Tilsotolimod

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. 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-01- 引言：从“佐剂配角”到“免疫先锋”， CpG的逆袭之路 肿瘤免疫治疗的核心命题在于打破肿瘤微环境“冷寂”状态，重塑系统性抗肿瘤免疫应答。在PD-1/PD-L1抑制剂等明星靶点之外，Toll样受体（TLR）信号通路因其先天免疫激活能力，成为近年来领域内的重要突破方向。其中，以CpG寡聚脱氧核苷酸（CpG-ODN）为代表的TLR9激动剂，凭借其独特的免疫调节功能，从传统疫苗佐剂逐步进阶为肿瘤免疫治疗的关键组合拼图。  作为人工合成的非甲基化CpG基序DNA短链，CpG通过激活TLR9诱导强有力的Th1型免疫反应（IFN-α/γ、TNF-α等），直接刺激树突状细胞（DC）成熟与B细胞增殖，同时重塑肿瘤微环境中的抑制性成分（如Treg、MDSCs）。目前，全球已有多项临床研究聚焦于CpG-ODN在不同实体瘤及血液瘤中的单药或联合应用潜力，CpG已成为生物制药企业不可错过的研发赛道。 -02- 生物学功能拆解： A/B/C型CpG的免疫机制差异化图谱 CpG-ODN因骨架修饰与基序排布差异，可以分为A型（D型）、B型（K型）、C型三大阵营，其作用机制与适应场景显著分化： 1. B型CpG：激活B细胞与快速免疫应答的“主力军” 结构特征：硫代磷酸骨架增强核酸酶抗性，含单一/多重CpG基序；  核心功能：优先刺激B细胞分泌IgM并增殖，同时通过早期内体-晚期内体快速转运，诱导pDC释放TNF-α； 2. A型CpG：I型干扰素生产“专业户” 结构特征：中心回文序列+两端polyG尾，部分硫代修饰维持结构稳定性； 核心功能：通过自组装成高级结构长期滞留早期内体，驱动pDC大量分泌I型干扰素（IFN-α），但B细胞激活能力弱。 3. C型CpG：双功能协同的“跨界新秀” 结构特征：全硫代磷酸骨架+B型特征，回文基序允许形成茎环/二聚体结构。  核心功能：兼具A型干扰素诱导能力与B型B细胞刺激作用，同时延长体内半衰期（>8小时）。 -03- TLR9激动剂的发展历程： 迭代升级的四代进化 第一代TLR9激动剂主要包括A类、B类和C类CpG ODNs。这些激动剂通过模拟细菌DNA中的CpG基序，激活TLR9，诱导免疫反应。然而，由于这些激动剂的稳定性较差，容易在体内降解，因此其临床应用受到了一定的限制。 随着研究的深入，第二代TLR9激动剂应运而生。这些激动剂通过引入化学修饰或结构优化，提高了其稳定性和活性。例如，IMO-2055和IMO-2125等第二代激动剂通过将两个CpG ODNs的3'端连接起来，形成了二聚体结构，从而增强了其免疫刺激效果。 第三代TLR9激动剂则采用了更为先进的结构设计。MGN1703作为第三代激动剂的代表，采用了双茎环结构，这种结构不仅提高了其稳定性，还降低了其毒性。此外，MGN1703还具有良好的耐受性，适用于长期治疗。 近年来，第四代TLR9激动剂的研究也取得了显著进展。这些激动剂采用了纳米材料作为载体，提高了其在体内的稳定性和靶向性。例如，球形核酸（SNAs）作为一种新型的纳米载体，能够将ODNs密集地包裹在球形纳米颗粒中，从而提高了其免疫刺激效果。此外，SNAs还能够直接进入细胞，避免了传统给药方式的局限性。 -04- 在研药物全景图： 从单药到联用的临床突破 Vidutolimod（CMP-001）是一种CpG-a寡核苷酸，包装在由噬菌体外壳蛋白Qβ形成的病毒样颗粒内。在最近公布的一项1b期临床研究（NCT02680184）中，评估了肿瘤内注射Vidutolimod联合pembrolizumab的疗效和安全性，有4个CR，7个PR，显示出克服晚期黑色素瘤患者的PD-1抑制剂耐药性的潜力。 HP007为华普生物技术公司自主开发的新型C型CpG。HP007联合PD-1抗体、CTLA-4抗体和CD40激动性抗体在转移性去势耐受性前列腺癌患者中表现出卓越的临床反应。在13名可评估的患者中，12人出现了客观响应，其中6人CR，6人PR，总响应率（ORR）高达92.3%。 除了HP007和Vidutolimod外，还有几个TLR9激动剂处于在研阶段。Tilsotolimod由Idera Pharmaceuticals开发，获得了美国FDA的快速通道，联合Ipilimumab用于治疗抗PD-1抗体难治性黑色素瘤，以及孤儿药物资格指定用于治疗IIb-IV期黑色素瘤。在I/II期临床试验中，ORR为22%，疾病控制率为71%，中位总生存期(OS)为21个月。目前处于黑色素瘤的关键3期临床（NCT03445533）阶段。 D-101是另一个TLR9激动剂，在黑色素瘤和头颈部鳞癌（NCT02521870）、淋巴瘤（NCT02266147）中都进行了临床研究，显示增加了肿瘤浸润淋巴细胞数量。目前主要和免疫检查点抑制剂联用，处于临床2期阶段。 此外，还有MGN1703，是由Mologen AG研发的TLR9激动剂，目前招募的临床包括HIV和晚期实体瘤。PF-3512676是Pfizer在10多年前开发的TLR9 B型激动剂，但是因为III期试验阴性结果，已经终止开发。 -05- 未来突围：组合策略与纳米递送 CpG-ODN的联合潜力与技术创新持续推动其迈向临床获批： 1.“冷肿瘤加热”组合拳： 免疫检查点抑制剂（PD-1/CTLA-4）：CpG激活DC递呈抗原，ICB解除T细胞耗竭，形成“抗原释放-呈递-杀伤”正向循环。 放疗/化疗：诱导免疫原性细胞死亡（ICD），释放肿瘤抗原，增强CpG的局部免疫招募效应。 2. 纳米载体赋能的第四代技术： 无机材料（氧化石墨烯、多孔硅）：提升淋巴靶向性，控制突释毒性。 自组装DNA结构（四面体框架、纳米笼）：实现TLR9/STING等多通路共激活，减少脱靶风险。 -06- 结语：站在产业变革的临界点 TLR9激动剂的研发历程，映射出肿瘤免疫治疗从单一靶向到系统调控的范式转变。随着K药、O药为代表的ICI进入专利悬崖期，联合疗法的开发窗口正在打开。数据监测显示，全球CpG相关临床试验数量近三年增长217%，其中73%为联合方案。对于生物制药企业而言，TLR9靶点的价值不仅在于其本身的成药可能，更在于其作为免疫治疗"启动开关"的战略地位。在这个领域，中国药企与世界巨头站在同一起跑线上。未来十年的产业竞技，或许将从这条古老的免疫通路开启新的战局。 公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！ 公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。