / radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

开始日期2022-01-27

申办/合作机构

Johnson & Johnson Enterprise Innovation, Inc.

NCT04484909

/ Recruiting临床1期IIT

Phase I Study of NBTXR3 Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Ductal Adenocarcinoma

To find the recommended dose of NBTXR3 that can be given in combination with radiation therapy to patients with pancreatic cancer. To learn if the dose NBTXR3 found in Part 1 can help to control the disease.

开始日期2020-07-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT03589339

/ Recruiting临床1期

A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.

开始日期2019-01-16

申办/合作机构

Nanobiotix SA

100 项与氧化铪纳米制剂相关的临床结果

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100 项与氧化铪纳米制剂相关的转化医学

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100 项与氧化铪纳米制剂相关的专利（医药）

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23,502

项与氧化铪纳米制剂相关的文献（医药）

2025-10-01·JOURNAL OF THE EUROPEAN CERAMIC SOCIETY

Air-plasma ablation behavior and mechanisms of C/C-(Zr,Hf,Ti)C composites prepared by an unidirectional RMI method

作者: Zhang, Hongbo ; Liu, Zaidong ; Wang, Yalei ; Liu, Junwen ; Xiong, Xiang ; Li, Zhiqiang ; Wang, Jinming ; Long, Quanyuan ; Ye, Zhiyong ; Li, Tongqi

(Zr,Hf,Ti)C ceramics with various components were introduced into a C/C skeleton to prepare C/C-(Zr,Hf,Ti)C composites using an unidirectional reactive melt infiltration method.A gradient distribution of Ti was observed along the infiltration direction.The microstructure and ablation behaviors of the C/C-(Zr,Hf,Ti)C composites were investigated at temperatures up to 2600 °C.A coherent and compact oxide layer was formed on the composite containing 10 at% Ti, resulting in optimal ablation resistance with the linear ablation rate being recorded at -2.62 μm/s.Enhanced intergranular diffusion in solid-oxide, facilitated by a suitable amount of liquid phase within the grain boundary, contributes to the superior mech. erosion resistance of the dense layer.A deficient or excessive amount of liquid phase is believed to escalate the formation of cracks and voids, thereby diminishing the ablation resistance under high-speed air-plasma conditions.

2025-10-01·JOURNAL OF THE EUROPEAN CERAMIC SOCIETY

Composition design and preparation of rare-earth-free high-entropy fluorite oxides

作者: Chen, Guangjin ; Zhang, Yuwei ; Li, Cuiwei ; Liu, Tianyu ; Zhao, Chenran ; Chen, Kepi

High-entropy fluorite oxides (HEFOs) demonstrate a broader application prospect as thermal insulators due to their outstanding properties.Currently, the synthesized HEFOs contain at least one type of rare earth elements (REEs), which are listed as critical materials by some international institutions.To explore the possibility of rare-earth-free HEFOs, first-principals calculations and the solid state reaction method were employed by adjusting the mean cation radius (r) and oxygen vacancy concentration (O_vac) of (Ca,Zr,Hf,Sn,Ti)O_2-δ.The first-principles calculations results indicate that the Gibbs free energy change (ΔG(T)) could be controlled by adjusting r and O_vac, and the ΔG(T) of (Ca_0.2Zr_0.2Hf_0.2Sn_0.2Ti_0.2)O_2-δ was slightly higher than zero.After further detailed composition design, a novel rare-earth-free HEFOs composed of (Ca_0.2Zr_0.28Hf_0.28Sn_0.19Ti_0.05)O_2-δ with a higher r has been successfully synthesized for the first time.Its thermal conductivity is 1.22 W·m^-1·K^-1, which is much lower than that of most HEFOs mainly composed of REEs.

