Juncell Therapeutics Files for Hong Kong IPO, Aiming to Become China's First TIL Therapy-Focused Public Biotech

TIL, fully known as Tumor Infiltrating Lymphocytes (TIL), are immune cells present within tumor tissues. They possess advantages such as high tumor specificity, broad tumor target recognition, and strong tumor homing ability.TIL Therapy isAn adoptive cell therapy that involves extracting fromTumor tissueInfiltrating lymphocytes were obtained in China and processed in vitro.Isolation, Amplification, Activation, thenInfused back into the patient's body to kill tumor cells.

Since 1986, when American scholar Rosenberg first reported the use of TIL for adoptive immunotherapy in cancer, significant progress has been made in experimental research on TIL.On February 16, 2024, the U.S. FDA announced the approval ofTIL Therapy Developed by Iovance BiotherapeuticsAmtagvi（lifileucel），For Advanced Melanoma Progressing After PD-1/PD-L1 Therapy, priced at 515,000 USD (approximately 3.7 million RMB).ThisIs the world's first approved and marketed TIL cell therapy.Except for melanoma, TILThe therapy has demonstrated impressive clinical benefits for patients with cervical cancer and has also shown preliminary efficacy in colorectal cancer, cholangiocarcinoma, non-small cell lung cancer, and breast cancer.

In addition to Iovance Biotherapeutics, many companies in China and abroad have already laid out TIL therapy. Representative foreign companies includeAchilles Therapeutics, Instil Bio, Obsidian, and TurnstoneWait, there are 19 companies in China that have laid out TIL therapy. The editor summarizes as follows:

Source: PharmaCloud Database

The company's core R&D platforms include the StemTexp® dry TIL expansion technology platform, StaViral® viral stable transfection process, ImmuT Finder® immunomodulatory target discovery platform, and KOReTIL® high-efficiency gene knockout system, based on which a series of next-generation gene-edited TIL drugs have been developed.Currently, there are 6 TIL drugs in its pipeline, targeting various solid tumors such as melanoma, cervical cancer, lung cancer, ovarian cancer, and gastrointestinal tumors.

Product Pipeline

GT101 Injection, a TIL product independently developed and produced by Grail Bio, is the first TIL product in China to enter clinical trials. Based on the clinical outcomes of the Phase 1 trial, GT101 has officially launched a pivotal Phase 2 clinical study in China, targeting recurrent or metastatic cervical cancer.This is the first and only TIL product in China to enter the critical clinical stage.

Grit Biotechnology's next-generation product GT201 has officially received the clinical trial tacit approval from the CDE, becomingThe First Gene-Edited TIL Drug in China to Enter Registration Clinical Trials. Currently in Phase I clinical trials, the indication is for recurrent or metastatic solid tumors.At the ASCO Annual Meeting, Grail Bio announced the latest Phase I clinical data for GT201 in advanced solid tumors.Efficacy results showed that tumors shrank significantly and conditions improved in multiple patients, with one patient experiencing a 69% reduction in tumor size after receiving GT201 treatment. Among all non-small cell lung cancer patients, the disease control rate of GT201 reached 100%.

Juncell Therapeutics, founded in 2019 and based in Shanghai, China, is a biotechnology company dedicated to the innovation of TIL therapies and the development of new drugs. Relying on its proprietary DeepTIL® cell expansion and NovaGMP® gene modification platforms, Juncell Therapeutics has developed a series of globally leading innovative natural TIL cell products and gene-modified TIL cell products.

Currently, the company has two innovative TIL therapies (GC101, GC203) in clinical trial stages, demonstrating excellent clinical efficacy across nine different types of advanced solid tumors (including pancreatic cancer and high-grade gliomas that have failed multiple lines of treatment). Among these, tumors in 7 patients were completely cleared, with the longest tumor-free survival time nearing 3 years.

On April 28, 2024, JunSai Biotech Gene-Modified TIL Cell InjectionGC203Received the implied permission for clinical trials from the National Medical Products Administration (NMPA) for the treatment of advanced solid tumors.Phase I clinical trials are currently underway.This is the world's first non-viral vector gene-modified TIL therapy.

The Company's First Natural TIL Cell New DrugGC101It was approved to conduct clinical trials in April 2022 (the first batch in China). This isThe world's first natural TIL cell drug that requires no lymphodepletion and no IL-2 injection, which is currently in Phase II clinical trials. GC101 has demonstrated excellent clinical efficacy and good safety in treating various types of advanced solid tumors. Previous clinical data show that GC101 exhibited superior clinical efficacy in the treatment of multiple types of advanced solid tumors: four patients have achieved complete tumor clearance, reaching CR efficacy, with the longest tumor-free survival time nearing 3 years.

