ViroMissile Initiates First-in-Human Trial of IDOV-Immune Oncolytic Virus Therapy for Advanced Solid Tumors
核心洞察
ViroMissile (搜索) has dosed the first patient with IDOV-Immune (搜索), an investigational oncolytic vaccinia virus (搜索) therapy, at The Alfred Hospital (搜索) in Melbourne, Australia, marking the start of a Phase I trial for advanced solid tumors (搜索).
The multi-center trial will enroll up to 78 patients across the United States and Australia to evaluate the safety, tolerability, and preliminary anti-tumor activity of a single intravenous infusion of IDOV-Immune (搜索).
IDOV-Immune (搜索) represents a novel approach using systemically delivered oncolytic viruses that can target tumors throughout the body while activating both innate and adaptive immune responses.
ViroMissile (搜索), Inc. has initiated its first-in-human clinical trial of IDOV-Immune (搜索), an investigational oncolytic vaccinia virus (搜索) therapy for patients with advanced solid tumors (搜索). The company announced that the first patient was dosed at The Alfred Hospital (搜索) in Melbourne, Victoria, Australia, with additional trial sites across the United States expected to begin enrolling in 2026 pending U.S. IND clearance.
Novel Oncolytic Virus Platform
IDOV-Immune (搜索) is built on ViroMissile (搜索)'s proprietary IDOV™ (Intravenously Deliverable Oncolytic Virus) platform, which represents what the company describes as a new class of systemically administered cancer immunotherapy. According to Nanhai George Chen, PhD, CEO and founder of ViroMissile, "IDOV-Immune was engineered to penetrate the tumor, destroy cancer cells directly, and activate a coordinated immune response against the disease in a convenient systemic dose."
The therapy is designed to selectively target tumors while sparing healthy tissue, combining direct tumor killing with immune activation. Shah Rahimian, MD, chief medical officer at ViroMissile (搜索), emphasized the significance of delivering "a single intravenous dose that can reach tumors throughout the body, while also activating both innate and adaptive immunity."
Phase I Trial Design and Objectives
The Phase I, open-label, multi-center trial (NCT06910657) is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of a single intravenous infusion of IDOV-Immune (搜索). The study plans to enroll up to 78 adult participants at study sites across the United States and Australia, including leading cancer centers.
The primary objective focuses on determining the safety and tolerability of IDOV-Immune (搜索), including characterization of treatment-emergent adverse events through Day 90 and dose-limiting toxicities during the first 28 days. The trial also aims to establish the maximum tolerated dose and recommended dose for Phase 2 studies.
Secondary objectives include evaluating the pharmacokinetic and pharmacodynamic profile of IDOV-Immune (搜索), characterizing immunologic responses and the development of neutralizing antibodies, and assessing preliminary signs of antitumor activity. Efficacy measures will include objective response rate, disease control rate, progression-free survival, overall survival, and duration of response over a 12-month follow-up period.
Targeting Treatment-Resistant Cancers
The trial specifically targets patients with advanced solid tumors (搜索) who have exhausted standard treatment options. ViroMissile (搜索) positions its IDOV platform as designed to extend the reach of immunotherapy to metastatic and treatment-resistant cancers (搜索), addressing a significant unmet medical need in oncology.
The company claims to be the first to demonstrate effective intravenous tumor targeting with an oncolytic virus in humans, potentially representing an important evolution in viral immunotherapy. The systemic delivery approach aims to reach tumors throughout the body, differentiating it from localized oncolytic virus treatments that require direct injection into tumors.