Viromissile Completes First Dose Cohort Of Phase I Trial Of Intravenously-Dosed IDOV-2 Safety Review Committee Clears Advancement To Next Cohort
The company also reported that multiple patients in the initial cohort currently have stable disease across multiple solid tumor types, including one patient with confirmed stable disease at six months. These early signals of anti-tumor activity following a single intravenous (IV) dose of IDOV-2, even at starting dose levels, are notable because oncolytic virus (OV) development has largely been confined to tumors accessible by intratumoral or local injection, since IV-dosed OVs are typically cleared by the immune system before they can spread effectively to and within tumors. The company's proprietary platform leverages an engineered vaccinia strain with increased production of extracellular enveloped virus (EEV) to potentially enhance spread between cancer cells and reach a broader range of cancers through effective and efficient systemic administration.
“Clearance from the Safety Review Committee to move into the next dose cohort is an important validation of the tolerability profile we've seen so far, and it keeps this trial moving at the pace our patients deserve,” said Nanhai George Chen, PhD, CEO and founder of ViroMissile.“We are especially encouraged to see confirmed stable disease at six months in a patient treated at our lowest planned dose. It is an early but potentially meaningful signal that IDOV-2 is doing what we engineered it to do, causing the tumor itself, regardless of solid tumor type, to become an anti-tumor“drug” factory, delivering cytokines, chemokines, or other proteins to kill the tumor.”
Shah Rahimian, MD, chief medical officer at ViroMissile, added,“Successfully completing this first cohort gives us confidence as we advance to higher, potentially more active dose levels. We are grateful to the investigators and patients who made this milestone possible, and we look forward to building on this early signal of clinical benefit as enrollment continues.”
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-2. The study plans to enroll up to 78 adult participants at leading cancer centers across the United States and Australia using a dose-escalation design to determine the maximum tolerated dose and recommended dose for Phase 2 studies. Secondary objectives include evaluating the PK and PD profile of IDOV-2, 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.
About ViroMissile, Inc.
ViroMissile, Inc. is a cancer immunotherapy company harnessing a systemically delivered oncolytic virus that seeks and selectively destroys 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 IDOVTM (Intravenously Deliverable Oncolytic Virus) platform is designed to extend the reach of immunotherapy to metastatic and treatment-resistant cancers. ViroMissile Australia Pty Ltd, a subsidiary of ViroMissile, Inc., conducts the company's clinical trial operations in Australia.
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