CBMG Biotech is a global clinical-stage biopharmaceutical company focused on developing T-cell therapy products for cancer, inflammation, and immune diseases.In 2014, Cellular Biomedicine Group (CBMG) was listed on the NASDAQ stock exchange in the United States, becoming the first Chinese cell therapy biopharmaceutical company to be listed on NASDAQ. Therefore, CBMG is highly sensitive to market demands. Based on the substantial market demand, CBMG has also made a strategic layout in the TIL field.

In CBTM's pipeline, there is a TIL therapy called C-TIL051,After ex vivo expansion of patients' tumor-infiltrating lymphocytes using CBMG's proprietary manufacturing process, the cells are reinfused into the patient for the treatment of solid tumors.October 2022 FDAOfficially ApprovedC-TIL0511Clinical development application for the treatment of advanced non-small cell lung cancer (NSCLC) patients who are refractory or relapsed to PD-1 antibody therapy.

Galea Biomed is driven by AI and bioinformatics to develop the next generation of cell therapies, with a particular focus on the development and clinical trials of immunotherapy products for solid tumors, as well as clinical translation. Galea Biomed's technological foundation relies on a dual-driven approach—importing technology from Galea USA while emphasizing localized R&D team efforts. The TABR-BERT learning model proposed by Galea Biomed's bioinformatics team, based on AI deep learning prediction methods, significantly enhances the precise identification of T-cell and antigen interactions, providing a new pathway for predicting unknown antigens and advancing the development of cellular immunotherapy. Galea Biomed represents the "next generation of TIL products," characterized by more efficient treatment of solid tumors and offering personalized precision cell therapy.

Beijing Xunsheng Biomedical Research Co., Ltd. (hereinafter referred to as Xunsheng Medicine) is an innovative biopharmaceutical company focused on cancer immunotherapy research, dedicated to the development of novel personalized cancer immunotherapy products. Collaborating with scientists both in China and internationally, the company targets the most cutting-edge immunotherapy technologies to provide safer and more effective innovative drugs and treatment solutions for patients worldwide. Currently, its product pipeline includes cancer cell immunotherapy products and therapeutic cancer vaccines.

Shengxun Medical is currently the only company in Beijing engaged in TIL cell therapy research and has received CDE approval to conduct clinical trials. The TIL cell therapy product ReT01 ACT injection, developed by the Shengxun Institute of Translational Immunology and transformed for commercial use by Beijing Anweisen Biopharmaceutical Co., Ltd., targets pan-cancer diseases with indications for gynecological and other solid tumors. It is currently in Phase I clinical trials.

Based on the AVL-TIL immunocyte therapy platform, the company's current pipeline includes: AVL-201 (First-generation TIL), indicated for triple-negative breast cancer, non-small cell lung cancer, and cervical cancer; AVL-202 (Second-generation TIL), indicated for glioblastoma, endometrial cancer, etc.; AVL-301 (undisclosed), indicated for solid tumors.On August 24, 2022, according to the announcement on the CDE official website, the clinical trial application for "Tumor-Infiltrating T Lymphocytes" by Shengxun Medicine has been accepted.

Hebei Senlang Biotechnology Co., Ltd., established in 2016, is a high-tech biopharmaceutical enterprise specializing in the research, development, and application of innovative immunocyte therapeutic drugs.The company owns an efficient innovative technology platform for cell therapy, covering autologous CAR-T cell therapy, allogeneic cell therapy, TIL cell therapy, etc.

Senlang Bio seized the advantages of TIL therapy over CAR-T cell therapy, such as multi-targeting, strong tumor tropism and infiltration capabilities, and minimal side effects. Collaborating with Academician Chunyan Li of the Chinese Academy of Engineering, they jointly initiated research on "TIL Treatment for Glioblastoma." This innovative design aims to address the unmet needs in the solid tumor treatment market.

Through independent research and development, Huasai Berman has built the PowerTexp® High-Efficiency TIL Production Process Platform and the TMExpT® Tumor Microenvironment Modulation Expression Platform. The current product pipeline includes the autologous natural enhanced TIL product HS-IT101 and the genetically modified super TIL product HS-IT201. The IND application for HS-IT101 injection for the treatment of advanced solid tumors received implicit permission for clinical trials from the NMPA on November 29, 2023, and Phase I clinical trials were initiated on January 18, 2024.In March 2024, the Phase I clinical trial of HS-IT101 injection, led by Professor Li Ning, Vice President of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, successfully completed the first dosing of the first subject.

Medicinal Biotech is an innovative pharmaceutical company focused on the research and development of immunotherapy drugs for solid tumors and clinical studies for autoimmune diseases.MedTop R&D Center owns a 2,000-square-meter standard GMP laboratory. The team members have mastered several high-tech barrier core technologies of immune cell therapy and possess more than ten years of extensive experience in clinical trials/clinical applications of immune cell treatments for various cancers.

The core technology focuses on the development of novel Tumor-Infiltrating Lymphocyte (TIL) culture and treatment strategies.TIL therapy alone has completed clinical treatment for more than 100 cancer patients. MedTop Biotech's entire cultivation system has fully realized domestic substitution in China, with the culture medium independently developed and formulated from scratch, which can significantly reduce treatment costs.

