Tasly Biopharma’s Advanced Malignant Solid Tumors of Digestive Tract Drug T601 Successfully Completes the First Subject Administration of Phase I/IIa Clinical Trial

Tasly Biopharma’s Advanced Malignant Solid Tumors of Digestive Tract Drug T601 Successfully Completes the First Subject Administration of Phase I/IIa Clinical Trial

On November 20, 2019 at Shanghai East Hospital Tongji University, Transgene Tasly (Tianjin) Biopharmaceutical Co., Ltd. (hereinafter referred to as Transgene Tasly), a wholly-owned subsidiary of Tasly Biopharmaceuticals Co., Ltd. (hereinafter referred to as “Tasly Biopharma”), successfully completed the first subject administration in the Phase I/IIa clinical trial of T601 (a vaccinia virus targeted for advanced malignant solid tumors of digestive tract) developed by it. The administration process went smoothly, and the subject has no adverse reactions.

Basic Information of T601

T601 is a dual-effect recombinant oncolytic virus vaccine that is intended to treat advanced malignant solid tumors of digestive tract. T601 uses the recombinant vaccinia virus (“rVV”) strain Copenhagen, where the thymidine kinase gene and the ribonucleotide reductase gene are deleted (“TK-RR-”), as the vector to carry the gene encoding the prodrug-converting enzyme, i.e. FCU1. It has both the oncolytic mechanism and the targeted chemotherapy mechanism. Compared with traditional chemotherapy, T601 has high affinity to tumor cells and fewer side effects.

T601 was initially developed by French Transgene. Transgene Tasly undertook the research and development of this product in China and has the commercialization rights of T601 in China. At present, French Transgene is also simultaneously developing a product TG6002 with overseas rights in Europe, and has obtained permission of new drug clinical trials in France, Belgium, Spain and the United Kingdom for the proposed indications for advanced malignant solid tumors of digestive tract.

French Transgene has initiated a phase I/IIa clinical study of TG6002 for advanced malignant solid tumors of digestive tract since October 2018. The study includes dose exploration and expansion studies, and is currently in dose exploration. So far, the fourth dose group (3E+8pfu) has been started, and no serious drug-related adverse reactions have been found.

Pre-clinical research data show that T601 has good anti-tumor activity against a variety of malignant solid tumors, especially malignant tumors of the digestive tract.

T601’s Clinical Development Progress

On April 15, 2019, Transgene Tasly received the T601 drug clinical trial notification approved and issued by the National Medical Products Administration. On November 20, 2019, the first subject administration of T601 was completed at the START-SEH New Drug Phase I Clinical Trial Center of Shanghai East Hospital Tongji University. The first administration process went smooth, and the subjects had no adverse reactions.

At present, the prinpical investigator of the single-arm, open-label phase I/IIa clinical trial of T601 being developed in China is Professor Li Jin. The main purpose is to evaluate the safety, tolerability and preliminary anti-tumor activity of T601 in single and multiple intravenous administration and combined oral administration of 5-formylcytosine (a non-cytotoxic drug that can be converted into a prodrug of the classic chemotherapy drug 5-fluorouracil through the insertion gene of T601). Meantime, it will also evaluate the pharmacokinetic characteristics and biodistribution of T601. Phase I of this study will enroll about 40 patients with advanced malignant solid tumors who have failed standard treatments, and phase IIa will enroll 30 patients with advanced gastric, liver, and pancreatic cancer.

T601’s Future Market Prospects

Solid tumors account for a very high proportion of cancer cases. The five most common cancers in China — lung cancer, stomach cancer, liver cancer, colorectal cancer and breast cancer, are all malignant solid tumors. In 2018, about 1.6 million people in China suffered from gastrointestinal tumors. From 2018 to 2023, this number is estimated to grow at a compound annual growth rate of 2.9%, and it will reach about 1.9 million in 2023.