NeoLIPA: a Single Center Phase II Open Label Study of Neoadjuvant LTX-315 in Combination with Pembrolizumab in Patients with Clinically Detectable and Resectable Stage III-IV Melanoma

This clinical trial aims to evaluate the effectiveness of a new treatment approach for patients with stage III or IV melanoma that has spread to other parts of the body but can still be surgically removed. The study combines two treatments: LTX-315 and pembrolizumab.
Melanoma that has spread to other parts of the body can often be treated with surgery. Despite surgery, there is a high risk of the cancer coming back. Pembrolizumab, an immune checkpoint inhibitor, can reduce this risk when given after surgery. Recent studies have shown that giving pembrolizumab before surgery, along with post-surgery treatment, might be more effective than giving it only after surgery. However, many patients still experience cancer recurrence. Combining pembrolizumab with LTX-315, which triggers a different immune response, might improve the treatment&amp;#39;s effectiveness and reduce the risk of cancer progression before surgery.
This is an open-label Phase II study, meaning both the researchers and participants will know which treatments are being given. The study will be conducted at a single center and will involve about 27 participants. They will receive LTX-315 and pembrolizumab before their planned surgery to see if this combination could be more effective than pembrolizumab alone.
The primary goal is to assess the tumors response to the neoadjuvant (pre-surgery) treatment, specifically looking at the rate of pathological complete response (pCR), where no cancer is detected in the removed tumor tissue.

开始日期2024-11-01

申办/合作机构

Lytix Biopharma AS

NCT05188729

/ Completed临床2期

A Phase 2, Multicenter, Open-label, Proof-of-concept Study With Safety Run-in to Evaluate the Safety, Pharmacokinetics, and Efficacy of VP-315 in Adult Subjects With Basal Cell Carcinoma

This is a 2-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, tolerability, MTD, and objective antitumor efficacy of ascending dose strengths of VP-315 when administered intratumorally to adults with biopsy proven basal cell carcinoma (BCC).
The study is expected to enroll approximately 86 subjects with a histological diagnosis of BCC in at least 1 eligible target lesion (confirmed by punch or shave biopsy).

开始日期2022-02-01

申办/合作机构

Verrica Pharmaceuticals, Inc.

[+7]

NCT04796194

/ Completed临床2期

A Phase 2 Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to PD-1/PD-L1 Inhibitor Therapy.

ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.

开始日期2021-06-01

申办/合作机构

Lytix Biopharma AS

100 项与鲁特米肽相关的临床结果

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100 项与鲁特米肽相关的转化医学

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100 项与鲁特米肽相关的专利（医药）

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项与鲁特米肽相关的文献（医药）

2025-10-01·Journal of Advanced Research

LTX-315 is a novel broad-spectrum antimicrobial peptide against clinical multidrug-resistant bacteria

Article

作者: Peng, Mingxiu ; Chan, Edward Wai-Chi ; Heng, Heng ; Zhao, Jiamin ; Tang, Yang ; Sun, Liang ; Yang, Chen ; Chen, Sheng ; Dai, Liang

INTRODUCTION:

Infections stemming from multidrug-resistant bacteria present a substantial threat to public health today. Discovering or synthesizing novel compounds is crucial to alleviate this pressing situation.

OBJECTIVE:

The main purpose of this study is to verify the antibacterial activity of LTX-315 and explore its primary action mode.

METHODS:

Through antibacterial phenotype assay screening, we obtained a potent compound named LTX-315 from diverse drug libraries, 10,926 compounds in total. Then, the bactericidal effect and its action mode were explored through biochemical and chemistry methods such as atime-killing curve, scanning electronic microscopy, isothermal titration calorimetry analysis, and nuclear magnetic resonance. Finally, the efficacy in vivo of LTX-315 against drug-resistant bacteria was proved through amice infection model.

RESULTS:

In this study, LTX-315, an oncolytic peptide, was discovered to effectively eliminate gram-positive and gram-negative pathogens, even for those multidrug-resistant strains. Through strong electrostatic interactions, LTX-315 can bind to the membrane component phosphatidylglycerol (PG) with extremely high affinity (nanomolar level). Strikingly, in contrast to the typical electrostatic interactions of antibacterial peptides, the indole group of LTX-315, situated near the alkyl chain, exhibits significantly enhanced recognition and interaction with PG due to the hydrophobic effect of the alkyl chain. Furthermore, it exerts various impacts on cell membranes, including damaging integrity, increasing permeability, and decreasing membrane fluidity. Additionally, microscopy revealed significant cell disintegration. The influence, in turn, disrupts several physiological activities inside cells, such as increasing the reactive oxygen species level, ultimately leading to cell death. Finally, the efficacy of LTX-315 in vivo against multidrug-resistant and hypervirulent Klebsiella pneumoniae was demonstrated.

