ViroMissile Announces First-in-Human Phase I Trial of IDOV-Immune for Advanced Solid Tumors

Study examines the safety and early efficacy of an oncolytic virus via a single intravenous dose

SAN DIEGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV™ (Intravenously Deliverable Oncolytic Virus) platform, today announced the initiation of a first-in-human clinical trial evaluating IDOV-Immune, its investigational oncolytic vaccinia virus therapy, in patients with advanced solid tumors (NCT06910657). Additional trial sites across the United States are expected to begin enrolling in 2026, pending clearance of the U.S. IND. The first patient was dosed at The Alfred Hospital in Melbourne, Victoria, Australia.

“Launching this first-in-human trial marks an important milestone for ViroMissile and our mission to reshape cancer immunotherapy with selective viruses that target tumors while sparing healthy tissue,” said 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. We are excited to begin evaluating this therapy in patients who have exhausted standard options and to advance a new class of immunotherapies that may meaningfully improve outcomes.”

The Phase I, open-label, multi-center trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of a single intravenous (IV) infusion of IDOV-Immune. 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 is to determine the safety and tolerability of IDOV-Immune, including characterization of treatment-emergent adverse events (TEAEs) through Day 90 and dose-limiting toxicities (DLTs) during the first 28 days, and to determine the maximum tolerated dose and recommended dose for Phase 2 studies. Secondary objectives include evaluating the PK and PD profile of IDOV-Immune, characterizing immunologic responses and the development of neutralizing antibodies, and assessing preliminary signs of antitumor activity, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR) over a 12-month follow-up period.

Shah Rahimian, MD, chief medical officer at ViroMissile, added, “As we enroll patients into this first-in-human study, we are particularly encouraged by the opportunity to evaluate IDOV-Immune as a systemically administered oncolytic therapy. Delivering a single intravenous dose that can reach tumors throughout the body, while also activating both innate and adaptive immunity, represents an important evolution in the field. This trial will help us understand the safety profile, viral kinetics, and early biological activity of IDOV-Immune, and we are deeply grateful to the patients who make this work possible.”

About ViroMissile, Inc.
ViroMissile, Inc., is a cancer immunotherapy company harnessing a systemically delivered oncolytic virus designed to selectively seek out and destroy tumors throughout the body. As the first company to demonstrate effective intravenous tumor targeting with an oncolytic virus in humans, ViroMissile is leading a new era of viral immunotherapy that combines direct tumor killing with immune activation for durable responses in patients with advanced solid tumors. The company’s proprietary IDOV™ (Intravenously Deliverable Oncolytic Virus) platform is designed to extend the reach of immunotherapy to metastatic and treatment-resistant cancers.

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Maggie Whitney
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