Immvira Bio Files for Hong Kong IPO with Phase II Oncolytic Immunotherapy MVR-T3011

Immvira Bioscience Inc. filed for an initial public offering on the Hong Kong Stock Exchange (HKEX), advancing its pipeline of oncolytic immunotherapies and engineered exosome therapies. The company’s lead asset, MVR-T3011, a novel HSV-1 based oncolytic virus expressing anti-PD-1 antibody and IL-12, is in Phase II trials for full-spectrum bladder cancer and third-line head and neck squamous cell carcinoma (HNSCC).

Company Overview

Technology & Product Profile

MVR-T3011: Novel Oncolytic Immunotherapy

• Platform: Herpes simplex virus type 1 (HSV-1) backbone engineered for tumor-selective replication
• Mechanism: Combines potent tumor lytic activity with local expression of anti-PD-1 antibody and IL-12, creating a dual-pronged attack (direct oncolysis + immune activation)
• Delivery: Intratumoral injection for solid tumors
• Advantages:
• Overcomes systemic toxicity of checkpoint inhibitors
• IL-12 expression enhances T-cell/NK cell infiltration
• Anti-PD-1 expression maintains sustained immune pressure within tumor microenvironment

Engineered Exosome Platform

• Pipeline: 5 exosome products (indications undisclosed)
• Potential: Direct commercial applications or therapeutic delivery vehicles

Clinical Development

• Full-Spectrum Bladder Cancer Coverage: Only oncolytic therapy addressing entire disease continuum from non-muscle invasive to muscle-invasive disease
• Phase II Design: Open-label, multi-cohort study (n = ~150) evaluating both monotherapy and combination regimens

Market Opportunity

• Unmet Need: BCG-unresponsive NMIBC represents major gap; MVR-T3011 could capture 30% market share upon approval
• Strategic Value: Full-spectrum bladder cancer approach enables comprehensive commercial strategy and higher market penetration

Financial & Strategic Positioning

• IPO Proceeds: Estimated USD 200‑250 million (based on comparable HKEX biotech listings)
• Use of Funds: 60% clinical development, 25% manufacturing scale-up, 15% platform expansion
• Manufacturing: In-house GMP facility in Shenzhen (capacity for 10,000 doses/year)
• Valuation: Pre-money estimated at $800‑900 million , supported by Phase II data and dual-platform technology
• Intellectual Property: 28 patents covering HSV-1 backbone modifications, transgene expression cassettes, and exosome engineering

Forward-Looking Statements
This brief contains forward-looking statements regarding Immvira Bio’s IPO timeline, clinical development plans, and market positioning. Actual results may differ due to market conditions, regulatory review timelines, and competitive dynamics in oncolytic immunotherapy.-Fineline Info & Tech