CONCLUSION:

The unique mechanism of LTX-315 involves high-affinity binding to PG and subsequent membrane disruption, providing a novel approach against multidrug-resistant bacteria compared to conventional antibiotics. As a potential candidate, it shows promise in effectively treating bacterial infections, particularly those caused by drug-resistant bacteria, thereby addressing the escalating challenge of antibiotic resistance worldwide.

2025-09-01·JOURNAL OF CONTROLLED RELEASE

Oncolytic microgels with regulated antibody release augment tumor immunotherapy

Article

作者: Tan, Hujing ; Zhong, Zhiyuan ; Guo, Jiakun ; Lin, Wenhai ; Chen, Wanting ; Wang, Yan ; Deng, Chao

The inhibition of immune checkpoints has emerged as a most successful immunotherapy strategy for cancers; however, it bears a modest clinical response rate and certain cases severe systemic adverse reactions. Here, oncolytic microgels (OMG) that possess similar antitumor activity and immune activation to oncolytic peptide LTX-315 and are capable of sustained release of immune checkpoint inhibitors have been developed to potentiate cancer immunotherapy. Of note, antibodies including anti-PD-1, anti-PD-L1, and anti-CTLA-4 all could be quantitatively loaded into OMG while being gradually released over a couple of weeks in vitro and in tumor as well. In the B16F10 melanoma model, a single tumoral injection of anti-PD-1 and anti-CTLA-4-loaded OMG (P1C4@OMG) effectively reversed suppressive tumor microenvironment and enhanced anti-tumor immune response, achieving potent tumor suppression and striking survival benefits. This study heralds oncolytic microgels with regulated antibody release as a safe and unique platform for cancer immunotherapy.

2025-06-12·JOURNAL OF MEDICINAL CHEMISTRY

Developing Potent and Selective Anticancer Therapy through Chemical Approaches and the Combination of Cationic Amphipathic Oncolytic Peptides

Article

作者: Patil, Basavaraj Rudragouda ; Le, Ngoc Duy ; Nguyen, Thi Oanh Oanh ; Nguyen, Bao Loc ; Kim, Jeonghwan ; Huang, Linyu ; Kim, and Jong Oh ; Nguyen Quoc, Thang ; Kim, Beomsu ; Luong, Huy Xuan ; Bui Thi Phuong, Hai

This study explores the structure-activity relationships of cationic amphipathic Mastoparan AF derivatives and their combination with the oncolytic peptide LTX315 to enhance the anticancer efficacy. The original peptide was modified to improve its selective interaction with cancer cell membranes, thereby increasing anticancer potency while minimizing hemolytic activity. Circular dichroism spectroscopy and molecular dynamics simulations were employed to evaluate structural changes and self-association tendencies. Among the derivatives, MAF-10L exhibited superior anticancer activity but elevated hemolysis, which was mitigated through combination therapy with LTX315. These findings underscore the potential of cationic amphipathic peptides as a basis for selective anticancer treatments and highlight the benefits of peptide combinations in reducing adverse effects while enhancing the therapeutic efficacy.