2025-10-01·JOURNAL OF THE EUROPEAN CERAMIC SOCIETY

Microstructure and interfacial stability of diffusion bonded HfB2-SiC and ZrB2-SiC based composites

作者: Singh, Kunwar Pratap ; Setia, Prince ; Venkateswaran, T. ; Bajpai, Shipra ; Balani, Kantesh

Manufacturing of complex-shaped UHTCs occasionally requires joining of dissimilar materials.Herein diffusion bonded (1800 °C and 40 MPa) two dissimilar composites, ZrB₂-20vol%SiC (ZS) and HfB₂-20vol% SiC (HS), are compared with similar ones i.e., ZS-ZS.The ZS-ZS joints exhibit a seamless interface with uniform hardness (∼20 GPa) and Young′s Modulus (∼366 GPa).For ZS-HS, diffusion and reactivity between Hf and Zr created an interface with (Zr, Hf)B₂ solid solution, thus, decreasing interfacial hardness and Young′s modulus (by ∼17 %, ∼3 %) from HS sides, but were similar to that of ZS side.Under compressive stresses, both joints exhibited interfacial stability and comparable bending and shear strength, i.e., (∼259 MPa, ∼87 MPa for ZS-HS, and ∼296 MPa, ∼113 MPa for ZS-ZS).Though good thermal stability of joints is observed when oxidized at 1400 °C, 60 min, ZS-ZS joints with uniform mech. properties and good structural and thermal stability are more promising for complex shape applications.

142

项与氧化铪纳米制剂相关的新闻（医药）

2025-05-21

·ir.nanobiotix.com

Nanobiotix Provides First Quarter 2025 Operational and Financial Update

Dosing of a first patient in the CONVERGE study, a Phase 2 randomized controlled clinical trial for patients with stage 3 unresectable non-small cell lung cancer Presentation of data at the European Lung Cancer Conference in a Phase 1 study of re-irradiation with JNJ-1900 (NBTXR3) in locoregional recurrent NSCLC and a Phase 1 study of JNJ-1900 (NBTXR3) in combination with nivolumab or pembrolizumab for patients with lung metastases from NSCLC or other solid tumors Strengthened financial position through an amendment to the global licensing agreement for JNJ-1900 (NBTXR3) which extended cash runway into mid-2026 and permanently reduced operational cash burn €39.8 million in cash and cash equivalents as of March 31, 2025 PARIS and CAMBRIDGE, Mass., May 21, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today provided an update on operational progress and reported financial results for the first quarter of 2025. “We are pleased with the execution across the JNJ-1900 (NBTXR3) development programs and are excited for the important milestones ahead. NANORAY-312 continues to advance in head and neck cancer, with our ongoing global transfer of sponsorship moving toward completion, and the recent expansion of development into lung cancer through the CONVERGE study. We were also pleased by the updated clinical data further supporting expansion into indications including lung cancer amenable to re-irradiation recently presented by MD Anderson at ESTRO and ELCC, respectively and locally advanced or borderline resectable pancreatic cancer,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. Operational Highlights Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE) First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025 NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson) Presented first data showing a favorable safety profile and early signals of efficacy from the completed dose escalation part of a Phase 1 study evaluating radiotherapy-activated JNJ-1900 (NBTXR3) as a second or later line (2L+) therapy at the 2025 European Lung Cancer Conference (ELCC). Amendment to global licensing agreement for JNJ-1900 (NBTXR3) extended cash runway to mid-2026 with a meaningful reduction in cash burn expected moving forward Removed the vast majority of the funding obligation for NANORAY-312 and released Johnson & Johnson from select future potential milestone payments, while safeguarding hundreds of millions in potential milestone and royalty payments for lead programs for Nanobiotix First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer (“NSCLC”) in 1Q2025 Presented first data showing a favorable safety profile and early signals of efficacy from the completed dose escalation part of a Phase 1 study evaluating radiotherapy-activated JNJ-1900 (NBTXR3) as a second or later line (2L+) therapy at the 2025 European Lung Cancer Conference (ELCC). Removed the vast majority of the funding obligation for NANORAY-312 and released Johnson & Johnson from select future potential milestone payments, while safeguarding hundreds of millions in potential milestone and royalty payments for lead programs for Nanobiotix Subsequent events Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson")) Presented full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) demonstrating encouraging oncologic outcomes and a favorable safety profile supporting further exploration in a randomized study at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025) Recruitment ongoing in new cohort evaluating JNJ-1900 (NBTXR3) combined with standard-of-care chemotherapy followed by concurrent chemoradiation (“CCRT” – with capecitabine or 5-FU) with first patient already injected Presented full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) demonstrating encouraging oncologic outcomes and a favorable safety profile supporting further exploration in a randomized study at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025) Recruitment ongoing in new cohort evaluating JNJ-1900 (NBTXR3) combined with standard-of-care chemotherapy followed by concurrent chemoradiation (“CCRT” – with capecitabine or 5-FU) with first patient already injected First Quarter Financial Updates Cash and Cash Equivalents: based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €39.8 million as of March 31, 2025, will fund its operations into mid-2026. About JNJ-1900 (NBTXR3) JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter. Disclaimer This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts Attachment 2025-05-21 -- NBTX -- 1Q25 Financial Results -- FINAL

