1. Introduction to the Project

1.1 Introduction to technical achievements

TIL drugs belong to adoptive cell transfer therapy (ACT). ACT refers to the isolation of immune active cells from tumor patients, in-vitro amplification and functional identification and then reinfusion to patients in order to directly kill tumors or stimulate the body’s immune response to kill tumor cells.

1.2 Technical analysis and advantages

Tumor infiltrating lymphocyte (TIL) therapy is an experimental cell therapy currently under development for the treatment of solid tumors. Compared with CAR-T cell therapy and PD-1/PD-L1 antibodies, TIL therapy has the advantages of multiple targets, strong tumor tendency and infiltration ability, and minimal side effects. Firstly, TIL’s immune cells come from the tumor tissue and directly determine their ability to recognize tumors. It is estimated that over 60% of immune cells isolated from tumors can recognize tumors, while less than 0.5% of immune cells are isolated from blood. Secondly, this new type of therapy is not simply amplification and reinfusion, but involves identifying specific mutations in the patient’s case, then using mutation information to find T cells that can most effectively target these mutations, and finally extracting T cells specifically for cell mutations in the patient’s tumor. These cells have the ability to accurately identify cancer cells. The project aims to improve the traditional use of TIL cell drugs, achieving less clearance and less use of IL-2, making patients safer, with fewer side effects. Cellular drugs have relatively low preparation costs.

1.3 Main products and applications of technical achievements

The project products are a series of infiltrating lymphocyte (TIL) drug products. In the treatment of malignant tumors, the first phase indications for TILs immune cell drug therapy include surgical resection of stage 2 and 3 gastric cancer, advanced liver cancer, ovarian cancer, etc., solving the postoperative recurrence and metastasis problems, improving the patient’s quality of life, and prolonging the patient’s survival.

1.4 Stage of technological achievements

The technical achievements of the project are currently in the small trial stage.

1.5 Technical team

The technical ownership of the project belongs to Jilin Yifeinidi Biopharmaceutical Co., Ltd. Since its establishment in August, 2023, the company has been committed to the research and development of a series of infiltrating lymphocyte (TIL) drug products. On the basis of ensuring the effectiveness of TIL, the company continuously improves its production process, shortens the preparation cycle, and forms a stable production process.

Sheng Chunhua, the founder of the company, is a visiting scholar at Stanford University. He is a doctor with nearly 30 years of clinical experience in cancer and has completed over 10000 clinical cases of cell therapy. Professor Wu Ning is the Director of the Innovation Center of the Institute of Cell Transformation, Chinese Academy of Sciences. The basic research team is led by Professor Bao Yongli from Northeast Normal University, and the clinical research collaboration team is led by Professor Fang Xuedong from China-Japan Union Hospital, working closely with Academician Yang Baofeng.

2. Market Potential Analysis

Tumor infiltrating lymphocyte (TIL) therapy is a highly differentiated, customized, and targeted immunotherapy that is similar to CAR-T cell therapy, but TIL therapy has more significant anti-cancer advantages. TIL therapy is an adoptive cellular immunotherapy regimen, and clinical research began in the 1980s. The early development of TIL therapy was slow. In recent years, with the continuous deepening of research, TIL therapy has attracted market attention for the treatment of solid tumors such as melanoma and advanced cervical cancer. The tumor infiltrating lymphocyte (TIL) treatment method LN-145 in the United States has been awarded the breakthrough therapy title by the FDA for the treatment of advanced cervical cancer patients who relapse after chemotherapy.

So far, various clinical studies on TIL therapy have been completed globally, with the indications including melanoma, NSCLC, ovarian cancer, head and neck cancer, colorectal cancer and osteosarcoma, etc. Among them, melanoma is the main research type. By now, TIL therapy and products have not yet been launched, but there are many global research and development enterprises. With the continuous deepening of research, the time for TIL therapy products to be launched is only a matter of time.

The TIL therapy market in China has a high prosperity. Since 2020, there has been a continuous increase in the investment and financing events within the TIL therapy industry, with more than 15 events and a total financing amount of over 2.4 billion yuan. Among them, there were 9 financing events in 2021, with a total disclosed financing amount of over 1.5 billion yuan. Thanks to technological progress, capital layout, and improved research level, the research and development speed of TIL therapy in China has accelerated, and the gap between China and the international level is constantly narrowing. From a domestic perspective, there are a large number of companies that have established TIL therapy in China, including Jinfeng Biotechnology, Juncell Therapeutics, GRIT Biotechnology, Chineo, CBM, Oricell Therapeutics, LMBio, and Aeonvital. But overall, the participants in TIL therapy in China are mainly startup enterprises. With the deepening of research, TIL therapy has gradually become a key tumor treatment method. At present, there are no TIL therapy products launched globally. Driven by technology empowerment and capital assistance, the launch of TIL therapy products is not far away.

3. Financing Needs and Purposes

The project is planned to raise 3 million yuan to complete IND and apply for clinical trial approval.

4. Analysis of Technical Achievements and Benefits

4.1 Economic benefits

After the commercialization of the technical achievements of the project, a market value of approximately 95 million yuan can be generated.

4.2 Social benefits

TIL therapy has advantages such as strong tumor specificity, high safety, large amplification quantity, and low preparation cost, and has achieved good therapeutic effects in the treatment of various solid tumors. It is expected to become a sharp sword to overcome solid tumors and fill the clinical needs that are not met in the current field of solid tumor treatment.

5. Contact Method

Contact person: Sheng Chunhua

Tel: 13604320568