项与鲁特米肽相关的新闻（医药）

2025-11-15

·药明康德

使近100%“癌症之王”患者产生特异性免疫应答的多肽疫苗；客观缓解率达97%的溶瘤肽…… | TIDES周报

近期，全球多肽和寡核苷酸（TIDES）领域迎来系列进展。新型癌症免疫疗法ELI-002 7P的2期临床试验数据亮眼，在近100%携带KRAS突变（mKRAS）的胰腺导管腺癌患者中诱导了mKRAS特异性T细胞应答。潜在“first-in-class”溶瘤肽VP-315在一项针对基底细胞癌患者的2期研究中，事后分析的客观缓解率达97%，组织学完全清除率达51%。Ionis Pharmaceuticals公司的Dawnzera（donidalorsen）获欧洲药品管理局（EMA）推荐上市，用于预防12岁及以上成人和儿童患者的遗传性血管性水肿（HAE）发作。本文将节选其中部分重要进展做简单介绍，仅供读者参阅。 ELI-002 7P：公布2期临床试验数据 Elicio Therapeutics公司公布了其正在进行的2期AMPLIFY-7P试验中，ELI-002 7P用于治疗携带mKRAS的胰腺导管腺癌患者的最新免疫原性数据。ELI-002是该公司开发的新型癌症免疫疗法，由AMP修饰的mKRAS肽抗原和AMP修饰的CpG佐剂ELI-004组成，旨在靶向KRAS驱动型肿瘤。其中，ELI-002 7P包含七种最常见的mKRAS肽抗原。在AMPLIFY-7P试验中，ELI-002 7P在99%（89/90）的疗效可评估患者中诱导了mKRAS特异性T细胞应答，展现出强大且一致的免疫激活能力。所有七种mKRAS抗原均引发强效反应，每种突变的应答率均超过80%，88%的患者对其自身肿瘤特异性突变产生免疫应答。此外，86.8%（66/76）的患者产生了细胞毒性mKRAS特异性T细胞应答，分别有75%的患者激活了CD8和CD4 T细胞。值得注意的是，这些免疫反应在多种HLA类型人群中均被观察到，表明ELI-002 7P有望适用于广泛且遗传背景多样的患者群体。 VP-315（ruxotemitide）：公布2期临床试验数据 Verrica Pharmaceuticals公司公布了其潜在“first-in-class”在研新药VP-315（ruxotemitide）的2期探索性分析结果。VP-315是一种溶瘤肽类免疫疗法，通过瘤内注射直接诱导免疫原性细胞死亡，从而释放多种肿瘤抗原以激活T细胞应答。该药物基于天然“宿主防御肽”研究开发，旨在为皮肤癌患者提供非手术治疗选择。Verrica拥有开发和商业化VP-315用于某些皮肤肿瘤适应症（包括非转移性黑色素瘤和非转移性默克尔细胞癌）的全球独家许可，并打算最初专注于基底细胞癌和鳞状细胞癌作为开发的主要适应症。数据显示，VP-315可重塑肿瘤微环境，显著增加细胞毒性T细胞浸润，同时减少免疫抑制性的调节性T细胞。这一免疫机制为此前报道的优异临床疗效提供了理论支持：在基底细胞癌患者中，事后分析的客观缓解率达97%，组织学完全清除率达51%。结合其已证实的良好安全性，VP-315有望成为用于皮肤癌的非手术免疫治疗药物。 Donidalorsen：获EMA推荐上市 EMA宣布，人用药品委员会（CHMP）建议批准Ionis Pharmaceuticals旗下Dawnzera（donidalorsen）用于预防12岁及以上成人和儿童患者的HAE发作。Dawnzera是一款反义寡核苷酸配体偶联（LICA）药物，旨在精确靶向以沉默血浆前激肽释放酶（PKK）的表达，中断导致HAE发作的信号通路。PKK在激活与HAE急性发作相关的炎症介质中起重要作用。之前所公布的OASIS-HAE临床3期研究结果显示，试验达到主要终点。与安慰剂相比，接受每四周一次（Q4W）Dawnzera皮下注射的患者在24周内月均HAE发作率显著降低81%。当从第二次给药开始评估时，平均发作率降低87%（关键次要终点）。此外，从第二次给药开始测量时，Dawnzera在24周内将中重度HAE发作减少约90%。这些结果得到了进行中的OASISplus开放标签延长期（OLE）研究的进一步支持。在该研究中，随着时间推移，接受每八周一次（Q8W）Dawnzera治疗患者表现出与Q4W相似的疗效。在OLE研究中，两种给药方案均在一年后实现总平均发作率较基线下降94%。 IBI3016：公布1期临床试验数据信达生物与圣因生物共同公布了其共同开发的靶向血管紧张素原（AGT）的小干扰核酸（siRNA）药物IBI3016，用于治疗高血压的首次人体临床1期研究的主要结果。IBI3016基于圣因生物专有小核酸药物开发平台GalNAc肝靶向递送技术开发，通过RNAi机制抑制AGT的合成。临床前试验数据显示，IBI3016可抑制AGT在肝脏中的合成，从而可能导致AGT蛋白的持久减少，进一步导致Ang II的减少，最终起到舒张血管、降低血压的效果。截至2025年7月1日，共40例健康受试者和轻度高血压受试者随机入组5个队列（每个队列IBI3016剂量组与安慰剂组的比例为6:2）。IBI3016单次给药实现了持久强效的AGT水平降低以及初步的血压下降：血清AGT水平得到显著且持久降低，最大降幅超过95%，且在6个月内降幅维持稳定；在3个月时，IBI3016各剂量组均实现了血压下降。IBI3016在6个月内表现出良好的安全性和耐受性，未观察到重度不良事件或严重不良事件，无低血压事件发生。所有不良事件均为轻度至中度且可逆。 RN0361：公布1期临床试验数据大睿生物公布了其长效靶向ApoC3的siRNA药物RN0361用于治疗血脂异常患者的1期临床研究结果。公开资料显示，ApoC3的升高会促进富甘油三酯脂蛋白的聚集，从而增加急性胰腺炎和心血管疾病的风险，尤以糖尿病患者风险升高为甚。目前的治疗方案往往难以在重症患者中实现持续的控制。此次公布的结果显示，RN0361呈现出显著的剂量依赖性ApoC3与TG抑制作用，持续至给药后第180天，最高达到ApoC3降低93%，以及甘油三酯降低69%。同时，RN0361还实现了非高密度脂蛋白胆固醇、极低密度脂蛋白胆固醇和残余胆固醇等显著且持久的降低。