临床1期临床2期引进/卖出临床结果临床3期

2025-05-20

·微信

《癌度早报2025年5月20日》

癌度临床试验病友交流群（点击）一、新药快讯1、联合疗法治疗晚期小细胞肺癌，83%的患者病灶显著缩小根据一项二期临床试验CeLEBrATE研究结果，PD-L1抑制剂阿替利珠单抗联合抗血管生成靶向药贝伐单抗、化疗药物卡铂和依托泊苷，一线治疗广泛期小细胞肺癌效果显著。可评估治疗效果的患者中，83.3%的患者病灶显著缩小或完全消失，48名患者中的40名患者部分缓解，仅有4名患者病情进展。2、免疫治疗药物西米普利单抗治疗肺癌脑转移患者效果显著根据一项三期临床试验，PD-1抑制剂西米普利单抗（Cemiplimab）在PD-L1表达≥50%且存在脑转移的晚期非小细胞肺癌表现出较好效果，西米普利单抗的中位总生存时间是52.4个月，而对照组化疗的中位总生存时间是20.7个月，中位无进展生存时间是12.5个月，而对照组化疗的中位无进展生存时间仅为5.3个月。脑转移患者使用该药的脑病灶中位无进展生存时间是20.6个月。3、抗癌新药JNJ-1900治疗晚期胰腺癌展现出较好疗效和安全性近日，2025年欧洲放射肿瘤学年会上报道了一项研究，新药JNJ-1900（NBTXR3）在一项治疗局部晚期或边界可切除胰腺癌中展现出较好的效果，JNJ-1900通过直接注射到肿瘤内部，依靠放疗进行激活。22名用药的胰腺癌患者的平均总生存时间是23个月，而在MD安德森治疗的胰腺癌患者平均总生存时间仅为19.2个月。JNJ-1900治疗的局部无进展生存时间是13.3个月。二、抗癌前沿1、ALK的二代靶向药阿来替尼联合贝伐单抗，生存时间和应答率显著延长近期，根据发布在国际学术期刊《自然通讯》上的研究，ALK基因融合突变晚期肺腺癌患者，使用二代靶向药阿来替尼联合抗血管生成靶向药贝伐单抗，12个月病情无进展比例是97.1%，3年病情无进展比例是64.2%，100%的患者对治疗产生应答，也就是所有患者使用联合治疗病灶缩小超过30%以上，生存时间超过3年的比例是87.9%。欢迎关注癌度，肿瘤用药基因检测，临床试验免费用药欢迎联系癌度咨询!

临床结果免疫疗法临床3期临床2期

2025-05-19

·PRNewswire

Intra-tumoral Cancer Therapies Market to Show Tremendous Growth at a CAGR of 31.3% During the Study Period (2020-2034) | DelveInsight

