IDOV‑Safe™ Gets Ethics Approval, Enters Clinic

January 26, 2024 – Longyao Bio announced that its lead asset, IDOV-Safe™, has received ethics committee approval from the Peking University Cancer Hospital & Institute's Center for Clinical Research of Anti-tumor Innovative Drugs. Professor Shen Lin, Director of the Department of Gastrointestinal Oncology and Director of the Phase I Clinical Trial Unit, will serve as the principal investigator (PI). This approval marks the formal initiation of the product's clinical trial at a top-tier national cancer center.

Peking University Cancer Hospital is a Grade III Level A specialized oncology hospital, ranked 4th nationally and 2nd in North China for oncology specialty reputation, and is renowned for its rigorous and professional ethics review process. This approval represents the first authoritative recognition of the innovation and clinical safety of Longyao Bio's lead asset, IDOV-Safe™.

About Principal Investigator Professor Shen Lin

Professor Shen Lin is a Beijing Scholar and Chief Scientist of the National Key R&D Program. She currently serves as Director of the Department of Gastrointestinal Oncology and Director of the Phase I Clinical Trial Unit at Peking University Cancer Hospital, Director of the Beijing Key Laboratory of Cell and Gene Therapy for Solid Tumors, and also holds the positions of Chief Scientist and Gastrointestinal Oncology Discipline Leader at Beijing GoBroad Hospital.

As a leading figure in China's gastrointestinal oncology field, Professor Shen has dedicated over three decades to precision treatment and translational research in gastrointestinal cancers, and is a founder and advocate of the multidisciplinary team (MDT) approach for gastrointestinal tumors in China. She holds key leadership positions including Honorary Chair of the Tumor Precision Therapy Committee of the China Anti-Cancer Association and Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO).

Professor Shen has long been committed to clinical and translational research of anti-cancer drugs. As a leading PI, she has spearheaded over 100 international and domestic multi-center clinical trials, directly contributing to the approval of 16 anti-cancer drug indications in China and advancing 38 drugs into Phase I-II clinical studies. Her research achievements have cumulatively rewritten over 40 clinical practice guidelines both domestically and internationally. As first or corresponding author, she has published more than 250 SCI papers in prestigious journals including Nature, BMJ, JAMA, The Lancet, and Nature Medicine, with 15 papers selected as ESI 1% highly cited papers, earning recognition as a "Highly Cited Researcher" and "World's Top 2% Scientist." She holds 18 national patents. The gastrointestinal cancer clinical and translational research system she established was selected for the China Association for Science and Technology's "Tech China" Pioneer Technology List. In June 2025, the world's first randomized controlled trial of CLDN18.2 CAR-T for gastric cancer, designed and led by her team, was published in The Lancet, representing a landmark breakthrough in solid tumor cell therapy.

Professor Shen's research focus in gastrointestinal oncology aligns closely with the core indications of IDOV-Safe™. Her leadership in this clinical trial provides top-tier academic guidance and quality assurance for exploring IDOV-Safe™ in MSS-type colorectal cancer and other gastrointestinal tumors.

About IDOV-Safe™

IDOV-Safe™ is developed from Longyao Bio's globally leading IDOV™ (Intravenously Deliverable Oncolytic Virus) platform—a vaccinia virus-based technology specifically designed 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 broadly reach tumors throughout the body. IDOV-Safe™ features an exclusively designed "Magic Switch" gene module controllable by a small molecule: when activated, viral replication is selectively inhibited in normal cells (inhibition rate >99.7%), while proceeding normally in tumor cells. This design achieves potent oncolytic efficacy while significantly expanding the therapeutic safety margin, and confers specific and potent killing advantage against MSS-type colorectal cancer (10–100 fold increased potency).

This collaboration not only provides Longyao Bio's oncology pipeline with a top-tier clinical research setting, but also establishes the company's R&D credibility in the oncolytic virus field, laying a solid foundation for future multi-center trials and accelerated product registration. Longyao Bio remains committed to advancing the clinical development of IDOV-Safe™, striving to bring the hope of a cure to more patients with refractory solid tumors through this revolutionary technology platform.