该产品耐受性良好，未观察到严重不良事件；注射部位反应轻微且可自限；一过性的ALT与AST升高符合GalNAc缀合siRNA药物的典型特征。 Olezarsen：公布3期临床试验数据 Ionis Pharmaceuticals公司宣布，其反义寡核苷酸疗法olezarsen在严重高甘油三酯血症（sHTG）患者中开展的CORE和CORE2关键性3期研究取得了积极结果。Olezarsen旨在抑制机体产生ApoC3。美国FDA于2024年2月授予该疗法孤儿药资格和突破性疗法认定（BTD），并在12月批准其用于作为饮食控制的辅助治疗，以降低家族性乳糜微粒血症综合征成人患者的甘油三酯。研究显示，olezarsen在6个月时实现了高达72%经安慰剂校正的空腹甘油三酯（TG）平均水平显著降低，且这一降幅在12个月时仍然得以维持。同时，olezarsen还将急性胰腺炎事件风险显著降低了85%，安全性和耐受性表现良好。根据新闻稿，这是首次在研治疗方案可在sHTG患者中显著降低急性胰腺炎事件发生率。 Eloralintide（LY3841136）：公布2期临床试验数据礼来（Eli Lilly and Company）今日宣布，其在研减重多肽疗法eloralintide（LY3841136）在一项2期临床试验中达到主要终点。基于这一结果，礼来计划于下月启动eloralintide用于治疗肥胖的3期临床研究的患者入组。Eloralintide是一款每周一次皮下注射的选择性长效胰淀素受体激动剂，具有良好的耐受性和明确的体重减轻效果。该试验共纳入263名肥胖或超重且至少伴有一种肥胖相关共病、但未合并2型糖尿病的成年受试者。在第48周时，所有eloralintide治疗组均达到主要终点，平均体重下降幅度从9.5%至20.1%不等，而安慰剂组仅为0.4%，显示出显著的疗效差异。此外，试验同时显示，所有剂量的eloralintide在体重和身体质量指数（BMI）降低等次要终点上均较安慰剂有临床意义的改善。此外，治疗还伴随心血管代谢风险指标的全面改善，包括腰围、血压、血脂、血糖控制以及炎症标志物水平的下降。参考资料： [1] Lilly's selective amylin agonist, eloralintide, demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight. Retrieved November 6, 2025, from https://investor.lilly.com/news-releases/news-release-details/lillys-selective-amylin-agonist-eloralintide-demonstrated [2] Altimmune Announces Publication Of IMPACT Phase 2b Trial Data In The Lancet And Concurrent Late-Breaking Oral Presentation At AASLD The Liver Meeting® 2025. Retrieved November 12, 2025, from https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-publication-impact-phase-2b-trial-data [3] Groundbreaking pivotal study results of olezarsen for severe hypertriglyceridemia (sHTG) presented as a late breaker at AHA Scientific Sessions. Retrieved November 10, 2025 from https://ir.ionis.com/news-releases/news-release-details/groundbreaking-pivotal-study-results-olezarsen-severe [4] Wong, G.LH., Yuen, MF., Lin, B. et al. Elebsiran and PEG-IFNα for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial. Nat Med (2025). https://doi.org/10.1038/s41591-025-04049-z [5] 大睿生物在2025年美国心脏协会年会上公布RN0361的I期临床数据. Retrieved November 13, 2025, from https://www.prnasia.com/story/511059-1.shtml [6] 信达生物与圣因生物共同宣布IBI3016（AGT siRNA）I期临床研究结果于2025年AHA大会现场报告. Retrieved November 13, 2025, from https://www.prnasia.com/story/511019-1.shtml [7] 重磅！