As per DelveInsight's estimates, among the 7MM, the US captured the highest market of intra-tumoral cancer therapies of nearly USD 74 million in 2024, which is expected to increase due to the launch of emerging therapies such as CAN-2409, RP1 (vusolimogene oderparepvec), SP-002 (ASN-002), Bizaxofusp (MDNA55), and others. LAS VEGAS, May 19, 2025 /PRNewswire/ -- DelveInsight's Intra-tumoral Cancer Therapies Market report includes a comprehensive understanding of current treatment practices, emerging intra-tumoral cancer therapies, market share of individual therapies, and current and forecasted intra-tumoral cancer therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Intra-tumoral Cancer Therapies Market Report Currently, only three Intra-tumoral Cancer Therapies are approved; namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen), approved in the US and Europe in 2015, DELYTACT (teserpaturev/G47Δ; Daiichi Sankyo) approved in Japan in 2021, and HENSIFY in Europe in 2019. As per DelveInsight's analysis, the total market size of intra-tumoral cancer therapies in the 7MM was USD 109 million in 2024 and is projected to grow during the forecast period (2025-2034). In 2024, the total cases of selected indication (based on current landscape and pipeline activity) were 8.9 million in the 7MM, which is anticipated to increase by 2034. Leading intra-tumoral cancer therapies companies, such as Janssen, Stamford Pharmaceuticals, Ascend Biopharmaceuticals, Replimune, Highlight Therapeutics, Cytovation ASA, Intensity Therapeutics, Ascendis Pharma, Treovir, Matica Biotechnology, QBiotics, NanOlogy, Lokon Pharma AB, EpicentRx, Medicenna Therapeutics, Philogen S.p.A., Candel Therapeutics, Lytix Biopharma, Verrica Pharmaceuticals, CEI-SCI, and others, and others, are developing novel intra-tumoral cancer therapies that are expected to enter the intra-tumoral cancer therapies market in the coming years. Some of the key intra-tumoral cancer therapies in the pipeline include INT230-6, Vusolimogene oderparepvec (RP1), Nidlegy (Daromun), G207, Ilixadencel (INTUVAX), Tigilanol tiglate, SP-002 (ASN-002), BO-112, Bizaxofusp (MDNA55), and others. In March 2025, NANOBIOTIX announced topline data from the completed dose-escalation portion of a Phase I study, conducted under the sponsorship of The University of Texas MD Anderson Cancer Center, evaluating JNJ-1900 (NBTXR3) activated by radiation therapy as a second-line or later (2L+) treatment for patients with locally advanced NSCLC eligible for re-irradiation. In March 2025, NANOBIOTIX announced an amendment to its global licensing agreement with Janssen Pharmaceutica NV. The amendment removes NANOBIOTIX's funding obligation for NANORAY- 312 and releases Johnson & Johnson from select future potential milestone payments while safeguarding NANOBIOTIX's path to sustainable cash flow through significant potential milestone payments. In March 2025, Candel Therapeutics and IDEA Pharma announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel's lead asset, CAN-2409. In January 2025, Lokon Pharma AB announced that the Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the company's product candidate LOAd703 for the treatment of pancreatic cancer. In January 2025, Intensity Therapeutics announced that the Data Monitoring Committee (DMC) recommended the continuation of its Phase III sarcoma trial (INT230-6, INVINCIBLE-3) without modification based on data reviewed from July 2024 to December 2024. Some factors, such as the precedence of failure of emerging therapies, insufficient knowledge about Intra-tumoral Cancer Therapies , and several other drawbacks, might hinder the Intra-tumoral Cancer Therapies market growth. Discover which therapies are expected to grab the intra-tumoral cancer therapies market share @ Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Market Dynamics The intra-tumoral cancer therapies market dynamics are expected to change in the coming years. Various classes of intra-tumoral immunotherapies, including radioenhancer nanoparticles, recombinant fusion proteins, oncolytic therapy, gene therapy, synthetic dsRNA complexes, and others, are currently in preclinical and clinical development. These therapies increase drug concentration and availability within the tumor microenvironment while limiting systemic exposure and reducing the likelihood of immune-related side effects in other parts of the body. Intra-tumoral therapeutic strategies offer a powerful approach to in situ vaccine development, utilizing immune-stimulating agents to trigger local and systemic anti-tumor immune responses. Additionally, the ability of intra-tumoral immunotherapy combinations to elicit both T-cell and B-cell antitumor responses presents a potential strategy to overcome immune escape mechanisms, such as the loss of HLA-I expression on tumor cells, which are often associated with immune checkpoint therapy monoclonal antibody monotherapies. Furthermore, potential therapies are being investigated, and it is safe to predict that the treatment space will significantly impact the intra-tumoral cancer therapies market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the intra-tumoral cancer therapies market in the 7MM. However, several factors may impede the growth of the intra-tumoral cancer therapies market. The lack of standardized guidelines for intra-tumoral