This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of Intravenous Administration of IDOV-SAFETM in patients with advanced solid tumors.

开始日期2024-12-10

申办/合作机构

复旦大学

NCT06380309

/ Recruiting早期临床1期IIT

An Open Label, Dose-escalation and Extension, Phase I Clinical Study on Evaluating Safety, Tolerability and Pharmacodynamics of Intravenous Administration of IDOV-SAFE in Patients with Advanced Malignant Solid Tumors Who Have Failed in Standard Treatment.

Subjects were Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focused on MSS type colon and rectal cancer) who had failed standard systemic therapy and were inoperable.
The first stage was the dose escalation stage, which was divided into 4 dose groups according to the "3+3" dose escalation principle. One patient was enrolled in the first dose group, and 3-6 patients were enrolled in each of the latter three dose groups, with a total of 10-19 patients enrolled.
The second stage is the security extension stage, which is selected by SMC 1-2 dose cohorts were expanded for safety and divided into three cohorts in total(IIA, IIB, IIC) to explore the safety of sequential or combined administration modes with immune targeted therapy. Each cohort included 6-12 subjects at different dose levels, and three cohorts could be carried out at the same time.
The third stage is the dose expansion stage. According to the safety, PK and clinical data of the three cohorts in the second stage, 1-2 cohorts were selected by SMC for dose expansion. The sample size of each cohort was expanded to 20 cases on the original basis. The estimated ORR of the trial drug was 24%, and the ORR of the standard treatment was 5%. When the type I error was one-sided 0.025, and the power was 80%, the sample size was estimated by the normal approximation method. So each dose expansion phase A minimum of 20 subjects were required to be enrolled in the cohort.

开始日期2024-05-06

申办/合作机构

北京大学

NCT06346041

/ Recruiting早期临床1期IIT

A Phase I Study of Evaluating the Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors

This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors.

开始日期2024-04-12

申办/合作机构

中国医学科学院肿瘤医院

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项与 IDOV-Safe 相关的文献（医药）

2024-03-01·Biochimica et biophysica acta. Reviews on cancer

Advances and prospects of mRNA vaccines in cancer immunotherapy

Review

作者: Zeng, Zhaoyang ; Liu, Yixuan ; Yan, Qijia ; Xiong, Wei ; Fan, Chunmei

Cancer vaccines, designed to activate the body's own immune system to fight against tumors, are a current trend in cancer treatment and receiving increasing attention. Cancer vaccines mainly include oncolytic virus vaccine, cell vaccine, peptide vaccine and nucleic acid vaccine. Over the course of decades of research, oncolytic virus vaccine T-VEC, cellular vaccine sipuleucel-T, various peptide vaccines, and DNA vaccine against HPV positive cervical cancer have brought encouraging results for cancer therapy, but are losing momentum in development due to their respective shortcomings. In contrast, the advantages of mRNA vaccines such as high safety, ease of production, and unmatched efficacy are on full display. In addition, advances in technology such as pseudouridine modification have cracked down the bottleneck for developing mRNA vaccines including instability, innate immunogenicity, and low efficiency of in vivo delivery. Several cancer mRNA vaccines have achieved promising results in clinical trials, and their usage in conjunction with other immune checkpoint inhibitors (ICIs) has further boosted the efficiency of anti-tumor immune response. We expect a rapid development of mRNA vaccines for cancer immunotherapy in the near future. This review provides a brief overview of the current status of mRNA vaccines, highlights the action mechanism of cancer mRNA vaccines, their recent advances in clinical trials, and prospects for their clinical applications.

2021-06-01·Cancer discovery1区 · 医学

Oncolytic Herpes Virus Shrinks Pediatric Gliomas

1区 · 医学

Article

Abstract:

In a small trial involving children with progressive high-grade gliomas, direct infusions of a genetically engineered strain of herpes simplex virus elicited responses in 11 of 12 recipients. The therapy also led to more than a doubling in average patient survival compared with historical expectations.

2017-09-01·Molecular therapy oncolytics2区 · 医学

Oncolytic Herpes Virus rRp450 Shows Efficacy in Orthotopic Xenograft Group 3/4 Medulloblastomas and Atypical Teratoid/Rhabdoid Tumors

2区 · 医学

ArticleOA

作者: Leonard, Jeffrey R ; Hutzen, Brian J ; Jackson, Eric M ; Haworth, Kellie B ; Cripe, Timothy P ; Pierson, Christopher R ; Studebaker, Adam W