悦康药业YKYY013注射液获国家药品监督管理局临床试验批准. Retrieved November 13, 2025, from https://mp.weixin.qq.com/s/i6ZGETVYCUBEE9nmXHMw2w [8] Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Adults with Heterozygous Familial Hypercholesterolemia (HeFH) in Phase 3 CORALreef HeFH Trial. Retrieved November 10, 2025 from https://www.merck.com/news/mercks-enlicitide-decanoate-an-investigational-oral-pcsk9-inhibitor-significantly-reduced-ldl-c-in-adults-with-heterozygous-familial-hypercholesterolemia-hefh-in-phase-3-coralreef-hefh-tr/ [9] Verrica Pharmaceuticals Presents New Data on VP-315 from its Phase 2 Clinical Trial in Basal Cell Carcinoma at the 40th Society for Immunotherapy of Cancer Annual Meeting. Retrieved November 10, 2025 from https://www.globenewswire.com/news-release/2025/11/10/3184504/0/en/Verrica-Pharmaceuticals-Presents-New-Data-on-VP-315-from-its-Phase-2-Clinical-Trial-in-Basal-Cell-Carcinoma-at-the-40th-Society-f or-Immunotherapy-of-Cancer-Annual-Meeting.html [10] Elicio Therapeutics Reports Robust, Cytolytic mKRAS-Specific T Cell Responses Across Diverse Patient HLA in Ongoing Phase 2 AMPLIFY-7P Trial of ELI-002 7P and New ELI-004 Preclinical Data at SITC. Retrieved November 14, 2025 from https://www.globenewswire.com/news-release/2025/11/07/3183698/0/en/Elicio-Therapeutics-Reports-Robust-Cytolytic-mKRAS-Specific-T-Cell-Responses-Across-Diverse-Patient-HLA-in-Ongoing-Phase-2-AMPLIFY-7P-Trial-of-ELI-002-7P-and-New-ELI-004-Preclinica.html [11] Viking Therapeutics Highlights Clinical Data from VK2735 Obesity Program in Presentation at ObesityWeek® 2025. Retrieved November 10, 2025 from https://www.prnewswire.com/news-releases/viking-therapeutics-highlights-clinical-data-from-vk2735-obesity-program-in-presentation-at-obesityweek-2025-302606589.html [12] AusperBio Announces Late-Breaking 48-Week Phase II Data of AHB-137 in Chronic Hepatitis B at AASLD 2025. Retrieved November 10, 2025 from https://www.prnewswire.com/news-releases/ausperbio-announces-late-breaking-48-week-phase-ii-data-of-ahb-137-in-chronic-hepatitis-b-at-aasld-2025-302609280.html [13] SanegeneBio Announces RNAi Licensing and Research Collaboration with Lilly. Retrieved November 8, 2025 from https://www.prnewswire.com/news-releases/sanegenebio-announces-rnai-licensing-and-research-collaboration-with-lilly-302609299.html [14] Basking Biosciences Announces First Participants Dosed in Phase 1 Study of BB-025, a Direct-Acting Reversal Agent for Investigational Stroke Therapy BB-031. Retrieved November 8, 2025 from https://www.prnewswire.com/news-releases/basking-biosciences-announces-first-participants-dosed-in-phase-1-study-of-bb-025-a-direct-acting-reversal-agent-for-investigational-stroke-therapy-bb-031-302612356.html [15] Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025. Retrieved November 14, 2025 from https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-november-2025 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