immunotherapy delivery results in variations in lesion selection, injection frequency, and needle technique, which directly affect treatment outcomes and safety. Patients are required to visit clinics for each dosing session, and the administration necessitates both trained radiologists and logistics support alongside skilled physicians. While research into intra-tumoral therapies has grown in recent years, several therapies, such as tilsotolimod/Ipilimumab, sotigalimab (APX005M), and vidutolimod (CMP-001), have failed clinical trials, impacting the market. Additionally, tumors with high intra-tumoral heterogeneity may lead to poorer clinical outcomes for patients. Intra-tumoral Cancer Therapies Therapeutics Market Although significant progress has been made in cancer treatment through methods like surgery, chemotherapy, radiation, immunotherapy, and targeted therapies, many of these treatments still face limitations such as systemic toxicity, inadequate tumor penetration, and poor targeting. These issues contribute to high mortality rates, underscoring the need for more precise and localized treatment options. Recently, cancer treatment strategies have increasingly focused on alternative delivery methods, including intra-tumoral administration. This approach is being actively researched, with several therapeutic candidates—such as immune receptor agonists, viral therapies, fusion proteins, monoclonal antibodies, and gene therapies—currently undergoing preclinical and clinical trials. Intra-tumoral immunotherapy, which involves directly delivering agents into or near the tumor site, is emerging as a promising approach. This strategy aims to boost localized immune responses while reducing systemic side effects. The first oncolytic virus, IMLYGIC (T-Vec; Amgen), was approved by the US FDA for treating unresectable melanoma lesions after surgery, following a Phase III trial. The European Commission approved the treatment of advanced melanoma in 2015. In 2019, Nanobiotix's HENSIFY (NBTXR3), a hafnium oxide nanoparticle therapy combined with radiation, received European approval for soft tissue sarcoma, with plans for data releases through 2025-2026 across multiple cancers. For STS the drug is approved in Europe but not yet launched. In Japan, DELYTACT (G47∆; Daiichi Sankyo) was granted conditional approval for malignant glioma, marking the first oncolytic virus for brain cancer, and is still under evaluation for its clinical benefits. IMLYGIC from Amgen is the first and only FDA-approved viral therapy that is injected directly into melanoma tumors. Despite the initial hype for this exciting intra-tumoral mode of cancer gene therapy, IMLYGIC's debut did not translate into much commercial success in the melanoma market. Limitations of the intra-tumoral administration, no statistically significant benefit in overall survival (OS), and the intense competition from immune checkpoint inhibitors (ICIs) due to their efficacy and manageable side effects are some of the main factors for ithe nsignificant revenues of this novel therapy. Learn more about the FDA-approved intra-tumoral cancer therapies @ Intra-tumoral Cancer Therapies Treatment Key Emerging Intra-tumoral Cancer Therapies and Companies The emerging pipeline of intra-tumoral cancer therapies is robust, including drugs from key players such as Candel Therapeutics (CAN-2409), Lytix Biopharma/Verrica Pharmaceuticals (LTX-315 [VP-315]), CEI-SCI (MULTIKINE), Philogen (Daromun [NIDLEGY; a combo of L19IL2 + L19TNF]), Replimune (RP2 and RP1 [vusolimogene oderparepvec]), Highlight Therapeutics (BO-112), Cytovation ASA (CY-101), Intensity Therapeutics (INT230-6), Ascendis Pharma (TransCon IL-2 β⁄γ), Treovir/Matica Biotechnology (G207), QBiotics (Tigilanol tiglate), NanOlogy (NanoPac), EpicentRx (AdAPT-001), Medicenna Therapeutics (Bizaxofusp [MDNA55]), and others. RP1 (vusolimogene oderparepvec), Replimune's lead product candidate, is based on a proprietary strain of Herpes Simplex Virus (HSV) engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor killing potency, immunogenicity, and activation of a systemic antitumor immune response. In November 2024, Replimune announced that the FDA granted Breakthrough Therapy Designation (BTD) to RP1 in combination with nivolumab for the treatment of advanced melanoma in adult patients who have previously received an anti-PD1 regimen. Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and which are mixed prior to intralesional administration. In July 2024, Philogen and Sun Pharmaceutical announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy. CAN-2409 (Candel Therapeutics) is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV thymidine kinase (HSV-tk) gene to a patient's specific tumor and induce an individualized, systemic immune response against the tumor. In March 2025, according to the company's corporate highlights, the preparations for Biologics License Application (BLA) for CAN-2409 in prostate cancer are underway, with submission expected in Q4 2026. The anticipated launch of these emerging therapies are poised to transform the intra-tumoral cancer therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the intra-tumoral cancer therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about intra-tumoral cancer therapies clinical trials, visit @ Intra-tumoral Cancer Therapies Intra-tumoral Cancer