IDOV-Safe(IDOV-Safe) - 在研适应症：结直肠癌，晚期恶性实体瘤_专利_临床

概要

基本信息

药物类型

溶瘤病毒

别名

IDOV-SAFETM、Oncolytic Virus(Cancer Hospital Chinese Academy of Medical Sciences)

靶点-

作用方式-

作用机制-

治疗领域

肿瘤消化系统疾病

在研适应症

结直肠癌晚期恶性实体瘤

非在研适应症-

原研机构

在研机构

非在研机构-

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)临床1期

特殊审评-

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关联

3

项与 IDOV-Safe 相关的临床试验

NCT06718946

/ Recruiting早期临床1期IIT

A Phase I Clinical Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors

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

100 项与 IDOV-Safe 相关的临床结果

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100 项与 IDOV-Safe 相关的转化医学

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100 项与 IDOV-Safe 相关的专利（医药）

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1

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

100 项与 IDOV-Safe 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
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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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO_SITC2020	N/A	肿瘤	-	SNV1	淵願願醖糧艱顧壓廠顧(餘選積艱醖鑰襯齋網壓) = 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 齋廠網鹹衊願製襯壓餘 (簾積憲夢壓範壓憲鹽廠 ) 更多	-	2020-02-06