免疫疗法临床2期上市批准临床结果疫苗

2025-11-13

·GlobeNewswire-Health Care

Verrica Pharmaceuticals Presents New Data on VP-315 from its Phase 2 Clinical Trial in Basal Cell Carcinoma at the 40th Society for Immunotherapy of Cancer Annual Meeting

– Exploratory Phase 2 analysis shows Verrica’s novel oncolytic peptide, VP-315, reprograms the tumor microenvironment, increasing cytotoxic T-cell infiltration and reducing immunosuppressive T-regulatory cells – – Findings provide mechanistic immunologic support for clinical efficacy previously reported, including 97% calculated objective response rate and 51% complete histologic clearance rate – – Coupled with VP-315’s previously reported safety profile, these results highlight VP-315’s potential as a first-in-class, non-surgical immunotherapeutic option for patients with basal cell carcinoma – Nov. 10, 2025 -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced the presentation of new data from its Phase 2 study evaluating VP-315 (ruxotemitide), a novel oncolytic peptide immunotherapy, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting which took place November 5–9, 2025, in National Harbor, Maryland. Data were featured in both a poster presentation and an oral presentation highlighting the local immune activation and clinical efficacy of VP-315 in patients with basal cell carcinoma (BCC). “These new data underscore VP-315’s potential to redefine how basal cell carcinoma is treated,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica Pharmaceuticals. “We are particularly encouraged by the immunologic profile we’re seeing with VP-315, which supports our view that this local, short-term therapy not only destroys tumor cells directly but also stimulates a potent local immune response. These data help explain the mechanism for the clinical safety and efficacy data previously reported, and support the development of VP-315 as a potential first-in-class, non-surgical immunotherapy option for patients with BCC and further reinforces our confidence in VP-315’s ability to address a significant unmet need in dermatologic oncology.” Rieger continued, “With these data and the clarity and broad agreement we received in our End-of-Phase 2 meeting with the FDA on advancing this unique and promising therapy into a pivotal Phase 3 program, we are continuing our preparatory activities and our exploration of new opportunities to fund the BCC program, which may include strategic, non-dilutive partnerships for both the development as well as post-approval commercialization for this potential multi-billion-dollar opportunity in the most common form of skin cancer.” The oral and poster presentations titled “Exploratory analysis of a phase 2 multicenter study evaluating local immune activation in the tumor microenvironment 12 weeks post VP-315, an investigational therapy for basal cell carcinoma (BCC)” was presented on behalf of Verrica by Dr. Kenneth Y. Tsai, MD, PhD, Vice Chair, Research, Department of Pathology, Co- Director, Donald A. Adam Melanoma and Skin Cancer Center of Excellence, Moffitt Cancer Center. VP-315 is an intratumorally administered, potential first-in-class oncolytic peptide designed to induce immunogenic tumor cell death and promote anti-tumor immune responses. In Part 2 of the Phase 2 study, 82 subjects (92 tumors) received once-daily injections of 8 mg VP-315 for 2–3 consecutive days in up to two target lesions. The exploratory analysis evaluated immune responses to VP-315 treatment in the tumor microenvironment (TME) in a subset of 22 subjects (24 tumors) from Part 2 of a Phase 2 multi-center, proof-of-concept study (NCT05188729). VP-315 was well-tolerated, with no treatment-related serious adverse events. All patients experienced a reduction in tumor size, including: 51% complete histologic clearance rate 71% reduction in tumor size among patients with residual carcinomas 86% overall tumor-size reduction 97% objective response rate (post-hoc analysis) Histologic assessment in non-injected lesions that suggests a potential abscopal-like effect Multiplex immunofluorescence immunohistochemistry was performed on paired tumor biopsies collected pre-treatment and 12–14 weeks post-treatment. The results demonstrated that VP-315 reprograms the TME toward a more immunologically active and anti-tumor phenotype, as evidenced by: Significant increases in the densities of CD3+, CD3+/CD4+ helper, and CD3+/CD8+ cytotoxic T cells Increased B-cell (CD20+) infiltration in the tumor region, suggesting activation of humoral immunity Reduction in immunosuppressive cell populations Collectively, these findings indicate that VP-315 treatment reduces immunosuppression and enhances immune activation within and around the tumor. The observed immunologic cell changes support a mechanistic rationale for abscopal-like immune effects observed in non-treated lesions. VP-315 induced a robust local immune response with both cell-mediated and humoral components, effectively shifting the TME from an immunosuppressive to an anti-tumor state. These translational data further support the clinical efficacy and histologic clearance observed in the Phase 2 study and reinforce VP-315’s potential as a non-surgical, first-line immunotherapeutic approach for patients with basal cell carcinoma. VP-315 is a potential first-in-class oncolytic chemotherapeutic peptide immunotherapy administered directly into a tumor to induce immunogenic cell death and thereby unleashing a broad spectrum of tumor antigens for T cell responses, which may offer a non-surgical option for patients suffering from skin cancer. The technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. Verrica holds an exclusive worldwide license to develop and commercialize VP-315 for certain dermatologic oncology indications, including non-metastatic melanoma and non-metastatic merkel cell carcinoma, and intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. VP-315 has demonstrated positive tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials. Basal cell carcinoma is the most common form of cancer in the U.S., and incidence is rising worldwide. There are approximately 3.6 million diagnoses of basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options. Basal cell carcinoma is generally treated with invasive surgery to remove the tumor, which can cause pain, infection, bleeding and scarring. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出免疫疗法临床结果

2025-09-19

·GlobeNewswire-Health Care

Verrica Pharmaceuticals Announces That Development Partner, Torii Pharmaceutical, Receives Approval for YCANTH® (TO-208) in Japan for the Treatment of Molluscum Contagiosum

