Longyao Bio’s IDOV-Immune™ Gets FDA IND Approval

Recently, Longyao Bio and its co-development partner ViroMissile, Inc. (USA) announced that their strategic upgrade product, IDOV-Immune™, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), paving the way for the initiation of a Phase I clinical trial in the United States. This milestone represents a significant breakthrough for the jointly developed pipeline in the global pharmaceutical market, following the series of clinical progress achieved by IDOV-Safe™ in China and Australia.

IDOV-Immune™ is developed based on the world's first oncolytic vaccinia virus technology platform designed for systemic intravenous administration — the IDOV™ platform, jointly owned by Longyao Bio and ViroMissile. By expressing potent immune factors, it systemically activates anti-tumor immune responses, converting "cold tumors" into "hot tumors" and promoting significant infiltration of CD8+ T cells. Preclinical studies have demonstrated that a single intravenous injection of IDOV-Immune™ achieves complete tumor clearance in immunocompetent mouse models, with efficacy significantly superior to the base platform virus and other immune-activation strategies.

As one of the core pipeline assets jointly developed by both parties, IDOV-Immune™ is exclusively held by Longyao Bio for development and commercialization rights in Mainland China. This FDA IND approval marks a new phase in the product's global clinical development and lays a solid foundation for future clinical trials and regulatory submissions in China.

Mr. Deng Xiang, Founder of Longyao Bio, stated: "The FDA IND approval of IDOV-Immune™ is a key achievement of the deep collaboration between Longyao Bio and ViroMissile in advancing our global clinical development strategy. We firmly believe that with the revolutionary technological advantages of the IDOV™ platform and the exceptional execution of our global clinical teams, this innovative therapy will bring new hope to patients with refractory solid tumors worldwide. Longyao Bio will continue to work closely with ViroMissile to accelerate the global clinical development of IDOV-Safe™ and IDOV-Immune™, striving to transform more 'incurable' cancers into treatable and manageable diseases."

To date, the joint R&D pipeline of Longyao Bio and ViroMissile has formed a robust product portfolio. The core product IDOV-Safe™ has successively received ethics approvals from Peking University Cancer Hospital, Cancer Hospital Chinese Academy of Medical Sciences, Fudan University Shanghai Cancer Center, and Beijing GoBroad Hospital in China, continuously improving its nationwide multi-center clinical footprint and demonstrating breakthrough efficacy in MSS-type colorectal cancer and other indications. Its clinical trial at The Alfred Hospital in Melbourne, Australia, has also been officially initiated with dosing commenced. The strategic upgrade product IDOV-Immune™, now with FDA IND approval in the U.S., will further expand the impact of both companies in the global solid tumor therapy landscape.

Moving forward, Longyao Bio will continue to deepen its global collaboration with ViroMissile, accelerating the clinical development of IDOV-Safe™ and IDOV-Immune™, and striving to lead a new era in solid tumor therapy with this revolutionary technology platform.