亦诺微医药继续冲刺国内「溶瘤病毒第一股」：主打产品瞄准膀胱癌新一代核心疗法

Core Viewpoint - Immvira Bioscience is advancing its IPO process with a pre-IPO valuation of $485 million, focusing on innovative cancer therapies and leveraging its unique capabilities in CMC and production [1][9]. Company Overview - Immvira Bioscience is the only biotechnology company globally with mature CMC and production capabilities, offering a pipeline that includes oncolytic immunotherapy candidates for solid tumors and innovative engineered exosome therapeutic products [3]. Product Pipeline - The core product, MVR-T3011, is a novel oncolytic immunotherapy based on HSV-1, designed to target a wide range of solid tumors, including bladder cancer and head and neck squamous cell carcinoma [5]. - MVR-T3011 is undergoing a structured development roadmap, with a phased strategy in bladder cancer, including a key Phase II clinical trial for high-risk NMIBC, which is set to complete its first patient dosing in June 2025 [5][6]. - The company has reported promising efficacy and safety data for MVR-T3011 in treating BCG-unresponsive NMIBC, with a 20% objective response rate and a 65% disease control rate observed in prior studies [6]. Regulatory and Development Strategy - The company benefits from a unified "umbrella IND" regulatory framework, allowing multiple clinical evaluations under a single protocol, which enhances development efficiency [7]. - Immvira has established a collaboration with Shanghai Pharmaceuticals for the clinical development and commercialization of MVR-T3011 in Greater China, receiving an upfront payment of 20 million yuan and potential milestone payments up to 1.1 billion yuan [8]. Innovation Platform - The OVPENS platform is central to Immvira's innovative product development, integrating oncolytic immunotherapy and engineered exosome development, covering the entire process from target validation to IND application and GMP-compliant production [8]. - The platform's expansion has also advanced the pipeline of engineered exosome products, which include commercially viable aesthetic products and therapeutic candidates undergoing traditional clinical regulatory pathways [9]. Investment and Valuation - Since its establishment, Immvira has attracted investments from various institutions, with a post-Series C valuation of $485 million [9].