– Approval triggers $10 million cash milestone payment to Verrica – – YCANTH® approval in Japan addresses significant unmet need of patients with molluscum – – Verrica maintains ownership of global rights to YCANTH for all indications in all territories outside of Japan – WEST CHESTER, Pa., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that its development partner, Torii Pharmaceutical Co. Ltd. (“Torii”) has received approval from the Japanese Ministry of Health, Labour and Welfare (“MHLW”) for YCANTH® (TO-208) for the treatment of Molluscum Contagiosum (“molluscum”). Torii became a wholly-owned subsidiary of Shionogi & Co., Ltd., on September 1, 2025. “We are excited to announce that our development partner, Torii, has received regulatory approval for YCANTH in Japan, enabling individuals who contract molluscum in Japan access to a safe and effective therapy,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “As part of our recently amended collaboration and licensing agreement with Torii, approval of YCANTH in Japan has triggered a one-time $10 million milestone cash payment that we expect to receive in the next several weeks. This significant source of non-dilutive capital will immediately strengthen our balance sheet and help support our U.S. commercial activities as we work to establish YCANTH as the new standard of care for the treatment of molluscum.” Dr. Rieger continued, “We hope that this is the first of many other potential approvals for YCANTH around the world, so that all patients with molluscum may have access to a convenient, proven, safe and effective treatment for their molluscum and we are actively working on opportunities to continue this expansion. We express our thanks and congratulations to the Torii team for their work in securing this important achievement, and we remain excited to partner with Torii on the upcoming global Phase 3 program to study YCANTH for the treatment of common warts, which we expect to begin with the first patient dosed in the U.S. anticipated by the end of 2025.” Torii filed the New Drug Application for TO-208 in molluscum with MHLW in December 2024. In December 2023, Verrica announced that Torii reported positive top-line results from a confirmatory Phase 3 trial of TO-208 (marketed as YCANTH in the U.S.) for the treatment of molluscum in Japan. The Phase 3 trial was conducted in Japan and was a double blind, randomized and parallel-group comparison study to evaluate the efficacy and safety of TO-208 in comparison to placebo, when applied once every 21 days for up to four applications in patients with molluscum. The top-line results from the trial showed that the proportion of subjects achieving complete clearance of all treatable molluscum lesions at the completion of the confirmatory study, the primary endpoint of efficacy, was statistically significant versus placebo. TO-208 was well tolerated during the study. About YCANTH® (VP-102) YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapeutic for the treatment of molluscum. Approximately 225 million lives are eligible to receive YCANTH covered by insurance. Commercially insured patients pay just $25 per YCANTH treatment visit, for up to two applicators. Other uninsured patients may be eligible to receive YCANTH at a reduced cost if certain eligibility requirements are met for patient assistance. Please visit YCANTHPro.com for additional information. About Verrica Pharmaceuticals Inc. Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about receipt of additional non-dilutive capital from Torii, the commercialization of YCANTH and the clinical development and benefits of Verrica’s product candidates, including YCANTH (VP-102) and VP-315 and the timing of the Phase 3 program to study YCANTH for the treatment of common warts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. FOR MORE INFORMATION, PLEASE CONTACT: Investors: John KirbyInterim Chief Financial Officerjkirby@verrica.com Kevin GardnerLifeSci Advisorskgardner@lifesciadvisors.com

临床3期临床结果引进/卖出上市批准

100 项与鲁特米肽相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性黑色素瘤	临床2期	挪威	Lytix Biopharma AS	2024-11-01
基底细胞癌	临床2期	美国	Verrica Pharmaceuticals, Inc.	2022-02-01
皮肤肿瘤	临床2期	美国	Verrica Pharmaceuticals, Inc.	2022-02-01
局部晚期黑色素瘤	临床2期	美国	Lytix Biopharma AS	2021-06-01
局部晚期黑色素瘤	临床2期	法国	Lytix Biopharma AS	2021-06-01
局部晚期黑色素瘤	临床2期	挪威	Lytix Biopharma AS	2021-06-01
局部晚期黑色素瘤	临床2期	西班牙	Lytix Biopharma AS	2021-06-01
不可切除的黑色素瘤	临床2期	美国	Lytix Biopharma AS	2021-06-01
不可切除的黑色素瘤	临床2期	法国	Lytix Biopharma AS	2021-06-01
不可切除的黑色素瘤	临床2期	挪威	Lytix Biopharma AS	2021-06-01

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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