Shenzhen Leman Biotech Co., Ltd. is a clinical-stage immunometabolism innovation drug research and development company jointly founded by Professor Li Tang's team from the Swiss Federal Institute of Technology Lausanne (EPFL) and XtalPi. Based on the innovative technology of immunometabolic reprogramming + cutting-edge artificial intelligence, the company focuses on the research, production, and commercialization of novel cancer immunotherapy drugs.

Lemang Bio has two TIL therapies in its pipeline, developed using its metabolic enhancement cell therapy platform. The indications are for various solid tumors, and both are currently in the preclinical stage.

Wuhan Changsheng Technology has developed a TIL cell therapy, which is currently undergoing an IIT clinical trial (NCT06084299) for the treatment of patients with advanced liver cancer. The trial began recruiting participants on October 16, 2023, and is expected to be completed by August 30, 2026.

Founded in 2021, BeneGen focuses on the field of cell therapy, primarily targeting globally innovative cell therapies for cancer and autoimmune diseases. Its self-developed autologous tumor-infiltrating lymphocyte (TIL) injection, BEN101, is indicated for advanced recurrent or metastatic solid tumors (ovarian cancer, cervical cancer, renal cell carcinoma, and urothelial carcinoma), and is currently in the IIT research stage. Additionally, several other TIL therapies for solid tumors are in the preclinical stage.

The company has completed two rounds of financing, namely the Angel Round and the Angel+ Round, raising several hundred million RMB. The investors include well-known institutions such as Gaoling Venture Capital, ChenDe Capital, INCE Capital, Life Science Park Venture Capital, ZhiCheng Capital, and Westlake Education Fund.In March 2023, BioNRG and Porton Biologics reached a strategic cooperation to establish a long-term strategic partnership in the R&D pipeline of cell and gene therapies, rapidly advancing the R&D and commercialization of innovative drugs such as TIL.

BST02 Injection is a T-cell therapy product based on the expansion of the patient's own tumor-infiltrating lymphocytes.On January 23, 2024, according to the official website of the CDE, Baiji ShengBST02 Injection, the World's First Exclusive Innovative Product Pipeline, Approved for Clinical Trial of New Drug to Treat All Types of Liver Cancer.On October 26 last year, the U.S. FDA approved the Phase I/II clinical trial application for BST02.BST02 Injection is the world's firstTIL Cell Therapy Drug for Liver Cancer Entering Clinical Stage.

On January 15, 2024, Biotheus's third globally pioneering product pipeline, BRL03 Injection, received approval for new drug clinical trials in China. It will be used to treat various advanced solid tumors, including lung cancer and gastric cancer.September 9th last year,The US FDA Approved the Phase I/II Clinical Trial Application for BRL03. As a self-developed product by BioGend,The First TCR-T to Enter Clinical TrialsProduct, IIT studies show that BRL03 injection has good safety and preliminary efficacy in the treatment of solid tumors.

Wuhan Yishou Technology Company was founded in 2017. The team is composed of world-class scientists from the National University of Singapore and Huazhong University of Science and Technology, led by Professor Xia Tian's team from the Artificial Intelligence Institute of Huazhong University of Science and Technology.

OriCell Biotech focuses on the development of new products in the field of tumor immunotherapy. The products developed using the company's independently innovated OriTIL—high-efficiency cell expansion and culture technology platform—feature significant increases in both the quantity and quality attributes of TIL cell expansion. These products effectively overcome the technical bottlenecks of TIL therapy, ensuring its safety and efficacy in clinical applications.

Origin Biosciences has laid out three TIL product pipelines: OriTIL-001 (indication for osteosarcoma), OriTIL-002 (indication for cervical cancer), and OriTIL-003 (indication for non-small cell lung cancer). Among them, OriTIL-001 and OriTIL-002 have passed hospital ethics reviews and initiated exploratory clinical studies.Thanks to the platform advantages of OriTIL, the TILs product pipeline of Yuanqi has achieved gratifying progress in the clinical stage and entered the clinical application phase.

Summary

In recent years, China has also achieved remarkable results in the field of TIL therapy,Multiple novel TIL therapies have been approved for human clinical trials, covering a variety of solid tumors including melanoma, lung cancer, cervical cancer, biliary tract tumors, and head and neck cancers.Overall, the TIL therapy companies with faster progress in China are Grail Bio and JunCell Bio, which have entered Phase II clinical trials., is expected to reach a new milestone this year.。In addition, genetically modified TIL therapies are also making further progress. Companies such as Grail Bio and Cat's Eye Medical have next-generation TIL therapies under research. It is expected that China's TIL cell therapy will continue to advance rapidly in the new year and shine brightly in the field of solid tumor treatment.

References: Official websites and official WeChat accounts of various companies