Therapies Overview Cancer is a highly diverse disease, with its signs, symptoms, and treatments varying across different types, making it crucial to create targeted therapies for individual patients. Current treatment options for cancer include immunotherapy, radiotherapy, chemotherapy, targeted drug therapies, and more. While these approaches have improved OS and patient outcomes, they still have limitations and are not effective for everyone. Researchers are therefore working to develop new treatments that can overcome these challenges, with intra-tumoral cancer therapies emerging as a promising strategy. Intra-tumoral immunotherapy represents an innovative approach, where sophisticated antibodies are directly injected into tumors instead of being administered intravenously. This method focuses on delivering immunostimulatory agents straight into primary or metastatic tumor sites to initiate or enhance an antitumor immune response. Normally, the immune system detects and eliminates early tumors, but in immunosuppressive tumor environments, malignant cells can proliferate undetected. Regulatory T cells (Tregs), drawn to the tumor by chemokines, suppress Antigen-Presenting Cells (APCs) that would otherwise trigger an immune attack on tumor antigens. Moreover, tumor cells often release anti-inflammatory and regulatory cytokines like TGF-β and IL-10, which promote tumor growth and inhibit dendritic cell (DC) activation. To counteract this immunosuppressive environment, immunostimulants can be introduced. These agents work by attracting immune cells to the tumor or by activating the immune system to recognize and destroy cancer cells. Immunostimulants activate immune cells in the presence of tumor antigens, allowing them to travel to lymph nodes, where they stimulate tumor antigen-specific T cells through cross-presentation. These activated T cells can then return to the tumor or spread to distant tumors, leading to the targeted destruction of cancer cells. Intra-tumoral Cancer Therapies Epidemiology Segmentation In 2024, the total indication-wise treated cases of Intra-tumoral Cancer Therapies were 3.3 million in the 7MM, which is anticipated to increase by 2034. The intra-tumoral cancer therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of Selected Indications Indication-wise Target Patient Pool of Intra-tumoral Cancer Therapies Indication-wise Treated Cases of Intra-tumoral Cancer Therapies Scope of the Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Therapeutic Assessment: Intra-tumoral current marketed and emerging therapies Intra-tumoral Cancer Therapies Market Dynamics: Conjoint Analysis of Emerging Intra-tumoral Cancer Therapies Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Intra-tumoral Cancer Therapies Market Access and Reimbursement Discover more about intra-tumoral cancer therapies in development @ Intra-tumoral Cancer Therapies Clinical Trials Table of Contents Related Reports Oncolytic Virus Market Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of oncolytic virus, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus companies, including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichio Sankyo, among others. Oncolytic Virus Competitive Landscape Oncolytic Virus Competitive Landscape – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key oncolytic virus companies, including Genelux Corporation, Candel Therapeutics, CG Oncology, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Virogin Biotech, Replimune, Viralytics, Oncolys Biopharma, Istari Oncology, Immvira Pharma, Seneca Therapeutics, Treovir, LLC, Targovax, Lokon Pharma, ORCA Therapeutics, Beijing SyngenTech, ViruCure, Tasly Pharmaceuticals, Turnstone Biologics, BioInvent, Transgene, Elicera Therapeutics, Orgenesis, Virttu Biologics, Imugene, Astellas Pharma, Wuhan Binhui Biotechnology Co., Ltd., Mustang Bio, Virogin Biotech, Vaxiion Therapeutics, ImmVirX, Memgen, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, VCN Biosciences, Candel Therapeutics, Sorrento Therapeutics, Imugene Limited, Calidi Biotherapeutics, Replimune, TILT Biotherapeutics, Guangzhou Virotech Pharmaceutical, DNAtrix, Oncorus, BioEclipse Therapeutics, among others. Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key NSCLC companies including AstraZeneca, Boehringer Ingelheim, Pfizer, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, Pfizer, GSK, Gilead Sciences, BieGene, Nuvalent , among others. Prostate Cancer Market Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key prostate cancer companies including Janssen Research and Development, Sanofi, AstraZeneca, Merck, Pfizer, Astellas Pharma, Bayer, Novartis, Curium, Merck, Orion, Janssen Pharmaceutical, Pfizer, Exelixis, Ipsen Pharma, Takeda, AB Science, Lantheus, Eli Lilly, POINT Biopharma, Telix Pharmaceuticals, Tavanta Therapeutics, Jiangsu Hengrui Pharmaceuticals, Kangpu Biopharmaceuticals, Fusion Pharma, Merus, Bristol-Myers Squibb, Syntrix Pharmaceuticals, Promontory Therapeutics, Xencor, Taiho Pharmaceutical, Madison Vaccines, MacroGenics, Zenith Epigenetics, Modra Pharmaceuticals, Arvinas, Laekna Therapeutics, Blue Earth Therapeutics, Oncternal Therapeutics, Essa Pharma, Clarity Pharmaceuticals, BioNTech, DualityBio, Daiichi Sankyo, Fortis Therapeutics, ORIC Pharmaceuticals, Amgen , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床3期上市批准快速通道引进/卖出

