IDOV‑Safe™ Gains Ethics Approval from Fudan University Shanghai Cancer Center

July 29, 2024 – Longyao Bio announced that its lead asset, IDOV‑Safe™, has received ethics committee approval from Fudan University Shanghai Cancer Center (FUSCC). Professor Hongxia Wang, Director of the Department of Medical Oncology, Director of the Cell and Gene Therapy Center, and recipient of the National Science Fund for Distinguished Young Scholars, will serve as the principal investigator (PI). This approval marks the company’s oncology pipeline’s official entry into a top‑tier cancer center in East China, representing a major advancement in its nationwide clinical research layout.

Fudan University Shanghai Cancer Center is a leading oncology institution in East China and a nationally renowned specialized cancer hospital. As the birthplace of the “Chinese Classification” of breast cancer, it has achieved outstanding accomplishments in precision oncology, proton therapy, and heavy ion therapy. Its ethical review process is widely recognized for rigorous standards in evaluating the clinical value of innovative drugs. This rapid approval further validates the innovation and clinical safety of IDOV‑Safe™, confirming that its distinct advantages in solid tumor targeted therapy align closely with FUSCC’s research priorities.

About Principal Investigator Professor Hongxia Wang

Professor Hongxia Wang is Director of the Department of Medical Oncology and Director of the Cell and Gene Therapy Center at Fudan University Shanghai Cancer Center. She is a Chief Physician and PhD Supervisor, a recipient of the National Science Fund for Distinguished Young Scholars, and Chief Scientist of the National Key R&D Program. She has been honored with numerous awards, including the Chinese Young Female Scientist Award, National March 8th Red Banner Pacesetter, National Women’s Meritorious Pacesetter, Shanghai Outstanding Academic Leader, and Shanghai Medical Artisan.

In academic leadership roles, Professor Wang serves as Chair of the Tumor Heterogeneity and Personalized Therapy Committee of the China Anti‑Cancer Association, Standing Committee Member of the Youth Council of the China Anti‑Cancer Association, and Vice Chair of the Shanghai Anti‑Cancer Association.

Professor Wang has long been dedicated to basic and translational research on recurrent and metastatic tumors, with a focus on precision diagnosis and treatment of breast cancer and immunotherapy for solid tumors. Her team handles more than 500,000 outpatient visits for patients with recurrent or metastatic diseases annually. She leads hundreds of multi‑center clinical trials (Phase I to III) and has initiated multiple investigator‑initiated trials (IITs). As principal investigator, she has directed multiple national projects, including the National Key R&D Program, the National Science Fund for Distinguished Young Scholars, and key programs of the National Natural Science Foundation of China.

In scientific innovation, Professor Wang’s research focuses on tumor stemness and the tumor microenvironment, with an emphasis on translational development of novel immunotherapies including oncolytic viruses and tumor vaccines. Her team identified a novel fibroblast subpopulation in the tumor microenvironment linked to chemoresistance, offering new strategies to overcome chemotherapy resistance in triple‑negative breast cancer. As sole or corresponding author, she has published in high‑impact international journals including Lancet, Cell Research, Cancer Discovery, Nature Cell Biology, Science Translational Medicine, and PNAS, with more than 50 SCI papers. She holds 21 national patents and 1 PCT patent.

Professor Wang’s profound expertise in solid tumor immunotherapy and translational research of novel therapies is highly aligned with the clinical development direction of IDOV‑Safe™. She upholds the philosophy of “clinical practice guiding research, and research empowering clinical practice,” and is committed to translating promising scientific discoveries into clinically applicable treatments. Her leadership in this trial provides high‑level academic guidance and quality assurance for the development of IDOV‑Safe™ in solid tumor therapy.

About IDOV‑Safe™

IDOV‑Safe™ is developed based on Longyao Bio’s globally leading IDOV™ (Intravenously Deliverable Oncolytic Virus) platform, a vaccinia virus‑based technology engineered specifically for systemic intravenous administration. Its core breakthrough lies in a proprietary high‑yield EEV (extracellular enveloped virus) strain, which enables the virus to evade immune clearance and effectively distribute to systemic tumor lesions.

IDOV‑Safe™ carries an exclusive “Magic Switch” gene module regulated by a small molecule: upon activation, viral replication is selectively inhibited in normal cells (inhibition rate >99.7%), while remaining unimpeded in tumor cells. This design delivers potent oncolytic efficacy while greatly expanding the therapeutic safety window, and provides specific, strong killing activity against MSS colorectal cancer (10–100‑fold enhanced potency).

This collaboration with Fudan University Shanghai Cancer Center not only opens a key clinical research pathway for Longyao Bio in East China, but also supports pipeline optimization via access to the institution’s academic and clinical resources, accelerating the translation of innovative therapies into clinical applications. Longyao Bio will continue to advance the clinical development of IDOV‑Safe™, committed to bringing curative potential to more patients with refractory solid tumors through this revolutionary technology platform.