Pediatric brain tumors including medulloblastoma and atypical teratoid/rhabdoid tumor are associated with significant mortality and treatment-associated morbidity. While medulloblastoma tumors within molecular subgroups 3 and 4 have a propensity to metastasize, atypical teratoid/rhabdoid tumors frequently afflict a very young patient population. Adjuvant treatment options for children suffering with these tumors are not only sub-optimal but also associated with many neurocognitive obstacles. A potentially novel treatment approach is oncolytic virotherapy, a developing therapeutic platform currently in early-phase clinical trials for pediatric brain tumors and recently US Food and Drug Administration (FDA)-approved to treat melanoma in adults. We evaluated the therapeutic potential of the clinically available oncolytic herpes simplex vector rRp450 in cell lines derived from medulloblastoma and atypical teratoid/rhabdoid tumor. Cells of both tumor types were supportive of virus replication and virus-mediated cytotoxicity. Orthotopic xenograft models of medulloblastoma and atypical teratoid/rhabdoid tumors displayed significantly prolonged survival following a single, stereotactic intratumoral injection of rRp450. Furthermore, addition of the chemotherapeutic prodrug cyclophosphamide (CPA) enhanced rRp450's in vivo efficacy. In conclusion, oncolytic herpes viruses with the ability to bioactivate the prodrug CPA within the tumor microenvironment warrant further investigation as a potential therapy for pediatric brain tumors.

项与 IDOV-Safe 相关的新闻（医药）

2025-05-07

·PRNewswire

ViroMissile Unveils IDOV™ Platform: A Potential One-Shot Cure for Cancer

SAN DIEGO, May 7, 2025 /PRNewswire/ -- ViroMissile was recognized by "Life Sciences Review" magazine as the Top Cancer Destroying Platform 2025. A pioneering biotech firm headquartered in San Diego, ViroMissile is transforming the landscape of cancer treatment with its Intravenously Deliverable Oncolytic Virus (IDOV™) platform. This innovative approach aims to provide a universal, single-dose therapy capable of targeting and eliminating various cancer types. At the core of ViroMissile's breakthrough is a genetically engineered vaccinia virus designed to selectively infect and destroy cancer cells while simultaneously activating the body's immune response. Unlike traditional oncolytic viruses that require direct tumor injections, the IDOV™ platform enables systemic intravenous delivery, allowing the therapeutic virus to reach tumors throughout the body. "Our goal is to develop a broadly applicable therapy that leverages the immune system to combat cancer," said Dr. Nanhai George Chen, CEO of ViroMissile. "By focusing on fundamental characteristics of cancer cells, such as rapid division, we aim to create a treatment effective across multiple cancer types." Since launching its operations in 2018, ViroMissile has made significant strides in developing its third-generation oncolytic viruses. Pre-clinical studies in mouse models have demonstrated that a single injection can eradicate multiple cancers. Early clinical trials in China have provided compelling evidence that the virus successfully reaches tumors in human patients. The next round of clinical trials will take place in the United States and Australia. The IDOV™ platform includes several product candidates: IDOV-Safe™: Engineered for enhanced safety profiles. IDOV-Immune™: Designed to boost immune system activation. IDOV-Stealth™: Optimized to evade immune detection for improved delivery. IDOV-Anti-Angio™: Targets tumor blood vessel formation to inhibit growth. ViroMissile's approach addresses a critical challenge in oncology: delivering effective therapies with minimal invasiveness and maximum efficiency. By enabling intravenous administration, the company aims to overcome limitations associated with localized treatments, potentially offering a more patient-friendly alternative. The company's lean operational model, combined with strategic investments, has facilitated rapid progress without excessive overhead. This efficiency positions ViroMissile to bring its innovative therapies to market swiftly, addressing unmet needs in cancer treatment. As ViroMissile continues to advance its clinical programs, the company is actively seeking partnerships and investment to support further development and commercialization efforts. With its promising platform, ViroMissile stands at the forefront of a new era in cancer therapy. For more information, please visit . Contact: Derek Danziger, APR 619-200-2145 cell [email protected] SOURCE ViroMissile WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究

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适应症	最高研发状态	国家/地区	公司	日期
结直肠癌	临床1期	中国	ViroMissile, Inc.	2025-05-01
晚期恶性实体瘤	临床1期	中国	中国医学科学院肿瘤医院	2024-04-12

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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


ASCO_SITC2020	N/A	肿瘤	-	SNV1	簾淵醖鹽膚築鬱範憲壓(網膚觸窪糧築構窪窪衊) = Five days after SNV1 administration, tumor infiltrating lymphocytes (TILs) from both treated and untreated tumors showed increased CD4 and CD8 T-cell populations. As well as decreased frequency of Tregs, and improved effector to Treg ratios, which was associated with inhibition of tumor growth at the treated tumor site and also at distant untreated sites 餘鹹範餘淵廠蓋鬱襯襯 (襯鏇鏇鹹鹹築鏇窪繭醖 ) 更多	-	2020-02-06