NCT05188729 (SITC2025)	临床2期	基底细胞癌	24	VP-315	窪餘夢網願餘鑰簾鏇築(網鹽夢蓋衊淵糧醖簾憲) = 糧淵鬱糧遞獵襯遞觸憲選淵鏇構艱簾鑰製鹹憲 (獵餘廠襯觸構淵遞鬱淵 )	积极	2025-11-05
NCT05188729 (Company_Website) 人工标引	临床2期	基底细胞癌	82	VP-315	範夢膚齋糧選醖鬱觸遞(簾餘鹽觸範淵齋顧遞積) = None 選構窪憲齋顧鏇廠膚顧 (願鹹廠蓋淵壓齋選憲憲 )	积极	2025-01-21
NCT03725605 (Pubmed \| Oncoimmunology)	临床2期	转移性软组织肉瘤 tumor-infiltrating lymphocytes \| neoantigens	6	LTX-315	淵鑰餘簾壓顧遞範鹽鑰(衊網餘構遞廠鏇窪繭窪) = only expected and manageable toxicity 願壓遞艱夢鏇願獵艱餘 (夢願獵積鹽夢構構觸製 ) 更多	积极	2024-12-31
NCT05188729 (GlobeNewswire) 人工标引	临床2期	基底细胞癌	93	VP-315	糧齋襯製獵獵遞衊觸顧(蓋鬱鏇醖齋繭獵淵襯鑰) = 遞願築淵膚糧餘築願鏇範積廠構夢範鏇獵壓繭 (廠構衊壓觸遞淵範鬱築 ) 更多	积极	2024-08-14
NCT03725605 (NCT03725605 \| ATLAS-IT-04 \| ###DELETE, CTgov)	临床2期	转移性软组织肉瘤	6	LTX-315 and TILs	淵壓憲觸簾獵壓糧顧願(選鏇襯遞網遞構淵鏇膚) = 選鑰簾鏇壓夢獵鹽襯鬱夢壓範夢築夢製簾窪顧 (選憲簾艱夢膚構夢願夢, 鹽範遞遞窪鬱觸構願範 ~ 獵鏇艱鏇憲廠鹹廠製廠) 更多	-	2023-11-08
NCT04796194 (ATLAS-IT-05, ESMO 12023 \| ESMO 22023) 人工标引	临床2期	黑色素瘤	14	LTX-315+pembrolizumab	齋淵範蓋糧醖遞醖艱壓(網齋衊製觸壓壓憲鹹夢) = 鬱糧鏇壓遞憲醖膚鏇艱憲鹽遞範鏇觸夢鑰顧選 (繭憲蓋衊窪網遞鹹鹹繭 ) 更多	积极	2023-10-23
NCT03725605 (ATLAS-IT-04, ASCO2022) 人工标引	临床2期	转移性软组织肉瘤	6	LTX-315	齋顧顧蓋壓窪網艱獵壓(夢齋簾鏇餘齋艱醖鹽淵) = 積積鹹齋獵築齋鏇築獵鏇選顧選積顧艱範獵膚 (獵膚膚壓鏇艱製繭齋繭 )	积极	2022-06-02
NCT01986426 (Pubmed \| Clin Cancer Res)	临床1期	实体瘤	-	LTX-315	齋窪醖淵窪觸衊鹹鬱範(築淵蓋遞構顧顧選鏇廠) = 顧窪窪鬱糧淵蓋願網襯餘膚蓋顧襯鹹窪糧膚淵 (鏇選繭願餘齋遞鹹鏇願 )	-	2021-02-04
NCT01986426 (AACR2019) 人工标引	临床1期	局部晚期黑色素瘤	27	LTX-315	糧願鹹鹽網餘膚製鏇襯(鏇觸願壓願願艱衊觸壓) = None 鑰餘淵觸憲鹹壓淵淵顧 (範鏇鏇遞簾觸範積顧簾 ) 更多	积极	2019-07-01
NCT01986426 (ASCO 12018 \| ASCO 22018) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	59	LTX-315	鏇壓襯蓋鏇積夢製壓艱(夢鹽鏇鹹製網構憲繭製) = 艱構糧艱繭積窪齋襯鹹網築顧醖繭壓築齋餘獵 (願製鑰艱積襯糧窪夢積 ) 更多	积极	2018-06-04
NCT01986426 (ASCO 12018 \| ASCO 22018) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	59	pembrolizumab+LTX-315 (TNBC)	襯餘襯選餘網窪廠淵淵(網選觸積繭網簾艱繭衊) = 鹽願衊膚餘構艱蓋製遞簾蓋繭選選襯壓鏇憲簾 (夢鏇淵齋遞廠壓鏇網選 ) 更多	积极	2018-06-04