100 项与氧化铪纳米制剂相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
头颈部鳞状细胞癌	临床3期	美国	Janssen Pharmaceuticals, Inc.	2023-07-10
局部晚期头颈部鳞状细胞癌	临床3期	美国	上海联拓生物科技有限公司	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	美国	Nanobiotix SA	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	美国	Valdepharm	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	日本	Valdepharm	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	日本	Nanobiotix SA	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	日本	上海联拓生物科技有限公司	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	奥地利	Nanobiotix SA	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	奥地利	上海联拓生物科技有限公司	2021-12-10
局部晚期头颈部鳞状细胞癌	临床3期	奥地利	Valdepharm	2021-12-10

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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


NCT04484909 (Company_Website) 人工标引	临床1期	胰腺癌	22	JNJ-1900 (NBTXR3)	鑰壓積遞膚襯壓簾鬱廠(艱構構鹹齋壓顧鹽憲顧) = 鬱壓齋鹹選鹽積遞觸選觸鏇餘壓餘淵顧願齋餘 (觸選憲鬱繭簾遞壓製製, 17 ~ NR) 更多	积极	2025-05-05
NCT03589339 (Company_Website) 人工标引	临床1期	局部晚期恶性肿瘤二线	12	NBTXR3 (JNJ-1900)	膚窪糧網構鑰夢衊範蓋(築壓觸淵製膚鏇繭窪網) = 窪鑰糧構鏇顧淵糧獵觸鹹廠觸鏇築簾積獵窪築 (願憲糧顧憲襯衊鑰積廠 ) 更多	积极	2025-03-27
NCT03589339 (Study 1100, ESMO_ELCC2025) 人工标引	临床1期	实体瘤 \| 非小细胞肺癌	29	NBTXR3/stereotactic body RT (SBRT) followed by nivolumabnivolumab or pembrolizumab	夢鏇鑰衊襯鏇窪餘構鑰(鹽網繭壓選鬱簾觸醖範) = 鏇觸廠鬱淵窪廠願網淵網憲鹹觸壓壓夢範鹽顧 (鹽鑰衊艱膚鹽鏇鑰壓範 ) 更多	积极	2025-03-26
				NBTXR3/stereotactic body RT (SBRT) followed by nivolumabnivolumab or pembrolizumab (ICI naïve)	夢鏇鑰衊襯鏇窪餘構鑰(鹽網繭壓選鬱簾觸醖範) = 齋淵齋網繭顧膚網構廠網憲鹹觸壓壓夢範鹽顧 (鹽鑰衊艱膚鹽鏇鑰壓範 ) 更多
NCT01946867 (ESMO_ASIA2024) 人工标引	临床1期	头颈部鳞状细胞癌	56	NBTXR3 (All treated population)	鑰製鏇顧夢鹹範鏇鹹廠(繭衊憲衊範網鏇蓋積餘) = 膚鏇蓋網網廠鑰簾艱築觸積膚鏇構壓築網願壓 (築窪窪糧選憲膚繭願蓋 ) 更多	积极	2024-12-07
				NBTXR3 (Evaluable population)	鏇壓艱範鑰糧衊窪構醖(簾構淵製廠願鬱選網膚) = 膚衊願艱簾鹽窪齋鏇糧鏇襯糧壓襯壓範膚構獵 (選壓顧糧齋鬱鹽選簾製 ) 更多
ASTRO2024	N/A	肝转移	-	NBTXR3 Radioenhancer (NBTXR3 activated by SBRT)	蓋膚鹹襯蓋衊襯顧築憲(網鹽鑰簾艱築遞鏇壓積) = Grade 3 bile duct stenosis, grade 3 lymphocytosis, grade 4 anaphylaxis 選憲淵選選憲網積製艱 (鏇艱蓋鬱衊夢構選壓鏇 )	-	2024-10-01
NCT03589339 (Study 1100, GlobeNewswire) 人工标引	临床1期	头颈部鳞状细胞癌	68	RT+ NBTXR3 + anti-PD-1	鏇觸醖網觸網選選憲膚(夢網構鏇醖觸壓艱窪選) = 夢鑰範憲製鏇憲觸遞鹽積艱範廠鏇淵觸窪鹹願 (遞顧鏇艱衊顧餘選餘獵 ) 更多	积极	2024-06-02
				RT+ NBTXR3 + anti-PD-1 (anti-PD-1 naïve)	鏇觸醖網觸網選選憲膚(夢網構鏇醖觸壓艱窪選) = 簾網艱襯膚夢網構鹽選積艱範廠鏇淵觸窪鹹願 (遞顧鏇艱衊顧餘選餘獵 ) 更多
NCT01946867 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	头颈部鳞状细胞癌	44	NBTXR3	壓築蓋簾膚齋構齋鬱壓(蓋鏇範觸鬱壓衊顧製遞) = 糧艱選鏇蓋構壓構網窪鬱廠壓築鹹鑰網願簾襯 (觸築淵糧網鹹鑰鬱觸廠 ) 更多	积极	2023-10-22
				NBTXR3 (IT lesion)	壓築蓋簾膚齋構齋鬱壓(蓋鏇範觸鬱壓衊顧製遞) = 壓衊蓋淵製鬱淵觸夢築鬱廠壓築鹹鑰網願簾襯 (觸築淵糧網鹹鑰鬱觸廠 ) 更多
NCT03589339 (Study 1100, ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性头颈部鳞状细胞癌 \| 复发性头颈部鳞状细胞癌	16	stereotactic body radiotherapy+anti-PD-1 therapy+NBTXR3	餘廠願製壓顧範製窪鬱(簾醖窪夢繭積製製鏇構) = 獵衊積窪醖糧築蓋顧膚艱鏇襯繭夢鑰遞鹽願鏇 (顧獵膚憲廠積選範鹽齋 ) 更多	积极	2023-05-31
				stereotactic body radiotherapy+anti-PD-1 therapy+NBTXR3 (metastatic HNSCC)	簾餘願廠艱製構夢蓋餘(醖鹹夢衊顧簾艱淵選範) = 築餘蓋窪窪選製願構構構願糧選憲構繭糧蓋鏇 (餘鑰願廠鑰糧壓鹽淵築 )
NCT04484909 (GlobeNewswire) 人工标引	临床1期	胰腺癌	11	NBTXR3	網網醖鑰鏇齋餘膚顧積(夢壓簾壓製網壓窪獵鏇) = 醖夢築願齋淵齋範膚簾廠衊衊網顧網積齋餘積 (壓醖鹹簾鹽夢鏇願構簾 )	积极	2022-11-14
NCT03589339 (1100, SITC2022) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	28	NBTXR3+nivolumab or pembrolizumab	醖蓋構獵憲選齋襯觸壓(窪淵艱壓構簾淵選夢糧) = 膚廠淵選獵廠範鹽構鑰夢構衊遞糧網壓衊製夢 (廠鏇簾築艱餘鏇鏇膚簾 ) 更多	积极	2022-11-01